(104 days)
The UASS 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.
The Navigator TM 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 semi-rigid 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.
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.
The proposed device is provided sterile single use. The packaging materials used for the proposed Navigator™ HD are commonly used materials for packaging medical devices and similar to the predicate device. The device will be packaged in a labeled, single polyfilm/tyvek peel pouch, which will be placed in a labeled, paperboard shelf carton.
Acceptance Criteria and Study for Navigator™ HD Ureteral Access Sheath
The Navigator™ HD Ureteral Access Sheath is a Class II medical device, and its acceptance criteria and the study proving its compliance were assessed through performance testing (bench evaluation) to demonstrate substantial equivalence to its predicate device, the Navigator™ Ureteral Access Sheath. This is a traditional 510(k) pathway, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy trials for novel devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test were implicitly met if the "results of the performance testing demonstrate equivalence of the Navigator™ HD to the predicate Ureteral Access Sheath Set." The document explicitly states this after listing the conducted tests. The device performance (results) for each specific test are not numerically provided in this summary but are summarized as demonstrating equivalence.
| Acceptance Criteria Category | Specific Test (Performance Parameter) | Reported Device Performance |
|---|---|---|
| Physical Dimensions | Working Length | Equivalence to predicate demonstrated |
| Sheath & Dilator Outer Diameter | Equivalence to predicate demonstrated | |
| Mechanical Properties | Sheath & Dilator Stiffness | Equivalence to predicate demonstrated |
| Dilator Tip Stiffness | Equivalence to predicate demonstrated | |
| Sheath & Dilator Tensile Strength | Equivalence to predicate demonstrated | |
| Sheath & Dilator Hub to Shaft Integrity | Equivalence to predicate demonstrated | |
| Dilator Tip to Shaft Integrity | Equivalence to predicate demonstrated | |
| Latch Holding Force & Durability | Equivalence to predicate demonstrated | |
| Fluid/Flow Characteristics | Dilator Luer (Compliance with ISO 594-2) | Equivalence to predicate demonstrated |
| Dilator Hub Leak Resistance | Equivalence to predicate demonstrated | |
| Ease of Use/Functionality | Dilator/Guidewire Trackability | Equivalence to predicate demonstrated |
| Transition Force of Dilator and Sheath Tips | Equivalence to predicate demonstrated | |
| Sheath Circular Profile | Equivalence to predicate demonstrated | |
| Dilator Slideability from Sheath | Equivalence to predicate demonstrated | |
| Sheath Internal Passage Resistance/Friction | Equivalence to predicate demonstrated | |
| Sheath Internal Passage Durability | Equivalence to predicate demonstrated | |
| Overall Safety/Effectiveness | (Implied through all above tests) | Considered safe and effective for intended use; substantially equivalent to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each individual performance test. It broadly states "Boston Scientific has conducted performance testing with samples aged at T=0 and T=25 months accelerated aging."
- Data Provenance: The data is from retrospective bench testing conducted by Boston Scientific, the device manufacturer. The "country of origin of the data" is not explicitly stated but is implied to be internal testing by Boston Scientific (headquartered in Marlborough, MA, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" here is based on engineering specifications and performance benchmarks, not human expert interpretation of medical images or conditions. The tests are objective measurements of physical and mechanical properties.
4. Adjudication Method for the Test Set
Not applicable. Performance testing, particularly bench testing for medical devices, involves objective measurements against predefined specifications or comparison to a predicate device's performance, not subjective adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted. This device is a physical instrument, and its effectiveness is determined by its mechanical properties and ability to facilitate procedures, not by human interpretation of its output. MRMC studies are typically for diagnostic imaging devices or algorithms that aid in clinical decision-making.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical ureteral access sheath, not an algorithm or AI system. Therefore, no standalone algorithm performance study was performed.
7. Type of Ground Truth Used
The "ground truth" for this device's performance testing is based on engineering specifications and established performance characteristics of the predicate device. The tests quantify physical attributes and functional capabilities (e.g., tensile strength, stiffness, trackability, leak resistance) against acceptable ranges or the performance of a similar, already-approved device.
8. Sample Size for the Training Set
Not applicable. As this is a physical medical device and not an AI/ML algorithm requiring a training set, there is no "training set" in the context of this submission. The "training" for the device's design comes from engineering principles and existing device knowledge.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The device's design and manufacturing processes are established based on engineering standards and regulatory requirements.
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Navigator™ HD Ureteral Access Sheath Set Traditional 510(k)
SECTION 5
Boston Scientific
DEC 1 2 2012
K122649 510K SUMMARY
510(k) Summary for Navigator™ HD Ureteral Access Sheath
A. Sponsor
Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01756
B. Contact
Huda Yusuf Specialist II, Regulatory Affairs 508-683-4216 huda.yusuf(@bsci.com
or
Nichole Riek Manager, Regulatory Affairs 508-683-4175 riekn@bsci.com
C. Device Name
| Trade name: | 'Navigator™ HD Ureteral Access Sheath Set |
|---|---|
| Common/usual name: | Ureteral Access Sheath |
| Classification Name: | FED - Endoscopic Access Overtube, Gastroenterology-Urology21 CFR 876.1500 Class II |
D. Predicate Device
| Trade name: | Navigator TM Ureteral Access Sheath Set |
|---|---|
| Common/usual name: | Ureteral Access Sheath Set |
| Classification Name: | KOD – Catheter, Urological |
| 21 CFR 876.5130, Class II | |
| Premarket Notification: | Boston Scientific, K022135 (9/13/2002) and K030956 (5/23/2003) |
E. Device Description
The Navigator TM 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 semi-rigid 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.
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
{1}------------------------------------------------
510K SUMMARY
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.
The proposed device is provided sterile single use. The packaging materials used for the proposed Navigator™ HD are commonly used materials for packaging medical devices and similar to the predicate device. The device will be packaged in a labeled, single polyfilm/tyvek peel pouch, which will be placed in a labeled, paperboard shelf carton.
F. 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.
G. Technological Characteristics
The proposed device is substantially equivalent in design and materials to previously cleared devices. Like the predicate device, the proposed device has a hydrophilic coating to facilitate device placement and withdrawal.
H. 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. The Navigator™ HD is as safe, as effective, and performs as well as the predicate devices.
I. Performance Testing (Bench Evaluation)
Boston Scientific has conducted performance testing with samples aged at T=0 and T=25 months accelerated aging in support of Navigator™ HD's design change and additional size configurations. The following testing was completed to evaluate the effects of the design change and sizes:
- . Working Length
- Sheath & Dilator Outer Diameter .
- . Sheath & Dilator Stiffness
- Dilator Tip Stiffness .
- Sheath & Dilator Tensile Strength ●
- Sheath & Dilator Hub to Shaft Integrity .
- Dilator Tip to Shaft Integrity
- Latch Holding Force & Durability .
- . Dilator Luer (Compliance with ISO 594-2)
- Dilator Hub Leak Resistance .
- . Dilator/Guidewire Trackability
- . Transition Force of Dilator and Sheath Tips
- . Sheath Circular Profile
- Dilator Slideability from Sheath · .
- Sheath Internal Passage Resistance/Friction .
- Sheath Internal Passage Durability .
{2}------------------------------------------------
Navigator™ HD Ureteral Access Sheath Set Traditional 510(k)
Boston Scientific
SECTION 5
510K SUMMARY
K
22/149
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three wavy lines forming the staff and snakes, giving it a modern and abstract appearance. The text is in a sans-serif font and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 12, 2012
Boston Scientific Corporation Urology/Women's Health % Ms. Huda Yusuf, MSc Specialist II, Regulatory Affairs 100 Boston Scientific Way MARLBOROUGH MA 01752
Re: K122649
Trade/Device Name: Navigator™ HD Ureteral Access Sheath Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: November 20, 2012 Received: November 21, 2012
Dear Ms. Yusuf:
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.
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Page 2 – Ms. Huda Yusuf, MSc
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/R. 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
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Navigator™ HD Ureteral Access Sheath Set Traditional 510(k)
. Boston Scientific
SECTION 4 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - INDICATIONS FOR USE
Indications for Use Statement
| 510(k) Number | To be determined. K122649 |
|---|---|
| Device Name | Navigator™ HD Ureteral Access Sheath |
| Indications For Use | The UASS 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)
| Benjamin R. Fisher -S |
|---|
| 2012.12.12.10:31:04 -05'00' |
| (Division Sign-Off) |
| Division of Reproductive, Gastro-Renal, and |
Urological Devices 102000 510(k) Number _
§ 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.