CARDIOVIT AT-102

{0}------------------------------------------------ SCHILLER AG Allaosse 68. Postfact MWST Nr. 212858 e mail: sales@schiller.c buving schiller 110://www.schiller.ch 2031557 p 1 of 3 Image /page/0/Picture/3 description: The image shows the word "SCHILLER" in bold, black letters. Below the word is a thin, black line. Underneath the line, the word "SWITZERLAND" is written in smaller, black letters. The text appears to be a logo or brand name. ## APR 1 4 2004 Food and Drug Administration Center for Devices and Radiological Health Document Control Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 USA 14. of May 03 ## Pre-market Notification Letter, 510 (k) Notification Dear Documentation Control Clerk: In accordance with Section 510 (k) of the Federal Food, Drug and Cosmetic Act, and in conforniance 21 CFR 807, this pre-market notification is being submitted prior to the date when SCHILLER AG Switzerland, proposes to introduce into interstate commerce for commercial distribution of a new-dev CARDIOVIT AT-102 | 1. Trade Names: | CARDIOVIT AT-102 | |-----------------|------------------| |-----------------|------------------| - 2. Common Name: - 3. Address of Manufacturing Facility: System, ECG, Analysis Product code: 74 LOS - SCHILLER AG, Switzerland Altgasse 68 CH-6341 Baar - 4. Classification: - 5. Reason for Premarket Notification: - ნ. Substantially Equivalent Devices: - 7. Substantial Equivalence: - Class II New Device CARDIOVIT AT-1C K953396 For all technical specifications, substantial equivalence is claimed with the SCHILLER device, CARDIOVIT AT-1C (K953396) Image /page/0/Picture/23 description: The image shows three distinct shapes against a black background. On the left, there is a white heart shape with a defined outline. In the middle, there are a few scattered white spots and small shapes. On the right, there is a dark, irregular shape with a textured edge. 5K14005 {1}------------------------------------------------ 10. MWS1 Nr. 212858 e mail: sales@schiller.ch buying@schiller.ch http://www.schiller.ch Image /page/1/Picture/2 description: The image shows handwritten text on a white background. The text "K031557" is on the first line. The text "p 2 of 3" is on the second line. Image /page/1/Picture/3 description: The image shows the word "SCHILLER" in large, bold, black letters. Below the word is a horizontal line, and below that is the word "SWITZERLAND" in smaller, sans-serif letters. The text appears to be a logo or brand name. - 8. ECG measurement: - 9. ECG interpretation: Safety Standards: Common Standards for Quantitative Electrocardiograph (CSE), multi lead atlas measurement results CSE study Detection of acute myocardial infarcation - a) performance verified by enzyme evolvement (PREMIS study) - performance verified by Cardiologists b) (Boehringer Ingelheim Study) EN 60601-1 (Safety), EN 60601-1-2 (EMC), IEC 601-1-4 (Software Quality) - 11. Table of Comparison to Legally Marketed Device(s): (Predicate device CARDIOVIT AT-1C (K953396) | | AT-1C K953396 | CARDIOVIT AT-102 | |--------------------------------------|-------------------------------|----------------------------| | Dimensions: | 290x210x69mm | 380x328x100mm | | Weight: | 2.9 kg | 5.0 kg | | Environmental Conditions: | | | | Operating temperature | +10° - 40° C | same | | Storage temperature | -10° - +50° C | same | | Relative humidity | 25% - 95%<br>(non condensing) | same | | Leads: | Standard / Cabrera | same | | Battery capacity: | 2 hrs of normal use | same | | Frequency range of digital recorder: | 0 to 150Hz | same | | Control panel | Pad keys, LED indications | Alphanumerics, LCD Display | | Myogram Filter | 25Hz or 35Hz programmable | same | | Paper speed | 5/25/50mm/s (direct) | 5/10/25/50mm/s direct | | Printing process | High resolution thermal | same | {2}------------------------------------------------ K031557 p 30f3 | | inch(amplitude axes)<br>40dots per mm / 1000<br>dots per inch time axes,<br>25mm/s | | |-------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Chart paper | Thermoreactive, Z-<br>folded, 90mm | Thermoreactive, Z-folded,<br>210mm | | Recording tracks | 3 channels, positioned<br>at optimal with on 80<br>mm / 3.2 inch<br>automatic baseline<br>adjustment | 6 channels, positioned at<br>optimal with on 80 mm /<br>3.2 inch automatic<br>baseline adjustment | | Automatic lead programs | 3 channel<br>representation of 12<br>simultaneously<br>acquired standard<br>leads | 6 channel representation<br>of 12 simultaneously<br>acquired standard leads | Discusson of Differences: None of the above differences (1, 2 or 3) can be considered as safety relevant differences. We consider the submitted device to be as safe and effective as the Predicate (CARDIOVIT AT-1C) device. M. Bu, Fe Markus Buetler 14.05.03 (Date) / (Date) lead {3}------------------------------------------------ Public Health Service 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 stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 1 4 2004 SCHILLER AG c/o Mr. Markus Buetler Quality Assurance and Regulatory Affairs Manager Altgasse 68, Postfach CH-6341 Baar SWITZERLAND Re: K031557 Trade Name: CARDIOVIT AT-102 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: DPS Dated: March 19, 2004 Received: March 23, 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 (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), please contact the Office of Compliance at (301) 594-4648. 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 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, Dma R. lochner Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K031557 p L at L ## U.S. Food and Drug Administ Image /page/5/Picture/2 description: The image shows the logo of the Department of Health and Human Services. The logo consists of a stylized eagle on the left and the text "Department of Health and Human Services" on the right. The text is stacked in three lines, with "Department of" on the top, "Health and" in the middle, and "Human Services" on the bottom. CENTER FOR DEVICES AND RADIOLOGICAL I FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH ## Indications for Use 510(k) Number (if known): K031557__ Device Name: _Cardiovit_AT=102_ /_P8000Power___ Indications for Use: The AT-102 is a 12-channel, ECG Device used for the recording, analysis and evaluation of ECG recordings. Recordings made with the AT-102 can be used as a diagnostic aid for heart function and heart conditions. The AT-102 is designed for indoor use. The device provide an optional interface to the SP-250 for pulmonary function data. **SCHILLER AG** Altgasse, 68 CH-6341 Baar/Switzerland 469 Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Duna R. Lachine A (Division Sign-Off) Division of Cardiovascular Devices **510(k) Number** K031557