(87 days)
Grasping forceps are intended to be used to grasp tissue and / or retrieve foreign bodies, excised tissue, and stents from within the gastrointestinal tract.
The EndoChoice grasping forceps are designed for grasping tissue and / or retrieving foreign body, and excised tissue under endoscopic visualization. These forceps consist of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws.
The provided text describes a 510(k) premarket notification for the EndoChoice Grasping Forceps. Crucially, the document states: "No performance standards exist for this device." and "No performance data or studies were required to establish substantial equivalence for the EndoChoice Grasping Forceps."
Therefore, a detailed table of acceptance criteria and reported device performance, and information about specific studies, training/test sets, ground truth, and expert involvement, as requested, cannot be provided from the given text.
The submission focuses on establishing substantial equivalence to a predicate device (Olympus FG – 4/14/20/21/22/26/32/38/40/##-1) based on technological characteristics and intended use, rather than formal performance testing against defined acceptance criteria.
The conclusion of the 510(k) summary explicitly states: "Based on the technological characteristics and overall performance of the devices, EndoChoice, Inc. believes that the grasping forceps and the predicate device selected are substantially equivalent and that the differences between the devices are minor which do not raise new issues of safety or effectiveness."
In summary, none of the requested information (performance data, specific acceptance criteria, study details, sample sizes, ground truth methodology, or expert involvement) is present in the provided K101298 submission. The device was cleared based on its similarity to existing devices.
§ 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.