(25 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a physical medical device (ureteral access sheath) and do not mention any software, algorithms, or data processing related to AI/ML.
No
A therapeutic device is one that treats a disease or condition. This device is used to facilitate other procedures and protect the ureter, not to treat a condition itself.
No
This device is designed to facilitate access and passage of instruments within the urinary tract and for fluid injection, serving as a procedural aid rather than for diagnosing medical conditions.
No
The device description clearly outlines physical components (inner tapered semirigid dilator, outer semi-rigid sheath) and physical characteristics (French sizes, lengths, radiopaque, hydrophilic coating), 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 intervention on the patient's body.
- Device Description: The device is a physical sheath and dilator designed to be inserted into the urinary tract.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (like urine or tissue) in vitro (outside the body) to diagnose a condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical/interventional tool used directly on the patient.
N/A
Intended Use / Indications for Use
The Navigator™ HD Ureteral Access Sheath Set 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
The Navigator ™ HD Ureteral Access Sheath Set is designed to provide the physician with reliable access to the urinary tract, the ability to inject fluids, and act as a conduit for device exchanges. Like all ureteral access sheath sets, Navigator™ HD also protects the ureter during device exchanges, thus helping reduce tissue trauma. This set consists of two components: an inner tapered semirigid dilator and an outer semi-rigid sheath. The outer sheath fits over the inner dilator, and the design of the hub allows the dilator to lock into the sheath. Both the dilator and sheath are radiopaque and have a lubricous hydrophilic coating. The device is offered in three French sizes, 11/13 Fr, 12/14 Fr and 13/15 Fr, in lengths up to 46cm. The Navigator ™ HD Ureteral Access Sheath Set is intended for single use only.
To guide the access sheath into the body orifice, the dilator is advanced over up to a .038" guidewire. The device can be visualized under x-ray (fluoroscopy) during placement to confirm location. The proposed device can accept other urological instrumentation with OD's compatible with the sheath's OD of 11, 14 and 13 Fr.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray (fluoroscopy)
Anatomical Site
urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / 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)
Performance Testing (Bench Evaluation)
Boston Scientific has conducted performance testing with samples aged at T=0 to support the addition of a flexural durability specification to Navigator™ HD.
The following testing was completed to evaluate the effects of the design change and sizes:
- Dilator Tip Weld / Shaft Integrity
- Flexible Tip Weld Integrity (Durability)
The results of the performance testing demonstrate equivalence of the Navigator™ HD to the predicate Ureteral Access Sheath Set. The Navigator™ HD UASS are considered safe and effective for their intended use.
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.
Boston Scientific, K122649
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
Boston Scientific
K140323 Page 1 of 2
| SECTION 6 | 510K SUMMARY | MAR - 7 20 |
|---|---|---|
| ----------- | -------------- | ------------ |
510(k) Summary for Navigator™ HD Ureteral Access Sheath
A. Date Prepared
February 07, 2014
B. Sponsor
Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01756
C. Contact
Nichole Riek Regulatory Affairs Manager 508-683-4175 riekn@bsci.com
D. Device Name
| Trade name: | Navigator™ HD Ureteral Access Sheath Set |
|---|---|
| Common/usual name: | Ureteral Access Sheath Set |
| Classification Name: | FED - Endoscopic Access Overtube, |
| Gastroenterology-Urology | |
| 21 CFR 876.1500. Class II |
E. Predicate Device
| Trade name: | Navigator™ HD Ureteral Access Sheath Set |
|---|---|
| Common/usual name: | Ureteral Access Sheath Set |
| Classification Name: | FED – Endoscopic Access Overtube, |
| Gastroenterology-Urology | |
| 21 CFR 876.1500, Class II | |
| Premarket Notification: | Boston Scientific, K122649 (12/12/2012) |
F. Device Description
The Navigator ™ HD Ureteral Access Sheath Set is designed to provide the physician with reliable access to the urinary tract, the ability to inject fluids, and act as a conduit for device exchanges. Like all ureteral access sheath sets, Navigator™ HD also protects the ureter during device exchanges, thus helping reduce tissue trauma. This set consists of two components: an inner tapered semirigid dilator and an outer semi-rigid sheath. The outer sheath fits over the inner dilator, and the design of the hub allows the dilator to lock into the sheath. Both the dilator and sheath are radiopaque and have a lubricous hydrophilic coating. The device is offered in three French sizes, 11/13 Fr, 12/14 Fr and 13/15 Fr, in lengths up to 46cm. The Navigator ™ HD Ureteral Access Sheath Set is intended for single use only.
1
Boston Scientific
510K SUMMARY SECTION 6
To guide the access sheath into the body orifice, the dilator is advanced over up to a .038" guidewire. The device can be visualized under x-ray (fluoroscopy) during placement to confirm location. The proposed device can accept other urological instrumentation with OD's compatible with the sheath's OD of 11, 14 and 13 Fr.
G. Intended Use
The Navigator™ HD Ureteral Access Sheath Set 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.
H. Technological Characteristics
The proposed device is substantially equivalent in design and materials to the predicate Navigator HD Ureteral Access Sheath Set. Like the predicate device, the proposed device has a hydrophilic coating to facilitate device placement and withdrawal.
I. Substantial Equivalence
Utilizing FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated 510(k)s" a direct comparison of key characteristics demonstrates that the proposed Navigator™ HD UASS is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance characteristics.
J. Performance Testing (Bench Evaluation)
Boston Scientific has conducted performance testing with samples aged at T=0 to support the addition of a flexural durability specification to Navigator™ HD. There are no changes to the device design or device materials, packaging materials, sterilization method, intended use or contraindications proposed in this 510(k) Premarket Notification that would impact aging. See Section 14 for further discussion. The following testing was completed to evaluate the effects of the design change and sizes:
- Dilator Tip Weld / Shaft Integrity ●
- Flexible Tip Weld Integrity (Durability) .
The results of the performance testing demonstrate equivalence of the Navigator™ HD to the predicate Ureteral Access Sheath Set. The Navigator™ HD UASS are considered safe and effective for their intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus-like design with three wavy lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2014
Boston Scientific Corporation Urology/Women's Health Nichole Riek Regulatory Affairs Manager 100 Boston Scientific Way Marlborough, MA 01752
Re: K140323
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 7, 2014 Received: February 10, 2014
Dear Nichole Riek,
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 (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. 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.
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.
3
Page 2 - Nichole Riek
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin Fisher-S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Navigator™ HD Ureteral Access Sheath Set Special 510(k): Corrective Action Being Effected Boston Scientific
SECTION 5 . BAND STATE FACT ANDICATIONS FOR USE
Indications for Use Statement
510(k) K140323 Number
Navigator™ HD Ureteral Access Sheath Set Device Name
Indications For Use
The Navigator™ HD Ureteral Access Sheath Set 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.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Beniami 05'00' 2014.03
11- 12-5-13