FLEXILOG LS 13921
Device Facts
| Record ID | K961895 |
|---|---|
| Device Name | FLEXILOG LS 13921 |
| Applicant | Oakfield Instruments, Ltd. |
| Product Code | KLA · Gastroenterology, Urology |
| Decision Date | Nov 4, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1725 |
| Device Class | Class 2 |
Indications for Use
The FLEXILOG LS is used for the location of the lower esophageal sphincter and the measuring of the nares to lower 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.
Device Story
FLEXILOG LS; single-channel pressure monitoring system. Inputs: pressure signals from catheter-tip or water-perfused pressure transducers. Processing: transducer excitation, signal amplification, digitization, transmission via optically isolated RS232 to PC. Output: real-time pressure signal display on Windows-based VDU. Usage: clinical setting; operated by healthcare professionals. Function: assists in locating lower esophageal sphincter and measuring nares-to-sphincter distance to guide pH catheter placement for gastroesophageal reflux quantification. No automated analysis or data storage features.
Clinical Evidence
Bench testing only. Device demonstrated accurate measurement and display of pressure signals.
Technological Characteristics
Single-channel pressure monitoring system. Compatible with standard catheter-tip and water-perfused pressure transducers. Standalone electronics module. Connectivity: optically isolated RS232 interface to PC. Software: Windows-based display program for real-time visualization. No data analysis or storage algorithms.
Indications for Use
Indicated for patients undergoing ambulatory pH studies requiring location of the lower esophageal sphincter and measurement of the nares to lower esophageal sphincter distance for accurate pH catheter placement.
Regulatory Classification
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.
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