(242 days)
The Motility Visualization System obtains a high resolution mapping of pressures within tubular organs of the gastrointestinal tract. These organs include the esophagus from the pharyngeal region to the stomach, the proximal gut (stomach/duodenum), and the anus/recturn. It is used in a medical clinical setting to sense the pressures and store the corresponding data. The system also provides analysis information. The real time data as well as the analysis information can then be viewed by a physician for diagnostic and analysis purposes.
The Motility Visualization System (MVS) obtains a high resolution mapping of pressures within tubular organs of the gastrointestinal tract. It is used in a medical clinical setting to sense the pressures along the gastrointestinal tract and stores the corresponding data. The system also provides analysis information. The real time data as well as the analysis information can be viewed by a physician for diagnostic and analysis purposes.
The system includes a catheter probe with 36 pressure sensing elements. During the clinical procedure, the catheter is inserted transnasally and pressures inside the upper esophageal sphincter (UES), esophagus, lower esophageal sphincter (LES), and proximal gut are measured as the patient typically swallows small amounts of water. Alternatively, the catheter may be inserted in the anus/rectum for measurement of contractile pressures in that region. Real-time data is sampled from each sensing element via the MVS interface electronics and made available to the MVS software during each sample period. The software displays the data in real-time to support the clinical procedure.
The software also supports operational utility functions such as providing the user an interface for operating the pressure calibration system. It obtains the catheter sensor and calibration chamber data during the calibration process and determines the correction factors to be used in subsequent data collection.
The MVS supports physician diagnosis and analysis by means of a playback function, which replays a stored session using previously recorded data instead of real-time data. The MVS also indicates estimated parameters such as LES location, LES resting pressure, LES relaxation, LES residual pressure inversion point (PIP) location, UES pressure, and motility metrics such as peristaltic wave amplitude, duration and velocity.
The provided text refers to a 510(k) Summary for the Motility Visualization System (MVS). It describes the device, its intended use, and claims substantial equivalence to a predicate device (K011472 - Medtronic, Polygraf ID and Polygram 98 software). However, it does NOT contain details about acceptance criteria, specific studies, sample sizes, ground truth establishment, or expert involvement as requested.
Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text. The document is primarily a descriptive summary for regulatory submission, not a 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).