(25 days)
This device is intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP
The proposed Endoscopic Wire Guide is a modification to existing wire guides currently marketed by Wilson-Cook Medical, Inc. The Endoscopic Wire Guide is .025" in diameter and is compatible with a full range of Wilson-Cook accessories.
The provided 510(k) summary (K122816) does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML powered medical device.
This document describes an "Endoscopic Wire Guide," which is a physical medical device (a wire guide for ERCP procedures). The performance data section states: "We believe risks associated with the modifications to the subject device to be adequately addressed through our Design Control Processes. We believe the proposed device to be substantially equivalent to the named predicate in terms of its intended use, performance characteristics tested and biocompatibility."
This suggests that the performance evaluation was likely based on traditional engineering tests, biocompatibility assessments, and comparison to a predicate device's established performance, rather than a clinical study with acceptance criteria related to diagnostic accuracy, sensitivity, specificity, or human reader improvement, which would be typical for an AI/ML-powered device.
Therefore, I cannot provide the requested information for acceptance criteria and related study details for an AI/ML device from this submission.
§ 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.