(250 days)
The FLEXILOG LS is used for the location of the lower and/or upper esophageal sphincter and the measuring of the nares to esophageal sphincter distance. This procedure being carried out prior to the accurate placement of a pH sensitive catheter for an ambulatory pH study to quantify gastroesophageal reflux.
The FLEXILOG LS, Esophagea1 Sphinctor Locator, is to be used for the manometric location of the lower and upper esophageal sphincters. That is the measurement of the distance from the nares to the sphincter.
The FLEXILOG LS is a single channel, pressure monitoring system comprising of a module of electronics that provides transducer excitation, amplification and transmission of the signal to a computer via an optically isolated RS232 connector. The pressure signal is displayed on the computer VDU via a Microsoft Windows display program. The program does not provide any analysis or data saving options.
The electronics module is designed to be compatible with catheter tip perfused pressure transducers currently available in the US market.
The provided document is a 510(k) premarket notification for the FLEXILOG LS Esophageal Sphincter Detector. It does NOT contain information about acceptance criteria or a study proving that a device meets such criteria.
The document includes:
- Trade Name: FLEXILOG LS
- Common Name: Esophageal Sphincter Detector
- Classification Name: Monitor, esophageal motility and tube
- Indications for Use: For the location of the lower and/or upper esophageal sphincter and the measuring of the nares to esophageal sphincter distance, prior to accurate placement of a pH sensitive catheter for an ambulatory pH study to quantify gastroesophageal reflux.
- Description: A single-channel pressure monitoring system that provides transducer excitation, amplification, and signal transmission to a computer via an optically isolated RS232 connector. The pressure signal is displayed on a computer VDU without analysis or data saving options.
- Technological Characteristics: Similar to predicate devices (FLEXILOG LS Lower Esophageal Sphincter Detector, RMS III, the LES Locator, Digitrapper MKIII, Digitrapper MD) but with electronics in a standalone box, not integrated with ambulatory pH recorders, and not requiring connection to a pH recorder. Displays data on a computer screen.
- Testing: Only a general statement is provided: "The FLEXILOG LS has been shown to accurately measure and display pressure." No specific study details, methodology, sample sizes, ground truth establishment, or acceptance criteria are given.
- Predicate Devices: Oakfield Instruments Limited, FLEXILOG LS; Sandhill Medical Inc., RMS III; Biolab, The LES Locator; Synectics Medical Limited, Digitrapper MKIII; Synectics Medical Limited, Digitrapper MD PC Polygraph HR.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.
§ 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).