POWERHEART CARDIAC RHYTHM MODULE

{0}------------------------------------------------ # 510(k) SUMMARY ### Submitter's Name and Address 10.1 NOV 1 6 2001 CARDIAC SCIENCE, INC. 16931 Millikan Avenue Irvine, CA. 92606 # Contact person: Sew-Wah Tay, PhD Vice President Cardiac Science, Inc. 5420 Feltl Road Minneapolis, MN 55343 Tel: 952-939-2942 Fax: 952-939-4191 Email: stay@cardiacscience.com ### 10.2 Date Summary was Prepared October 21, 2001 ### 10.3 Device Name Proprietary: Powerheart® Cardiac Rhythm Module™ (CRMTM) Common: Automatic External Cardioverter Defibrillator ### 10.4 Classification - 1. 870.5300 DC-defibrillator - 2. 870.5550 External Transcutaneous Cardiac Pacemaker (Noninvasive) - 3. Class III 74 MJK ### 10.5 Predicate Device Powerheart® AECD®, K993533 ### 10.6 Description of Device The Powerheart Cardiac Rhythm Module (CRM) is a compact, lightweight, automatic external cardioverter defibrillator. It incorporates essential circuitry and software to provide a detection/analysis/defibrillation/pacing system, in a single device, for monitoring and providing therapy to patients at risk for Sudden Cardiac Arrest. {1}------------------------------------------------ #### 10.7 Intended Use of Device ### Indication for Use: The Powerheart Cardiac Rhythm Module (CRM) is intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province or country regulations in which they practice. The Powerheart CRM can be used in three modes: fully automatic mode, advisory mode or manual mode and includes a pacer which allows an operator to deliver external stimuli for temporary transcutaneous cardiac pacing. The Powerheart has previously undergone clinical testing on adults which support the safety and effectiveness of using the device on patients at risk of sudden cardiac arrest who are at least 8 years of age. The device is not classified as a wearable external defibrillator and is not in the home environment. # Fully Automatic Mode In this mode, the device continuously monitors the patient's ECG rhythm, detects shockable ventricular tachyarrhythmias and automatically provides defibrillation therapy for the treatment of sudden cardiac arrest. ### Advisory (AED) Mode In this mode, the device continuously monitors the patient's ECG rhythm, detects shockable ventricular tachyarrhythmias and advises the operator to press the shock button to deliver defibrillation therapy for the treatment of sudden cardiac arrest. ### Manual Mode In this mode, as is the case with all standard manual defibrillators, the operator manually selects the energy setting, manually selects the charge button, determines if the patient has a shockable ventricular tachyarrhythmia and decides when to manually deliver defibrillation therapy. # Pacing The device includes a non-invasive external pacer that allows a physician and/or trained medical person to provide temporary external cardiac pacing for patients with symptomatic bradycardia or asystole. #### 10.8 Summary of Technological Characteristics The Powerheart CRM utilizes an FDA-cleared and patented arrhythmia detection software that continuously monitors, detects and delivers therapy, according to physician-prescribed parameters, to patients experiencing ventricular tachyarrhythmias. The delivery output is an FDA-cleared, biphasic truncated exponential waveform, which the Powerheart CRM can transmit in one of three modes: Automatic, Advisory and Manual. The Powerheart CRM also provides non-invasive temporary cardiac pacing. #### 10.9 Summary of Performance Data The performance tests conducted on the Powerheart Cardiac Rhythm Module will follow the applicable portions of the ANSIAAMI DF2 and DF39 requirements for cardiac defibrillator devices and automatic external defibrillators to demonstrate the safety and efficacy of the CRM device. {2}------------------------------------------------ ### 10.10 Conclusion The performance tests conducted on the Powerheart CRM will be subjected to pre-determined pass criteria that will support claims of substantial equivalence. {3}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 1 6 2001 Sew-Wah Tay, Ph.D. Vice President Cardiac Science, Inc. 5420 Feltl Road Minneapolis, MN 55343 Re: K012197 Trade Name: Powerheart® Cardiac Rhythm Module Regulation Number: 21 CFR 870.5300 Regulation Name: Defibrillator, Automatic, External Regulatory Class: Class III (three) Product Code: MKJ, LDD, DRO Dated: October 29, 2001 Received: October 30, 2001 Dear Ms. Tay: 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 - Sew-Wah Tay, Ph.D. 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, signature James H. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Image /page/5/Picture/2 description: The image shows a heavily edited or obscured piece of text. Due to the extensive alterations, it is impossible to discern the original content or meaning of the text. The image appears to be a close-up of the text, with the modifications applied directly to the characters. 510(k) Number: K012197 NOV 1 6 2001 Device Name: Powerheart® Cardiac Rhythm Module # Indication for Use: The Powerheart Cardiac Rhythm Module (CRM) is intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province or country regulations in which they practice. The Powerheart CRM can be used in three modes: fully automatic mode, advisory mode or manual mode and includes a pacer which allows an operator to deliver external stimuli for temporary transcutaneous cardiac pacing. The Powerheart has previously undergone clinical testing on adults which support the safety and effectiveness of using the device on patients at risk of sudden cardiac arrest who are at least 8 years of age. The device is not classified as a wearable external defibrillator and is not intended for use in the home environment. # Fully Automatic Mode In this mode, the device continuously monitors the patient's ECG rhythm, detects shockable ventricular tachyarthythmias and automatically provides defibrillation therapy for the treatment of sudden cardiac arrest. # Advisory (AED) Mode In this mode, the device continuously monitors the patient's ECG rhythm, detects shockable ventricular tachyarrhythmias and advises the operator to press the shock button to deliver defibrillation therapy for the treatment of sudden cardiac arrest. # Manual Mode In this mode, as is the case with all standard manual defibrillators, the operator manually selects the energy setting, manually selects the charge button, determines if the patient has a shockable ventricular tachyarrhythmia and decides when to manually deliver defibrillation therapy. # Pacing The device includes a non-invasive external pacer that allows a physician and/or trained medical person to provide temporary external cardiac pacing for patients with symptomatic bradycardia or asystole. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |--------------------------------------------------------|----|----------------------| | Division of Cardiovascular & Respiratory Devices | | | | K012/197 | | | | Prescription Use | OR | Over-The Counter Use | | (Per 21 CFR 801.109) | | |