FLEXILOG 3000

K964589 · Oakfield Instruments, Ltd. · KLA · Mar 4, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964589
• Device Name: FLEXILOG 3000
• Applicant: Oakfield Instruments, Ltd.
• Product Code: KLA · Gastroenterology, Urology
• Decision Date: Mar 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2

Intended Use

The FLEXILOG 3000 system is to be used for the recording, display and analysis of pH and pressure data from the upper gastrointestinal tract in ambulant subjects. It provides information that aids in the diagnosis and management of motility disorders. The FLEXILOG 3000 also has a limited stationary manometry capability to aid sensor placement prior to an ambulatory study.

Device Story

Ambulatory/stationary multi-channel recording system; collects pH and pressure data via plug-in modules; supports up to 24 channels. Ambulatory mode stores data on PCMCIA card for later PC upload; stationary mode transmits via isolated RS232 to PC. Operated by clinicians in clinical settings. FLEXISOFT III Windows-based software displays signals, performs analysis, and generates reports. Output aids clinicians in diagnosing/managing GI motility disorders and verifying sensor placement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-channel recording system; modular parameter electronics; PCMCIA memory card storage; RS232 serial connectivity; Windows-based software (FLEXISOFT III); compatible with third-party pH and pressure catheters.

Indications for Use

Indicated for ambulant subjects requiring recording, display, and analysis of upper gastrointestinal tract pH and pressure data to aid diagnosis and management of motility disorders.

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.

Predicate Devices

• Superlogger (Sandhill Medical Inc)
• MicroDigitrapper (Synectics Medical Inc)
• UPS-2020 (Medical Measurement Systems)

Submission Summary (Full Text)

{0}

Re: FDA 510(k) Submission -
FLEXILOG 3000 Multi Channel, Multi Parameter, Recording System

# 510(k) SUMMARY

Oakfield Instruments Limited,
Oakfield Industrial Estate,
Stanton Harcourt Road,
Eynsham, WITNEY,
Oxfordshire, OX8 1JA,
United Kingdom.

MAR - 4 1997

K964589
P192

TEL: [phone]
FAX: [phone]

John Giddings, Sales & Marketing Manager
28th October 1996

Trade Name: FLEXILOG 3000
Common Name: Multi Channel, Multi Parameter Recording System
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. | Superlogger |
| --- | --- |
| Synectics Medical Inc
1425 Greenway Drive
Irving
TX 75038, U.S.A. | MicroDigitrapper |
| Medical Measurement Systems
PO Box 40178
7504 RD Enschede
THE NETHERLANDS | UPS-2020 |

## 1. Description

The FLEXILOG 3000 system is a multi channel, multi parameter, ambulatory recording system with stationary capability. It is comprised of a recorder that supports data collection on up to 24 channels. The data collected is determined by up to 5 plug-in parameter modules. At present only pH (4 channel) and pressure (3 channel) modules are available. Multiple modules of the parameters can be installed to give the required number of channels.

In ambulatory mode, data is saved onto a PCMCIA card and subsequently uploaded to the computer. In stationary mode, data is transferred via a patient isolated RS232 outlet to the computers serial port. The signals, recorded or online, are displayed on the computer VDU via a Microsoft Windows based program, FLEXISOFT III.

FLEXISOFT III provides display, analysis and report generation options.

The FLEXILOG 3000 is compatible with pressure and pH catheters currently approved for sale in the U.S.A. and manufactured and marketed by third parties.

OAKFIELD INSTRUMENTS LTD 28.10.96 Page 1 of 2

{1}

Re: FDA 510(k) Submission -
G-2

# FLEXILOG 3000 Multi Channel, Multi Parameter, Recording System

## 510(k) SUMMARY

R964589
P2-72

### 2. Indications for use

The FLEXILOG 3000 system is to be used for the recording, display and analysis of pH and pressure data from the upper gastrointestinal tract in ambulant subjects. It provides information that aids in the diagnosis and management of motility disorders. The FLEXILOG 3000 also has a limited stationary manometry capability to aid sensor placement prior to an ambulatory study.

### 3. Technology Characteristics

The FLEXILOG 3000 is similar to the predicate devices having both ambulatory and stationary capability; being multi channel and recording both pH and pressure data. The system differs in that the parameter electronics are modular and data is saved to a PCMCIA memory card.

Control display and analysis software are Microsoft Windows based.

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