Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)
K253468 · Nova Eye, Inc. · MPA · Aug 10, 2026 · Gastroenterology, Urology
Device Facts
Record ID
K253468
Device Name
Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)
Applicant
Nova Eye, Inc.
Product Code
MPA · Gastroenterology, Urology
Decision Date
Aug 10, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic, Real-World Evidence
Real-World Evidence
Submission
Device
Sponsor
RWD Sources
RWE Use Summary
Key Tags
K253468 · Aug 10, 2026
Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)
Nova Eye, Inc.
iTrack Global Data Registry (iTGDR); Published clinical literature (retrospective studies)
The sponsor used real-world data from a prospective registry and retrospective literature to support the safety and effectiveness of the iTrack 250A device when used via an 'ab interno' surgical approach, which was a labeling update from the predicate.
Glaucoma; Canaloplasty; Ab interno; Registry; Systematic literature review
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
iTrack Global Data Registry (iTGDR); Prospective, multi-center, observational study; Follow-up/Duration: Minimum 12 months; Study Period: Data reported in 2026
Patients with glaucoma or ocular hypertension requiring canaloplasty; Sample Size: Not explicitly stated for the registry total, but 256 eyes reported in safety analysis; Number of Sites: 12
Systematic Literature Review (Retrospective Studies); Retrospective studies; Follow-up/Duration: 12 months to 6 years; Study Period: Various (publications 2018-2024)
Adult patients with open-angle glaucoma; Sample Size: 241 eyes (effectiveness), 668 eyes (safety); Number of Sites: Not applicable
The Nova Eye iTrack™ 250A is indicated for fluid infusion and aspiration during surgery. The Nova Eye iTrack™ 250A is indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma.
Device Story
Flexible microcatheter; 200-micron shaft; 250-micron tip; fiber optic illumination for tip guidance. Used in ophthalmic surgery (ab externo or ab interno approach) by surgeons. Connects to accessory ViscoInjector and iLumin fiberoptic illuminator. Surgeon inserts microcatheter into Schlemm's canal; performs 360-degree catheterization; manually delivers viscoelastic fluid via ViscoInjector rotation during withdrawal. Tactile clicks on injector confirm fluid delivery. Reduces intraocular pressure in open-angle glaucoma patients. Single-use; sterile.
Clinical Evidence
Clinical evidence includes a prospective multi-center registry (iTGDR) and 3 retrospective studies (total 241 eyes). Mean IOP reduction at 12 months ranged from -6.4 to -9.4 mmHg (combo) and -4.9 to -7.9 mmHg (standalone). Mean medication reduction ranged from -0.7 to -2.3 (combo) and -1.1 to -1.6 (standalone). Safety data from 668 eyes showed common adverse events: IOP elevation, hyphema, choroidal effusion, and CDVA loss. Results support safety and effectiveness for ab interno approach.
Indicated for fluid infusion and aspiration during surgery, and catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open-angle glaucoma.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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FDA U.S. FOOD & DRUG ADMINISTRATION
August 10, 2026
Nova Eye, Inc.
Don Watton
Head of Global Operations
41316 Christy St.
Fremont, California 94538
Re: K253468
Trade/Device Name: Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: Class II
Product Code: MPA, HMX
Dated: July 7, 2026
Received: July 8, 2026
Dear Don Watton:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253468 - Don Watton
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
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K253468 - Don Watton
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CLAUDINE H. KRAWCZYK -S
Claudine Krawczyk
Assistant Director
DHT1A: Division of Ophthalmic Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253468 | ? |
| Please provide the device trade name(s). | | ? |
| Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A) | | |
| Please provide your Indications for Use below. | | ? |
| The Nova Eye iTrack™ 250A is indicated for fluid infusion and aspiration during surgery. The Nova Eye iTrack™ 250A is indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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# 510(k) SUMMARY
K253468
# I. Submitter Information
510(k) Owner: Nova Eye, Inc.
41316 Christy St.
Fremont, CA 94538
Contact Person: Don Watton
dwatton@nova-eye.com
+61-417-865-044
Date Prepared: August 9, 2026
# II. Device Name and Classification
Device Trade Name: Nova Eye iTrack™ 250A Canaloplasty Microcatheter
Common Name: Canaloplasty Microcatheter
Regulation Numbers (Product Code): 21 CFR 876.1500 (MPA), 21 CFR 886.4350 (HMX)
Device Classification: Class 2
# III. Predicate Device
# Predicate Device
- iTrack™ 250A Canaloplasty Microcatheter (Nova Eye, Inc.) (K080067)
# IV. Device Description
The Nova Eye iTrack™ 250A Canaloplasty Microcatheter (“iTrack™ 250A”) is a flexible microcatheter designed to allow atraumatic catheterization of spaces in the eye for infusion and aspiration of fluids during surgery. The device allows catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open angle glaucoma.
The microcatheter has a lumen with a proximal Luer connector through which fluids can be introduced and delivered to the microcatheter tip under the control of the surgeon. The microcatheter also has a fiber optic for surgical illumination and guidance. The illumination is readily visualized when the microcatheter is within Schlemm’s canal, allowing the surgeon to control the placement of the microcatheter tip.
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The device is provided sterile and is intended for single use. Refer to Figure 1 provides a photo of the iTrack™ 250A.
Figure 1: iTrack 250A Canaloplasty Microcatheter
# V. Indications for Use
The Nova Eye iTrack™ 250A is indicated for fluid infusion and aspiration during surgery. The Nova Eye iTrack™ 250A is indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma.
# VI. Comparison of Technological Characteristics with the Predicate Devices
The subject iTrack™ 250A device and the predicate device share the same technological characteristics. The one difference in labeling between the subject and predicate devices does not raise different types of questions of safety and effectiveness.
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| Characteristic | Nova Eye iTrack™ 250A Canaloplasty Microcatheter SUBJECT DEVICE | Nova Eye iTrack™ 250A Canaloplasty Microcatheter (K080067) PREDICATE DEVICE | COMPARISON OF SUBJECT TO PREDICATE DEVICE |
| --- | --- | --- | --- |
| **Intended Use** | Delivery of controlled amounts of viscoelastic fluid during ophthalmic surgery, fluid infusion and aspiration, and catheterization and viscodilation (canaloplasty) | Delivery of controlled amounts of viscoelastic fluid during ophthalmic surgery, fluid infusion and aspiration, and catheterization and viscodilation (canaloplasty) | Same |
| **Indications For Use** | The Nova Eye iTrack™ 250A is indicated for fluid infusion and aspiration during surgery. The Nova Eye iTrack™ 250A is indicated for catheterization and viscodilation of Schlemm’s canal (canaloplasty) to reduce intraocular pressure in adult patients with open-angle glaucoma. | The Nova Eye iTrack™ 250A is indicated for fluid infusion and aspiration during surgery. The Nova Eye iTrack™ 250A is indicated for catheterization and viscodilation of Schlemm’s canal (canaloplasty) to reduce intraocular pressure in adult patients with open-angle glaucoma. | Same |
| **Regulation** | 876.1500 (Endoscope and accessories) 886.4350 (Manual ophthalmic surgical instrument) | 876.1500 (Endoscope and accessories) 886.4350 (Manual ophthalmic surgical instrument) | Same |
| **Device Class** | Class II | Class II | Same |
| **Product Code** | MPA (Endoscope) HMX (Manual Ophthalmic Surgical Instrument) | MPA (Endoscope) HMX (Manual Ophthalmic Surgical Instrument) | Same |
| **Prescription Status** | Prescription use only | Prescription use only | Same |
| **Target Anatomy** | Schlemm’s Canal | Schlemm’s Canal | Same |
| **Recommended Accessories** | - Ophthalmic ViscoInjector™ (K050716) - iLumin™ Fiberoptic Illuminator (K062259) | - Ophthalmic ViscoInjector™ (K050716) - iLumin™ Fiberoptic Illuminator (K062259) | Same |
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| Characteristic | Nova Eye iTrack™ 250A Canaloplasty Microcatheter SUBJECT DEVICE | Nova Eye iTrack™ 250A Canaloplasty Microcatheter (K080067) PREDICATE DEVICE | COMPARISON OF SUBJECT TO PREDICATE DEVICE |
| --- | --- | --- | --- |
| Viscoelastic Accessories | Viscoelastic is supplied separately by third-party manufacturers. Viscoelastic is delivered to/attaches to device via luer fitting. | Viscoelastic is supplied separately by third-party manufacturers. Viscoelastic is delivered to/attaches to device via luer fitting. | Same |
| Dispensing Control | Manual rotation of accessory ViscoInjector knob to dispense controlled amounts viscoelastic fluid | Manual rotation of accessory ViscoInjector knob to dispense controlled amounts viscoelastic fluid | Same |
| User Determines Amount of Fluid to Dispense | Yes, by rotating the proximal knob on the accessory ViscoInjector | Yes, by rotating the proximal knob on the accessory ViscoInjector | Same |
| Passive or Energized Device to Dispense Viscoelastic | Passive | Passive | Same |
| Volume Dispensed | 2.25 µL per click of the accessory ViscoInjector | 2.25 µL per click of the accessory ViscoInjector | Same |
| Dispensing Mechanism | Syringe volume exchange | Syringe volume exchange | Same |
| Operating Principle | Manual | Manual | Same |
| Surgical Approach | Labeling specifies *ab externo* and *ab interno* as being acceptable surgical approaches for accessing Schlemm's canal | Labeling specifies *ab externo* as being acceptable surgical approach for accessing Schlemm's canal | Different, but the difference does not raise different types of questions of safety and effectiveness. A systematic literature review was performed to characterize the safety and effectiveness of the subject device using an *ab interno* approach. Selected references from this systematic literature review were used to demonstrate the safety and effectiveness of the *ab interno* |
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| Characteristic | Nova Eye iTrack™ 250A Canaloplasty Microcatheter SUBJECT DEVICE | Nova Eye iTrack™ 250A Canaloplasty Microcatheter (K080067) PREDICATE DEVICE | COMPARISON OF SUBJECT TO PREDICATE DEVICE |
| --- | --- | --- | --- |
| | | | approach to the iTrack™ 250A procedure to reduce IOP in adult patients. |
| **Mechanism of Action** | - The Microcatheter is connected to the accessory ViscoInjector™ and primed with viscoelastic fluid from a cartridge retained with the ViscoInjector. - The Microcatheter is connected to a powered iLumin™ Fiberoptic Illuminator which illuminates the Microcatheter tip. - The surgeon directs the microcatheter using micro forceps through the surgical incision into the ostium of the Schlemm's canal. - The Microcatheter can access 360° of Schlemm's canal in one pass. - As surgeon withdraws the microcatheter from the Schlemm's canal, viscoelastic fluid is delivered into the canal by the surgeon by manual clockwise rotation of the knob on ViscoInjector. - Clicks on the accessory ViscoInjector tactilely indicate precise delivery of viscoelastic fluid. | - The Microcatheter is connected to the accessory ViscoInjector™ and primed with viscoelastic fluid from a cartridge retained with the ViscoInjector. - The Microcatheter is connected to a powered iLumin™ Fiberoptic Illuminator which illuminates the Microcatheter tip. - The surgeon directs the microcatheter using micro forceps through the surgical incision into the ostium of the Schlemm's canal. - The Microcatheter can access 360° of Schlemm's canal in one pass. - As surgeon withdraws the microcatheter from the Schlemm's canal, viscoelastic fluid is delivered into the canal by the surgeon by manual clockwise rotation of the knob on ViscoInjector. - Clicks on the accessory ViscoInjector tactilely indicate precise delivery of viscoelastic fluid. | Same |
| **Materials** | Medical grade materials including: Polyimide, Polycarbonate, PEBAX, Stainless Steel, Polystyrene, PMMA, PVDF, Cyanoacrylate, Thermoplastic Elastomer | Medical grade materials including: Polyimide, Polycarbonate, PEBAX, Stainless Steel, Polystyrene, PMMA, PVDF, Cyanoacrylate, Grilamid | Similar |
| **User Interface** | Handheld | Handheld | Same |
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| Characteristic | Nova Eye iTrack™ 250A Canaloplasty Microcatheter SUBJECT DEVICE | Nova Eye iTrack™ 250A Canaloplasty Microcatheter (K080067) PREDICATE DEVICE | COMPARISON OF SUBJECT TO PREDICATE DEVICE |
| --- | --- | --- | --- |
| Microcatheter Shaft Outer Diameter | 200 microns | 200 microns | Same |
| Microcatheter Tip Outer Diameter (nominal) | 250 microns | 250 microns | Same |
| Length of Distal Shaft of Microcatheter | 45mm | 45mm | Same |
| Sterile and Single Use | Provided sterile. Single patient use | Provided sterile. Single patient use | Same |
| Sterilization Method | Gamma radiation | Gamma radiation | Same |
| Sterility Assurance Level | 10^{-6} | 10^{-6} | Same |
| Packaging | Closed tray inside a sealed Tyvek pouch | Closed tray inside a sealed Tyvek pouch | Same |
| Shelf Life | 2 years | 2 years | Same |
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The Directions for Use for the iTrack 250A were updated to reflect that the procedure can be performed via an ab interno approach. This change does not raise new types of questions regarding the safety and effectiveness of the device.
In addition, minor changes were made to device since the previous 510(k) clearance which did not require a 510(k) notification. These minor changes included a change to an integrated control hub, minor changes to a luer material and microcatheter material, and updating a connector design.
# VII. Summary of Non-Clinical Testing
No bench testing was performed to support this labeling change. Testing that was carried out to support minor changes was reviewed to support the substantial equivalence determination.
The following testing was performed to support the minor changes made to device since the previous 510(k) clearance which did not require a 510(k) notification:
- Bench Testing: Bench testing of the iTrack 250A included dimensional verification of several critical dimensions. Additionally, mechanical testing was performed in accordance with ISO 10555-1:2023 including tensile strength, burst pressure, line leakage and fluid infusion testing. Results demonstrated that the device met all applicable specifications and acceptance criteria.
- Packaging Validation/Shelf Life: Packaging validation and shelf-life studies were performed to validate the packaging and claimed shelf life. Packaging validation was conducted in accordance with ISO 11607-1:2019, ISO 11607-2:2019. Transit conditioning and distribution testing were conducted in accordance with ASTM D4332-22 and ASTM D4169-23. Aging studies were conducted in accordance with ASTM F1980-21. Package integrity, seal integrity, visual inspection, and label adhesion/legibility testing were performed, including seal strength testing in accordance with ASTM F88/F88M-23.
- Sterilization Validation: Sterilization validation was performed in accordance with ISO 11737-1:2018, ISO 11737-2:2019, ISO 11137-1:2006/Amd 2:2018 and ISO 11137-2:2013/Amd 1:2022. The iTrack 250A maintains a sterility assurance level of SAL 10⁻⁶.
- Bacterial Endotoxin Testing: Routine Endotoxin testing is performed on kits from this product family in accordance with FDA's 2015 Endotoxin Guidance, "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices" and relevant portions of USP-NF Chapter <85> and USP-NF Chapter <161>. The kits conform to the established specification of ≤0.2 EU/device.
- Biocompatibility Testing: The biocompatibility profile of the direct and indirect tissue contacting components of the device were assessed for cytotoxicity, sensitization, Irritation, acute systemic toxicity, and material-mediated pyrogenicity as recommended in FDA's 2020 Biocompatibility Guidance, "Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories,
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and Food and Drug Administration Staff” and relevant parts of ISO 10993-1 Biological Evaluation of Medical Devices standard series.
- **Light Hazard Testing:** A light hazard assessment was performed in accordance with ANSI Z80.36:2021 and ISO 15752:2010. The iTrack™ 250A is classified as a Group 1 device for light hazard.
### VIII. Clinical Evidence
iTrack 250A results from the iTrack Global Data Registry (iTGDR)$^{1}$ were used to characterize the safety and effectiveness of *ab interno* iTrack 250A. The iTGDR is a prospective, multi-center, observational study of the iTrack 250A and iTrack Advance devices which recruited patients at 12 sites in the US, Australia, Germany and the United Kingdom. The study enrolled patients with glaucoma or ocular hypertension requiring canaloplasty to reduce IOP and/or medications, treated with iTrack 250A or iTrack Advance with or without concomitant cataract surgery, and a minimum of 12 months follow-up. Exclusion criteria included diagnosis of angle-closure glaucoma, iTrack surgery combined with other glaucoma surgery, and abnormalities of the angle (angle recession, neovascularization, peripheral anterior synechiae). Follow-up visits were performed at 1 day, 1 week, 1-, 3-, and 6- months and half-yearly follow-ups thereafter (12-, 18-, 24-, 30- months and so on).
In addition, three other publications from a systematic literature review were selected to characterize the effectiveness of *ab interno* iTrack™ 250A.
The combined safety data from the iTGDR and other selected studies were used to characterize the safety of *ab interno* iTrack™ 250A.
#### Effectiveness
Effectiveness data from a total of 241 eyes treated with *ab interno* iTrack™ 250A were obtained from one prospective study$^{1}$ and 3 retrospective studies.$^{2,3,4}$ Across the studies, an average of 85%-95% of eyes were diagnosed with POAG, the mean age of patients treated ranged from 70-75 years old, and approximately 50-60% were female, on average. One hundred sixty-six (166)
$^{1}$ Kerr N, Lubeck D, Barton K, Aref AA, Cheng J, Spaulding J, Shoham-Hazon N, Thomsen S, Patel S, Harasymowycz P, Singh H, Mercieca K, Ahmed IK. A Prospective, Real-World, Multicenter Study to Support the Role of Ab-Interno Canaloplasty in Glaucoma Management. Am J Ophthalmol. 2026 Apr;284:235-246.
$^{2}$ Gallardo MJ, Supnet RA, Ahmed II. Viscodilation of Schlemm’s canal for the reduction of IOP via an ab-interno approach. Clin Ophthalmol. 2018 Oct 23:2149-55
$^{3}$ Gillmann K, Aref A, Niegowski LJ, Baumgartner JM. Combined *ab interno* viscocanaloplasty (ABiC) in open-angle glaucoma: 12-month outcomes. Int Ophthalmol. 2021 Oct;41(10):3295-301.
$^{4}$ Khaimi MA, Koerber N, Ondrejka S, Gallardo MJ. Consistency in standalone canaloplasty outcomes using the iTrack microcatheter. Clin Ophthalmol. 2024 Dec 31;18:173-83.
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eyes were treated with ab interno iTrack™ 250A in combination with cataract surgery, and 75 were treated with ab interno iTrack™ 250A alone.
Table 1 below summarizes the IOP over time across the studies, stratified by the type of procedure performed (combo vs. standalone). This summary shows that the average baseline IOP for the ab interno iTrack™ 250A studies ranged from 19.4 – 23.6 mmHg. The average IOP at 12 months ranged from 13.0 – 19.8 mmHg. For combo surgery, the mean reduction in IOP at 12 months was reported to range from -6.4 to -9.4 mmHg. For standalone surgery, the mean reduction in IOP at 12 months ranged from -4.9 to -7.9 mmHg.
Table 1: Summary of Change in IOP, Stratified by Type of Procedure Performed
| Combo | | | |
| --- | --- | --- | --- |
| Source | Kerr^{1,5} | Gallardo^{2} | Gillman^{3} |
| N eyes | 78 | 34 | 54 |
| Baseline IOP (mmHg) (Mean ± SD) | 22.7 ± 5.0 | 19.41^{6} | 23.6 ± 7.4 |
| 12 Month IOP (mmHg) (Mean ± SD) | 15.2 ± 3.6 | 12.97^{6} | 14.2 ± 2.9 |
| **Mean Absolute IOP Reduction from BL (mmHg)^{7}** | **-7.5** | **-6.4** | **-9.4** |
| % of Eyes with ≥ 20% IOP Reduction at 1 Year Compared to BL | 78.9% (56/71) | 88.2% (30/34) | NR |
| % of Eyes with ≥ 20% IOP Reduction at 1 Year Compared to BL and Medication Free | NR | NR | 46% (25/54) |
| Stand-Alone | | | |
| Source | Kerr^{1} | Khaimi^{4} | |
| N eyes | 11 | 64 | |
| Baseline IOP (mmHg) (Mean ± SD) | 24.6 ± 4.7 | 22.9 ± 7.03 | |
| 12 Month IOP (mmHg) (Mean ± SD) | 19.8 ± 7.6 | 15.0 ± 2.90 | |
| **Mean Absolute IOP Reduction from BL (mmHg)^{7}** | **-4.9** | **-7.9** | |
| % of Eyes with ≥ 20% IOP Reduction at 1 Year Compared to BL | 37.5% (3/8) | 77.6% (45/64) | |
NR: Not reported
Table 2 summarizes the number of glaucoma medications used over time. For combo surgery, the mean reduction in glaucoma medications at 12 months ranged from -0.7 to -2.3
5 Data for the subgroup of iTrack 250A eyes with higher baseline IOP (IOP > 18 mmHg) are presented.
6 Standard deviation not reported for the combo sub-group.
7 If mean reduction was not reported in the publication, it was approximated by final IOP – baseline IOP.
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medications. For standalone surgery, the mean reduction in glaucoma medications at 12 months ranged from -1.1 to -1.6 meds.
Table 2: Summary of Change in Glaucoma Medication Use, Stratified by Type of Procedure Performed
| Combo | | | |
| --- | --- | --- | --- |
| Source | Kerr | Gallardo | Gillman |
| N eyes | 78 | 34 | 54 |
| # Meds at Baseline (BL) (Mean ± SD) | 1.9 ± 1.2 | 2.59 | 2.9 ± 1.0 |
| # Meds at 12 Mo (Mean ± SD) | 1.1 ± 1.3 | 0.85 | 0.6 ± 1.1 |
| Mean Medication Reduction from BL | -0.7 | -1.74 | -2.3 |
| Stand-Alone | | | |
| Source | Kerr | Khaimi | |
| N eyes | 11 | 64 | |
| # Meds at Baseline (BL) (Mean ± SD) | 2.4 ± 0.9 | 2.78 ± 0.83 | |
| # Meds at 12 Mo (Mean ± SD) | 1.3 ± 1.5 | 1.14 ± 1.12 | |
| Mean Medication Reduction from BL | -1.1 | -1.64 | |
### Safety
Table 3 presents the safety data for ab interno iTrack™ 250A. To provide the most comprehensive analysis of safety data for the ab interno iTrack™ 250A, safety data are presented separately for all relevant studies (n=12). Adverse event data from a total of 668 eyes treated with ab interno iTrack™ 250A are presented. \( ^{8} \) The publications from which the safety data were compiled had a follow-up range from 12 months to 6 years.
The most common adverse events reported were IOP elevation (n=68 eyes), CDVA loss of \( \geq \) 2 lines (n=19 eyes), choroidal effusion (n=27 eyes), and hyphema (n=29 eyes). All others adverse events were reported in < 2.0% of eyes. A total of 34 secondary surgical interventions were reported.
The rate of CDVA loss of \( \geq \) 2 lines was reported in one study \( ^{1} \) which had longer mean follow-up duration of 22 months. Visual acuity loss in this study was most commonly attributed to pre-
\( ^{8} \) One study evaluated rates of postoperative endophthalmitis for ab interno canaloplasty with iTrack 250A and reported 1 case out of 3256 eyes (0.03%). No eye which underwent standalone ab interno canaloplasty (n = 1332) experienced postoperative endophthalmitis, while 1 eye which had ab interno canaloplasty combined with cataract surgery (n = 1924) did. Given the large number of eyes and the exclusive focus on endophthalmitis, data from this report was only included in the rate of endophthalmitis.
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existing advanced disease or unrelated ocular comorbidities. BCVA loss of ≥ 2 lines in the other studies was reported in a combined total of 5 eyes.
The varying rate of occurrence of IOP elevation may be due in part to varying definitions of IOP elevation across studies – some defined it as ≥ 10 mmHg above baseline and others defined it as IOP ≥ 30 mmHg.
All the reported choroidal effusions (n=27 eyes) were from one study reported by Yin, et al.⁹ Yin, et al performed anterior segment swept-source OCT (AS-OCT) at each follow-up visit to identify and monitor supraciliary effusion. Using this imaging method, they reported that supraciliary effusion occurred at a rate of 71% (27/38) for the ab interno iTrack™ 250A group and 92% for their comparator gonioscopy-assisted transluminal trabeculotomy (GATT) group. Given the high rate of choroidal effusion reported in this study for both treatment groups, and that fact that no other studies reported this event, it seems likely that the OCT imaging performed in this study detected sub-clinical findings and the rate of clinically relevant choroidal effusion for ab interno iTrack™ 250A is much lower.
The definition for reporting hyphema was not uniform across all studies. In addition, the Yin, et al study reported that hyphema, almost all of which absorbed within 1 week, occurred at a high rate of 47% (18/38) for ab interno iTrack 250A group and 87% for its comparator GATT group.
⁹ Yin P, Li J, Shi Y, Cao K, Han Y, Wang H et al. Ab interno canaloplasty versus gonioscopy-assisted transluminal trabeculotomy in open-angle glaucoma: a randomised controlled trial. Br J Ophthalmol. 2024 May 1;108(5):687-94.
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Table 3: Safety Data for *ab interno* iTrack 250A
| | Kerr 2026^{1} | Gallardo 2018^{10} | Gallardo 2018^{2} Gallardo 2022^{11} | Gillmann 2021^{3} | Kazerounian 2020^{12} | Khaimi 2021^{13} | Khaimi 2024^{4} | Khan 2022^{14} | Kicińska 2022^{15} Kicińska 2023^{16} | Koerber 2024^{17} Koerber 2022^{18} | Koerber 2018^{19} | Patel 2023^{20} | Yin 2023^{9} |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| N eyes *ab interno* iTrack 250A | 256 | 12 | 81 | 54 | 25 | 45 | 22^{21} | 3256 | 16 | 27 | 20 | 72 | 38 |
| Anterior chamber inflammation | 1 (0.4%) | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Aqueous misdirection^{22} | 1 (0.4%) | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| BCVA loss of ≥ 2 lines Snellen | NR | NR | 4/75 (5.3%)^{23} | 0 (0%) | NR | NR | 0 (0%) | NR | 0 (0%) | NR | NR | NR | 1 (2.6%)^{24} |
$^{10}$ Gallardo MJ, Supnet RA, Ahmed II. Circumferential viscodilation of Schlemm's canal for open-angle glaucoma: ab-interno vs ab-externo canaloplasty with tensioning suture. Clin Ophthalmol. 2018 Dec 5;2493-98.
$^{11}$ Gallardo MJ. 36-month effectiveness of ab-interno canaloplasty standalone versus combined with cataract surgery for the treatment of open-angle glaucoma. Ophthalmol Glaucoma. 2022 Sep 1;5(5):476-82.
$^{12}$ Kazerounian S, Zimbelmann M, Lörtscher M, Hommayda S, Tsirkinidou I, Müller M. Canaloplasty ab interno (AbiC) - 2-year-results of a novel minimally invasive glaucoma surgery (MIGS) technique. Klin Monbl Augenheilkd. 2021 Oct;238(10):1113-1119.
$^{13}$ Khaimi MA. Long-term medication reduction in controlled glaucoma with iTrack ab-interno canaloplasty as a standalone procedure and combined with cataract surgery. Ther Adv Ophthalmol. 2021 Sep;13:2515841421045751.
$^{14}$ Khan A, Riaz KM, Rangu N, Shah VA, Hussain ZS, Khaimi MA. Incidence and clinical characteristics of postoperative endophthalmitis after ab-interno canaloplasty. Clin Ophthalmol. 2022 Nov 22;16:3875.
$^{15}$ Kicińska AK, Danielewska ME, Rękas M. Safety and Efficacy of Three Variants of Canaloplasty with Phacoemulsification to Treat Open-Angle Glaucoma and Cataract: 12-Month Follow-Up. J Clin Med. 2022 Nov 2;11(21):6501.
$^{16}$ Kicińska AK, Rękas M. Safety and efficacy of three modifications of canaloplasty to treat open-angle glaucoma: 3-year outcomes. J Clin Med. 2023 Oct 11;12(20):6475.
$^{17}$ Koerber N, Ondrejka S. 6-year efficacy and safety of iTrack ab-interno canaloplasty as a stand-alone procedure and combined with cataract surgery in primary open angle and pseudoexfoliative glaucoma. J Glaucoma. 2024 Mar 1;33(3):176-82.
$^{18}$ Koerber N, Ondrejka S. Four-Year Efficacy and Safety of iTrack Ab-interno Canaloplasty as a Standalone Procedure and Combined with Cataract Surgery in Open-Angle Glaucoma. Klin Monbl Augenheilkd. 2023 Dec;240(12):1394-1404.
$^{19}$ Körber N. Ab interno canaloplasty for the treatment of glaucoma: a case series study. Spektrum Augenheilkd. 2018 Dec;32(6):223-7.
$^{20}$ Patel S, Reiss G. Long-term clinical and safety outcomes of canaloplasty performed across all grades of glaucoma severity. J Ophthalmol. 2023;2023(1):5625990.
$^{21}$ While 64 eyes were treated in this study, only the 22 eyes unique to this study (i.e., no overlap with Gallardo 2022 or Koerber 2022 cohorts) are reported.
$^{22}$ This event occurred in an eye undergoing combined cataract extraction and canaloplasty and is not specific to the canaloplasty procedure.
$^{23}$ When 2 eyes were treated, BCVA loss was only reported for the 75 first-enrolled eyes reported in Gallardo 2022 so as to only include 1 eye per subject; all 4 cases of BCVA loss were attributed to ocular surface disease.
$^{24}$ BCVA loss noted to be due to crystalline lens opacity.
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| | Kerr 2026^{1} | Gallardo 2018^{10} | Gallardo 2018^{2} Gallardo 2022^{11} | Gillmann 2021^{3} | Kazerounian 2020^{12} | Khaimi 2021^{13} | Khaimi 2024^{4} | Khan 2022^{14} | Kicińska 2022^{15} Kicińska 2023^{16} | Koerber 2024^{17} Koerber 2022^{18} | Koerber 2018^{19} | Patel 2023^{20} | Yin 2023^{9} |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| CDVA loss of ≥ 2 lines Snellen^{25} | 19 (7.4%) | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Cataract Surgery within 12 M postop | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | 0 (0%) |
| Choroidal Detachment | NR | NR | NR | NR | NR | NR | NR | NR | 0 (0%) | 0 (0%) | NR | NR | 0 (0%) |
| Choroidal (Supraciliary) Effusion | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | 27 (71.1%)^{26} |
| Corneal Decompensation | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | 0 (0%) |
| Corneal Erosion | NR | NR | NR | NR | NR | NR | NR | NR | 1 (6.3%) | NR | NR | NR | NR |
| Cystoid Macular Edema | 1 (0.4%) | NR | NR | NR | NR | NR | NR | NR | 0 (0%) | NR | NR | NR | NR |
| Descemet Membrane Detachment | 1 (0.4%) | NR | NR | 2 (3.7%) | 1 (4.0%)^{27} | NR | NR | NR | NR | 1 (3.7%) | 1 (5.0%) | 1 (1.4%) | NR |
| Descemet Folds, Transient | NR | NR | NR | NR | NR | NR | NR | NR | 6 (37.5%) | NR | NR | NR | NR |
| Endophthalmitis | NR | NR | NR | NR | NR | NR | NR | 1 (0.03%) | NR | NR | NR | NR | NR |
| Endothelial Blood Stain | NR | NR | NR | 1 (1.9%) | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Fibrin Plug | NR | NR | NR | 1 (1.9%) | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Hyphema | 4 (1.6%) | NR | 3 (3.7%) | NR | 3 (12.0%) | 0 | 0 | NR | 1 (6.3%) | NR | 0 (0%) | NR | 18 (47.4%)^{26} |
| Hypotony | NR | NR | NR | 0 (0%) | NR | NR | NR | NR | 0 (0%) | NR | NR | NR | 0 (0%) |
| IOL Subluxation | NR | NR | NR | 1 (1.9%) | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Iris Atrophy | NR | NR | NR | 1 (1.9%) | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Iris Trauma | NR | NR | NR | 1 (1.9%) | NR | NR | NR | NR | NR | NR | NR | NR | NR |
$^{25}$ Mean follow-up duration for this study was 22.2±7.9 months.
$^{26}$ Refer to discussion in Safety section.
$^{27}$ Noted as a localized crescent-shaped elevation close to the limbus, which resolved spontaneously over 4 weeks.
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| | Kerr 20261 | Gallardo 201810 | Gallardo 20182 Gallardo 202211 | Gillmann 20213 | Kazerounian 202012 | Khaimi 202113 | Khaimi 20244 | Khan 202214 | Kicińska 202215 Kicińska 202316 | Koerber 202417 Koerber 202218 | Koerber 201819 | Patel 202320 | Yin 20239 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| IOP Elevation ≤30 days post-op | | | | | | | | | | | | | |
| Elevation ≥ 10 mmHg above baseline IOP | 35/234 (15.0%) | 0 (0%) | 3 (3.7%) | 12 (22.2%) | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| IOP >30 mmHg | 27/234 (11.5%) | NR | NR | NR | NR | NR | NR | NR | 2 (12.5%)28 | NR | NR | NR | 16 (42.1%)28 |
| Posterior Capsular Rupture | NR | NR | NR | 1 (1.9%) | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Pupillary Block | NR | NR | NR | 1 (1.9%) | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Retinal Detachment | 1 (0.4%) | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Secondary Surgical Interventions (SSI) | | | | | | | | | | | | | |
| Overall SSI | 12 (4.7%) | NR | 4 (4.9%) | 7 (13.0%) | 3 (12.0%) | NR | 4 (18.2%) | NR | 0 (0%) | 1 (3.7%) | NR | NR | 3 (7.9%) |
| Ab Externo Canaloplasty | 1 (0.4%) | NR | NR | NR | 3 (12.0%) | NR | NR | NR | NR | NR | NR | NR | NR |
| Cyclophotocoagulation | 2 (0.8%) | NR | NR | NR | NR | NR | 1 (4.5%) | NR | NR | NR | NR | NR | NR |
| ExPress Shunt | 1 (0.4%) | NR | 2 (2.5%) | NR | NR | NR | 3 (13.6%) | NR | NR | NR | NR | NR | NR |
| Glaucoma Drainage Device | 2 (0.8%) | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| iStent | NR | NR | NR | NR | NR | NR | NR | NR | NR | 1 (3.7%)29 | NR | NR | NR |
| Preserlo Microshunt | 1 (0.4%) | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Selective Laser Trabeculoplasty | 4 (1.6%) | NR | 1 (1.2%) | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Trabeculectomy | 1 (0.4%) | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| XEN Gel Stent | NR | NR | 1 (1.2%) | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Unspecified Glaucoma Surgery | NR | NR | NR | 7 (13.0%) | NR | NR | NR | NR | NR | NR | NR | NR | 3 (7.9%) |
NR = None reported
\( ^{28} \) Definition used by Kicinska and Yin was ≥30 mmHg.
\( ^{29} \) At 5 years postoperative.
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This analysis of data from the literature showed that ab interno iTrack™ 250A provided a clinically meaningful reduction in IOP at 12 months, for both combo and standalone surgery. The types of adverse events reported for ab interno iTrack™ 250A are similar to that reported for other canal-based ab interno glaucoma procedures and the rates of these events were acceptable. These data demonstrate the safety and effectiveness of ab interno iTrack™ 250A for lowering intraocular pressure in patients with open angle glaucoma.
## IX. Conclusions
The design of the iTrack™ 250A is identical to the design of the Predicate device. In addition, the iTrack™ 250A maintains the same intended use, indications, target population, target anatomy, principle of operation, mechanism of action, and key technological characteristics as the Predicate device. All devices are manually operated and utilize a microcatheter with an illuminated tip to access Schlemm's canal and deliver viscoelastic fluid. The modification to the product labeling of the subject device, specifying both ab externo and ab interno as being acceptable surgical approaches for accessing Schlemm's canal, does not raise different types of questions of safety or effectiveness.
Ab interno iTrack 250A clinical performance data from the iTGDR registry as well as data from other ab interno publications from the systematic literature review demonstrate that the clinical performance data for ab interno iTrack™ 250A is substantially equivalent to that of the predicate ab externo iTrack™ 250A device.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
