(28 days)
The EndoGator Endoscopy Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit).
The ENDOGATOR Endoscopy Irrigation Tubing is composed of the following: 1) EndoGator™ Irrigation Tubing, and 2) EndoGator™ Irrigation Accessories. The ENDOGATOR Endoscopy Irrigation Tubing is indicated for irrigation during endoscopic procedures by using it in conjunction with an irrigation pump or cautery units, irrigation accessory, endoscope and disposable sterile water bottle. All tubing sets contain a back flow valve at the distal tip that allows irrigation water to travel in one direction, and therefore the risk of cross contamination is significantly reduced. The irrigation tubing sets are for twenty-four hour use and are to be discarded daily. The accessories are single-use devices and are to be discarded between patients. Tubing sets do not come into direct contact with patient tissue.
The provided text describes the 510(k) Summary for the ENDOGATOR Endoscopy Irrigation Tubing. This document details a medical device and its comparison to a predicate device for substantial equivalence with the FDA. It does not contain information about the acceptance criteria and study design for an AI/ML powered device.
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML powered medical device, nor can I describe a study proving the device meets said criteria from this document. The document pertains to non-clinical performance testing of irrigation tubing, not an AI/ML diagnostic or therapeutic 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.