LIFEPAK 12 DEFIBRILLATOR/MONITOR

K063510 · Medtronic Emergency Response Systems, Inc. · MKJ · Jan 26, 2007 · Cardiovascular

Device Facts

Record IDK063510
Device NameLIFEPAK 12 DEFIBRILLATOR/MONITOR
ApplicantMedtronic Emergency Response Systems, Inc.
Product CodeMKJ · Cardiovascular
Decision DateJan 26, 2007
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 870.5310
Device ClassClass 3
AttributesTherapeutic, Pediatric

Intended Use

In automated external defibrillation mode, the LIFEPAK 12 defibrillator/monitor is intended for use on patients in cardiopulmonary arrest by personnel who are authorized by a physician/medical director and have, at a minimum, the following skills and training: CPR training. AED training equivalent to that recommended by the American Heart Association. Training in the use of the LIFEPAK 12 defibrillator/monitor in automated external defibrillation mode.

Device Story

LIFEPAK 12 is a portable defibrillator/monitor for hospital and pre-hospital settings (ambulances, emergency departments). Inputs include ECG signals (via electrodes), pulse oximetry, blood pressure, EtCO2, and invasive pressure transducers. Device performs manual/automated defibrillation, synchronized cardioversion, and noninvasive pacing. In AED mode, it analyzes ECG rhythms to detect shockable arrhythmias; modified with cprMAX options for protocol flexibility per 2005 AHA guidelines. Output is displayed on-screen for clinician review; used to guide resuscitation, drug titration, and cardiac monitoring. Benefits include rapid rhythm analysis and therapeutic intervention for life-threatening arrhythmias.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by design control activities and a declaration of conformity to design controls.

Technological Characteristics

Multi-parameter monitor/defibrillator. Features manual/AED defibrillation, noninvasive pacing, ECG (3/7/12-lead), pulse oximetry, NIBP, EtCO2, and invasive pressure monitoring. Powered by battery or AC. Software-based AED rhythm analysis. No specific material standards or algorithm architecture details provided.

Indications for Use

Indicated for: Manual defibrillation (ventricular fibrillation, symptomatic ventricular tachycardia); Synchronized cardioversion (atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, stable ventricular tachycardia); AED mode (cardiopulmonary arrest, patients >8 years old, unconscious, pulseless, apneic); Noninvasive pacing (symptomatic bradycardia); 12-lead ECG (cardiac disorders, acute myocardial infarction); Pulse oximetry (hypoxemia risk); Noninvasive blood pressure (hypertension/hypotension trends, shock, perfusion evaluation); EtCO2 monitoring (breathing efficacy, CPR effectiveness, endotracheal tube placement); Invasive pressure monitoring (arterial, venous, intracranial pressures). Contraindications: PEA, asystole (defibrillation); ventricular fibrillation, asystole (pacing).

Regulatory Classification

Identification

An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K063510 # SECTION E - 510(k) SUMMARY Submitter's Name and Address: JAN 2 6 2007 Medtronic Emergency Response Systems 11811 Willows Road Northeast Redmond, WA 98052 Contact Person: Michelle Ackermann Senior Regulatory Affairs Specialist Date Summary Prepared: January 3, 2007 Device: Medtronic LIFEPAK® 12 Defibrillator/Monitor Classification: | Classification Name | Class | |-----------------------------------------------------------|-------| | Low Energy DC-Defibrillator | II | | Automatic External Defibrillator | III | | Cardiac Monitor (Including Cardiotachometer & Rate alarm) | II | | Cardiac External Transcutaneous (Non-invasive) | II | | Pacemaker | II | | Oximeter | II | | Noninvasive Blood Pressure Measurement System | II | | Blood Pressure Computer | II | | Carbon Dioxide Gas Analyzer | III | {1}------------------------------------------------ #### Substantial Equivalence: The features and functions of the modified LIFEPAK 12 defibrillator/monitor are substantially equivalent to the previously cleared LIFEPAK 12 defibrillator/monitor (K041459, K040775, K033275, K010918, K002445, K990338, K991910, K973486). ### 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 a battery or AC 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 LIFEPAK 12 defibrillator/monitor has been modified with new setup options in automated external defibrillation (AED) mode to give medical directors or physicians flexibility in establishing their AED protocols including consistency with the recently updated 2005 AHA Guidelines for CPR and ECC. #### Intended Use: In automated external defibrillation mode, the LIFEPAK 12 defibrillator/monitor is intended for use on patients in cardiopulmonary arrest by personnel who are authorized by a physician/medical director and have, at a minimum, the following skills and training: - CPR training . - AED training equivalent to that recommended by the American Heart . Association - Training in the use of the LIFEPAK 12 defibrillator/monitor in . automated external defibrillation mode 063510 {2}------------------------------------------------ ### 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. 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. K063510 {3}------------------------------------------------ # 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 post-defibrillation 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. 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. Technological characteristics of new and predicate device: The new cprMAX setup options only affect operation in automated external defibrillation mode. Other features and functions of the modified LIFEPAK 12 defibrillator/monitor are the same as those of the predicate device. 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 12 defibrillator/monitor is substantially equivalent to the predicate device. {4}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The text is likely part of a document or sign, indicating an affiliation with a public health organization. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 6 2007 Medtronic Emergency Response Systems C/O Michelle Ackermann Senior Regulatory Affairs Specialist 11811 Willows Road Northeast Redmond, WA 98052 Re: K063510 Trade/Device Name: Lifepak 12 Defibrillator/Monitor Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ, LDD, DRT, DRO, DQA, DXN, DSK, CCK Dated: December 27, 2006 Received: December 28, 2006 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. 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. Image /page/4/Picture/10 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three intertwined strands. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. {5}------------------------------------------------ Page 2 – Ms. 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); 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, B.Zimmerman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" in bold, black letters on the right. The circular graphic appears to contain a stylized representation of a person within a circle. # SECTION D - STATEMENT OF INDICATIONS FOR USE 510(k) Number (if known): not yet assigned Device Name: LIFEPAK 12 Defibrillator/Monitor 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. 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) B.H. Lammi Page 1 of 3 Division Sian-Off 510(k) Number {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" in bold, black letters on the right. The graphic appears to be an abstract representation of a medical device or anatomical structure. # 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 3 (Division 81gn-Off) Division of Cardiovascular Devices 510(k) Number K06 35 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" on the right. The graphic appears to be a stylized representation of a person in motion. The word "Medtronic" is written in a bold, sans-serif font. # 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. ## 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) An | Page 3 of 3 | |-------------| |-------------| Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) | Division of Cardiovascular Devices | | |------------------------------------|---------| | 510(k) Number | K003510 |
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