The Navigator HD Ureteral Access Sheath is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

Device Description

Navigator™ HD Ureteral Access Sheath Set consists of a semi-rigid outer sheath and a semi-rigid inner dilator with interlocking hub. The set permits utilization of a guidewire to assist in device placement.

Sheath: The Navigator™ HD Sheath has a sheath hub which is over-molded onto the sheath shaft has three layers: Outer Pebax layer, Reinforced stainless steel coil enhancing torqueability and maneuverability, Inner PTFE liner. The sheath outer layer contains Barium Sulphate as a radiopacifier. In addition to the stainlesssteel coil, a radiopaque marker band is sandwiched between the Pebax and PTFE layers. The radiopaque marker band is located at the sheath tip and, along with the radiopacifier added to the sheath outer layer, enhances fluoroscopic visualization of sheath placement during the procedure. A hydrophilic coating is applied to the entire length of the shaft to reduce friction and facilitate placement of the device.

Dilator: The Navigator™ HD dilator has a hub with a standard luer lock at the proximal end. The tab on the dilator hub allows it to lock into the sheath hub. The dilator shaft is made of extruded tube Pellethane to allow for dimensional stability, low moisture absorption, and chemical resistance. The dilator tip is made of a softer grade of Pellethane to improve tip flexibility to assist in atraumatic placement. Both the dilator shaft and tip contain Barium Sulfate as a radiopacifier, enhancing visualization under fluoroscopy during the procedure. A hydrophilic coating is applied to the entire length of the dilator to reduce friction and facilitate placement of the device, either when assembled with the sheath or when used separately as a dilatation device.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies that prove the device meets these criteria in the context of AI/ML are not applicable here.

The document discusses the substantial equivalence of the Navigator™ HD Ureteral Access Sheath Set to a previously cleared predicate device.

Here's the relevant information that can be extracted, addressing the spirit of the request as much as possible for a non-AI/ML device:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present "acceptance criteria" in the typical AI/ML sense (e.g., specific sensitivity/specificity thresholds). Instead, it relies on demonstrating substantial equivalence to an existing predicate device. The performance is assessed by comparing technological characteristics and performing design verification and usability testing related to a minor change.

Characteristic / "Acceptance Criteria"	Proposed Device Performance (Navigator™ HD Ureteral Access Sheath Set K250517)
Intended Use / Indication for Use	Identical to Predicate (K140323): Facilitate passage of endoscopes, urological instruments, and injection of fluids into the urinary tract in endoscopic procedures.
Reusability	Identical to Predicate: Single Use
Supplied Condition	Identical to Predicate: Sterile
Sterilization Method	Identical to Predicate: Ethylene Oxide (EO)
Packaging	Identical to Predicate: Tyvek/Poly pouch
Hydrophilic Coating	Similar but different (Lubricent UV540 vs. Lubricent UV460 in Predicate). Performance verified via Design Verification and Summative Usability.
Dilator & Sheath Mechanical Specifications	Unchanged from Predicate via implied equivalence. Confirmed by Design Verification.
Sizes Offered	Identical to Predicate: 11/13 F, 12/14 F, 13/15 F
Length (cm)	Identical to Predicate: 28, 36 & 46
Biocompatibility	Biological evaluation assessment concluded no biocompatibility risks, identical contact classification to predicate.
Shelf-life impact of change	Additional Design Verification testing executed to verify no impact.

2. Sample size used for the test set and the data provenance:

This is a physical medical device. The "test set" would refer to samples of the device undergoing engineering performance testing. The document does not specify sample sizes for the "Design Verification" or "Summative Usability" testing, nor does it mention data provenance (e.g., country of origin, retrospective/prospective clinical data). These would typically be detailed in internal test reports referenced by the submission but not included in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as this is not an AI/ML device requiring expert ground truth for classification or diagnosis. The "ground truth" for the device's performance relies on engineering specifications and established safety/efficacy profiles of similar devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable for a physical medical device. Adjudication methods are relevant for subjective interpretations of data, typically in clinical studies or AI/ML ground truth establishment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/ML device, and no human reader study with or without AI assistance was performed or needed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the device's acceptable performance is based on:

Engineering specifications and standards: Ensuring the device meets its design requirements.
Performance testing results: Demonstrating functional equivalence and safety (e.g., mechanical performance, biocompatibility).
Historical performance of predicate device: The K140323 device, which has a proven track record.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for a physical medical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 13, 2025

Boston Scientific Corporation Timilehin Adenekan Regulatory Affairs Specialist 100 Boston Scientific Way - Urology Division Marlborough, Massachusetts 01752

Re: K250517

Trade/Device Name: Navigator™ HD Ureteral Access Sheath Set Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: February 21, 2025 Received: February 21, 2025

Dear Timilehin Adenekan:

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.

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).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

{2}------------------------------------------------

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-device-advice-comprehensive-regulatoryassistance/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 J. Antonino -S

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

{3}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K250517

Device Name

Navigator™ HD Ureteral Access Sheath Set

Indications for Use (Describe)

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

{4}------------------------------------------------

K250517 510(k) Summary for Navigator™ HD Ureteral Access Sheath Sets

Date Prepared: March 13, 2025

A. Submitter

Boston Scientific Corporation Urology and Pelvic Health Division 100 Boston Scientific Way Marlborough, MA 01752

B. Contacts

Timilehin Adenekan Regulatory Affairs Specialist 651-581-1543 Timilehin.Adenekan@bsci.com

C. Device Name

Trade Names:	Navigator™ HD Ureteral Access Sheath Set
Common Name:	Ureteral Access Sheath Set
Regulation Number:	21 CFR §876.1500
Regulation Name:	Endoscopic Access Overtube, Gastroenterology - Urology
Classification:	Class II
Product Code:	FED

D. Predicate Devices

For the purposes of establishing substantial equivalence, the designs and technological characteristics of the proposed Navigator™ HD Ureteral Access Sheath Sets were compared to the following 510(k)-cleared device.

Table 11-1: Predicate Device for Establishing Substantial Equivalence
-----------------------------------------------------------------------	--	--	--

Characteristics	Predicate Device
Device Trade Name	Navigator™ HD Ureteral Access Sheath Sets
Regulation Name	Endoscopic Access Overtube, Gastroenterology -Urology
Regulation Number	21 CFR §876.1500
Classification	Class II
Product Code	FED
510(k) Submitter/Holder	Boston Scientific Corporation, Marlborough, MA
510(k) Clearance Number & Date	K140323 Cleared 07-March-2014

{5}------------------------------------------------

K250517 Page 2 of 4

E. Device Description

Sheath

The Navigator™ HD Sheath has a sheath hub which is over-molded onto the sheath shaft has three layers:

-Outer Pebax layer
। Reinforced stainless steel coil enhancing torqueability and maneuverability
-Inner PTFE liner

The sheath outer layer contains Barium Sulphate as a radiopacifier. In addition to the stainlesssteel coil, a radiopaque marker band is sandwiched between the Pebax and PTFE layers. The radiopaque marker band is located at the sheath tip and, along with the radiopacifier added to the sheath outer layer, enhances fluoroscopic visualization of sheath placement during the procedure. A hydrophilic coating is applied to the entire length of the shaft to reduce friction and facilitate placement of the device.

Dilator

The Navigator™ HD dilator has a hub with a standard luer lock at the proximal end. The tab on the dilator hub allows it to lock into the sheath hub. The dilator shaft is made of extruded tube Pellethane to allow for dimensional stability, low moisture absorption, and chemical resistance. The dilator tip is made of a softer grade of Pellethane to improve tip flexibility to assist in atraumatic placement. Both the dilator shaft and tip contain Barium Sulfate as a radiopacifier, enhancing visualization under fluoroscopy during the procedure. A hydrophilic coating is applied to the entire length of the dilator to reduce friction and facilitate placement of the device, either when assembled with the sheath or when used separately as a dilatation device.

F. Intended Use/Indication for Use

G. Operating Principle

The operating principle for the Navigator™ HD Ureteral Access Sheath Sets (submitted under K140323) remains unchanged.

{6}------------------------------------------------

K250517 Page 3 of 4

For the duration of the access procedure, a 0.89 mm (0.035 in.) or 0.97 mm (0.038 in.) guidewire is inserted through the urethra into the urinary tract. The dilator and sheath are secured together and then advanced over the guidewire to the target anatomy. Once positioned, the dilator is removed by grasping the luer and the tab, and the sheath is maintained in place for the duration of the procedure. To perform a retrograde pyelogram, the dilator should be re-inserted into the sheath, and the contrast injected through the luer fitting of the dilator.

H. Comparison of Key Technological/Performance Characteristics

The proposed Navigator™ HD Ureteral Access Sheath Sets have the same technological characteristics and fundamental design as the predicate Navigator™ HD Ureteral Access Sheath Sets (K140323).

Characteristics	Predicate Navigator™ HDUreteral Access SheathSets (K140323)	Proposed Navigator™ HDUreteral AccessSheath Sets (K250517)	Similarities /Differences
Indication for Use	Navigator HD is indicated foruse in endoscopicprocedures to facilitate thepassage of endoscopes,urological instruments andfor the injection of fluids intothe urinary tract.	Navigator HD is indicatedfor use in endoscopicprocedures to facilitatethe passage ofendoscopes, urologicalinstruments and for theinjection of fluids into theurinary tract.	Identical
Reusability	Single Use	Single Use	Identical
Nav HD isSupplied	Sterile	Sterile	Identical
Sterilization	Ethylene Oxide (EO)	Ethylene Oxide (EO)	Identical
Packaging	Tyvek/Poly pouch	Tyvek/Poly pouch	Identical
HydrophilicCoating	Lubricent UV460	Lubricent UV540	Similar
Dilator & Sheath Mechanical Specifications
Sizes Offered	11/13 F12/14 F13/15 F	11/13 F12/14 F13/15 F	Identical
Length (cm)	28, 36 & 46	28, 36 & 46	Identical

Table 11-2: Navigator™ HD Device Comparison and Substantial Equivalence

l. Substantial Equivalence

A direct comparison of key characteristics demonstrates that the proposed Navigator™ HD Ureteral Access Sheath Sets are substantially equivalent to the predicate Navigator™ HD Ureteral Access

{7}------------------------------------------------

Sheath Sets (K140323) in terms of intended use, technological characteristics, and performance characteristics. The proposed Navigator™ HD Ureteral Access Sheath Sets is as safe, as effective, and performs as well as the predicate devices (K140323).

J. Performance Testing

To evaluate the hydrophilic coating change introduced with the proposed Navigator™ HD Ureteral Access Sheath Sets, a Design Verification and Summative Usability was executed to support the safe and effective use of the proposed Navigator™ HD Ureteral Access Sheath Sets. Additional Design Verification testing was executed to verify that the proposed change had no impact to the shelf-life.

From a biocompatibility standpoint, the contact classification of the proposed Navigator™ HD Ureteral Access Sheath Sets is identical to the predicate Navigator™ HD Ureteral Access Sheath Sets (cleared under K140323). A biological evaluation assessment for the proposed Navigator™ HD Ureteral Access Sheath Sets was conducted and it was concluded there is no biocompatibility risks associated to the proposed Navigator™ HD Ureteral Access Sheath Sets.

K. Conclusion

Based on the intended use/indications for use, comparison of key technological characteristics, and performance testing presented in this premarket submission, it is concluded that the proposed Navigator™ HD Ureteral Access Sheath Sets are substantially equivalent to the predicate Navigator™ HD Ureteral Access Sheath Sets (cleared under K140323).

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.