POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101
Device Facts
| Record ID | K992713 |
|---|---|
| Device Name | POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101 |
| Applicant | Medtronic Functional Diagnostics A/S |
| Product Code | FFX · Gastroenterology, Urology |
| Decision Date | Nov 10, 1999 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1725 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Esophageal Manometry System is intended to record, store, view and analyze data on line in the gastrointestinal tract to assist in the diagnoses of gastrointestinal disorders.
Device Story
Stationary manometry system for gastrointestinal tract function evaluation. System captures pressure, respiration, and swallow data via patient-connected sensors. Data processed online, recorded for review, analysis, and reporting. Operated by trained technicians or physicians in clinical settings. System utilizes Polygram 98 software on Windows 98 to transform raw sensor inputs into visual tracings and calculated parameters (LES location, resting/residual pressure, motility amplitude/duration/velocity). Healthcare providers review signal tracings and automated reports to assist in clinical diagnosis. Benefits include standardized data collection and analysis for GI disorder assessment.
Clinical Evidence
No clinical trials performed. Substantial equivalence established via bench testing and verification of system performance against predicate device specifications.
Technological Characteristics
Stationary manometry system; 4-16 channels; 22-bit resolution; 105-1674 Hz sampling rate; USB connectivity. Power supply 24V DC. Insulation via HCPL-0710 and NMV 2405S. Software: Polygram 98 (C++, Visual Basic) running on Windows 98. Complies with EN 60601-1, UL 2601-1, and CAN/CSA C22.2 No.610.1-M90.
Indications for Use
Indicated for infants, pediatric, and adult patients requiring gastrointestinal tract pressure and function evaluation to assist in diagnosing gastrointestinal 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
- Medtronic Synectics Polygraf HR (K872712)
- Polygram for Windows, Base Module (K946322)
- Esophageal Manometry Analysis Module (K961070)
Submission Summary (Full Text)
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# 510(k) SUMMARY
as required per 807.92(c)
### 1. Submitters Name, Address:
Medtronic Functional Diagnostics A/S Tonsbakken 16-18 DK-2740 SKOVLUNDE Tel: (+ 45 ) 44 57 90 00 Fax: (+ 45 ) 44 57 90 10 Contact person for this submission: Ann-Christine Jönsson Date submission was prepared: 6d August, 1999
### 2. Trade Name, Common Name and Classification Name:
A. Trade Name: Esophageal Manometry System
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Classification<br>Number | Class | Regulation Number |
|--------------------------------------------------|--------------------------|-------|-------------------|
| Polygraf ID | 78 FFX | II | 21 CFR 876.1725 |
| Polygram 98, Esophageal Manometry<br>Application | 78 KLA,<br>FFX | II | 21 CFR 876.1725 |
# 3. Predicate Device Identification:
The functionality and intended use of the Esophageal Manometry System is equivalent to Medtronic Synectics Polygraf HR (K872712) with Polygram for Windows, Base Module (K946322) and Esophageal Manometry Analysis Module (K961070).
# 4. Device Description:
The system is a stationary manometry system for use in evaluating the function of the gastrointestinal tract. The system measures pressure and other parameters online using sensors on and in the patient. The parameters are presented during the capture and are also recorded for later display, analysis and reporting.
In its daily use, a trained technician and/or a physician are the main users of the system.
# 1 (4) COMPANY CONFIDENTIAL
Medtronic Functional Diagnostics A/S
Tonsbakken 16-18 DK-2740 SKOVLUNDE
Tel: + 45 44 57 90 00 Fax: + 45 44 57 90 10
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The main tasks when performing a manometry procedure with a stationary manometry system are:
- . Prepare equipment including calibration
- . Enter patient/study demographic information
- Perform procedure and obtain relevant data .
- Review, analysis and post procedure activities .
- . Create and print a report
The Polygram 98 Esophageal Manometry Application software runs on Microsoft Windows® 98
#### 5. Intended Use:
The Esophageal Manometry System is intended to record, store, view and analyze data on line in the gastrointestinal tract to assist in the diagnoses of gastrointestinal disorders.
### 6. Table of Device Similarities and differences to predicate device
| Manufacturer | Medtronic Synectics AB | Medtronic Functional<br>Diagnostics A/S | - |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| 510(k) number | Predicate devices<br>• Polygraf HR<br>- K 872712<br>• Polygram software,<br>base module<br>- K 946322<br>• Esophageal<br>Manometry Analysis<br>Module<br>- K 961070 | Modified Device<br>Esophageal Manometry System,<br>(EM System) i.e<br>- Polygraf ID &<br>- Polygram 98,<br>Esophageal Manometry<br>Application<br><br>K number to be decided | - |
| General: | Predicate devics:<br>- all | Modified Device<br>- EM System | Explanation of the differences<br>compared |
| | | | to the Predicate devices |
| Intended Use /<br>Indication of Use | Record, store, view and<br>analyze data on line in the<br>gastrointestinal tract to<br>assist in the diagnoses of<br>gastrointestinal disorders.. | Same | -- |
| Intended Populations | Infant, Pediatric to Adults | Same | -- |
| Sterilization | Accessories are not<br>supplied sterile,<br>manufacturer label the<br>accessories with cleaning<br>instructions. | Same | -- |
| Biocompatibility | The Sensors are the only<br>part that comes into<br>contact with the patients. | Same | -- |
#### COMPANY CONFIDENTIAL
Medtronic Functional Diagnostics A/S
Tonsbakken 16-18 DK-2740 SKOVLUNDE
Tel: + 45 44 57 90 00 Fax: + 45 44 57 90 10
{2}------------------------------------------------
| Technical Features: | Predicate devices<br>- Polygraf HR | Modified Device<br>- Polygraf ID | Explanation of the differences<br>compared<br>to the Predicate devices |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Number of Channels | Up to 16 | 4-16 channels | Enhanced performance |
| Sampling rate | 1/128 to 128 Hz | 105-1674 Hz | Enhanced performance |
| Power supply | 9-12 V DC | 24 V DC | 110-230 V Power Supply in one |
| Measuring range | 0-9 pH | -2.5 Vpm, 5 % to 2.5 Vpm 5% | Enhanced performance |
| Insulation | Burr Brown722 dual<br>isolated DC/DC converter | HCPL-0710. NMV 2405S, and<br>safety power supply: class I | Enhanced performance, isolation<br>provided also within each module of 4<br>channels (4, 8, 12, 16.) |
| Current consumption | 260 mA nom standard<br>(8bit) | Max 0.8 A | Enhanced performance requires more<br>power |
| Communication | Optical serial RS 232 | USB (Universal Serial Bus) | Enhanced performance (band width) |
| Resolution | 8 bit | 22 bit | Enhanced performance |
| Dimension | 11.2" x 2" x 6 " | 14" x 8.8" x 2.8" | More channels require more space |
| Weight | 1 050 g | < 3 000 g | Larger box weight more |
| On-line monitoring | Via PC Screen | Same | --- |
| Features: | Predicate devices<br>- Base module<br>&<br>- pH Analysis Module,<br>EsopHogram pH Reflux<br>Analysis | Modified Device<br>- Polygram '98, EM Extension | Explanation of the differences<br>compared<br>to the Predicate devices |
| Signals to analyze | Ph, pressure, flow, volume,<br>respiration, oxygen<br>saturation, pulse rate, body<br>position, snoring | Pressure, respiration and<br>swallow | Not all are implemented in this first<br>version. |
| User commands | Menu selections, keyboard<br>combinations, screen<br>"buttons" | Same | -- |
| Esophageal Analysis | - LES analysis<br>- Esophageal motility<br>analysis<br>- UES analysis | - LES analysis<br>- Esophageal motility analysis | - UES analysis, will be introduced in<br>coming versions of the SW. |
| Calculated<br>parameters | LES location<br>LES resting pressure<br>LES relaxation<br>LES residual pressure<br><br>Esophageal motility:<br>amplitude<br>duration<br>velocity<br><br>UES location<br>UES resting pressure<br>UES residual pressure<br>Quick calculations | LES location<br>LES resting pressure<br>LES relaxation<br>LES residual pressure<br><br>Esophageal motility:<br>amplitude<br>duration<br>velocity | The following parameters will be<br>introduced in coming versions of the<br>SW:<br>UES location<br>UES resting pressure<br>UES residual pressure<br>Quick calculations |
| Reports | Signal tracings and reports.<br>Optionally selections only. | Same | -- |
| Patient database | Relational database with<br>logical patient- recording<br>relations | Same | -- |
| Additional data | User definable additional<br>patient/recording<br>parameters | Same | -- |
| User help system | Online help system with<br>descriptions of procedures | Same | -- |
| Signal review method | Time - tracing based | Same | -- |
| Recording control | Real time monitoring of<br>signals | Same | -- |
| Calibration | Adjustable and fixed gain<br>method. Monitoring of<br>calibration result for range<br>and resolution requirement. | Same | -- |
| Recording<br>configuration | A template is used for each<br>type of recording. User<br>definable. Once used, not<br>possible to change,<br>ensuring recording<br>integrity | Same ('templates' are now<br>called 'protocols') | -- |
| Programming<br>language | 'C' | C++, Visual Basic | -- |
| Operating system | Windows 3.11, 95 | Windows 98 | Enhanced performance |
# 3 (4)
# COMPANY CONFIDENTIAL
Medtronic Functional Diagnostics A/S
Tonsbakken 16-18 DK-2740 SKOVLUNDE
{3}------------------------------------------------
### 7. Assessment of non-clinical performance data for equivalence:
Verifications results shows that the enhanced system performs as its predicate system.
#### 8. Assessment of clinical performance data for equivalence:
Clinical trials are not performed. This new system doesn't raise any new safety or performance issues.
#### 9. Biocompatability:
Not applicable .
### 10. Sterilization:
Not applicable
#### 11. Standards and Guidances:
The Esophageal Manometry System complies to the following standards:
- EN 60601-1:1990 and Amendments A1, A11, A12 and A13
- UL 2601-1, Second Edition, 1997
- CAN/CSA C22.2 No.610.1-M90
### 4 (4)
### COMPANY CONFIDENTIAL
Medtronic Functional Diagnostics A/S
Tonsbakken 16-18 DK-2740 SKOVLUNDE
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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 1999
Ms. Ann-Christine Jönsson Regulatory Affairs Medtronic Functional Diagnostics A/S Tonsbakken 16-18 Skovlunde DK-2740 DENMARK
Re: K992713 Esophageal Manometry Testing Application (Polygraf ID, Polygram '98) Dated: August 6, 1999 Received: August 12, 1999 Regulatory Class: II 21 CFR 876.1725/Procode: 78 FFX
Dear Ms. Jönsson:
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 legally marketed predicate 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). You may, therefore, market the device, 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 (Special Controls) or class III (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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting 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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# Indication for Use Statement
Page 1 of 1 --
510(k) Number (if known): K992713
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Esophageal Manometry System is intended to record, store, view and analyze data on line in the gastrointestinal tract to assist in the diagnoses of gastrointestinal disorders.
MRI Compatibility Statement:
The Esophageal Manometry System is not compatible for use in a MRI magnetic field.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ V (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K992713 |
|---------------|---------|
|---------------|---------|
### COMPANY CONFIDENTIAL
Medtronic Functional Diagnostics A/S
Tonsbakken 16-18 DK-2740 SKOVLUNDE
