DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111

{0}------------------------------------------------ ## 510(k) Notification pH Testing System 4 1998 FEB # 510(k) SUMMARY as required per 807.92(c) ## 1. Submitters Name, Address: Medtronic Synectics AB Renstiernas gata 12 S-116 28 STOCKHOLM Tel: (45 ) 44 57 90 00 Fax: (45 ) 44 57 90 10 Contact person for this submission: Ann-Christine Jönsson Date submission was prepared: 18th May, 1998 ## 2. Trade Name, Common Name and Classification Name: A. Trade Name: pH Testing System B. Common Name, Classification Name, Class and Regulation Number: | Common Name | Classification<br>Number | Class | Regulation Number | |--------------------------------------|--------------------------|-------|-------------------| | Digitrapper Delta | 78 FFX | II | 21 CFR 876.1725 | | Polygram '98, pH Testing Application | 78 FFX | II | 21 CFR 876.1725 | | pH catheters | 78 FFT | I | 21 CFR 876.1400 | ## 3. Predicate Device Identification: The functionality and intended use of the pH Testing System is equivalent to Medtronic Synectics Digitrapper MK III (K913387) with Polygram for Windows, Base Module (K946322) and EsopHogram reflux Analysis (K961346). {1}------------------------------------------------ #### 4. Device Description: The pH Testing System consists of a general purpose PC running the pH Application software namned EsopHogram '98, a recording device namned Digitrapper Delta and catheters appropriate for the study to be performed. The illustration below shows the various components. Image /page/1/Figure/3 description: The image shows a pH system with several components. A host PC with platform and pH extension software is connected via an IrDA 1.1 connection to a Delta Device with embedded software. Two catheters are connected to the Delta Device. The image provides a schematic representation of the pH system setup. The general process for use of the system occurs in two parts. In the first part, physiological data is collected by the Delta. This is done by a technician intubating a patient with the appropriate catheter(s), connect the catheter(s) to a Digitrapper Delta, turning on the recording, and allowing the patient to proceed with their normal life. At the prescribed time, the patient returns to the technician who removes the equipment from the patient. Following that, the technician transfers the recorded data in the Digitrapper Delta to the PC where the pH Extension software is used to analyze it. This analysis includes marking refluxes in the data traces and calculating a variety a measurements such as DeMeester score and the Boix-Ochoa scoring method. Hardcopies can be printed of the raw data as well as tailored reports. Results of the analysis are then used by a doctor to help make a diagnosis #### 5. Intended Use: The pH System is intended to record, store, view and analyze esophageal and gastric pH data to diagnose reflux disorders. The pH 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. {2}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ # 6. Table of Device Similarities and differences to predicate device | Manufacturer | Medtronic Synectics AB | Medtronic Synectics AB | | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | Predicate devices<br>MK III<br>- K 913387<br>Polygram software, base<br>module<br>- K 946322<br>pH Analysis Module<br>- K 961346 | Modified Device<br>Polyram 98' pH Testing<br>System, i.e<br>Digitrapper Delta &<br>Polygram '98,<br>pH Testing Application<br>- K 981733 | - | | 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 Use | Esophageal and gastric pH data<br>acquisition and analysis to diagnose<br>reflux disorders. | Same | -- | | Intended<br>Populations | Pediatric to Adults | Same | -- | | Sterilization | Accessories are not supplied sterile,<br>manufacturer label the accessories<br>with cleaning instructions. | Same | -- | | Biocompatibility | Catheters are the only part that<br>comes into contact with the<br>patients. | Same | -- | | Technical<br>Features: | Predicate devices<br>- MK III | Modified Device<br>- Digitrapper Delta | Explanation of the differences<br>compared<br>to the Predicate devices | | Number of<br>Channels | 4 pH, 1 p | Same | -- | | Sampling rate | 1/4, 1/8, 1/16 Hz | Programmable through 1/16Hz<br>up to 8 Hz | This new range captures all the<br>old range while also allowing the<br>possibility to be flexible enough<br>to cope with possible future<br>demands for higher sampling<br>rates. | | Memory Size | 96 kB | 4Mb Flash Data RAM | Larger memory size to<br>incorporate possible future<br>enhancements. | | Event markers | 4 | 3 | Customer requirement | | Built in memory<br>back up | 14 days | Now has Flash ram (no backup<br>required). Clock has 14 days<br>backup. | Flash RAM is non-volatile<br>therefor requires no 'backup'.<br>However the clock will keep the<br>time for convenience sake. (you<br>don't have to reset the time). | | Power supply | 9 V alkaline battery | 2 x 1.5 AA alkaline | More available batteries | | Measuring range | 0-9 pH | Same | -- | | Recording time | 24, 48 & 96 hours | 24 Hours | Customer requirement with only<br>24 hours. | | Current<br>consumption | 4 mA | 20mA | The new device runs at 3V so the<br>current increases to meet the<br>power demands. | | Communication | 8 bit parallel Synectics Liberty or<br>Combi Interface, Serial interface to<br>computer or printer | IrDA Communication<br>(Infra Red) | This is a standard device that is<br>present on all Notebooks. The IR<br>Dongle can also be plugged into | {3}------------------------------------------------ # 510(k) Notification pH Testing System : ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ----- | Resolution | 0.04 pH | Better than 0.01pH | not require a removal of the computer cover to install.<br>The MKIII has an 8 bit converter and fixed gain. The new one has 12bit resolution and adjustable gain. | | | | | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------|----|----| | Display | 32 character LCD LES identification display | 119 by 73 pixel graphic display. | Enhances user interface | | | | | | Clock | Built-in real time clock | Same | -- | | | | | | Dimension | 4.8 x 2.6 x 1.0 in | 115 x 140 x 50 | -- | | | | | | Weight | 10.6 oz (300g) | Approx. the same | -- | | | | | | On-line monitoring | Via own Screen | Same | -- | | | | | | Features: | Predicate devices<br>- Polygram software, base module &<br>- pH Analysis Module, EsopHogram pH Reflux Analysis | Modified Device<br>- Polygram '98, pH Testing Application | Explanation of the differences compared to the Predicate devices | | | | | | Signals to analyze | pH | Same | -- | | | | | | User commands | Menu selections, keyboard combinations, screen "buttons" | Same | -- | | | | | | Calculated parameters | 1. Maximum, Minimum<br>2. Duration of period<br>3. Number of acid refluxes<br>4. Number of long acid refluxes<br>5. Longest acid reflux<br>6. Total time pH below 4<br>7. Fraction time pH below 4<br>8. Symptom index<br>9. Symptom Association Probability<br>10. Number of alkaline shifts<br>11. Number of long alkaline shifts<br>12. Longest alkaline shift<br>13. Total tome pH above 8<br>14. Fraction time pH above 8 | Same<br>Not Available<br>Not Available | --<br>Excluded in the first version<br>Excluded in the first version | | | | | | Scoring, Normals | 1. DeMeester & Johnson (adult)<br>2. Boix-Ochoa (pediatric)<br>3. Infant normals percentile graph (ESPGAN normals) | Same<br>Not Available<br>Not Available | --<br>Excluded in the first version<br>Excluded in the first version | | | | | | LES identification | Bar Graph | Displays an actual manometric tracing on screen. | Enhanced LES identification. | | | | | | Reports | Signal tracings and reports. Optionally selections only. | Same | -- | | | | | | Patient database | Relational database with logical patient- recording relations | Same | -- | | | | | | Additional data | User definable additional patient/recording parameters | Same | -- | | | | | | User help system | Online help system with descriptions of procedures | Same | -- | | | | | | Signal review method | Time - tracing based | Same | -- | | | | | | Recording control | Real time monitoring of signals | Same | -- | | | | | | Recording configuration | Recording<br>configuration | A template is used for each type of recording. User definable. Once used, not possible to change, | A template is used for each type of<br>recording. User definable. Once<br>used, not possible to change,<br>ensuring recording integrity | Same | Same | -- | -- | {4}------------------------------------------------ - 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: Fields tests are on going. - 9. Biocompatability: Not applicable . 10. Sterilization: Not applicable ## 11. Standards and Guidances: The pH System complies to the following standard: - IEC 60601-1, Second edition, 1988 with Amendment 1, 1991 and Amendment 2, 1995. (EN 60601-1:1990 and Amendments A1, A11, A12 and A13) - UL 2601-1, 1994 - CAN/CSA-22.2 No 601.1-M90 - JIST 1001 - AS/NZS 3200-1-0 {5}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 4 1999 FEB > Ann-Christine Jönsson Regulatory Affairs Medtronic Functional Diagnostics AB 16-18 Tonsbakken DK-2740 Skovlunde DENMARK Re: K981733 Digitrapper Delta, Model 9043G0201 and Polygram '98 pH Extension Dated: November 4, 1998 Received: November 9, 1998 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 pror 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 requlation (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 requlatory 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, M. Daniel C. Stahl, M.D. Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radioloqical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ : 510(k) Notification pH System # Indication for Use Statement Page 1 of 1 _ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications for Use: The pH System is intended to record, store, view and analyze esophageal and gastric pH data to diagnose reflux disorders. The pH 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 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 (Per 21 CFR 801.109) | <div> <br/> </div> | OR | Over-The-Counter Use (Optional Format 1-2-96) | |---------------------------------------|--------------------|----|-----------------------------------------------| |---------------------------------------|--------------------|----|-----------------------------------------------| (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices | 510(k) Number | K981733/500 | |---------------|-------------| |---------------|-------------|