(304 days)
WellCare Anoscope is intended for transanal use to provide physicians access to the anal sphincter, anus, and rectum and to perform various diagnostic and therapeutic procedures using additional accessories.
WellCare Anoscope is composed of Anoscope, Introducer and Sleeve.The anoscopes are divided into the following models according to the way the components are configured and the differences in size : WellCare-ANO-Light Sterile . WellCare-ANO-Truncated Sterile.This is a single use, disposable device(s), provided sterile.
The provided text describes the regulatory clearance of the WellCare Anoscope by the FDA, primarily relying on non-clinical (bench) testing. There is no information about any study that proves the device meets specific performance criteria related to AI or human-in-the-loop performance. The device described is a physical medical instrument, an anoscope, not a software or AI-driven diagnostic tool. Therefore, many of the requested details, such as those pertaining to AI assistance, ground truth establishment, expert qualifications, adjudication methods, and training/test set sizes for AI, are not applicable to this submission.
Here's the relevant information based on the provided text, focusing on the acceptance criteria and the non-clinical study conducted for the WellCare Anoscope:
1. A table of acceptance criteria and the reported device performance
| ID# | Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 1 | Appearance | Smooth surface of all parts, no sharp edges, no burrs. | Pass |
| 2.1 | Compatibility | The anal expander and the guide mirror opened and closed easily with the scope, without swing and jam. The end of the anal expander should be smooth and anastomosed with the endoscope, and the maximum gap should not be greater than 0.6mm. | Pass |
| 2.2 | Material strength | Any of the components (excluding the light source) should be able to withstand a 4 kg suspension without significant deformation. | Pass |
| 3.1 | Reducing substances (oxide prone) | The difference in the volume of potassium permanganate solution [ c(1/5KMnO4) = 0.01 mol/L ] consumed by the test solution and the blank control solution should not exceed 2.0 mL. | 0.4ml |
| 3.2 | pH | The difference between the pH of the test solution and that of the blank control solution should not exceed 1.5. | 1.01 |
| 3.3 | EO/ECH residues | Average daily dose to patient: EO |
§ 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.