(350 days)
The Solar GI system is intended to record, store, view and analyse pressure, EMG, swallow and respiration and various auxiliary input device data on-line anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphirycter of oddi, small bowel, colon and anorectal area including rectum and pelvic flor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Solar GI". It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication methods), or training set information.
Therefore, I cannot provide the requested information based on the input text. The letter only confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.
§ 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).