ANORECTAL MANOMETRY ANALYSIS MODULE

K972439 · Medtronic-Synectics · FFX · Sep 23, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972439
• Device Name: ANORECTAL MANOMETRY ANALYSIS MODULE
• Applicant: Medtronic-Synectics
• Product Code: FFX · Gastroenterology, Urology
• Decision Date: Sep 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The Anorectal Analysis Module is a software program that has been designed to analyze pressure data recorded from the lower gastrointestinal tract in pediatric and adult populations. The Anorectal Analysis Module includes the following analyses: Vector Volume Analysis; Automatic Base Line Analysis; Intepretation and Comments Analysis; Rectal Balloon Analysis; Tri-Level Analysis; Radial Pressure Analysis; Anal Canal Vector Volume Analysis; Tracing Clip-Out Analysis; Quick Calculation Analysis. 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

Anorectal Manometry Analysis Module is a software add-on for the Polygram Software for Windows. It processes pressure data recorded from the lower gastrointestinal tract. The device performs various physiological analyses, including Vector Volume, Automatic Base Line, Rectal Balloon, Tri-Level, Radial Pressure, and Anal Canal Vector Volume analyses. It is used in hospital environments by trained physicians to review tracings, calculate parameters (min/max values, selection length), and generate reports for diagnosis and post-treatment evaluation. The software allows for on-screen viewing and printing of analysis reports, which include patient demographics, procedure summaries, and physician comments.

Clinical Evidence

Bench testing only. Alpha testing (integration testing) and beta testing (hospital site testing) were performed and documented to verify that the software meets specified objectives.

Technological Characteristics

Software-based analysis module for Windows environment. Performs physiological pressure data analysis. Includes various calculation algorithms (Vector Volume, Radial Pressure, etc.). Standalone software application for use on personal computers.

Indications for Use

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

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 (DOS environment) (included in 872712 - Polygraf)

Reference Devices

• Polygram Software for Windows (K946322)

Submission Summary (Full Text)

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## 510(k) Summary

K972439
P192

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

| Submitter's name | Synectics Medical AB<br>Renstiernas gata 12<br>S-116 28 Stockholm<br>Sweden |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Synectics Medical Inc<br>3850 Victoria Street North<br>Mail Stop V215<br>Shoreview, MN 55126-2978 |
| | SEP 23 1997 |
| | Contact: Anna Pettersson |
| | Contact: Keith Jung |
| Name of device | Anorectal Manometry Analysis Module |
| Name of equivalent device | Polygram Software (DOS environment)<br>(included in 872712 - Polygraf) |
| | The Anorectal Analysis Module is identical, in function and types of analyses that can be performed, to the Polygram Software (DOS). The main difference is that the Polygram Software (DOS) is written for the DOS environment and the Anorectal Analysis Module is written for the Windows environment. Polygram Software (DOS) works in the DOS environment and the Anorectal Analysis Module works in the Windows environment. |
| 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 minimum and maximum values, length of selection. |
| | By adding the Anorectal 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 analysis report includes sections such as patient demographics; interpretation and comment (for user to insert); procedure summary; Anorectal tracing; analyses (as specified below); and physician signature section. |
| | <i>Analyses:</i> |
| | <ul><li>Vector Volume Analysis</li><li>Automatic Base Line Analysis</li><li>Intepretation and Comments Analysis</li><li>Rectal Balloon Analysis</li><li>Tri-Level Analysis</li><li>Radial Pressure Analysis</li><li>Anal Canal Vector Volume Analysis</li><li>Tracing Clip-Out Analysis</li><li>Quick Calculation Analysis</li></ul> |
| | The analysis report can then serve as a tool for the physician's diagnosis and |

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The analysis report can then serve as a tool for the physician's diagnosis and post treatment evaluation.

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| Performance<br>Testing | The Anorectal Analysis Module has been thoroghly tested during the<br>development phase, that is, alpha testing in terms of integration testing has been<br>performed and documented and beta testing in terms of hospital site testing has<br>been done and documented.<br>It has been concluded that the alpha and beta testing has meet and passed the<br>specified objectives and should therefore be released to the market. |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Statement of<br>intended<br>use/indication<br>for use | The Anorectal Analysis Module is a software program that has been designed to<br>analyze pressure data recorded from the lower gastrointestinal tract in pediatric<br>and adult populations. |
| | The Anorectal Analysis Module includes the following analyses: |
| | • Vector Volume Analysis |
| | • Automatic Base Line Analysis |
| | • Intepretation and Comments Analysis |
| | • Rectal Balloon Analysis |
| | • Tri-Level Analysis |
| | • Radial Pressure Analysis |
| | • Anal Canal Vector Volume Analysis |
| | • Tracing Clip-Out Analysis |
| | • Quick Calculation Analysis |

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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Micael Hamberg Medtronic Synectics Synectics Medical AB Renstiernas gata 12 S-116 28 Stockholm Sweden

Re: K972439 Anorectal Manometry Analysis Module Dated: June 26, 1997 Received: June 30, 1997 Regulatory Class: II SEP 2 3 1997 21 CFR 876.1725/Procode: 78 FFX

Dear Mr. Hamberg:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification sobmission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) prematet notification. The FDA finding of substantial equivalence of your device to a legally marked predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

William Yu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K972438

Device Name: Anorectal Manometry Analysis Module

Indications For Use:

The Anorectal Analysis Module is a suflware program that has heen designed to analyse pressure duta recorded from the lower gastrointestinal tract in podiatic and adult populations.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ONE)

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Prescription Use (Optional Format 1-2-96)

Over-The-Counter Use (Per 21 CFR 801 109)

Taher N. Rotting/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number