K Number
K102972
Device Name
LIFEPAK 12
Date Cleared
2010-12-22

(77 days)

Product Code
Regulation Number
870.5310
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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. 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.
Device 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.
More Information

Not Found

No
The document describes a multi-functional medical device (defibrillator/monitor) with various standard physiological monitoring capabilities. There is no mention of AI, ML, or any advanced analytical techniques beyond standard signal processing for interpreting physiological data. The focus is on the hardware and the addition of a new battery option.

Yes
The device is indicated for the termination of potentially fatal arrhythmias, noninvasive pacing, blood pressure monitoring, and monitoring of hypoxemia, all of which are therapeutic interventions or support therapeutic decision-making for patient treatment.

Yes
The description of the device clearly indicates it has multiple diagnostic capabilities, including 12-lead Electrocardiography for identifying and diagnosing cardiac disorders, Pulse Oximetry for detecting hypoxemia, Noninvasive Blood Pressure Monitoring for detecting trends in hypertension or hypotension, End-Tidal CO2 monitoring for monitoring breathing efficacy, and Invasive Pressure Monitoring for measuring various physiological pressures.

No

The device description clearly states it is a "defibrillator/monitor" with various hardware components and functions (defibrillation, pacing, ECG, pulse oximetry, blood pressure, CO2 monitoring, invasive pressure monitoring). It is a physical medical device, not software only.

Based on the provided text, the LIFEPAK 12 defibrillator/monitor is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • LIFEPAK 12 Functionality: The description of the LIFEPAK 12 focuses on direct patient monitoring and intervention. Its functions include:
    • Defibrillation and Pacing: Delivering electrical therapy directly to the patient.
    • ECG Monitoring: Measuring the electrical activity of the heart through electrodes placed on the skin.
    • Pulse Oximetry: Measuring oxygen saturation in the blood through a sensor placed on the skin.
    • Noninvasive Blood Pressure Monitoring: Measuring blood pressure through a cuff placed on the arm.
    • End-Tidal CO2 Monitoring: Measuring CO2 in exhaled breath.
    • Invasive Pressure Monitoring: Measuring physiological pressures using a catheter inserted into the body.

None of these functions involve the analysis of specimens outside the body. The device interacts directly with the patient to gather physiological data and deliver therapy.

N/A

Intended Use / Indications for Use

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.

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.

Product codes (comma separated list FDA assigned to the subject device)

MKJ, LDD, DRT, DRO, DQA, DXN, CCK, DSK

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

The LIFEPAK 12 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old for AED mode.
End-Tidal CO2 monitoring is intended for use on adult and pediatric patients.
Invasive Pressure Monitoring may be used on the adult or pediatric patient.

Intended User / Care Setting

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.)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K063510, K041459, K040775, K033275, K010918, K002445, K990338, K991910, K973486

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 870.5310 Automated external defibrillator system.

(a)
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.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

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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 NameClass
Low Energy DC-Defibrillator (Including Paddles), (21CFR
870.5300, Product Code LDD)II
Automatic External Defibrillators (Non-Wearable) (21CFR
870.5310, Product Code MKJ)III
Cardiac Monitor (Including Cardiotachometer & Rate Alarm)
(21CFR870.2300, Product Code DRT)II
External Cardiac Transcutaneous (Non-Invasive)
Pacemaker (21CFR870.5550, Product Code DRO)II
Oximeter (21CFR870.2700, Product Code DQA)II
Noninvasive Blood Pressure Measurement System
(21CFR870.1130, Product Code DXN)II
Carbon-Dioxide Gas Analyzer Gaseous-Phase
(21CFR868.1400 Product Code CCK)II
Blood Pressure Computer (21CFR870.1110, Product Code
DSK)II

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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) NumberClearance Date
K06351001/26/07
K04145907/01/04
K04077504/23/04
K03327511/06/03
K01091803/26/01
K00244501/31/01
K99033809/01/99
K99191006/03/99
K97348601/09/98

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

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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

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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

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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

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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

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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)
1111/.1172

Page 1 of 4

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_

8

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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

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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

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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) NumberK102972
------------------------