MDP2000 MEDICAL DATA PROCESSOR

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "VIDCO" in a bold, sans-serif font. The letters are outlined in black, giving them a hollow appearance. The letters are evenly spaced and aligned horizontally. OCT 22 1997 K972880 Information Display & Recording Systems July 31, 1997 ## VIDCO MDP2000 ### 510k SUMMARY # 510k number: Submitter: VIDCO, Inc. 6175 SW 112th Avenue Beaverton, OR 97008 Bradley A. Cohen Contact: Phone: (503) 641-1804 FAX (503) 641-1806 Device Name/Common Name: MDP2000 Medical Data Processor/Remote Display & Central Display The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected. It accepts analog and/or digital physiological information from patient monitoring equipment and processes these signals to provide outputs to: - Color monitors for display of information - Chart recorders or printers for hardcopy records - Media for storage - Other devices to share information The MDP2000 is substantially equivalent to current and previously marketed VIDCO products: VIDCO model 580CD (K926162) VIDCO model 620CSR (K932894) VIDCO model 580CDR (K934093) VIDCO model 516YT (K926219) VIDCO model 520 (K926298) The MDP2000 has no new questions of safety or effectiveness as it is performing essentially the same functions as the predicate devices. For the same rationale, no new hazards arise when comparing the MDP2000 to the predicate devices. Technical characteristics of the MDP2000 are similar to the predicate devices. Primary differences include: Reduced physical size, improved display resolution capabilities (aesthetics), and improved user interface to simplify operation. The MDP2000 has been tested to and conforms with UL2601, the domestic standard of IEC 601-1, as a Class I Type B device. Testing has been conducted by Intertek Testing Services (formerly Inchcape, Inc.), an NRTL (nationally recognized test laboratory), and Notified Body in the European Union. The MDP2000 is ETL listed indicating conformance to UL2601. The predicate devices, except 516YT and 520, were Underwriters Laboratory Listed under the now obsolete UL544. The MDP2000 has been tested to and conforms to the requirements of EN60601-1-2 (IEC 601-1-2), Collateral Standard for Electromagnetic Compatibility. The testing was conducted by Northwest EMC which is an FCC, NIST, and NVLAP recognized testing facility in the United States and accepted and accredited internationally by agencies such as TÜV and NEMKO. The EMC performance of the MDP2000 exceeds the predicate devices. Validation performed consists of bench testing of specifications as called out in the Engineering Instrument Specification that is an integral part of the Device Master Record. All tests were completed successfully and the MDP2000 meets it's specified performance including those related to ANSI/AAMI EC13 (1992) Heart Rate Meters & Alarms. The MDP2000 performance results are equivalent to or better than the predicate devices. {1}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Image /page/1/Picture/3 description: The image shows the date October 22, 1997. The month is abbreviated to OCT. The day is 22 and the year is 1997. The text is in a simple, sans-serif font. Mr. Bradley A. Cohen VIDCO, Inc. 6175 SW 112th Avenue 97008 Beaverton, Oregon Re: K972880 MDP2000 Medical Data Processor Regulatory Class: II (two) 74 MSX Product Code: Dated: July 31, 1997 Received: August 5, 1997 Dear Mr. Cohen: 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, 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 aqainst 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 Requlations, 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 requlations. {2}------------------------------------------------ Paqe 2 - Mr. Bradley A. Cohen 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 leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation 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.qov/cdrh/dsmamain.html". Sincerely yours, Thomas J. Callahon Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### VIDCO MDP2000 510k ### INTENDED USE STATEMENT **510k number:** K972880 Device Name: MDP2000 Medical Data Processor The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected. It accepts analog and/or digital physiological information from patient monitoring equipment and processes these signals to provide outputs to: - Color monitors for local and remote display of information - Chart recorders or printers for hardcopy records - · Media for storage - Other devices to share information Examples of areas where the MDP2000 is used include ICU, CCU, PACU, Emergency, Telemetry, Stepdown and other areas where patient's physiological information are to be observed at one or more locations. Typical information displayed includes ECG and blood pressure waveforms and numeric values such as heart rate and systolic, mean, and diastolic pressure. This ملكة الكم over (1) to sixteen (16) pedside moritir Block Diagram Image /page/3/Figure/10 description: The image shows a block diagram of a system labeled "MDP2000". The diagram has three inputs on the left side labeled "ANALOG", "DIGITAL", and "CONTROL". On the right side, there are four outputs labeled "VIDEO", "HARDCOPY", "DATA", and "SOUND". The arrows indicate the direction of signal flow from the inputs to the outputs through the MDP2000 system. Arth. A. Liarlowski (Division Sign-Off) Division of Cardiovascular, and Neurological Device 510(k) Number Prescription Use \$\frac{x}{(Per 21 CFR 801.109)}\$