PH ANALYSIS MODULE

K961346 · Synectics-Dantec · FFT · Jan 29, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K961346
• Device Name: PH ANALYSIS MODULE
• Applicant: Synectics-Dantec
• Product Code: FFT · Gastroenterology, Urology
• Decision Date: Jan 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1400
• Device Class: Class 1
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The pH Analysis Module is a software program that has been designed to analyze intragastroesophageal pH data recorded from the gastrointestinal tract in pediatric and adult populations. The program is to be used on a personal computer analyzing patient data in the hospital environment under supervision of a trained physician. The analyzed data can be viewed on the computer screen or printed out on a separate paper.

Device Story

pH Analysis Module; software add-on for Polygram Software for Windows. Inputs: recorded intragastroesophageal pH data. Processing: automated analysis of pH tracings; calculation of parameters including duration of recording, number of periods of interest, time below pH threshold, symptom correlation, and scoring. Output: analysis report containing patient demographics, procedure summary, pH tracing, period table, and physician signature section. Used in hospital environment; operated by trained physician. Benefit: assists physician in diagnosis and post-treatment evaluation of gastrointestinal pH data.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based analysis module; runs on personal computer; Windows-based environment; integrates with Polygram Software for Windows platform.

Indications for Use

Indicated for analysis of intragastroesophageal pH data recorded from the gastrointestinal tract in pediatric and adult populations.

Regulatory Classification

Identification

A stomach pH electrode is a device used to measure intragastric and intraesophageal pH (hydrogen ion concentration). The pH electrode is at the end of a flexible lead which may be inserted into the esophagus or stomach through the patient's mouth. The device may include an integral gastrointestinal tube.

Predicate Devices

• EsopHogram Software (K859361)

Reference Devices

• Polygram Software for Windows (K946322)

Submission Summary (Full Text)

{0}

JAN 29 1997
K961346

# 9. SMDA 510(k) Summary or Statement

## DRAERD 510(k)
Summary of Safety and Effectiveness Information

| Submitter's name | Synectics Medical AB
Renstiernas gata 12
S-116 28 Stockholm
Sweden |
| --- | --- |
| | Contact: Anna Pettersson |
| Name of device | pH Analysis Module |
| Name of equivalent device | EsopHogram Software (DOS environment)
(included in K859361 - Synectics pH System Comprising
Digitrapper Mark II, EsopHogram Software & Monocrystant
Catheter) |
| Description of device | 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 include min and max values, length of
selection.

By adding the pH Analysis Module to the Polygram Software for
Windows, the user can also have all the intragastroesophageal pH
data analyzed (data recorded from the gastrointestinal tract in
pediatric and adult population). The analysis report includes sections
such as patient demographics; interpretation and comment (for user
to insert); procedure summary; pH tracing; period table including
number such as duration of recording, number of periods of interest,
time where pH was below certain threshold value, symptom
correlation, scoring; physician signature section.

The analysis report can then serve as a part of the physician’s
diagnosis and post treatment evaluation. |
| Statement of intended
use/indication for use | The pH Analysis Module is a software program that has been
designed to analyze intragastroesophageal pH data recorded from
the gastrointestinal tract in pediatric and adult populations.

The program is to be used on a personal computer analyzing patient
data in the hospital environment under supervision of a trained
physician. The analyzed data can be viewed on the computer screen
or printed out on a separate paper. |

13-Jan-97