(54 days)
The GastroFlex M™ series of Confocal Miniprobes™ are intended to allow imaging of the internal microstructure of tissues in the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.
The GastroFlex™ M series of Confocal Miniprobes are used as part of the Cellvizio® 100 Series system and the Cellvizio" system, to allow imaging of the internal microstructure of tissues in the gastrointestinal system accessed by an endoscope or endoscopic accessories.
The provided text is a 510(k) Premarket Notification summary for the Cellvizio® 100 Series System and Cellvizio® System with Confocal Miniprobes™. It primarily focuses on demonstrating substantial equivalence to a predicate device and modifying the "Indications for Use."
Crucially, the provided document does NOT contain a study with acceptance criteria and reported device performance as requested. The document states that "Verification and validation testing has shown that the GastroFlex M™ Confocal Miniprobes are compatible with endoscopes and endoscopic accessories designed and commonly used for biliary and pancreatic imaging," but it does not present the details of such testing, acceptance criteria, or performance outcomes.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I describe a study that proves the device meets those criteria, as this information is not present in the provided text.
The document mainly focuses on:
- Device Description: The GastroFlex M™ Confocal Miniprobes are used with the Cellvizio system for imaging internal tissue microstructures in the gastrointestinal system, including biliary and pancreatic ducts. The current submission is for revisions to the Indication for Use, specifically verifying compatibility with specialized endoscopes.
- Comparison to Predicate Device: The subject device is stated to be identical to the previously cleared GastroFlex M™ Confocal Miniprobes (K120208). The change is to the Indications for Use to be consistent with the cleared device and the Boston Scientific SpyGlass Direct Visualization Probe.
- Indications for Use: The GastroFlex M™ series is intended to allow imaging of internal microstructures in the upper gastrointestinal tract, including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.
§ 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.