(260 days)
The Well Lead 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 Well Lead Ureteral Access Sheath is a single use sterile device, provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures. The Ureteral Access Sheath is comprised of three components: sheath, dilator and connector. The outer surface of the sheath has a hydrophilic coating. When activated, the hydrophilic feature allows for easier insertion and removal of the sheath. The sheath is offered in three French sizes: 10Fr, 12Fr and 14Fr, and range in length from 13cm (shortest) to 55cm (longest).
I am sorry, but the provided text is a 510(k) summary for a medical device (Well Lead Ureteral Access Sheath) and does not contain the specific information requested regarding an AI device's acceptance criteria and the study proving it meets those criteria.
The document focuses on the regulatory clearance process for a physical medical device, outlining its specifications, intended use, and substantial equivalence to predicate devices. It refers to performance testing for the physical device characteristics (e.g., attachment security, bending resistance, coefficients of friction, dimensions, biocompatibility), but not AI performance metrics like sensitivity, specificity, or reader improvement.
Therefore, I cannot fulfill your request based on the provided input.
§ 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.