Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006

Q: Who is the manufacturer of Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006?

Boston Scientific Corporation filed the 510(k) submission for Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006 (K250517).

Q: What is the FDA product code for Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006?

FED. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

Q: What is the regulatory pathway for Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006?

510(k) clearance (submission type: Special).

Q: Who can help prepare an FDA 510(k) submission like Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K250517 · Boston Scientific Corporation · FED · Mar 21, 2025 · Gastroenterology, Urology

Device Facts

Record ID	K250517
Device Name	Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006
Applicant	Boston Scientific Corporation
Product Code	FED · Gastroenterology, Urology
Decision Date	Mar 21, 2025
Decision	SESE
Submission Type	Special
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

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 Story

Navigator HD Ureteral Access Sheath Set consists of semi-rigid outer sheath and inner dilator with interlocking hub; used in endoscopic procedures to provide access to urinary tract. Device advanced over guidewire (0.035 or 0.038 inch) into target anatomy; dilator removed while sheath remains in place to facilitate instrument passage or fluid injection. Sheath features stainless steel coil reinforcement, PTFE liner, and Pebax outer layer with Barium Sulfate radiopacifier; dilator made of Pellethane. Both components feature hydrophilic coating to reduce friction. Used in clinical settings by urologists; fluoroscopic visualization used for placement. Benefits include atraumatic access and maintenance of working channel for urological instruments.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including design verification and summative usability testing to evaluate the impact of the hydrophilic coating change, and a biological evaluation assessment confirming no new biocompatibility risks.

Technological Characteristics

Semi-rigid sheath (Pebax, stainless steel coil, PTFE liner) and dilator (Pellethane). Features Barium Sulfate radiopacifier and hydrophilic coating (Lubricent UV540). Sizes: 11/13F, 12/14F, 13/15F; lengths: 28, 36, 46 cm. Sterilization: Ethylene Oxide (EO). Single-use. No software or electronic components.

Indications for Use

Indicated for use in endoscopic procedures to facilitate passage of endoscopes, urological instruments, and fluid injection into the urinary tract. No specific patient population, age, or gender restrictions are stated.

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.

Predicate Devices

Navigator™ HD Ureteral Access Sheath Sets (K140323)

Related Devices

K140323 — NAVIGATOR HD URETERAL ACCESS SHEATH SETS · Boston Scientific · Mar 7, 2014
K122649 — NAVIGATOR HD URETERAL ACCESS SHEATH SET · Boston Scientific Corp · Dec 12, 2012
K251599 — Single-use Ureteral Access Sheath · Hunan Vathin Medical Instrument Co., Ltd. · Jul 3, 2025
K030956 — NAVIGATOR URETERAL ACCESS SHEATH SET · Boston Scientific Corp · May 23, 2003
K140523 — RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM · Coloplast A/S · Jul 24, 2014

Submission Summary (Full Text)

{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) 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. 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 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. ### F. Intended Use/Indication for Use 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. ### 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™ HD Ureteral Access Sheath Sets (K140323) | Proposed Navigator™ HD Ureteral Access Sheath Sets (K250517) | Similarities / Differences | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------| | Indication for Use | Navigator HD 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. | Navigator HD 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. | Identical | | Reusability | Single Use | Single Use | Identical | | Nav HD is Supplied | Sterile | Sterile | Identical | | Sterilization | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Identical | | Packaging | Tyvek/Poly pouch | Tyvek/Poly pouch | Identical | | Hydrophilic Coating | Lubricent UV460 | Lubricent UV540 | Similar | | Dilator & Sheath Mechanical Specifications | | | | | Sizes Offered | 11/13 F 12/14 F 13/15 F | 11/13 F 12/14 F 13/15 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).