LIFEPAK 15 MONITOR/DEFIBRILLATOR

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo for Physio-Control. The logo is in a rectangular box with a black background. The words "PHYSIO" and "CONTROL" are stacked on top of each other in white, sans-serif font. K103567 p1/6 # SECTION E - 510(K) SUMMARY ## Submitter: Physio-Control, Inc. 11811 Willows Road Northeast P.O. Box 97006 Redmond, Washington 98073-9706 ## MAR 2 2 20i1 ## Contact Person: Michelle Ackermann Principal Regulatory Affairs Specialist Phone: 425-867-4744, Fax: (425) 867-4154 ## Date Summary Prepared: December 3, 2010 ## Device Trade Name: LIFEPAK®15 monitor/defibrillator ## Device Common Name: External monitor/defibrillator ## Device Classification: | Classification Name | Class | |-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Low Energy DC-Defibrillator (Including Paddles), (21CFR | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | 870.5300, Product Code LDD) | | | Automatic External Defibrillators (Non-Wearable) (21CFR | | | 870.5310, Product Code MKJ) | | | Cardiac Monitor (Including Cardiotachometer & Rate Alarm) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | (21CFR870.2300, Product Code DRT) | | | External Cardiac Transcutaneous (Non-Invasive) | - | | Pacemaker (21CFR870.5550, Product Code DRO) | | | Oximeter (21CFR870.2700, Product Code DQA) | ============================================================================================================================================================================== | | Noninvasive Blood Pressure Measurement System | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | (21CFR870.1130, Product Code DXN) | | | Carbon-Dioxide Gas Analyzer Gaseous-Phase | ll | | (21CFR868.1400 Product Code CCK) | | | Blood Pressure Computer (21CFR870.1110, Product Code | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | DSK) | | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a 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 E - 510(K) SUMMARY K103567 p 2/6 Clinical Electronic Thermometer. (21CFR880,2910, Product Code FLL) #### Predicate Device: The features and functions of the proposed LIFEPAK 15 monitor/defibrillator are substantially equivalent to the previously cleared LIFEPAK 15 monitor/defibrillator. The LIFEPAK 15 monitor/defibrillator was cleared under 510(k) number K082937 on 03/11/09. #### Description: The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LIFEPAK 15 monitor/defibrillator was designed for use in a variety of hospital and pre-hospital settings including emergency rooms, catheterization laboratories, electrophysiology laboratories, crash carts, operating rooms, and ground ambulances. Features of the LIFEPAK 15 monitor/defibrillator include manual and automated external defibrillation, noninyasive pacing, ECG monitoring (3-lead, 7-lead and interpretive 12-Lead), pulse oximetry (SpO2, SpCO. and SpMet), synchronized cardioversion, noninvasive blood pressure monitoring, end-tidal CO2 monitoring and invasive pressure monitoring. The existing LIFEPAK 15 monitor/defibrillator is powered by rechargeable lithium-ion batteries. The proposed LIFEPAK 15 monitor/defibrillator includes all of the same features and functions as the predicate device plus 2 new features: 1) temperature monitoring and 2) auxiliary power. The temperature monitoring feature allows continuous monitoring of body temperature with the use of temperature probes. The temperature reading can be trended and displayed on the LIFEPAK 15 monitor/defibrillator screen. The temperature trend graph can also be printed or saved and transmitted to the Physio-Control CODE-STAT" software for post event review. The new auxiliary power feature gives users an additional option for powering the LIFEPAK 15 monitor/defibrillator. In addition to the existing rechargeable lithium-ion batteries, users will have the option to operate their device from AC power sources via an AC power adapter {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Physio-Control. The logo is a black rectangle with the word "PHYSIO" in white, block letters on top. Below that is the word "CONTROL" in smaller, white, block letters. The logo is simple and easy to read. Image /page/2/Picture/3 description: The image shows handwritten text on a white background. The text includes the alphanumeric string "K1035B7" on the first line. The second line contains the letter "p" followed by the fraction "3/6", indicating a page number or a similar reference. or from DC power sources via a DC power adapter. The LIFEPAK 15 monitor/defibrillator charges installed batteries when connected to auxiliary power. ## Intended Use: The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older. Indications for Use: ## Manual Defibrillation: ## Indications Manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy 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 15 monitor/defibrillator is not intended for use on pediatric patients less than 8 years old. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for Physio-Control. The logo is white text on a black background. The text is stacked in two rows, with "PHYSIO" on the top row and "CONTROL" on the bottom row. The text is in a sans-serif font and appears slightly distressed. K103567 p 4/6 ## 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 ST-elevation myocardial infarction (STEMI). ## Pulse Oximetry ## Indications Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. SpO2 monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused. SpCO and SpMet accuracies have not been validated under motion or low perfusion conditions. ## Noninvasive Blood Pressure Monitoring: ## Indications Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension and monitoring BP trends in patient conditions such as, but not limited to, shock, acute dysrhythmia, or major fluid imbalance. ## End-Tidal CO2 monitoring: ## Indications EtCO2 monitoring is used to detect 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 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo for Physio-Control. The logo is black and white and features the words "PHYSIO" stacked on top of the word "CONTROL". The text is in a bold, sans-serif font and is contained within a rectangular box. K103567 p 5/6 compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully. ## Invasive Pressure Monitoring: #### Indications Invasive pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient's condition or response to therapy. It may also be used to aid in medical diagnosis. ## Temperature Monitoring: #### Indications Temperature monitoring is indicated for use in patients who require continuous monitoring of body temperature. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo for Physio-Control. The logo is a black square with the words "PHYSIO" stacked on top of the word "CONTROL" in white, block letters. The text is centered within the square. K103567 p6/6 ## Technological characteristics of the proposed and predicate device: The main difference between the predicate LIFEPAK 15 monitor/defibrillator and the proposed LIFEPAK 15 monitor/defibrillator is the addition of 2 new features; temperature monitoring and auxiliary power. Device characteristics such as the defibrillation waveform and ECG analysis system are unchanged from the predicate device. ## Conclusion of Testing The information in this 510(k) notification demonstrates that the LIFEPAK 15 monitor/defibrillator is substantially equivalent to the predicate LIFEPAK 15 device with respect to safety, effectiveness, and performance. E-6 {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. 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 MAR 2 2 2011 Re: K103567 Trade/Device Name: LIFEPAK 15 monitor/defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: March 10, 2011 Received: March 14, 2011 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. {7}------------------------------------------------ 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/AboutFDA/CentersOffices/CDRH0ffices/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. F.S. Gind Dr. Bram D. Zuckerman, M.D. Bram D/Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Physio-Control. The logo is in a rectangular box. The text "PHYSIO CONTROL" is stacked on top of each other in a sans-serif font. 510(k) Number (if known): not yet assigned ## Device Name: LIFEPAK 15 monitor/defibrillator Indications For Use: ## Manual Defibrillation: #### Indications Manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy 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 15 monitor/defibrillator is not intended for use on pediatric patients less than 8 years old. | Prescription Use<br>(Part 21 CFR 801 Subpart D) | √ | |-------------------------------------------------|---| |-------------------------------------------------|---| AND/OR | Over-The-Counter Use<br>(21 CFR 807 Subpart C) | ________________ | |------------------------------------------------|------------------| |------------------------------------------------|------------------| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CBBH: Office/of Device Evaluation(ODE) | (Division Sign-Off) | |------------------------------------| | Division of Cardiovascular Devices | | Page 1 of 4 | D-1 | |-------------|-----| |-------------|-----| | 510(k) Number | K103567 | |---------------|---------| |---------------|---------| {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Physio-Control. The logo is a black rectangle with the word "PHYSIO" stacked on top of the word "CONTROL" in white, sans-serif font. The words are centered within the rectangle. 510(k) Number (if known): not vet assigned Device Name: LIFEPAK 15 monitor/defibrillator 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 ST-elevation myocardial infarction (STEMI). ## Pulse Oximetry #### Indications Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoqlobinemia. SpO2 monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused. SpCO and SpMet accuracies have not been validated under motion or low perfusion conditions. 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) | <span style="text-decoration: overline;"></span> <span style="float: right;">BDC</span> | |--------------------------------------------------------|-----------------------------------------------------------------------------------------| | Page 2 of 4 | | | | (Division Sign-Off) | | | Division of Cardiovascular Devices | | 510(k) Number | K102567 | | | <span style="float: right;">D-2</span> | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the words "PHYSIO CONTROL" stacked on top of each other. The words are in white and are on a black background. The words are in a sans-serif font and are bolded. 510(k) Number (if known): not yet assigned Device Name: LIFEPAK 15 monitor/defibrillator Indications For Use: ## Noninvasive Blood Pressure Monitoring: #### Indications Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension and monitoring BP trends in patient conditions such as, but not limited to, shock, acute dysrhythmia, or major fluid imbalance. ## End-Tidal CO2 monitoring: #### Indications EtCO2 monitoring is used to detect 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. 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 (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number 1103567 {11}------------------------------------------------ Image /page/11/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. 510(k) Number (if known): not yet assigned Device Name: LIFEPAK 15 monitor/defibrillator Indications For Use: #### Invasive Pressure Monitoring: #### Indications Invasive pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient's condition or response to therapy. It may also be used to aid in medical diagnosis. #### Temperature Monitoring: #### Indications Temperature monitoring is indicated for use in patients who require continuous monitoring of body temperature. 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) 5 | Concurrence of CDRH, Office of Device Evaluation (ODE) | <i>signature</i> BOZ | |--------------------------------------------------------|------------------------------------| | Page 4 of 4 | (Division Sign-Off) | | | Division of Cardiovascular Devices | | | 510(k) Number K103567 D-4 |