(142 days)
The Flexor® Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract. Thirteen (13) cm length is intended for use in pediatric patients two (2) years of age and over.
The Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
The Flexor® Ureteral Access Sheath and Flexor® ParalleI™ Rapid Release™ Ureteral Access Sheath are available with outside diameters ranging from 9.5 to 14 French and lengths ranging from 13 to 55 centimeters. These devices are available in a single lumen configuration and include a sheath and a dilator. The dilator component includes a tapered and a hydrophilically coated distal tip. In addition, the Flexor Parallel Rapid Release Ureteral Access Sheath also includes a skive and slit in the tip of the dilator which allows the wire guide to run outside and parallel to the sheath and to be separated from the sheath while inside the body to serve as a safety wire. Both Ureteral Access Sheaths are constructed of Nylon with a 304 Stainless Steel coil and a TFE liner. The dilator component is constructed of polyethylene.
The provided text is a 510(k) summary for the Flexor® Ureteral Access Sheath and Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
However, the document does not contain information about:
- A table of acceptance criteria and reported device performance for specific metrics. It lists types of tests performed (e.g., Dilator Buckling Force, Sheath Tensile Strength, Kink Resistance) but does not provide quantitative acceptance criteria or the specific numerical results obtained for these tests.
- Sample sizes used for a test set (clinical or otherwise)
- Data provenance (country of origin, retrospective/prospective)
- Number of experts or their qualifications for establishing ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth used (pathology, expert consensus, outcomes data)
- Sample size for the training set
- How ground truth for the training set was established
This type of information is typically found in clinical study reports or detailed engineering design verification reports, which are not included in this 510(k) summary. The summary focuses on demonstrating substantial equivalence through a comparison of technological characteristics and general testing categories.
Therefore, for the requested information, I must state:
The provided document does not contain the specific details regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment relevant to the performance metrics of the device as if it were an AI/CADe device.
The document primarily states that "The following tests were performed to demonstrate that the Flexor® Ureteral Access Sheath and Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath met applicable design and performance requirements and support a determination of substantial equivalence." It then lists categories of tests:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Generic Description from Document) | Reported Device Performance (Generic Statement from Document) |
|---|---|
| Device specific testing requirements - Mechanical (e.g., Dilator Buckling Force, Sheath Tensile Strength, Dilator Tensile Strength, Sheath to Hub Tensile Strength, Dilator to Hub Tensile Strength, Dilator Tip Tensile Strength) | "met applicable design and performance requirements" |
| Device specific testing requirements - Functional (e.g., Lubricity Length, Kink Resistance, Bench Testing/Simulated Use, Tip Flexibility, Sheath Inner Lumen Passability (Resistance), Sheath Inner Lumen Durability) | "met applicable design and performance requirements" |
| Device specific testing requirements - Radiopacity | "met applicable design and performance requirements" |
| General testing requirements (e.g., Biocompatibility, Sterilization, Distribution Testing, Shelf Life/Stability) | "met applicable design and performance requirements" |
Note: The document only provides categories of tests and a general statement of compliance, not specific quantitative criteria or results.
2. Sample size used for the test set and the data provenance: Not mentioned in the provided text. The listed tests appear to be bench and laboratory tests, not clinical trials with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. This device is not an AI/CADe system requiring expert ground truth in this context.
4. Adjudication method for the test set: Not applicable/not 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. This is not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
7. The type of ground truth used: For the physical and functional tests, the ground truth would be the established engineering specifications and recognized testing standards (e.g., ISO, ASTM). For biocompatibility, it's defined by biological response criteria.
8. The sample size for the training set: Not applicable. This is not an AI/CADe device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/CADe device.
§ 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.