BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER

{0}------------------------------------------------ 8 2002 NOV K011471 Page 1 of 5 510(k) Notification 43S11 Polygram 98 pH Testing System (incl. bile) # 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 95 02 Fax: + 45 44 57 90 10 Contact person for this submission: Tove Kjaer Date submission was prepared: May 10, 2001 #### 2. Trade Name, Common Name and Classification Name: A. Trade Name: Polygram 98 pH Testing System (incl. bile) B. Common Name, Classification Name, Class and Regulation Number: | Common Name | Classificat<br>ion<br>Number | Class | Regulation<br>Number | |------------------------------------|------------------------------|-------|----------------------| | Bilitec 2000 | 78 FFX | II | 21 CFR 876.1725 | | Optical Fiber Probe | 78 FFX | II | 21 CFR 876.1725 | | Polygram 98 pH Testing Application | 78 FFX | II | 21 CFR 876.1725 | #### 3. Predicate Device Identification: The functionality and intended use of the Polygram 98 pH Testing System (incl. bile) is equivalent to Medtronic Functional Diagnostics A/S's Polygram 98 pH Testing System (K 981733). {1}------------------------------------------------ #### 4. Device Description: The system is an ambulatory system for use in evaluating reflux disorders in the gastrointestinal tract. The system measures bile online using sensors in the patient. The data is captured and recorded. The data is uploaded from the Bilitec 2000 by use of the Polygram 98 pH Testing Application software for later display, analysis and reporting. In its daily use, a trained technician and/or physician are the main user of the system. The Main tasks when performing a reflux festing procedure: - . Prepare equipment including calibration - . Enter patient demographic information - perform procedure and obtain relevant data . - Review, analysis and post procedure activities - . Create and print a report #### 5. Intended Use: The Polygram 98 pH Testing System is intended to record, store, view and analyze esophageal and gastric refluxate data to diagnose reflux disorders. The Polygram 98 pH Testing System can also be used to locate the position of the proximal Lower Esophageal Sphincter (LES) manometrically, to assist in the accurate placement of the pH catheter. #### 6. Table of Device Similarities and differences to predicate device | Manufacturer | Medtronic Synectics AB | Medtronic Functional<br>Diagnostics A/S | | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | Predicate Device<br>Polygram 98° pH<br>Testing System, i.e<br>• Digitrapper pH<br>• Polygram '98,<br>pH Testing<br>Application<br>• K 981733 | Modified Device<br>Polygram 98 pH Testing System<br>v2.2 (incl. Bile), i.e<br>• Bilitec 2000<br>• Polygram 98,<br>pH Testing Application v2.2<br>(including Bile) | Polygram 98 software has been<br>updated in order to facilitate<br>upload and analysis of data<br>recorded by the Bilitec 2000<br>device | | General: | Predicate devics:<br>- all | Modified Device<br>- pH System | Explanation of the differences<br>compared<br>to the Predicate devices | | Intended Use /<br>Indication of<br>Use | The pH System is<br>intended to record,<br>store, view and analyze<br>esophageal and gastric<br>pH data to diagnose<br>reflux disorders. The pH<br>System can also be<br>used to locate the<br>position of the proximal<br>Lower Esophageal<br>Sphincter (LES)<br>manometrically, to<br>assist in the accurate<br>positioning of the pH<br>catheter | The pH System is intended to<br>record, store, view and analyze<br>esophageal and gastric refluxate<br>to diagnose rellux disorders.<br>The pH System can also be<br>used to locate the position of the<br>proximal Lower Esophageal<br>Sphincter (LES) manometrically,<br>to assist in the accurate<br>positioning of the pH catheter | Same | | Intended<br>Populations | Pediatric to Adults | Same | | | Sterilization | Accessories are not<br>supplied sterile,<br>manufacturer label the<br>accessories with<br>cleaning instructions. | Same | | | Biocompatibility | Catheters are the only<br>part that come into<br>contact with the<br>patients. | Same | | | Technical<br>Features: | Predicate devices<br>- Digitrapper pH | Modified Device<br>- Bilitec 2000 | Explanation of the differences<br>compared<br>To the Predicate devices | | Number of<br>Channels | 4 channels pH, 1<br>pressure | 2 channels Bile | | | Sampling rate | ¼ Hz | 1 Hz with 4, 8 or 16sec<br>averaging time | | | Memory Size | 2Mb Flash Data RAM | 128 Kbytes flash memory | | | Event markers | 3 | 1 event marker | | | Built in memory<br>back up | Now has Flash ram (no<br>backup required). Clock<br>has 14 days backup. | Has Flash ram. | Flash RAM is non-volatile therefor<br>requires no 'backup'. The Bilitec<br>has no clock and no back-up of<br>date/time information is then<br>required | | Power supply | 2 x 1.5V AA alkaline | 4 x 1,5V AA size alkaline<br>batteries | | | Measuring<br>range | 0-9 pH | Absorbance from 0 to 1 unit | The spectrophotometric<br>measurement of the absorbance<br>of Bile (bilirubin) is measured in<br>the range of 0 to 1 (0-100%) | | Recording time | 24 Hours | 24 Hours | | | Current<br>consumption | 20mA | 30 mA in normal mode and 16<br>mA on average in Sampling/idle<br>mode | The set-up mode and the<br>spectrophotometric measurement<br>requires different levels of current<br>consumption | | Communication | IrDA Communication<br>(Infra Red) | Serial communication 9600<br>baud | This is a standard serial port as on<br>all PC's. | | Resolution | Better than 0.01pH | <= 0,004 absorbance unit | | | Display | 119 by 73 pixel graphic<br>display. | LCD consists of 4 rows with 16<br>characters | | | Dimension | 115 x 140 x 50 mm | 200mm x 100mm x 35mm | | | Weight | 300 gr. | 450 gr. | | | On-line<br>monitoring | Via own Screen | Same | | | Signals to<br>analyze | pH | PH and Bile | | | User<br>commands | Menu selections,<br>keyboard combinations,<br>screen "buttons" | Same | | | Calculated,<br>parameters | 1. Maximum,<br>Minimum<br>2. Duration of period<br>3. Number of acid<br>refluxes<br>4. Number of long<br>acid refluxes<br>5. Longest acid reflux<br>6. Total time pH<br>below 4<br>7. Fraction time pH<br>below 4<br>8. Symptom index<br>9. Symptom Association<br>Probability<br>10. Number of alkaline<br>shifts<br>11. Number of long<br>alkaline shifts<br>12. Longest alkaline<br>shift<br>13. Total tome pH<br>above 8<br>14. Fraction time pH<br>above 8 | Same for pH, plus for Bile<br>analysis:<br>1. Maximum, Minimum<br>2. Duration of period<br>3. Number of bile refluxes<br>4. Number of long bile<br>refluxes<br>5. Longest bile reflux<br>6. Total time bile above 0,14<br>7. Fraction time bile above<br>0,14<br>8. Symptom index<br>9. Symptom Association<br>Probability | Calculated parameters for bile are<br>similar to the pH analysis | | Scoring,<br>Normals | 15. DeMeester &<br>Johnson (adult)<br>16. Bolx-Ochoa<br>(pediatric)<br>17. Infant normals<br>percentile graph<br>(ESPGAN normals) | Same for pH.<br>NA for the Bile analysis | No scoring system exists for Bile<br>analysis | | Reports | Signal tracings and<br>reports. Optional<br>selections only. | Same | | | Patient<br>database | Relational database with<br>logical patient- recording<br>relations | Same | | | Additional data | User definable additional<br>patient/recording<br>parameters | Same | | | User help<br>system | Online help system with<br>descriptions of<br>procedures | Same | | | Signal review<br>method | Time - tracing based | Same | | | Recording<br>control | Real time monitoring of<br>signals | Same | | | Recording<br>configuration | A template is used for<br>each type of recording. | Same | | {2}------------------------------------------------ K011471 # 510(k) Notification 43S11 Polygram 98 pH Testing System (incl. bile) Page 3 of 5 {3}------------------------------------------------ # 510(k) Notification 43\$11 Polygram 98 pH Testing System (incl. bile) Page 4 of 5 Features: Predicate Device - Polygram '98, pH Testing Application Modified Device - Polygram '98, pH Testing Application v2.2 (including Bile) Explanation of the differences compared to the Predicate devices {4}------------------------------------------------ #### Page 5 of 5 - 7. Assessment of non-clinical performance data for equivalence: Verifications results show that the enhanced system performs as its predicate system. # 8. Assessment of clinical performance data for equivalence: Clinical trials have not been performed. This new system does not raise any new safety or performance issues. #### 9. Biocompatability: The Optical Fiber probe has been tested for biocompatibility. #### 10. Sterilization: Not applicable #### 11. Standards and Guidances: The Polygram 98 pH testing System (incl bile) conforms to the following voluntary and mandatory standards: - . EN 60601-1, Medical equipment The following guidances were followed: - DRAERD Premarket Notification 510(k) Screening checklist, RRG Rev. 3/14/95 - ODE Guidance for the Content of Premarket Submission for Medical Device Containing Software Draft Document {5}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. #### Public Health Service #### 8 2002 NOV Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Toni Kennet Jørgensen Regulatory Affairs Specialist Medtronic Functional Diagnostics A/S Tonsbakken 16-18 DK-2740 Skovlunde DENMARK #### Re: K011471 Trade/Device Name: Polygram '98 pH Testing System (incl Bile), Bilitec™ 2000 and Optical Fiber Probe Regulation Number: 21 CFR 8876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: 78 FFX Dated: August 9, 2002 Received: August 12, 2002 Dear Mr. Jørgensen: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 cither class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. {6}------------------------------------------------ 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | . 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html. Sincerely yours, Nancy Chrizdon. Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure Page 2 {7}------------------------------------------------ # Indication for Use Statement # Page 1 of 1 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ . Device Name: Polygram 98 pH Testing System (incl. bile) Indications for Use: The Polygram 98 pH Testing System is intended to record, store, view and analyze esophageal and gastric refluxate data to diagnose reflux disorders. The Polygram 98 pH Testing System can also be used to locate the position of the proximal Lower Esophageal Sphincter (LES) manometrically, to assist in the accurate placement of the pH catheter. ### MRI Compatibility Statement: The Ambulatory pH 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 | <div style="display:inline-block; vertical-align:middle;">/</div> | OR | Over-The-Counter Use ______ | |----------------------|-------------------------------------------------------------------|----|-----------------------------| | (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) | | (Division Sign-Off) | | |------------------------------------------------------------------|--| | Division of Reproductive, Abdominal,<br>and Radiological Devices | | | 510(k) Number | |