(265 days)
The ArgoCap has been designed to be attached to the distal end of the endoscope to facilitate endoscopic therapy.
The ArgoCap is intended for the following:
- Gastrointestinal endoscopic mucosal resection and coagulation
- Keeping the suitable depth of the endoscope's view field
Not Found
I am sorry, but the provided text from the FDA 510(k) clearance letter for the ArgoCap (200.52) does not contain any information regarding the acceptance criteria or the study that proves the device meets the acceptance criteria.
This document is a formal notification of substantial equivalence for a medical device, outlining regulatory information such as:
- Device name and product codes
- Regulation numbers and regulatory class
- Indications for Use
- General controls provisions of the Act
- Links to FDA guidance documents
- Requirements for Quality System (QS) regulation, UDI rule, and medical device reporting
It does not include details about:
- Specific performance metrics or acceptance criteria for the device itself
- Clinical or non-clinical study design, results, or statistical analyses
- Sample sizes, data provenance, ground truth establishment, or expert qualifications
- Adjudication methods or MRMC studies
Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported performance, nor can I provide information on the various aspects of the study mentioned in your prompt, as none of that data is present in the document.
§ 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.