← Product Code [KLA](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KLA) · K961895 # FLEXILOG LS 13921 (K961895) _Oakfield Instruments, Ltd. · KLA · Nov 4, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KLA/K961895 ## Device Facts - **Applicant:** Oakfield Instruments, Ltd. - **Product Code:** [KLA](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KLA.md) - **Decision Date:** Nov 4, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1725 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## 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. ## Regulatory 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. ## Predicate Devices - RMS III - The LES Locator - Biolab - Digitrapper MKIII - Digitrapper MD - PC Polygraph HR ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Oakfield Industrial Estate Stanton Harcourt Road, Eynsham, Witney, Oxon, OX8 1JA Tel: Oxford (01865) 882532 Fax: (01865) 883970 Re: 510K Submission - FLEXILOG LS, Lower Esophageal Sphincter Detector D 510K SUMMARY Oakfield Instruments Limited, Oakfield Industrial Estate, Stanton Harcourt Road, Eynsham, WITNEY, Oxfordshire, OX8 1JA, United Kingdom. TEL: (+44) 1865 882532 FAX: (+44) 1865 883970 John Giddings, Sales & Marketing Manager 13th May 1996 Trade Name: FLEXILOG LS Common Name: Lower Esophageal Sphincter Detector Classification Name: Substantial equivalence is claimed to the following devices: Sandhill Medical Inc 8955 South Ridgeline Blvd #500 Highlands Ranch CO 80126 U.S.A. RMS III The LES Locator Biolab Synectics Medical Limited 215 Willow Road ENFIELD Middlesex EN1 3BT Digitrapper MKIII Digitrapper MD PC Polygraph HR Description The FLEXILOG LS is a single channel, pressure monitoring system comprising of a module of electronics that provides transducer excitation, amplification, digitisation 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 and water perfused pressure transducers currently available in the US market. {1} OAKFIELD INSTRUMENTS LTD HEALTH CARE PRODUCTS Oakfield Industrial Estate, Stanton Harcourt Road, Eynsham, Witney, Oxon, OX8 1JA Tel: Oxford (01865) 882532 Fax: (01865) 883970 -2- ## Indications 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. ## Technological Characteristics The FLEXILOG LS is a single channel pressure measuring system similar to those in the predicate devices RMS III, the LES Locator, Digitrapper MK III and Digitrapper MD. However, the electronics are contained in a standalone box, not contained within the ambulatory pH recorder box as in the RMS II, Digitrapper MK III and Digitrapper MD. Nor does it require to be connected to a pH recorder as does the LES locator. Pressure data is displayed on a computer screen as with the multi channel Biolab and PC Polygraph HR systems. ## Testing The FLEXILOG LS has been shown to accurately measure and display pressure. ![img-0.jpeg](img-0.jpeg) --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KLA/K961895](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KLA/K961895) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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