LIFEPAK 12

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a logo for Physio Control. The logo is black and white and features the words "PHYSIO CONTROL" stacked on top of each other in a bold, sans-serif font. The words are contained within a black rectangle. The logo is simple and easy to read. Physio-Control Inc. LIFEPAK 12 defibrillator/monitor 510(k) Premarket Notification # SECTION E - 510(K) SUMMARY ## Submitter: DEC 2 2 2010 Physio-Control, Inc. 11811 Willows Road Northeast P.O. Box 97006 Redmond, Washington 98073-9706 #### Contact Person: Michelle Ackermann Principal Regulatory Affairs Specialist Phone: 425-867-4744, Fax: (425) 867-4154 #### Date Summary Prepared: October 1. 2010 ## Device Trade Name: LIFEPAK®12 defibrillator/monitor ## Device Common Name: External defibrillator/monitor ### Device Classification: | Classification Name | Class | |------------------------------------------------------------------------------------------------|-------| | Low Energy DC-Defibrillator (Including Paddles), (21CFR<br>870.5300, Product Code LDD) | II | | Automatic External Defibrillators (Non-Wearable) (21CFR<br>870.5310, Product Code MKJ) | III | | Cardiac Monitor (Including Cardiotachometer & Rate Alarm)<br>(21CFR870.2300, Product Code DRT) | II | | External Cardiac Transcutaneous (Non-Invasive)<br>Pacemaker (21CFR870.5550, Product Code DRO) | II | | Oximeter (21CFR870.2700, Product Code DQA) | II | | Noninvasive Blood Pressure Measurement System<br>(21CFR870.1130, Product Code DXN) | II | | Carbon-Dioxide Gas Analyzer Gaseous-Phase<br>(21CFR868.1400 Product Code CCK) | II | | Blood Pressure Computer (21CFR870.1110, Product Code<br>DSK) | II | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Physio-Control. The logo is in a rectangular box. The word "PHYSIO" is on the top line, and the word "CONTROL" is on the bottom line. #### Predicate Devices: The features and functions of the proposed LIFEPAK 12 defibrillator/monitor are substantially equivalent to the previously cleared LIFEPAK 12 defibrillator/monitor. 510(k) numbers for the predicate LIFEPAK 12 defibrillator/monitor are listed below. | 510(k) Number | Clearance Date | |---------------|----------------| | K063510 | 01/26/07 | | K041459 | 07/01/04 | | K040775 | 04/23/04 | | 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 was designed for use in a variety of hospital and pre-hospital settings including emergency departments. critical care areas, and air and ground ambulances. The LIFEPAK 12 defibrillator/monitor is powered by either AC power or battery power. LIFEPAK 12 defibrillator/monitor features include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-lead, 7-lead and interpretive 12-Lead), pulse oximetry, synchronized cardioversion, noninvasive blood pressure monitoring, end-tidal CO2 monitoring, and invasive pressure monitoring. The proposed LIFEPAK 12 defibrillator/monitor has the same features and functions as the predicate LIFEPAK 12 defibrillator/monitor and includes an additional battery option; a rechargeable lithium-ion battery. Use of the proposed lithium-ion battery in the LIFEPAK 12 defibrillator/monitor provides an increase in the available operating time and an increase in the number of 360-Joule discharges available while on battery power as compared to using the existing batteries. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo for Physio-Control. The logo is white text on a black background. The text is stacked, with "PHYSIO" on top and "CONTROL" on the bottom. ### Intended Use: Intended users of the LIFEPAK 12 defibrillator/monitor are Advanced Life Support and Basic Life Support providers in a variety of hospital and pre-hospital settings. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care. operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.) ## Indications for Use: #### Manual Defibrillation: #### Indications Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia. #### Contraindications Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as indioventricular or ventricular escape rhythms, and in the treatment of asystole. #### Automated External Defibrillation: #### Indications AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally 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. #### Noninvasive Pacing #### Indications Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse. Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the words "PHYSIO CONTROL" stacked on top of each other. The words are in a bold, sans-serif font and are white in color. The background is black, creating a high contrast. The text is likely part of a logo or branding for a company or product related to physiological control or medical devices. Indications for Use, cont) ### 12-lead Electrocardiography: #### Indications The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute myocardial infarction. ### Pulse Oximetry #### Indications Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia. #### Noninvasive Blood Pressure Monitoring: #### Indications 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 postdefibrillation recovery analysis. ## End-Tidal CO2 monitoring: #### Indications EtCO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for monitoring breathing efficacv and treatment effectiveness 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. It is intended for use on adult and pediatric patients. #### Invasive Pressure Monitoring: #### Indications The LIFEPAK 12 invasive pressure monitor is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using and invasive catheter system with a compatible transducer. It may be used on the adult or pediatric patient. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo for Physio Control. The logo is in black and white, with the words "PHYSIO CONTROL" stacked on top of each other. The text is in a bold, sans-serif font. The background is black, and the text is white. ## Technological characteristics of the proposed and predicate device: The only difference between the predicate LIFEPAK 12 defibrillator/monitor and the proposed LIFEPAK 12 defibrillator/monitor is an additional rechargeable battery option. Use of the lithium-ion rechargeable battery in the LIFEPAK 12 defibrillator/monitor provides an increase in the available operating time and an increase in the number of 360-Joule discharges available while on battery power as compared to using existing LIFEPAK 12 batteries. The defibrillation waveform, ECG analysis system, and monitoring and defibrillation features of the proposed LIFEPAK 12 defibrillator/monitor are unchanged from the previously cleared LIFEPAK 12 defibrillator/monitor. ## Conclusion of Testing The information in this 510(k) notification demonstrates that the LIFEPAK 12 defibrillator/monitor is substantially equivalent to the predicate LIFEPAK 12 device with respect to safety, effectiveness, and performance. {5}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Physio-Control, Inc. c/o Ms. Michelle Ackermann Principal Regulatory Affairs Specialist 11811 Willows Road Northeast P.O. BOX 97006 Redmond, WA 98073-9706 DEC 2 2 2010 Re: K102972 Trade/Device Name: LIFEPAK 12 defibrillator/monitor Lithium-ion battery Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: November 29, 2010 Received: November 30, 2010 Dear Ms. Ackermann: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {6}------------------------------------------------ Page 2 - Ms. Michelle Ackermann 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/Aboutf-DA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo for Physio Control. The logo is in a black box. The words "PHYSIO CONTROL" are stacked on top of each other in white letters. Physio-Control Inc. LIFEPAK 12 defibrillator/monitor 510(k) Premarket Notification ## SECTION D - STATEMENT OF INDICATIONS FOR USE 510(k) Number (if known): not yet assigned Device Name: LIFEPAK 12 defibrillator/monitor Indications For Use: DEC 2 2 2010 K102972 ## Manual Defibrillation: #### Indications Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia. #### Contraindications Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as indioventricular or ventricular escape rhythms, and in the treatment of asystole. #### Automated External Defibrillation: #### Indications AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally 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. ﻢ 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, Sffice of Device Evaluation (ODE) | | | | |--------------------------------------------------------|------|------|--| | 11 | 11/. | 1172 | | Page 1 of 4 (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_ {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Physio-Control. The logo is white text on a black background. The text is stacked, with "PHYSIO" on top and "CONTROL" on the bottom. ## SECTION D - STATEMENT OF INDICATIONS FOR USE 510(k) Number (if known): not yet assigned Device Name: LIFEPAK 12 defibrillator/monitor Indications For Use: ## Noninvasive Pacing #### Indications Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse. Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole. #### 12-lead Electrocardiography: #### Indications The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute myocardial infarction. ## Pulse Oximetry Indications Pulse Oximetry 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) Page 2 of 4 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Physio-Control. The logo is in a rectangular box. The word "PHYSIO" is on the top line, and the word "CONTROL" is on the bottom line. ## SECTION D - STATEMENT OF INDICATIONS FOR USE 510(k) Number (if known): not yet assigned Device Name: LIFEPAK 12 defibrillator/monitor Indications For Use: ## Noninvasive Blood Pressure Monitoring: #### Indications 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 postdefibrillation recovery analysis. ## End-Tidal CO2 monitoring: ## Indications EtCO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness 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. It is intended for use on adult and pediatric patients. ? 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) Page 3 of 4 D-3 {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Physio-Control. The logo is in a black box with white text. The text is stacked on top of each other with "PHYSIO" on top and "CONTROL" on the bottom. # SECTION D -- STATEMENT OF INDICATIONS FOR USE 510(k) Number (if known): not yet assigned Device Name: LIFEPAK 12 defibrillator/monitor Indications For Use: #### Invasive Pressure Monitoring: #### Indications The LIFEPAK 12 invasive pressure monitor is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using and invasive catheter system with a compatible transducer. It may be used on the adult or pediatric patient. | 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) | |--------------------------------------------------------| |--------------------------------------------------------| Page 4 of 4 | (Division Sign-Off) | |------------------------------------| | Division of Cardiovascular Devices | | 510(k) Number | K102972 | |---------------|---------| |---------------|---------|