DINAMAP MPS SELECT PORTABLE MONITOR

{0}------------------------------------------------ AUG | 4 |998 K982342 # 510(k) Summary く | Date | July 1, 1998 | |-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact | Annette M. Hillring<br>Director, Regulatory Affairs<br>Critikon, Division of Johnson & Johnson Medical, Inc.<br>4110 George Road<br>Tampa, Florida 33634<br>Telephone: (813) 887-2256<br>Telefax: (813) 887-2263<br>email: ahillrin@crtus.jnj.com | | Device Name | DINAMAP MPS® Select® Portable Monitor | | Common<br>Names | Physiological or Vital Signs Monitor, Patient Monitor<br>Includes the following monitoring modules:<br><ul><li>Noninvasive Blood Pressure &amp; Heart Rate Monitor</li><li>Invasive Blood Pressure &amp; Heart Rate Monitor</li><li>Endtidal Carbon Dioxide &amp; Respiration Rate Monitor</li><li>Pulse Oximetry &amp; Heart Rate Monitor</li><li>Electrocardiograph (ECG), Respiration Rate, Heart Rate &amp; Temperature Monitor</li><li>Recorder</li></ul> | | Classification | The classification names, 21 Code of Federal Regulations (CFR) Part and Paragraph numbers, and classification of the modified DINAMAP MPS® Select® Portable Monitor and its modules follow. The tier categorization based on the list (January 27, 1994) distributed by the Office of Device Evaluation is also included. | | Classification Name | 21 CFR § & Class | Tier | |------------------------------------------------------------|------------------|------| | Monitor, Cardiac (including cardiotachometer & rate alarm) | 870.2300 II | 2 | | Electrocardiograph | 870.2340 II | 2 | Continued on next pageContinued on next page {1}------------------------------------------------ ### 510(k) Summary, Continued #### Classification (continued) { | Classification Name | 21 CFR § & Class | Tier | |-----------------------------------------------------|------------------|------| | Adapter, Lead Switching,<br>Electrocardiograph | 870.2350 II | 1 | | Analyzer, Gas, CO2, Gaseous Phase | 868.1400 II | 2 | | Monitor, Breathing Frequency | 868.2375 II | 2 | | System, Measurement, Blood Pressure,<br>Noninvasive | 870.1130 II | 2 | | Computer, Blood Pressure | 870.1110 II | 2 | | Alarm, Blood Pressure | 870.1100 II | 2 | | Oximeter | 870.2700 II | 2 | | Oximeter, Ear | 870.2710 II | 2 | | Thermometer, Clinical Electronic | 880.2910 II | 2 | | Recorder, Paper Chart | 870.2810 II | 1 | #### Predicate Device The modified DINAMAP MPS® Select® Portable Monitor is substantially equivalent to the currently-marketed DINAMAP MPS® Select® Portable Monitor which received marketing clearance September 19, 1997, via 510(k) K971569. The modified DINAMAP MPS® Select® Portable Monitor device Device Description description is identical to the currently-marketed device. The difference between the two devices lies only in the electromagnetic compatibility (EMC) emissions classification. The modified Portable Monitor meets CISPR 11 Class A emissions requirements; the original Portable Monitor met CISPR 11 Class B emissions requirements. All other EMC specifications remain unchanged. Continued on next page {2}------------------------------------------------ ## 510(k) Summary, Continued ( | Indications | The modified DINAMAP MPS® Select® Portable Monitor indications for<br>use remain unchanged from the currently-marketed DINAMAP MPS®<br>Select® Portable Monitor:<br><br>The DINAMAP MPS® Select® Portable Monitor is intended to monitor a<br>single patient's vital signs in the hospital, outpatient surgery and healthcare<br>practitioner facilities. The patient populations include adult, pediatric and<br>neonatal. The Portable Monitor networking capabilities are identical to the<br>predicate device (K955113) and include connection to the OBSERVER®<br>Central Station via VHF, spread spectrum or hardwire communication; host<br>communications for use on the auxiliary serial port or RS-232 serial port; and<br>remote view protocol over Ethernet enabling communication with other<br>devices such as currently-marketed DINAMAP® Monitors, remote display,<br>data collection or hospital information system, or remote alarm. In addition,<br>the Portable Monitor may be operated from internal NiMH batteries making<br>the device portable. This device is intended for use by qualified healthcare<br>personnel trained in its use. | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological<br>Characteristics | The modified DINAMAP MPS® Select® Portable Monitor has the same<br>technological characteristics as the predicate device, the currently-marketed<br>DINAMAP MPS® Select® Portable Monitor. There are no new<br>technological characteristics. | | Testing | Testing of a fully configured modified DINAMAP MPS® Select® Portable<br>Monitor was performed by an ANSI-certified test facility to demonstrate<br>compliance with CISPR 11 (Group 1, Class A) for both radiated and<br>conducted emissions. | | | Continued on next page | {3}------------------------------------------------ ## 510(k) Summary, Continued i | Conclusions | In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this premarket notification, Johnson & Johnson Medical concludes that the modified device, the DINAMAP MPS ^® Select ^® Portable Monitor, is safe, effective and substantially equivalent to the predicate device, the currently-marketed DINAMAP MPS ^® Select ^® Portable Monitor, as described herein. | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Other Information | Critikon will update and include in this summary any other information deemed reasonably necessary by the FDA. | 11.0 {4}------------------------------------------------ Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### AUG 1 4 1998 Ms. Annette M. Hillring Director, Requlatory Affairs Critikon, Inc. 4110 George Road Tampa, FL 33634 Re: K982342 DINAMAP MPS® Select® Portable Monitor Requlatory Class: II (two) Product Code: MSX Dated: July 1, 1998 Received: July 6, 1998 Dear Ms. Hillring: 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 (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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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. {5}------------------------------------------------ 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) 594-4648. 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" (21CFR 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/dsma/dsmamain.html". Sincerely yours, Thomas J. Callahan Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ### Indications for Use 510(k) Number: Device Name: DINAMAP MPS® Select® Portable Monitor Indications for Use: The DINAMAP MPS® Select® Portable Monitor is intended to monitor a single patient's vital signs in the hospital, outpatient surgery and healthcare practitioner facilities. The patient populations include adult, pediatric and neonatal. The Portable Monitor networking capabilities are identical to the predicate device and include connection to the OBSERVER® Central Station via VHF, spread spectrum or hardwire communication; host communications for use on the auxiliary serial port or RS-232 serial port; and remote view protocol over Ethernet enabling communication with other devices such as currently-marketed DINAMAP® Monitors, remote display, data collection or hospital information system, or remote alarm. In addition, the Portable Monitor may be operated from internal NiMH batteries making the device portable. This device is intended for use by qualified healthcare personnel trained in its use. ### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |-------------------------------------------------------------------|---------| | Division of Cardiovascular, Respiratory, and Neurological Devices | | | 510(k) Number | K982342 | | Prescription Use (Per 21 CFR 801.109) <span style="text-decoration: line-through;">X</span> | OR | Over-The-Counter Use ______ | |---------------------------------------------------------------------------------------------|----|-----------------------------| |---------------------------------------------------------------------------------------------|----|-----------------------------| *Trademark (Optional Format 1-2-96)