ARGUS, MODEL LCM

{0}------------------------------------------------ # 510 K Summary of Safety and Effectiveness according to 21 CFR 807.92 MAY 1 9 2006 - A1 . Address SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland Contact Name: Tel: Date: Mr. Markus Buetler 001 41 41 766 4252 02." May 2006 #### Device Name A2 | 1. Trade Name: | Argus LCM (Basic / Plus) | |-----------------|--------------------------| | 2. Common Name: | Monitoring System | ### Legally Marketed Device A3 Legally Marketed Device to which this submitted device is compared: | ARGUS PB-1000 System | K012226 | |----------------------|---------| | Cardiovit AT-102 | K031557 | #### A4 Intended Use The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as: - ECG: Heartrate, Respiration Rate . - Invasive Blood Pressure: systolic, diastolic and mean pressure - - Temperature: temperature - - Non Invasive Blood Pressure: systolic, diastolic and mean pressure - - CO2, etCO2 and CO2ins and respiration rate. - - SpO2: SpO2 and pulse rate There is alarm handling for all parameters except temperature. The ARGUS LCM is powered via the normal mains connection 230V/110V, and using an internal battery and an external power input. The system is inteded for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport. {1}------------------------------------------------ K053207 P2/4 ### Table of Comparison (1) A5 | | Argus PB-1000 System<br>(K012226) | ARGUS LCM | |---------------------------|-----------------------------------|-------------------| | Dimensions: | 210x115x45mm | 290x275x180mm1) | | Weight: | 980 g | 4.6 kg / 9.2lbs2) | | Environmental Conditions: | | | | Operating temperature | +10° - 40° C | same | | Storage temperature | -10° - +50° C | same | | Relative humidity | 25% - 95%<br>(non condensing) | same | Discussion of Differences: None of the above differences (1 or 2) can be considered as safety relevant differences. We consider the submitted device to be as safe and effective as the Predicate ARGUS PB-1000 (K 012226) device. | LCM<br>Plus | LCM<br>Basic | Module | Description | Reference | Standards | |-------------|--------------|--------|----------------------------------------------------------------------------------------|----------------------------------------------|-----------------------------------------------| | X | X | System | Schiller AT-102 | K031557, Schiller<br>AT-102 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-4 | | X | | ECG | Schiller AT-102 | K031557, Schiller<br>AT-102 | IEC 60601-1<br>IEC 60601-2-2 | | | X | ECG 3p | New Schiller ECG<br>Hardware amplifier<br>Amplifier Firmware<br>Filtering<br>Algorithm | K031557, Schiller<br>AT-102 | IEC 60601-1<br>IEC 60601-2-2 | | X | X | SPO2 | Masimo OEM SpO2<br>Module MS-7 | K990966, Masimo<br>SET 2000 | Verification and<br>Test Documer | | X | X | SPO2 | Nellcor OEM SpO2 Module<br>MP-100 | K021090, Nellcor N-<br>550 Pulse Oximeter | Verification and<br>Test Documer | | X | X | NIBP | Schiller NIBP Module<br>ARGUS PB-1000 | K012216, Schiller<br>ARGUS PB-1000<br>System | IEC 60601-2-3 | | X | X | Temp. | Schiller Temperature<br>Module ARGSU PB-1000 | K012216, Schiller<br>ARGUS PB-1000<br>System | EN 12470-4 | | X | X | CO2 | Welch Allyn OEM CO2<br>Module LC101 | K022084, Welch<br>Allyn Atlas Monitor | Specifications<br>Declaration | | X | X | IBP | Schiller IBP Module<br>ARGUS PB-1000 | K012216, Schiller<br>ARGUS PB-1000<br>System | IEC 60601-2-3 | ## Table of Comparison (2) {2}------------------------------------------------ ### B1 Non-Clinical Tests - 1. Electrical Safety and Reliability: The device has been tested to be in accordance with the following standards: EN 60601-1:1990: Safety of Medical Electrical Equipment part 1, General requirements. IEC60601-1-2: Electromagnetic Compatibility Test, Electrostatic Discharge, Radio Frequency Electromagnetic Field, Fast Transients. IEC60601-2-27:1996 Particular Requirements for the safety of electrocardiographic monitoring equipment. IEC60601-2-30:1995 Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment. IEC60601-2-34:1995 Particular requirements for the safety of the blood pressure monitoring equipment. IEC60601-2-49:2001 Particular Requirements for the safety of multifunction patient monitoring equipment EN865:1997 Pulse Oximeters-Particular Requirements All tests are passed. ### 4) Data related to software quality SCHILLER has reviewed its software development process following the guideline * reviewer guidance for computer controlled medical devices undergoing 510 (k) review". Device software requirements, software structure chart, software development, software revision/ modification, software identification, software verification, validation and testing are described in the data attached. #### B2 Clinical Tests n.a. ### B3 Summary of Performance Testing: The Argus LCM Monitoring and associated accessories have been tested and found to comply with recognized national and international performance, safety and electromagnetic compatibility standards for medical devices and product specifications listed in the Argus LCM labeling. A risk analysis, identifying potential hazards and documenting mitigation of the hazards. has been developed and verified/validated as part of SCHILLER AG. product development procedures. SCHILLER AG Quality System conforms to 21 CFR 820 and is Certified to ISO 9001:2000 and ISO 13485:2003 {3}------------------------------------------------ ### Conclusion As stated above, SCHILLER AG conclusion is that the Argus LCM Monitoring is safe, effective, comply with the appropriate medical device standards and equivalent to the Argus PB-1000 System (K012226) and Cardiovit AT-102 (K031557) currently on the market. Baar (Switzerland) 02™ May 2006 A. Bi. Ree Markus Buetler SCHILLER AG Quality Assurance and Regulatory Affairs Manager Section and Career of {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 9 2006 Mr. Markus Buetler Quality and Regulatory Department Schiller AG Altgasse 68 Baar, ZG, Switzerland 6341 Re: K053207 Trade/Device Name: Argus, Model LCM Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: MHX Dated: November 11, 2005 Received: November 16, 2005 Dear Mr. Buetler: 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 10 mo beared or 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. {5}------------------------------------------------ ### Page 2 - Mr. Markus Buetler Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase of acribed alla I termination that your device complies with other requirements of the Act that I Dr Amal statutes and regulations administered by other Federal agencies. You must or any I caster that to t'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 (21 CFR Part 807), accems (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. product faction control provided in arketing your device as described in your Section 510(k) I mis lotter will and w Jown FDA finding of substantial equivalence of your device to a legally premated predicated with 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), please If you active of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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 yours, Duna R. hochner Image /page/5/Picture/5 description: The image shows a handwritten symbol or character. It appears to be a combination of curved and angular lines, possibly resembling a stylized letter or a unique design. The lines are thick and dark, suggesting they were drawn with a pen or marker. The overall impression is abstract and artistic. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Indications for Use 510(k) Number (If know): KOS3207 Device Name: Argus LCM Indications for Use: The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as: - ECG: Heartrate, Respiration Rate ・ - Invasive Blood Pressure: systolic, diastolic and mean pressure - - Temperature: temperature ー - Non Invasive Blood Pressure: systolic, diastolic and mean pressure - - CO2, etCO2 and CO2ins - - SpO2: SpO2 and pulse rate - There is alarm handling for all parameters except temperature. The ARGUS LCM is powered via the normal mains connection 230V/110V, and using an internal battery and an external power input. The system is inteded for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport. SCHILLER AG Altgasse 68 341 Baar/Switzerland 10////0√ Prescription Use (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) ovascular Devices 510(k) Number k053207