(90 days)
The Kongsberg Instruments Inc. Motility Probe is manufactured for use in the evaluation and diagnosis of gastrum lerological dysfunction related to muscir tonus and the coundination of contractions between muscle groups. The Motility frobe provides several types of information with may be used in these diagnoses. Primary among these is pressure information at multiple sensor sites. Secondary to the pressure information is the ability of the probe to measure pH in the Stomach and esophagus. This can reveal the presence of gastric reflux from the stomach into the esophair.
Motility Probes: models P31-P38, P40-P43, and P50
This document is a 510(k) clearance letter from the FDA for a medical device called "Motility Probes." It does not contain a study proving the device meets acceptance criteria, nor does it provide acceptance criteria or device performance data.
Instead, this letter confirms that the FDA has found the device to be "substantially equivalent" to predicate devices already on the market, based on the information submitted by the manufacturer, Konigsberg Instruments, Inc. This clearance allows the manufacturer to market the device for the stated Indications for Use.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The document is a regulatory approval, not a scientific study report.
§ 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).