MONITORING SYSTEM, MODEL ARGUS PB-2200

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a handwritten text string that appears to be a combination of letters and numbers. The string reads 'K033738' on the first line, and 'P 1/3' on the second line. The handwriting is somewhat rough, and the characters are not perfectly formed. # 510 K Summary AUG 2 4 2004 according to 21 CFR 807.92 - A1 Address SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland | Contact Name: | Mr. Markus Buetler | |---------------|---------------------| | Tel: | 001 41 41 766 4252 | | Date: | 21.th November 2003 | - A2 Device Name | 1. Trade Name: | ARGUS PB-2200 | |-----------------|-------------------| | 2. Common Name: | Monitoring System | - A3 Legally Marketed Device Legally Marketed Device to which this submitted device is compared: ARGUS PB-1000 System K 012226 #### A4 Intended Use The Monitoring System ARGUS PB-2200 is for the monitoring of vital parameters such as: Invasive Blood Pressure: systolic, distolic and mean pressure CO2, etCO2 and CO2ins, main and/or sidestream FIO2 It will extend the functionality of the existing Argus PB -1000 System (K012226) The system comprises the Parameter Box PB-1000 and the Visualisation Unit AR-GUS PRO. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the PB-1000. This data is then transmitted to the visualisation unit ARGUS PRO or another generally used PC via the serial interface. All data can be shown and monitored on the ARGUS PRO. The PB-1000 operated using an internal battery and an external power input (RS 232/12V), which is, like the data transmission, completely separate from the visualisation unit. The ARGUS PRO is powered via the normal mains connection 230V/110V. The system is intended for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport. {1}------------------------------------------------ KO 33729 P.L. ### Table of Comparison A5 | | Argus PB-1000 System<br>(K012226) | ARGUS PB-2200 | |-------------------------------------------------------------------------------------------|-------------------------------------------|-------------------| | Dimensions: | 210x115x45mm | 210x115x64.5mm 1) | | Weight: | 980 g | 1200g 2) | | Environmental Conditions:<br>Operating temperature | +10° - 40° C | same | | Storage temperature | -10° - +50° C | same | | Relative humidity | 25% - 95%<br>(non condensing) | same | | Electrostatic Discharge /<br>Electromagnetic Compatibility:<br>ESD | EN 60601-1-2 | same | | | Fully functional below 4 kV<br>(Open Air) | same | | | No damage below 8 kV (Open<br>Air) | same | | Radiated Emissions | Less than 30 dB Microvolts | same | | Radiated Immunity | Less than 3 Volts per meter | same | | Safety Standards<br>Safety of Medical Electrical Equipment<br>part1. General requirements | EN 60601-1:1990 | same | | Safety requirements for medical<br>systems | EN 60601-1-1:1993 | same | | Safety requirements for programmable<br>electrical medical systems | EN 60601-1-4:1996 | same | | Requirements for the safety of the<br>blood pressure monitoring equipment | EN 60601-2-34:1995 | 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 System (K012226) device. {2}------------------------------------------------ #### Non-Clinical Tests B1 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. EN 60601-1-1:1993 Safety requirements for medical electrical systems. EN 60601-1-2: Electromagnetic Compatibility Test, Electrostatic Discharge, Radio Frequency Electromagnetic Field, Fast Transients. EN 60601-1-4:1996 Collateral Standard: Programmable electrical medical systems. EN 60601-2-34:1995 Particular requirements for the safety of the blood pressure monitoring equipment. All tests are passed. - 4) Data related to software quality SCHILLER has reviewed its software development process following the quideline " 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. - Conclusions from Tests B3 The fulfilling of the above standards ensures the safety and effectiveness of the submitted device. We consider the submitted device to be as safe and effective as the Predicate ARGUS PB-1000 System Device. (K 012226) Date: 21.11.2003 K. R. Ze. Martin Roth Markus Buetler Quality Assurance Manager SCHILLER AG {3}------------------------------------------------ Image /page/3/Picture/11 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 & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three wavy lines, resembling a bird or a symbol representing health and human services. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 2 4 2004 Mr. Markus Buetler Quality Assurance Manager SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland Re: K033738 Trade Name: ARGUS PB-2200 Patient Monitoring System Regulation Number: 21 CFR 870.1110 Regulation Name: Blood Pressure Computer Regulatory Class: Class II (two) Product Code: DSK Dated: August 2, 2004 Received: August 4, 2004 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 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. {4}------------------------------------------------ Page 2 - Mr. Markus Buetler 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 (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. 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), please contact the Office 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 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 yours, N.W.R.S. Oplien Barry D. Zuckerman, M.D. Bram D. Zuckern Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### Indications for Use ### 510(k) Number (if known): K033738 _ ## Device Name: Monitoring System ARGUS PB-2200 Indications For Use: The monitoring system ARGUS PB-2200 is for the monitoring of vital parameters such as: Invasive blood pressure: systolic, diastolic and mean pressure s and controller Brings and/or sidestream Invasive blood pressure. Systems, main and/or sidestream FIO2 lt will extend the functionality of the existing Argus PB-1000 system (K0122Z6). The function and the promoter her PB-1000 and the visualisation unit AR It will extend the functionality of the existing Algust PB-1000 (PB-100) (PB-100) The system comprises the parameter box PB-1000 and the visualisation unit ARGUS (PBS) and th The system compilses the parcined via a serial interface. PRO. The two units are connected via a serial intenated and calculated in the PB-2200. This All vital parameters and evaluations are registered and calouaced manager generally used data is then transmitted to the visualisation unit ARGUS PRO or another generally us data is then transmitted to the visuallsation und monitored on the ARGUS PRO. PC via the serial interface. All data can be shown and monitored on the ARGUS PRO. PC via the serial interface. All data can be snown and monecessed power input (RS The PB-2200 is operated using an internal battery and an external power input (RS e and the The PB-2200 is operated using an internal battery alle an and the manate from the 232/12V), which is, like the data transmission, completely sop visualisation unit. The ARGUS PRO is powered via the normal mains connection 230V/110V. The system is intended for use in the intensive care unit, in the recovery room, in the The system is intended for ass internal transports. SCHILLER AG Altgasse 68 CH-6341 Baar/Switzerland Prescription Use X (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) Nake. Spleen to B, Page 1 of 1 (Division Sian-Off) Jivision of Cardiovascular Devices **510(k) Number** KD33738