507EL VITAL SIGNS MONITOR

{0}------------------------------------------------ ## KOL2435 F.12- # AUG 1 4 2002 19 July 2002 # 510K Summary #### Model 507EL Vital Signs Monitor Alex Kaplan Contact: Manager of QA & RA Criticare Systems, Inc. 20925 Crossroads Circle Waukesha, WI 53186 USA 262-798-8282 Voice 262-798-8290 FAX 507EL Vital Signs Monitor Trade Name: Vital Signs Monitor Common Name: Classification Name: Monitor, Physiological, Patient (74 MWI) CSI Model 2200 Scholar Vital Signs Substantial Equivalence is claimed to : Monitor (K944860) #### Device Description: The 507EL monitor measures and displays real time physiological data of the patient, including waveforms and numerical data. The 507EL can be used to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), SpO3, Temperature, and Respiration. For all these vital parameters, the 507EL will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review. #### Intended Use: This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor. #### Comparison with predicate device: Criticare Systems Inc. has developed and distributed physiological monitoring devices worldwide since its inception in 1984. The 507EL monitor utilizes existing core technologies from the predicate Scholar 2200 monitor for patient monitoring of ECG, / ﻞ {1}------------------------------------------------ NIBP, Resp, SpO2, and Temp. The patient data collected by the 507EL monitor is displayed for the user on a flat panel display and LEDs as on the predicate device. The 507EL monitor utilizes Passive LCD or Active TFT LCD color display technologies in combination with LED numeric displays. Membrane key panels provide a user interface equivalent to the predicate device. The packaging design of the 507EL monitor is molded plastic and allows for it to be either a stationary monitor or to be used during patient translocation within the healthcare facility, as did the predicate Scholar 2200. #### Determination of Substantial Equivalence: The 507EL monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device. Additionally, the 507EL complies with applicable safety and performance standards (detailed below) for each monitoring modality and verification of compliance has been completed. The patient monitoring technologies present in the 507EL monitor have been in clinical use for at least six years in the predicate device, the Scholar 2200 monitor. CSI's field experience with these modalities in the predicate device has been satisfactory. This combination of equivalence testing, applicable objective standards compliance and field experience substantiates a high level of confidence in the safety and efficacy of the 507EL monitor. Therefore, the 507EL monitor is substantially equivalent to the predicate devices. #### Compliance to standards and regulations: The 507EL Vital Signs Monitor complies with the following national and international standards: #### Safety UL 544 Medical Electrical Safety IEC 601-1-2 EMC Compliance ISO 10993-5,10-11 Biocompatibility #### Performance EN 60601-2-30 NIBP Safety EN1060-1 NIBP Performance EN 1060-3 NIBP Performance {including EN 475 Alarm Performance} AAMI SP-10 NIBP Performance IEC 60601-2-27 ECG Safety AAMI EC-13 Basic ECG Performance EN 865 Oximetry Performance (Equivalent to ASTM F 1415) {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three distinct head profiles, suggesting a sense of community or collaboration. The bird is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is rendered in black and white. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 4 2002 Criticare Systems, Inc c/o Mr. Alex Kaplan Manager of QA & RA 20925 Crossroads Circle Waukesha, WI 53186 Re: K022435 Trade Name: Vital Signs Monitor Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulation Number: 21 CFR 870.2300 Regulatory Class: Class II (two) Product Code: DRT Dated: July 19, 2002 Received: July 25, 2002 Dear Mr. Kaplan: 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 either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ #### Page 2 - Mr. Alex Kaplan 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR 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/dsma/dsmamain.html Sincerely vours. Elisa Diaz Sn /Bram D. Zuckerman, N Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## 510(k) NUMBER (IF KNOWN) : DEVICE NAME: Vital Signs Monitor #### Indications for Use This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor. ### (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED.) X Prescription Use (Per 21 CFR 801.109) `OR` (Division Sign Division of Cardiovascular and Respiratory Dences Over - the - Counter - Use *_*_ (Optional Format 1-2-96) lar 510(k) Number JJ