(118 days)
The disposable Capsule Delivery Device is a single sheathed device indicated for transendoscopic delivery of the M2A® Capsule Endoscope to the duodenum in patients who are either unable to swallow the M2A® Capsule Endoscope, or unable to pass the M2A® Capsule Endoscope beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.
The disposable Capsule Delivery Device is a single sheathed device.
I am sorry, but the provided text is a 510(k) clearance letter for a "Capsule Delivery Device" and does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices, but it does not detail any performance metrics or studies to support this. Therefore, I cannot extract the requested information from the provided text.
§ 876.1300 Ingestible telemetric gastrointestinal capsule imaging system.
(a)
Identification. An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.(b)
Classification. Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”