K261915 · Boston Scientific Corporation · FED · Aug 4, 2026 · Gastroenterology, Urology
Device Facts
Record ID
K261915
Device Name
Navigator™ Flex Ureteral Access Sheath Set
Applicant
Boston Scientific Corporation
Product Code
FED · Gastroenterology, Urology
Decision Date
Aug 4, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
Navigator™ Flex Ureteral Access Sheath Set is intended to be used in establishing a conduit during endoscopic urological procedures, to facilitate the passage and use of endoscopes and other instruments into the urinary tract, and to remove urinary stones through the use of suction.
Device Story
Navigator™ Flex Ureteral Access Sheath Set is a flexible, navigable suction (FANS) ureteral access sheath used in healthcare facilities by physicians. It consists of an inner tapered dilator and an outer lubricious sheath with a semi-rigid distal shaft, flexible distal end, and a proximal suction control hub with a slider. The device creates a conduit for retrograde urological instruments and enables stone debris removal via external negative pressure (wall suction or pump). A tethered seal maintains vacuum when a scope is inserted. The device facilitates stone treatment and clearance in the urinary collecting system. It is a single-use, disposable device.
Clinical Evidence
No clinical tests or data were submitted, referenced, or relied upon. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993 series), packaging integrity (ASTM D4169, F1929, F2096, F1980, ISO 11607-1), and performance testing (dimensional, tensile, aspiration, durability, insertion, distal end functionality, frictional force, and radiopacity).
Technological Characteristics
Materials: Stainless steel, PTFE, polyurethane, polycarbonate, nylon, with hydrophilic coating. Energy: Passive (external suction source). Form factor: 11/13Fr and 12/14Fr diameters, 38-52cm lengths. Sterilization: Ethylene Oxide (10^-6 SAL). Connectivity: Standard medical-grade suction tubing. No software or electronic components.
Indications for Use
Indicated for patients undergoing retrograde endoscopic urological procedures requiring a conduit for instrument passage and urinary stone removal via suction. Contraindicated in patients who are contraindicated for retrograde urological procedures, have untreated urinary tract infections, or conditions leading to high viscous flow within the kidney.
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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August 4, 2026
Boston Scientific Corporation
Uma Ramnanan
Senior Regulatory Affairs Specialist
100 Boston Scientific Way
Marlborough, Massachusetts 01752
Re: K261915
Trade/Device Name: Navigator™ Flex Ureteral Access Sheath Set
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: FED, FAJ, FGA
Dated: June 8, 2026
Received: June 9, 2026
Dear Uma Ramnanan:
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: The Center for Devices and Radiological Health (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, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K261915 - Uma Ramnanan
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(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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K261915 - Uma Ramnanan
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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,
Mark R. Kreitz -S
for Mark J. Antonino, M.S.
Assistant Director
DHT3B: Division of Reproductive,
Gynecology, and Urology 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if
known) K261915
Device Name
Navigator™ Flex Ureteral Access Sheath Set (M0062504100, M0062504110,
M0062504120, M0062504200, M0062504210, M0062504220)
Indications for Use (Describe)
The Navigator™ Flex Ureteral Access Sheath Set is intended to be used in establishing a conduit during endoscopic urological procedures, to facilitate the passage and use of endoscopes and other instruments into the urinary tract, and to remove urinary stones through the use of suction.
Type of Use (Select one or both, as applicable)
☑
Prescription Use (Part 21 CFR 801 Subpart D)
☐
Over-The-Counter Use (21 CFR 801 Subpart C)
# CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
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K261915
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Navigator™ Flex Ureteral Access Sheath Set
510(k) Summary
# Navigator™ Flex Ureteral Access Sheath Set – 510(k) Summary
## 1. Submission Details
Date Prepared: 24 July 2026
Sponsor: Boston Scientific Corporation Urology Division
100 Boston Scientific Way
Marlborough, MA 01752
Primary Contact: Uma Ramnanan
+1 (508) 382-9595
uma.ramnanan@bsci.com
Secondary Contact: Justin Kapitan
+1 (508) 683-4518
justin.kapitan@bsci.com
Proposed Device:
| Premarket Notification – Traditional 510(k) | |
| --- | --- |
| Device Common Name | Ureteral Access Sheath |
| Device Trade Name | Navigator™ Flex Ureteral Access Sheath Set |
| Classification | Class II per 21 CFR §876.1500 |
| Classification Name | Endoscope and accessories |
| Product Code | FED (Endoscopic Access Overtube, Gastroenterology-Urology) FAJ (Cystoscope and Accessories, Flexible/Rigid) FGA (Kit, Nephroscope) |
Table 1: Scope of Submission
Predicate Device:
| Predicate 510(k) - K161110 | |
| --- | --- |
| Device Trade Name | ClearPetra Suction-Evacuation Sheath |
| Classification | Class II per 21 CFR §876.1500 |
| Classification Name | Endoscope and accessories |
| Product Code | FED (Endoscopic Access Overtube, Gastroenterology-Urology) FAJ (Cystoscope and Accessories, Flexible/Rigid) FGA (Kit, Nephroscope) |
Table 2: Predicate Device
Reference Device:
| Reference 510(k) - K250517 | |
| --- | --- |
| Device Trade Name | Navigator™ HD Ureteral Access Sheath |
| Classification | Class II per 21 CFR §876.1500 |
| Classification Name | Endoscope and accessories |
| Product Code | FED (Endoscopic Access Overtube, Gastroenterology-Urology) |
Table 3: Reference Device
Boston Scientific
1
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Navigator™ Flex Ureteral Access Sheath Set
K261915
Page 2 of 5
510(k) Summary
## 2. Device Description
The Navigator™ Flex Ureteral Access Sheath Set consists of an inner tapered dilator and an outer navigable sheath with aspiration capabilities. The device is designed to create a conduit for retrograde (transurethral) urological procedure instruments and for the removal of urinary system stone debris using suction. The sheath can be connected to an external negative pressure (i.e., suction) source (e.g., standard operating room “wall suction”, 3rd party fluid management system, pump) with standard medical-grade suction tubing.
Navigator™ Flex Ureteral Access Sheath Set includes three key components : (1) a lubricious outer sheath with a semi-rigid distal shaft, a flexible distal end, and a proximal suction control hub (a slider enables on/off control of suction); (2) a lubricious semi-rigid inner dilator, which interlocks with the sheath hub; and (3) a seal tethered to the sheath hub, used to cover the hub’s proximal end after the inner dilator is removed, to maintain a vacuum and thereby enable suction when scope is inserted through seal.
This device is an example of a flexible and navigable suction (FANS) ureteral access sheath (UAS), a class of devices used during treatment and clearance of stones in the urinary collecting system (urinary calculi or urolithiasis). Navigator™ Flex Ureteral Access Sheath Set functions as a catheter by providing a pathway for fluid and debris removal and as an access sheath that, when used with a ureteroscope offers steerable access to the urinary tract and enables suction.
Navigator™ Flex Ureteral Access Sheath Set Configurations
| Product Identification | Product Description |
| --- | --- |
| M0062504100 | Navigator™ Flex Ureteral Access Sheath Set 11/13 FR x 38 CM |
| M0062504110 | Navigator™ Flex Ureteral Access Sheath Set 11/13 FR x 46 CM |
| M0062504120 | Navigator™ Flex Ureteral Access Sheath Set 11/13 FR x 52 CM |
| M0062504200 | Navigator™ Flex Ureteral Access Sheath Set 12/14 FR x 38 CM |
| M0062504210 | Navigator™ Flex Ureteral Access Sheath Set 12/14 FR x 46 CM |
| M0062504220 | Navigator™ Flex Ureteral Access Sheath Set 12/14 FR x 52 CM |
## 3. Intended Use/Indications for Use
Navigator™ Flex Ureteral Access Sheath Set is intended to be used in establishing a conduit during endoscopic urological procedures, to facilitate the passage and use of endoscopes and other instruments into the urinary tract, and to remove urinary stones through the use of suction.
## 4. Comparison to Predicate Device
The subject device Navigator™ Flex Ureteral Access Sheath Set have similar technological characteristics and fundamental design as the legally marketed predicate ClearPetra Suction-Evacuation Sheath (predicate device, K161110).
| Characteristic | ClearPetra Suction-Evacuation Sheath (Predicate Device) | Navigator™ Flex Ureteral Access Sheath Set (Subject Device) | Comparison |
| --- | --- | --- | --- |
| Indications for Use | The ClearPetra Suction-Evacuation Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary | Navigator™ Flex Ureteral Access Sheath Set is intended to be used in establishing a conduit during endoscopic urological procedures, to facilitate the passage and use of endoscopes and other instruments into the urinary tract, and to remove urinary stones through the use of suction. | Similar |
Boston Scientific
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K261915
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510(k) Summary
Navigator™ Flex Ureteral Access Sheath Set
| Characteristic | ClearPetra Suction-Evacuation Sheath (Predicate Device) | NavigatorTM Flex Ureteral Access Sheath Set (Subject Device) | Comparison |
| --- | --- | --- | --- |
| | diseases during the endoscopic procedures. | | |
| Contraindications | Coagulation disordersAcute urinary tract infectionSevere cardiopulmonary insufficiencyUncorrected diabetes | Patients who are contraindicated for retrograde urological procedures.Patients who have untreated urinary tract infections or any other condition which may lead to a high viscous flow within the kidney. | Similar |
| Use Environment | Healthcare facility | Healthcare facility | Same |
| Material | Stainless Steel (SS)Polytetrafluoroethylene (PTFE)Polyethylene (PE)Nylon (PA)Polycarbonate (PC) disposable materials, with a hydrophilic coating | Stainless steel (SS)Polytetrafluropolymer (PTFE)Polyurethane (PU)Polycarbonate (PC)Nylon (PA) disposable materials, with a hydrophilic coating | Similar |
| Sterilization Method and Sterility | EO sterilizedSterility \( 10^{-6} \) | EO sterilizedSterility \( 10^{-6} \) | Same |
| Device Diagram |  |  | Similar. |
| Size | 10/12Fr x 13cm10/12Fr x 26cm10/12Fr x 36cm10/12Fr x 40cm10/12Fr x 46cm10/12Fr x 55cm11/13Fr x 13cm11/13Fr x 26cm11/13Fr x 36cm11/13Fr x 40cm11/13Fr x 46cm11/13Fr x 55cm12/14Fr x 13cm12/14Fr x 26cm12/14Fr x 36cm12/14Fr x 40cm12/14Fr x 46cm12/14Fr x 55cm13/15Fr x 13cm13/15Fr x 26cm13/15Fr x 40cm13/15Fr x 46cm13/15Fr x 55cm14/16Fr x 13cm14/16Fr x 26cm14/16Fr x 36cm14/16Fr x 40cm14/16Fr x 46cm14/16Fr x 55cm | 11/13Fr x 38cm11/13Fr x 46cm11/13Fr x 52cm12/14Fr x 38cm12/14Fr x 46cm12/14Fr x 52cm | The predicate device offers a broader range of sizes; however, the subject device falls within the range of sizes offered by the predicate. The selected subject sizes represent those that are clinically relevant and comparable for the intended use. |
Boston Scientific
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K261915
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Navigator™ Flex Ureteral Access Sheath Set
510(k) Summary
| Characteristic | ClearPetra Suction-Evacuation Sheath (Predicate Device) | NavigatorTM Flex Ureteral Access Sheath Set (Subject Device) | Comparison |
| --- | --- | --- | --- |
| Components | Sheath, Obturator, Connector, Rubber Cap | Sheath, Obturator, Connector, Rubber Cap, Slider | Similar. NavigatorTM Flex Ureteral Access Sheath Set has a slider for suction control. |
| Single Use | Yes | Yes | Same |
While the Intended Use is not identical, the subject and predicate device intended use are fundamentally the same. The Product Code, Class, Environment Use and Users are the same. The differences in technological characteristics have been assessed and do not raise any new questions of safety or effectiveness.
## 5. Performance Testing
The Navigator™ Flex Ureteral Access Sheath Set has undergone Performance Testing in the following ways:
### - Biocompatibility Testing
• Assessments of the safety of the patient contacting materials per:
■ ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (FDA Recognition Number: 2-258)
■ ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (FDA Recognition Number: 2-245)
■ ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (FDA Recognition Number: 2-296)
■ ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (FDA Recognition Number: 2-289)
■ ISO 10993-18 Second edition 2020-01 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (FDA Recognition Number: 2-276)
■ ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation (FDA Recognition Number: 2-291)
### - Performance Testing
- Assessment of the Navigator™ Flex Ureteral Access Sheath Set product and packaging to demonstrate safety and effectiveness over the proposed shelf-life utilizing internally developed bench test methods per
■ ASTM D4169: 2023 Standard practice for performance testing of shipping containers and systems (FDA Recognition Number: 14-576)
■ ASTM F1929:2023 Standard test method for detecting seal leaks in porous medical packaging by dye penetration (FDA Recognition Number: 14-600)
■ ASTM F2096:2011 Standard test method for detecting gross leaks in packaging by internal pressurization (bubble test) (FDA Recognition Number: 14-359)
■ ASTM F1980:2021 Standard guide for accelerated aging of sterile barrier systems for medical devices (FDA Recognition Number: 14-575)
- Assessment of Sterile Barrier Packaging to demonstrate safety and effectiveness over the proposed shelf-life per
■ ISO 11607-1 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)] (FDA Recognition Number: 14-594)
- Assessment of the overall performance of the subject device was evaluated using the following tests to demonstrate that the design requirements have been met
■ Dimensional evaluation
■ Tensile Testing
■ Aspiration Performance
■ Device Durability
Boston Scientific
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K261915
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Navigator™ Flex Ureteral Access Sheath Set
510(k) Summary
- Device Insertion
- Distal End Functionality
- Frictional Force
- Radiopacity
No clinical tests/data were submitted, referenced, or relied on in this 510(k) for determination of substantial equivalence.
The testing performed concludes that the Navigator™ Flex Ureteral Access Sheath Set performs both safely and effectively per their design requirements and does not introduce new safety concerns that would impact the device's intended use or substantial equivalence.
### 6. Conclusion
Based on the intended use, comparison of key technological characteristics, and performance testing presented in this premarket submission, it is concluded that the subject device Navigator™ Flex Ureteral Access Sheath Set is substantially equivalent to the predicate ClearPetra Suction-Evacuation Sheath (K161110).
Boston Scientific
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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.
