LIFEPAK 12

{0}------------------------------------------------ ## SECTION E: 510(k) SUMMARY Submitter's Name and Address: Medtronic Physio-Control Corp. 11811 Willows Road Northeast P.O. Box 97006 Redmond, WA 98073 Contact Person: Michelle Ackermann (425) 867-4744 Date Summary Prepared: March 25th, 2004 Device: Medtronic Physio-Control LIFEPAK® 12 Defibrillator/Monitor/Pacemaker Classification: Low Energy DC-Defibrillator: Class II Automatic External Defibrillator: Class III Substantial Equivalence: The features and functions of the modified LIFEPAK® 12 defibrillator are substantially equivalent to the previously cleared LIFEPAK 12 defibrillator, 510(k) numbers K033275 (11/06/03), K010918 (03/26/01), K002445 (01/31/01), K990338 (09/01/99), K991910 (06/03/99), K973486 (01/09/98). Description: The LIFEPAK® 12 defibrillator/Monitor/Pacemaker is a complete acute The Ett Life in the response system, which consists of a battery or auxiliary powered cardide response bystor automated), pacemaker, ECG monitor (3-lead, 5-lead, 5-lead and interpretive 12-Lead), pulse oximeter, noninvasive blood pressure monitor, end-tidal CO2 monitor, and invasive pressure monitor. The modified LIFEPAK® 12 defibrillator/monitor/pacemaker provides the user with a new method of transmitting data from the LIFEPAK 12 {1}------------------------------------------------ defibrillator; the user can transmit data using either a data transfer cable or wirelessly via Bluetooth® wireless technology. Intended Use: Intended users of the LIFEPAK® 12 defibrillator are Advanced Life Support michded users of the Eif iders in a variety of hospital and pre-hospital settings. The bepport pred in various areas of the hospital such as critical schuigs. The device is assess is, critical care, operating room, etc.) and general areas (e.g. medical/surgical). The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.) Technological characteristics of new and predicate device: The features and functions of the LIFEPAK® 12 The reatures and rest/pacemaker are the same as those of the currently marketed LIFEPAK®12 defibrillator/monitor/pacemaker. Summary of Design Controls: This 510(k) includes a summary of design control activities and a declaration of conformity to design controls. The information in this 510(k) notification demonstrates that the modified LIFEPAK I he mormation in uns 316(tr) neasis substantially equivalent to the predicate device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a bold, sans-serif font. The words are arranged on a single line and are left-aligned. Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings and tail feathers. The logo is rendered in black and white. APR 2 3 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Medtronic Physio-Control Corp. c/o Ms. Michelle Ackermann Senior Regulatory Affairs Specialist 11811 Willows Road Northeast P.O. Box 97006 Redmond, WA 98073 Re: K040775 K040775 Trade Name: LIFEPAK® 12 Defibrillator/Monitor/Pacemaker Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MKJ Dated: March 25, 2004 Received: March 26, 2004 Dear Ms. Ackermann: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained in substantially equivalent (for the indications referenced above and have determined the device is substantially interstale referenced above and have determined the devices marketed in interstate for use stated in the encrosule) to regally mances a procession in the Medical Device Ameralments, or to commerce prof to May 28, 1976, the chaomic and be arrange with Federal Food, Drug, devices that have been reclassified in accordance while approval application (PMA). and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmetic Act (Act) that do not require the general controls provisions of the Act. The Y our may, therefore, market the devices, see as a comments for annual registration, listing of general controls provisions of the Act include requirements for annual regist general controls provisions of the Fiel Inc. Includes seat. devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (sec above) mis existing major regulations affecting your device can may be subject to such additional controls. Existing major regulation EDA may be subject to such additional controls. Existing in the 21, Parts 800 to 898. In addition, FDA may be found in the Code of Federal Regulations, Title 21, Parts 800 to 8 be found in the Code of Feactal Regaraing your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination and mean Please be advised that 1 17A 5 tosames or our device complies with other requirements of the Act {3}------------------------------------------------ Page 2 - Ms. Michelle Ackermann or any Federal statutes and regulations administered by other Federal agencies and list or any Federal statutes and regulations daminities or registration and listing (21 l comply with all the Act's requirements, including, but not limited to reguirements as set comply with all the Act s requirements, me, good manufacturing practice requirements as setter CFR Parl 807); labeling (21 CFR Part 801); good and fapplicable, the electronic forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electro forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000product radiation control provisions (Declons of Controlled in your Section 510(k) This letter will allow you to begin marketing your device as described in your since to 10c I his letter will anow you to ocgin maneting your artial equivalence of your device to a legally premarket notheation. The PDA miding of backanding of 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 desire specific advice for your ac not 100 %. Also, please note the regulation entitled, contact the Office of Compliance to (Set Part 807.97) you may obtain. "Misbranding by reference to premailser nowlities under the Act may be obtained from the Other general mionmation on your responsional 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, uma R. Loclines (J) Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use #### 510(k) Number (if known): K040775 ### Device Name: LIFEPAK 12 Defibrillator/Monitor/Pacemaker Indications For Use: AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 12 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old. Munual Defibrillation is indicated for the termination of certain potentially fatal arthythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating attial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia. Noninvasive Pacing is indicated for patients with symptomatic bradycardia or asystole. 12-Lead Electrocardiography is useful in the carly detection and prompt treatment of patients with acute myocardial infarction. Pulse Oximetry is used to check the saturation of oxygen in arterial blood. It is indicated for use in any patient who is at risk of developing hypoxemia. 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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Duana R. Lochner novascular Devices 510(k) Number_ Page 1 of 2 {5}------------------------------------------------ ## Indications for Use #### 510(k) Number (if known): K040775 Device Name: LIFEPAK 12 Defibrillator/Monitor/Pacemaker Indications For Use: Noninvasive Blood Pressure Monitoring is indicated for detection in trends of hypertension or hypotension. These include patient conditions indicated by abnormalities in various physiologic parameters such as shock, evaluation of perfusion during dysrhythmias, major fluid shifts, evaluation of response to fluid therapy, and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be useful during ECG monitoring or for post-defibriliation recovery analysis. End-Tidal CO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for monitoring breathing efficacy in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully. Invasive Pressure Monitoring is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using an invasive catheter system with a compatible transducer. 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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Duna R. Lochner sion DigirOn) ision of Cardiovascular Devices Page 2 of 2 *(k) Number K040775