VITAL SIGNS MONITOR

{0}------------------------------------------------ 26 July 2010 # 510(k) Summary ## Model 9100 Family Vital Signs Monitor Contact: Alex Kaplan Director QA & RA Criticare Systems, Inc. 20925 Crossroads Circle Waukesha, WI 53186 USA 262-798-8282 Voice 262-798-8290 FAX Trade Name: 9100 Family Vital Signs Monitor Vital Signs Monitor Common Name: Classification Name: ST Segment Monitor with Alarm (MLD); Physiological Monitor (with Arrhythmia Detection or Alarms) (MHX) {CFR 870.1025} Substantial Equivalence is claimed to : 8100/8500 Vital Signs Monitor (K012059). 8100 w/Arrhythmia & ST Analysis Vital Signs Monitor (K030613). 9100 Vital Signs Monitor (K091050). ### Device Description: The 9100 monitor measures and displays real time physiological data of the patient, including a graphical plethysmogram and numerical data. The 9100 is a modular system and can be used to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP, Temperature, Respiratory Gases, Anesthetic Agent Gases and SpO2. Arrhythmia and ST Segment analysis of the ECG waveforms is also offered. For all these vital parameters, the 9100 will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review. #### Comparison with predicate device: Criticare Systems Inc. has developed and distributed physiological monitoring devices worldwide since its inception in 1984. The 9100 monitor utilizes existing core technologies from the predicate 8100 monitor for patient monitoring of ECG, Noninvasive BP (NIBP), Invasive BP, Temperature, Respiratory Gases, Anesthetic Agent Gases and SpO2. The patient data collected by the 9100 monitor is displayed for the user on a graphic LCD equivalent to the predicate device. Key panels and a touchscreen provide a user interface equivalent to the predicate device. The packaging design of the 1 2010 SEP {1}------------------------------------------------ 9100 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 8100. ## Determination of Substantial Equivalence: The 9100 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device. Additionally, the 9100 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 9100 monitor have been in clinical use for at least six years in the 8100 monitor and it's predicates. CSI's field experience with these modalities in the predicate devices 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 9100 monitor. Therefore, the 9100 monitor is substantially equivalent to the predicate devices. ## Compliance to standards and regulations: The 9100 Vital Signs Monitor complies with the following national and international standards: #### Safety IEC 60601-1 Medical Electrical Safety IEC 60601-1-2 EMC Compliance IEC 60601-1-8 Alarıs IEC 60601-2-49 Multi-parameter Monitor Safety ISO 10993-5,10-11 Biocompatibility #### Performance IEC 60601-2-30 NIBP Safety EN 1060-1 NIBP Performance EN 1060-3 NIBP Performance AAMI SP-10 NIBP Performance ISO 9919 Oximetry Performance IEC 60601-2-27 ECG Safety AAMI EC-13 Basic ECG Performance AAMI EC-57 Performance of Cardiac Rhythm and ST Segment Measurement Algorithms IEC 60601-2-34 Invasive Blood Pressure Safety · ISO 21647 Gas Monitor Performance EN 12470-4 Temperature Performance {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement around the left side of the logo. The text is in all caps and is smaller than the caduceus symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Criticare Systems, Inc. c/o Mr. Alex Kaplan Director QA & RA 20925 Crossroads Circle Waukesha, WI 53186 : _ _ !!. ﺎﺕ Re: K101602 Trade/Device Name: 9100 Family Vital Signs Monitor Regulatory Number: 21 CFR 870.1025 Regulation Name: ST Segment Monitor with Alarm Regulatory Class: II (two) Product Code: MLD, MHX Dated: June 30, 2010 Received: August 2, 2010 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its,toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. M. J. Weele ﻣﻬﻢ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 1 2010 SEP 510(k) Number (if known): KIO 160 Z 9100 Family Vital Signs Monitor Device Name: ## 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. The monitored parameters are: - 1. ECG - 2. Noninvasive Blood Pressure (NIBP) - 3. Invasive Blood Pressure (IBP) - 4. Temperature - 5. Respiratory Gases - 6. Anesthetic Agent Gases - 7. Respiratory Rate - 8. Pulse Oximetry (SpO2) - 9. Arrhythmia and ST Analysis of the ECG waveforms Prescription Use _ V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) M.A. Williem Division Sign Off Division Sign-Off Office of Device Evaluation Evaluation and Safety 510(K) K101602 ﻧﺴﺒﺔ ﻣﻦ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ Page 1of 1