(55 days)
The G&J Electronics Distender Series II Dual Drive Barostat device with the Protocol Plus software is an electro-pnuematic device used for volume/pressure measurement in tho alimentrary tract. This device is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of pationts with symptoms consistent with gastrointestinal motility disorders.
The G&J Electronics Distender Series II Dual Drive Barostat device with the Protocol Plus software is an electro-pnuematic device used for volume/pressure measurement in tho alimentrary tract.
The provided text is a 510(k) clearance letter from the FDA for a device called "Distender Series II Barostat" and its "Indications For Use." It does not contain information about acceptance criteria, device performance, a study conducted, sample sizes, ground truth establishment, or expert details.
Therefore, I cannot provide the requested information. The document serves as a regulatory approval and outlines the intended use of the device but does not detail the technical performance or validation studies.
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).