(30 days)
Biopsy valves are intended to provide access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.
The EndoChoice biopsy valve can be manufactured with a choice of two types – regular disposable biopsy valve and irrigating biopsy valve. Each of these types can be ordered for Olympus, Fujinon, and Pentax gastrointestinal endoscopes.
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) summary for a medical device (EndoChoice Biopsy Valves) which focuses on demonstrating substantial equivalence to a predicate device.
Here's why the requested information cannot be extracted from this document:
- No performance standards: The text explicitly states, "No performance standards exist for this device." This implies there are no pre-defined quantitative acceptance criteria that the device needs to meet through a specific performance study.
- Substantial Equivalence: The entire submission is based on showing "substantial equivalence" of the EndoChoice Biopsy Valve to a predicate device (US Endoscopy - Bioshield - ERCP Biopsy Valve). This means the focus is on comparing technological characteristics and overall performance to an already legally marketed device, rather than proving performance against new, independent acceptance criteria.
- Lack of detailed study data: The document mentions "Performance Data" but does not elaborate on any specific study, its design, sample size, ground truth, or statistical analysis. It only concludes that based on technological characteristics and overall performance, the device is substantially equivalent, and differences are minor without new safety or effectiveness issues.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, or MRMC studies because this information is not present in the provided 510(k) summary.
§ 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.