← Product Code [FED](/productcode/FED) · K262262

# Pathfinder Endoscope Overtube (K262262)

_Neptune Medical, Inc. · FED · Sep 18, 2026 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K262262

## Device Facts

- **Applicant:** Neptune Medical, Inc.
- **Product Code:** [FED](/productcode/FED.md)
- **Decision Date:** Sep 18, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Indications for Use

The Pathfinder Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).

## Device Story

Pathfinder Endoscope Overtube is a single-use, non-sterile accessory for flexible GI endoscopes. Device features a flexible overtube connected to a vacuum line via a rotating handle. Operator (physician) uses handle to toggle between two states: flexible (vented to atmosphere) for navigation through GI anatomy, and rigid (connected to vacuum) to maintain shape and stabilize the endoscope during procedures. Rigidization allows endoscope advancement/withdrawal with minimal anatomical disturbance. Device is discarded after use. Modifications include updated distal tip geometry/durometer for improved accessory passage, minor dimensional changes to inner diameter, and simplified irrigation/vacuum line design. Device is manufactured in ISO Class 8 cleanroom environment.

## Clinical Evidence

No clinical or animal studies were conducted. Substantial equivalence is supported by comprehensive bench testing, including simulated use, rigidization/de-rigidization cycling, trackability, and mechanical integrity testing. Biocompatibility was assessed per ISO 10993-1 and ISO 10993-5, confirming the device is non-cytotoxic.

## Technological Characteristics

Flexible overtube with vacuum-actuated rigidization mechanism. Materials are consistent with predicate. Dimensions range 65-145 cm length, 11-16 mm inner diameter. Non-sterile, single-use, manufactured in ISO Class 8 cleanroom. No electronic components or software.

## Regulatory 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.

## Predicate Devices

- Pathfinder Endoscope Overtube ([K191415](/device/K191415.md))
- Pathfinder Endoscope Overtube ([K211301](/device/K211301.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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**FDA U.S. FOOD & DRUG**
ADMINISTRATION

September 18, 2026

Neptune Medical, Inc.
% Keira Jessop
Regulatory Affairs Consultant
AlvaMed, Inc.
935 Great Plain Ave.
Unit 166
Needham, Massachusetts 02492

Re: K262262

Trade/Device Name: Pathfinder Endoscope Overtube

Regulation Number: 21 CFR 876.1500

Regulation Name: Endoscope And Accessories

Regulatory Class: Class II

Product Code: FED

Dated: July 2, 2026

Received: July 2, 2026

Dear Keira Jessop:

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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K262262 - Keira Jessop

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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.

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

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K262262 - Keira Jessop

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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,

SIVAKAMI VENKATACHALAM -S

for

Shanil P. Haugen, Ph.D.

Assistant Director

DHT3A: Division of Renal, Gastrointestinal,
Obesity and Transplant Devices

OHT3: Office of Gastrorenal, ObGyn,
General Hospital and Urology 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. | K262262 | ?  |
|  Please provide the device trade name(s). |   | ?  |
|  Pathfinder Endoscope Overtube  |   |   |
|  Please provide your Indications for Use below. |   | ?  |
|  The Pathfinder Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).  |   |   |
|  Please select the types of uses. | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ?  |
|  Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ?  |

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K262262
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# 510(k) Summary

## Submitter

Mr. Alex Tilson
CEO, Neptune Medical, Inc.

1828 El Camino Real, 5th Floor
Burlingame, CA 94010 USA
alex@neptunemedical.com
(650) 307-2176

## Correspondent/Primary Contact Person

Keira Jessop, M.S., RAC
Regulatory Affairs Consultant, AlvaMed, Inc.

935 Great Plain Avenue, Unit 166
Needham, MA 02492 USA
kjessop@alvamed.com
(888) 331-3485

Date Summary Prepared: July 1, 2026

## Device

Subject Device

|  Trade/Device Name | Pathfinder Endoscope Overtube  |
| --- | --- |
|  Manufacturer | Neptune Medical, Inc.  |
|  Common Name | Endoscopic Access Overtube  |
|  Regulation Number | 876.1500  |
|  Classification | Class II  |
|  Primary Product Code | FED  |
|  Review Panel | Gastroenterology and Urology  |

Predicate Device

|  Clearance | K191415 and K211301  |
| --- | --- |
|  Trade/Device Name | Pathfinder Endoscope Overtube  |
|  Manufacturer | Neptune Medical, Inc.  |
|  Common Name | Endoscopic Access Overtube  |
|  Regulation Number | 876.1500  |
|  Classification | Class II  |
|  Primary Product Code | FED  |
|  Review Panel | Gastroenterology and Urology  |

## Valid Predicate Discussion

Pathfinder Endoscope Overtube was selected as the valid predicate device to support the 510(k) submission because they received FDA clearance using well-established methods. The predicate meets the expected performance due to no reports of unexpected injury, deaths, or malfunctions associated with the device. After conducting a search on the Manufacturer and User Facility Device Experience (MAUDE) Database, Medical Device Reporting (MDR), MedSun Reports Database, Medical Device Safety and CBER Safety & Availability (Biologics) and Recall Database websites, it was found that there are no known unmitigated use-related or design safety issues and the predicate device has not been subject to a design-related recall.

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K262262^{}[] Page 2 of 4

|  Valid Predicate Device | A - Well established methods | B - Meets or exceeds expected predicate performance | C - Unmitigated use-related or design-related safety issues | D – Associated design-related recall  |
| --- | --- | --- | --- | --- |
|  Pathfinder Endoscope Overtube | Used relevant methods that were published in the public domain. | History of safe use established due to no reports of unexpected injury, deaths, or malfunctions associated with the device | No known unmitigated use related or design-related safety issues | No design-related recall identified  |

## Device Description

The Pathfinder Endoscope Overtube (Pathfinder) is a non-sterile, single-use overtube used with compatible flexible gastrointestinal endoscopes during procedures in the gastrointestinal tract. The device consists of a flexible overtube that may be connected to vacuum for rigidization via a rotating handle and is used with an endoscope for procedures in the gastrointestinal tract. The handle rotator is connected to the vacuum line which is connected to free space within the device and is completely contained, forming the vacuumable volume. The handle rotator has two positions: the first position connects the vacuumable volume within the device to atmosphere (vent) to stay in the flexible condition, and the second position connects the device to a source of vacuum to transition to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to surrounding anatomy. When transitioned to the flexible condition, the device is able to move relative to the patient anatomy and endoscope for navigation through the GI tract. After use, the device is discarded and disposed of in accordance with local regulations.

## Indications for Use

The Pathfinder Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).

## Summary of Technological Characteristics

Table 1 provides an overview of general technological characteristics in comparison to the predicate device. Any differences in the technological characteristics are minor and reflect market strategy and/or perceived user preferences and do not impact the safety, effectiveness, or substantial equivalence of the device.

**Table 1:** Comparison of Subject and Predicate Devices

|   | Subject Device Pathfinder Endoscope Overtube | Predicate Device Pathfinder Endoscope Overtube  |
| --- | --- | --- |
|  **510(k) Number** | TBD | K191415/K211301  |
|  **510(k) Submitter/Holder** | Same as predicate | Neptune Medical, Inc.  |
|  **Product Code** | Same as predicate | FED  |
|  **Regulation Number** | Same as predicate | 21 CFR 876.1500  |
|  **Regulation Description** | Same as predicate | Endoscope and accessories  |
|  **Indications for Use** | Same as predicate | The Pathfinder Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).  |
|  **Dimensions** | Same as predicate | Nine sizes, from 65 to 145 cm long  |

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|   | **Subject Device** Pathfinder Endoscope Overtube | **Predicate Device** Pathfinder Endoscope Overtube  |
| --- | --- | --- |
|   |  | and 11 to 16 mm inner diameter.  |
|  **Sterile** | Non-sterile | Sterile  |
|  **Single-use** | Same as predicate | Yes  |

### Discussion on Technical Differences

The subject Pathfinder Endoscope Overtube incorporates design modifications intended to improve compatibility with endoscopic accessories used during mucosal resection procedures while maintaining the same fundamental technology, operating principles, and intended use as the predicate device. Changes include:

- Updates to the distal tip geometry and material durometer to increase flexibility and facilitate passage of endoscopic tools
- Minor dimensional increases to the inner diameter of the medium-sized device handle and insertion portion to improve accessory tracking
- Shortening of the irrigation line and removal of pad printing on the irrigation and vacuum lines to enhance differentiation between connections

The device has also transitioned from a sterile, ethylene oxide (EO)-sterilized configuration to a non-sterile configuration manufactured and packaged in a controlled ISO Class 8 cleanroom environment with routine microbiological controls. These modifications do not alter the device's fundamental mechanism of action or performance characteristics.

### Shelf Life and Sterilization

The device is provided non-sterile with a shelf-life of 25-months. The shelf life is based on testing conducted on the predicate. The subject device utilizes equivalent materials and manufacturing processes, and the risk-based assessment does not contain newly introduced time-dependent degradation mechanisms. In addition, the predicate is sterilized via EO sterilization which creates additional conditioning, which is worst case from a material degradation perspective. The predicate device data therefore establishes a performance envelope that bounds the expected behavior of the subject device.

### Biocompatibility Testing

Biocompatibility of the proposed device was assessed in accordance with ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.". The distal tip modifications, including the material durometer change, do not affect the validity of the biocompatibility data previously reviewed under K211301. These evaluations previously submitted in the original submission, K191415, and subsequent Letters to File have confirmed the biocompatibility of the Pathfinder and compliance with the requirements of ISO10993-1:2018.

Additional cytotoxicity testing was performed in accordance with ISO 10993-5 to evaluate the presence of potential manufacturing-related residues, and the results demonstrated the device to be non-cytotoxic.

### Summary of Non-Clinical Functional and Performance Testing

The Pathfinder Endoscope Overtube underwent testing related to the following:

- Simulated use testing
- Climate Conditioning and Distribution Simulation
- Label Integrity and Bubble Leak
- Overtube Installation
- Rigidization/De-rigidization Cycling
- Time to Rigidize/Vent
- Overtube Rigidity
- Dimensional Measurements
- Overtube Trackability

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- Tip Gap
- Bend Radius
- Torsion
- Body/Tip Pinch
- Elongation/Compression
- Endoscope Trackability
- Surface Contamination and Defects
- Bonds and Handle Tensile
- Handle Cantilever Torque
- Endoscope with Distal Cap Trackability

Comprehensive bench testing was conducted to verify that the Pathfinder Endoscope Overtube meets all design specifications and performance requirements. The bench testing results support the finding of substantial equivalence to the predicate device and demonstrate that the Pathfinder Endoscope Overtube is safe and effective for its intended use.

### Summary of Animal and Clinical Data

No animal or clinical studies were conducted for this submission.

### Conclusion

Neptune Medical considers the Pathfinder Endoscope Overtube to be substantially equivalent to the predicate. Like the predicate, Pathfinder Endoscope Overtube, the Pathfinder Endoscope Overtube has been shown to be safe and effective through bench testing and biocompatibility testing. Differences in design and technology do not raise any unanswered questions of safety or effectiveness and the intended use remains unchanged.

The information present in the 510(k) supports that the Pathfinder Endoscope Overtube is as safe, as effective, and performs as well as the predicate device and is substantially equivalent to the identified predicate device in design rationale, methodology of use, and performance.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification it can be concluded that the subject device is substantially equivalent to the predicate device.

---

**Source:** [https://fda-staging.innolitics.com/device/K262262](https://fda-staging.innolitics.com/device/K262262)

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