(57 days)
Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract via antegrade and/or retrograde access.
The UASS II is designed to create a conduit for urological procedural instruments. This set consists of two components: an inner tapered semi-rigid dilator and an outer more flexible sheath. The outer flexible sheath fits over the semi-rigid inner dilator and it may be locked into place. These components are radiopaque and have a lubricous hydrophilic coating. The device is offered in two French sizes, 11/13 Fr, and 13/15 Fr. in lengths up to 46cm. The UASS II may be placed retrograde and/or antegrade. 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 working channel of 11 and 13 Fr, respectively. The proposed device is provided sterile single use. The packaging materials used for the proposed UASS 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 double sealed, which will be placed in a labeled, paperboard shelf carton.
The provided document is a 510(k) premarket notification for a medical device called the "Ureteral Access Sheath Set II" (UASS II). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria for device performance as would be found in a PMA (Premarket Approval) application.
Therefore, the document does not contain the detailed clinical study information typically provided for AI/ML-based devices, such as a table of acceptance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC studies. The device in question is a physical medical instrument, not an AI/ML algorithm.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide specific quantitative acceptance criteria or detailed performance results in a table format as would be seen for an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device.
The "performance data" mentioned focuses on physical comparison and functional testing to support this equivalence. The reported "performance" is that the device is determined to be substantially equivalent to the predicate.
| Acceptance Criteria Type (Inferred) | Reported Device Performance |
|---|---|
| Design Equivalence to Predicate | The UASS II is "substantially equivalent in design" to previously cleared devices. Description highlights two components (inner tapered semi-rigid dilator, outer more flexible sheath), radiopacity, and lubricious hydrophilic coating, which are characteristic of existing ureteral access sheaths. |
| Materials Equivalence to Predicate | The UASS II is "substantially equivalent in... materials" to previously cleared devices. Mention of packaging materials being "commonly used materials for packaging medical devices and similar to the predicate device." |
| Intended Use Equivalence | The UASS II has the same "intended use" as the predicate: "to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract via antegrade and/or retrograde access." |
| Principle of Operation Equivalence | The UASS II is "substantially equivalent to devices previously cleared... in terms of... principles of operation." It functions by creating a conduit and is advanced over a guidewire, visualized under fluoroscopy, similar to predicate devices. |
| Functional Testing (Implied) | "Results of physical comparison and functional testing support a determination of substantial equivalence..." Specific parameters or metrics of this functional testing are not detailed in this summary. These would likely include aspects like dimensional accuracy, guidewire compatibility, coating integrity, and mechanical strength. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not describe a "test set" in the context of clinical data for an AI/ML algorithm. For a physical device like this, "testing" would refer to engineering and bench testing. The sample sizes for these tests are not provided in this summary. Data provenance (country of origin, retrospective/prospective) is not applicable here as it's not a clinical data study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable. "Ground truth" in this context typically refers to clinical diagnoses or outcomes for AI/ML evaluation. For a physical device, testing involves engineering standards and functional verification, not expert interpretation of clinical cases for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as there's no clinical test set requiring expert adjudication mentioned.
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. MRMC studies are specific to evaluating human performance with and without AI assistance, which is not relevant for a physical ureteral access sheath.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for a physical device is its adherence to design specifications, material properties, and functional performance as determined by engineering tests and manufacturing standards, not clinical diagnostic outcomes.
8. The sample size for the training set:
Not applicable. "Training set" refers to data used to train an AI/ML model, which this device is not.
9. How the ground truth for the training set was established:
Not applicable.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of a human figure with outstretched arms, which is meant to symbolize care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. The logo is simple, yet recognizable, and represents the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Boston Scientific Corporation Microvasive Urology Ms. Janet A. McGrath Senior Regulatory Affairs Specialist, Urology One Boston Scientific Place Natick, MA 01760-1537
JUL 2 7 2015
K030956 Re: Trade/Device Name: Ureteral Access Sheath Set II Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KOD, FED Dated (Date on orig SE ltr): May 2, 2003 Received (Date on orig SE ltr): May 5, 2003
Dear Ms. McGrath,
This letter corrects our substantially equivalent letter of May 23, 2003.
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
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Page 2 -
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. 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 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 contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/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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Special 510 (k) Premarket Notification Ureteral Access Sheath Set II
Boston Scientific Corporation March 26, 2003
.. –
.. ». "
Indications for Use Statement
510(k) Number (if Known):
UASS II Device Name:
Indications for Use:
Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract via antegrade and/or retrograde access.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use / OR
Over-The-Counter Use (Optional Format 1-2-96)
David G. Seager
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Confidential and Proprietary to Boston Scientific Corporation
000002
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Boston Scientific Corporation March 26, 2003
Summary of Safety and Effectiveness
| 510(k) Summary: UASS IIMAY 23 2003 | |
|---|---|
| SPONSOR: | Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760 |
| CONTACT PERSON: | Janet A. McGrathSenior Regulatory Affairs SpecialistOrLorraine M. HanleyDirector Regulatory Affairs |
| DEVICE: | Ureteral Access Sheath Set II |
| TRADE NAME: | Navigator™ Access Sheath Set |
| COMMON NAME: | Ureteral Access Sheath Set |
| CLASSIFICATION: | Class II; 876.1500, Endoscope and AccessoriesClass II; 876.5130, Urological Catheter and Accessories |
| PREDICATE DEVICE: | Ureteral Access Sheath Set |
| DESCRIPTION: | The UASS II is designed to create a conduit for urologicalprocedural instruments. This set consists of two components: aninner tapered semi-rigid dilator and an outer more flexiblesheath. The outer flexible sheath fits over the semi-rigid innerdilator and it may be locked into place. These components areradiopaque and have a lubricous hydrophilic coating. The deviceis offered in two French sizes, 11/13 Fr, and 13/15 Fr. in lengthsup to 46cm.The UASS II may be placed retrograde and/or antegrade. Toguide the access sheath into the body orifice the dilator isadvanced over up to a .038" guidewire. The device can bevisualized under x-ray (fluoroscopy) during placement to confirmlocation. The proposed device can accept other urologicalinstrumentation with OD's compatible with the sheath's workingchannel of 11 and 13 Fr, respectively. |
The proposed device is provided sterile single use. The packaging materials used for the proposed UASS are commonly used materials for packaging medical devices and similar to the predicate device. The device will be packaged in a labeled, single
Confidential and Proprietary to Boston Scientific Corporation
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Special 510 (k) Premarket Notification Ureteral Access Sheath Set II
Boston Scientific Corporation March 26. 2003
polyfilm/tyvek peel pouch double sealed, which will be placed in a labeled, paperboard shelf carton.
INTENDED USE: The UASS II 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 antegrade and/or retrograde access. TECHNOLOGICAL The proposed device is substantially equivalent in design and CHARACTERISTICS: materials to previously cleared devices. The proposed device has hydrophilic coating to facilitate device placement and
withdrawal. Results of physical comparison and functional testing support a PERFORMANCE DATA: determination of substantial equivalence for the proposed device when compared to the predicate device. The proposed device is substantially equivalent to devices previously cleared via the 510(k) path in terms of technology, principles of operation, intended use, and materials.
Confidential and Proprietary to Boston Scientific Corporation
§ 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.