(172 days)
RMS III, The LES Locator, Biolab, Digitrapper MKII, Digitrapper MD, PC Polygraph HR
Not Found
No
The device description explicitly states that the program does not provide any analysis or data saving options, and there are no mentions of AI, DNN, or ML.
No.
The device is used for location and measurement purposes to aid in the placement of another device (a pH sensitive catheter) for diagnosis, rather than directly treating a condition. Its function is descriptive and diagnostic support, not therapeutic.
Yes
The device's intended use is to locate the lower esophageal sphincter and measure the distance to it, which are actions performed to provide information for the subsequent accurate placement of a pH sensitive catheter to quantify gastroesophageal reflux. This process of gathering information to understand a physiological state (quantifying gastroesophageal reflux) indicates a diagnostic purpose. While it doesn't quantify reflux itself, it provides crucial preliminary diagnostic information for a diagnostic procedure.
No
The device description explicitly states it comprises a "module of electronics" and connects to a computer via an "optically isolated RS232 connector," indicating hardware components beyond just software.
Based on the provided information, the FLEXILOG LS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- FLEXILOG LS Function: The FLEXILOG LS is a pressure monitoring system used in vivo (within the living body) to locate the lower esophageal sphincter and measure a distance. It interacts directly with the patient's anatomy using a catheter.
- Lack of Sample Analysis: The description explicitly states that the device measures pressure and displays it. There is no mention of analyzing biological samples or performing tests on them.
Therefore, the FLEXILOG LS falls under the category of a medical device used for physiological measurement and anatomical localization, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
Not Found
Device Description
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 and water perfused pressure transducers currently available in the US market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower esophageal sphincter
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The FLEXILOG LS has been shown to accurately measure and display pressure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RMS III, The LES Locator, Biolab, Digitrapper MKII, Digitrapper MD, PC Polygraph HR
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left has the words "REGISTERED FIRM" surrounding a triangle. The logo on the right has a crown on top of a check mark. The text "Certificate No FM20708" is at the bottom of the image.
FIELD INSTRUMENTS LTD
HEALTH CARE PRODUCTS
Oakfield Industrial Estate, Stanton Harcourt Road, Eynsham, Witney, Oxon, OX8 1JA el: Oxford (01865) 882532
Re: 510K Submission - FLEXILOG LS, Lower Esophageal Sphincte
510K SUMMARY
Oakfield Instruments Limited, Oakfield Industrial Estate, Stanton Harcourt Road, Eynsham, WITNEY Oxfordshire, OX8 1JA, United Kingdom.
TEL: (+44) 1865 882532
(+44) 1865 883970 FAX:
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 CQ 80126 U.S.A.
Synectics Medical Limited 215 Willow Road ENFIELD Middlesex EN1 3BT
RMS III The LES Locator Biolab
Digitrapper MKII 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 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
Image /page/1/Picture/0 description: The image shows two logos side by side. The logo on the left is circular and contains the words "REGISTERED FIRM" around the perimeter. Inside the circle is a triangular shape pointing downwards. The logo on the right is a square with a crown on top and a check mark. Inside the square is a plus sign. Below the logos is the text "Certificate No. FM20708".
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.
Jonn GIDDINGS
14/3/96