(53 days)
The US Endoscopy Distal Attachment Cap has been designed to the distal end of the endoscope to facilitate endoscopic therapy.
The US Endoscopy Distal Attachment Cap is intended for the following.
- Gastrointestinal mucosal resection (endoscopic mucosal resection) .
- Keeping the suitable depth of the endoscope's view field
The US Endoscopy Distal Attachment Cap has been designed to the distal end of the endoscope to facilitate endoscopic therapy.
The provided document is a 510(k) premarket notification letter from the FDA to United States Endoscopy Group, Inc. regarding their device, "The US Endoscopy Distal Attachment Cap." This document confirms that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices.
However, this document does not contain a detailed study description with specific acceptance criteria and performance data. The FDA letter is a regulatory approval, not a scientific study report. It merely states that "we have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This implies that the manufacturer submitted a study or data to the FDA, but the details of that study, including the acceptance criteria, sample sizes, ground truth establishment, or specific performance metrics, are not present in this letter.
Therefore, I cannot provide the requested information from this document. The letter itself does not describe the acceptance criteria or a specific study that proves the device meets those criteria.
§ 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.