ESOPHAGEAL MANOMETRY ANALYSIS MODULE

K961070 · Synectics Medical, Inc. · KLA · Jun 11, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961070
• Device Name: ESOPHAGEAL MANOMETRY ANALYSIS MODULE
• Applicant: Synectics Medical, Inc.
• Product Code: KLA · Gastroenterology, Urology
• Decision Date: Jun 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The Esophageal Manometry Analysis Module has been designed to analyze intragastroesophageal pressure data throughout the gastrointestinal tract. The Esophageal Manometry Analysis Module has been designed for the same intended use (analyze intragastroesophageal pH data) in both pediatric and adult populations. The product is to be used on patients in the hospital environment under supervision of a trained physician.

Device Story

Module functions as add-on to Polygram Software for Windows; processes intragastroesophageal pressure data; performs physiological analysis and compares results against normal values; outputs analyzed data for screen review or printing; used in hospital environments by trained physicians; assists in clinical assessment of gastrointestinal pressure parameters.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based analysis module; operates within Polygram Software for Windows environment; processes physiological pressure signals; provides automated parameter calculation and comparison against normative values.

Indications for Use

Indicated for pediatric and adult patients requiring analysis of intragastroesophageal pressure data throughout the gastrointestinal tract. Used in hospital settings under physician supervision.

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

• Polygram Software for Windows (K946322)

Submission Summary (Full Text)

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K961070

JUN 11 1996

# 9. SMDA 510(k) Summary or Statement

DRAERD 510(k)
Summary of Safety and Effectiveness Information

## Esophageal Manometry Analysis Module

The Polygram Software for Windows (K946322) was designed to record and handle/store physiological parameters. After a recording, the user is able to review the tracings on the computer screen and print the signal tracings or just parts of them. When reviewing the data on the computer screen, the user is able to mark certain segments and calculate certain parameters from the selected signal segments. These parameters are minimum value, maximum value, and the length of the selection.

By adding the Esophageal Manometry Analysis Module to the Polygram Software for Windows, the user can also have all the pressure data analyzed in terms of physiological properties, comparison with normal values, etc. The analyzed data can thereafter be viewed on screen or printed out on a separate paper.

The Esophageal Manometry Analysis Module has been designed to analyze intragastroesophageal pressure data throughout the gastrointestinal tract.

The Esophageal Manometry Analysis Module has been designed for the same intended use (analyze intragastroesophageal pH data) in both pediatric and adult populations. The product is to be used on patients in the hospital environment under supervision of a trained physician.

Sincerely
Synectics Medical