(28 days)
Not Found
No
The description focuses on the physical components and materials of a mechanical device used for access in the urinary tract. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The Navigator HD Ureteral Access Sheath is a device designed to facilitate endoscopic procedures, instrument passage, and fluid injection into the urinary tract; it does not directly treat a disease or medical condition.
No
This device is designed to facilitate the passage of endoscopes and instruments for endoscopic procedures and for fluid injection, not to diagnose a condition. It is a tool for accessing the urinary tract, not for detecting or identifying a disease.
No
The device description clearly details physical components like sheaths, dilators, hubs, and materials (Pebax, PTFE, stainless steel, Pellethane), indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for facilitating the passage of instruments and injecting fluids into the urinary tract during endoscopic procedures. This is a direct interaction with the patient's body for a procedural purpose.
- Device Description: The description details a physical device (sheath and dilator) designed for insertion into the urinary tract.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue.
This device is clearly an invasive surgical/procedural device used within the body, not an IVD.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
FED
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 |
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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).