(29 days)
The Wilson-Cook USW Cap and Wire Lock Device is an accessory to be used The Wilson Occh Cook Copy on one guide(s) in place during ERCP procedures.
This device is an accessory to be used with endoscopic biliary devices to lock the wire guide(s) in place during ERCP procedures. The device is supplied sterile and is intended for single use only.
The proposed USW Cap and Wire Guide Locking Device is and one-piece integrated system that secures onto the accessory channel of an endoscope. The access port in the center of the cap allows access of wire quides and other biliary accessories. The wire quide lock allows the practitioner to lock the wire guide in place for continued ductal access while proceeding with other ERCP therapies.
The provided text is a 510(k) summary for the Wilson-Cook USW Cap and Wire Lock, which is a medical device accessory used during ERCP procedures. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against specific acceptance criteria for a new AI/medical software device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not available in this document.
This type of submission (a 510(k)) typically relies on comparisons to legally marketed predicate devices to establish safety and effectiveness, rather than extensive new clinical performance studies with defined acceptance criteria in the way a novel AI/software device would. The "Performance Data" section explicitly states: "We believe the proposed device to be substantially equivalent to the named predicates in terms of Intended Use and performance characteristics tested." This implies that the performance evaluation was a comparison to existing devices, not a standalone study with defined acceptance criteria and detailed quantitative results presented here.
§ 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.