MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650

{0}------------------------------------------------ K02210 # OCT 0 4 2002 #### 510K SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 16: This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92. #### 16.1: ADMINSTRATIVE INFORMATION | Name and Address<br>Submitted by: | Cardiac Science Incorporated<br>16931 Millikan Ave<br>Irvine, CA 92606 | |-----------------------------------|------------------------------------------------------------------------| | Contact Person: | John Carline | | Telephone No.: | 952-939-4181, x2978 | | Facsimile No.: | 952-939-4191 | | Email: | jcarline@cardiacscience.com | Date Prepared: July 1, 2002 #### DEVICE INFORMATION 16.2: | Common or Usual Name: | Disposable Polymer (Hydrogel) External<br>Monitoring, Pacing, Cardioversion and<br>Defibrillation Electrode | |-----------------------|-------------------------------------------------------------------------------------------------------------| | Trade Name: | Powerheart® Multifunctional Electrodes<br>Models 9640 and 9650 | #### 16.3: DEVICE CLASSIFICATION | Classification Name: | Multifunctional Electrocardiograph Electrode | |----------------------|----------------------------------------------| | | 21 CFR 870.2360 | | | MLN | | Device Class: | III | #### 16.4: DEVICE DESCRIPTION . The Multifunctional Electrodes consist of a pair of single-use, hydrogel polymeric selfadhesive electrode pads of equal dimension intended to be used for defibrillation, synchronized cardioversion, ECG monitoring and external pacing. The Multifunctional Electrodes are for use with the Powerheart® Cardiac Rhythm Module and the Powerheart® Automatic External Cardiac Defibrillator (AECD). The electrodes are packaged in a pouch to prevent the gel from drying out. ______________________________________________________________________________________________________________________________________________________________________________ {1}------------------------------------------------ The Model 9640 contains an additional small right leg drive (RLD) electrode on the sternum pad. The RLD electrode is used to eliminate the voltage potential between the patient and defibrillator's ground reference. Inside each electrode connector is an electrode ID chip. The ID chip allows the defibrillator to read the electrode specific information contained in the ID chip. #### 16.5: INDICATION FOR USE The Multifunctional Electrodes, Models 9640 and 9650 are single use and intended to be used for defibrillation, synchronized cardioversion, ECG monitoring, and external pacing. ### 16.6: IDENTIFICATION OF PREDICATE DEVICE | Company | Device | 510(k) No. | Date Cleared | |-----------------------------------------------|------------------------------------------------------------------|------------|--------------| | Contour Medical<br>Technology<br>(Ludlow Co.) | Disposable Hydrogel<br>Defibrillation Electrode<br>Model MFE-116 | K960329 | July 1, 2002 | ## 16.7: SUBSTANTIAL EQUIVALENCE The Multifunctional Electrodes, Models 9640 and 9650 covered by this submission are substantially equivalent to other legally marketed electrodes for semi-automatic low power DC defibrillators. Specifically, the Multifunctional Electrodes are substantially equivalent to Contour Medical Technology (Ludlow Company) Disposable Hydrogel Defibrillation Electrode, Model MFE 116 cleared under premarket 510(k) notification, K960329 on July 2, 1996. ## 16.8: PERFORMANCE DATA ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Performance testing was conducted to verify that the Multifunctional Electrodes meet the applicable requirements for single use hydrogel electrodes in accordance with industry standards ANSI/AAMI DF-2, ANSI AAMI DF-39, and. ANSV/AAMI EC-12. In addition, biocompatibility assessments were conducted on the components that come into contact with the patient's skin. The Multifunctional Electrodes, Models 9640 and 9650 were found to perform as intended. {2}------------------------------------------------ #### 16.9: CONCLUSIONS Cardiac Science has demonstrated through its evaluation and testing of the Multifunctional electrodes, Models 9640 and 9650 that the device is equivalent to the predicate device with respect to intended use, technological characteristics, materials, function and safety and effectiveness. This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a symbol that appears to be three stylized human profiles facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 0 4 2002 Cardiac Science, Inc. c/o Mr. John Carline Manager, Regulatory Affairs 16931 Millikan Avenue Irvine, CA 92606 Re: K022210 Trade Name: Multifunctional Electrodes, Models 9640 and 9650 Regulation Number: 21 CFR 870.1025 Regulation Name: Automated External Defibrillator Electrode Regulatory Class: Class III (three) Product Code: MKJ Dated: July 1, 2002 Received: July 8, 2002 Dear Mr. Carline: 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. John Carline 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 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 yours, V Bram D. Zuckerman, M.D. uckerman. M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # INDICATIONS FOR USE 510(k) Number: | Device Name: | Multifunctional Electrodes | |--------------|----------------------------| | | Models 9640 and 9650 | - The Multifunctional Electrodes are single use and intended to Indications for Use: be used for defibrillation, synchronized cardioversion, ECG monitoring and external pacing. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) XQ6712 Division of Cardiovascular & Respiratory Devices 510(k) Number K022210 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use