MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER

K012274 · Medtronic Physio-Control Corp. · LDD · Feb 5, 2002 · Cardiovascular

Device Facts

• Record ID: K012274
• Device Name: MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER
• Applicant: Medtronic Physio-Control Corp.
• Product Code: LDD · Cardiovascular
• Decision Date: Feb 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5300
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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. The biphasic waveform has only been clinically studied on adults; it has not been studied on pediatric patients. The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 20 defibrillator/monitor is not intended for use on pediatric patients less than eight years old. Noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole. Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.

Device Story

Portable defibrillator/monitor/pacemaker for hospital/clinic use; operated by clinicians. Inputs: ECG signals (3-, 6-, 7-lead), pulse oximetry (SpO2). Operation: Biphasic waveform (2-360 Joules) for defibrillation; noninvasive pacing for bradycardia/asystole; ECG monitoring/rhythm interpretation; pulse oximetry. Features: AED mode for cardiopulmonary arrest; internal/external paddle compatibility; 50mm printer; digital remote sync; infrared/serial data download. Power: AC supply with NiMH battery backup. Output: Defibrillation shocks, pacing pulses, cardiac rhythm data, SpO2 levels. Clinical impact: Terminates fatal arrhythmias, treats symptomatic bradycardia/asystole, monitors patient status. Benefits: Portable, easy-to-use, facilitates rapid intervention during transport or bedside care.

Clinical Evidence

Bench testing only. Compliance with AAMI, IEC, and ISO standards for defibrillators, monitors, and pulse oximeters provided. No clinical trial data presented.

Technological Characteristics

Biphasic waveform defibrillator; energy range 2-360J. Features: external noninvasive pacemaker, pulse oximeter, 3/6/7-lead ECG. Power: AC with NiMH battery. Connectivity: Infrared and serial ports for data download, digital remote synchronization. Form factor: Portable, gurney-mountable. Software: Automated ECG rhythm analysis (AED mode).

Indications for Use

Indicated for adults (biphasic defibrillation) and patients at risk of hypoxemia (pulse oximetry). AED mode indicated for unconscious, pulseless, non-breathing patients in cardiopulmonary arrest (age 8+). Pacing indicated for symptomatic bradycardia or asystole.

Regulatory Classification

Identification

Low-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body. High-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.

Predicate Devices

• LIFEPAK 9P defibrillator/monitor (K902288)
• LIFEPAK 12 defibrillator/monitor (K973486)
• LIFEPAK 12 defibrillator/monitor (K991910)

Submission Summary (Full Text)

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FEB 0 5 2002

KO122 74

Medtronic Physio-Control Corp. LIFEPAK 20 Defibrillator/Monitor 510(k) Premarket Notification

## SECTION E - 510(k) SUMMARY

Submitter's Name and Address:

Medtronic Physio-Control Corp. 11811 Willows Road Northeast P.O. Box 97006 Redmond, WA 98073

Contact Person:

Sherri L. Pocock [phone]

Date Summary Prepared:

June 12, 2001

Device:

Medtronic Physio-Control LIFEPAK® 20 Defibrillator/Monitor/ Pacemaker

Classification:

Low-Energy DC - Defibrillators: Class II (21 CFR 870.5300)

Automatic External Defibrillators have been considered Class III devices by FDA.

Cardiac Monitors (including Cardiotachometers and Rate Alarms): Class II (21 CFR 870.2300)

External Transcutaneous Cardiac Pacemakers (Noninvasive): Class II (870.5550)

Oximeters: Class II (21 CFR 870.2700)

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Medtronic Physio-Control Corp. LIFEPAK 20 Defibrillator/Monitor 510(k) Premarket Notification

## Description:

The LIFEPAK 20 device is a defibrillator/monitor primarily intended for the hospital and clinic setting. It is easy to use, portable, easy to maintain, and fits comfortably on a gurney during transport. It has a built in AC power supply and backup NiMH battery. It uses a biphasic waveform with an energy range from 2 - 360 Joules.

Features and options include: external noninvasive pacemaker; pulse oximeter; 3-, 6-, and 7-lead ECG; defibrillation paddles; ability to use all disposable electrodes or paddles currently used with the LIFEPAK 12 defibrillator/monitor/pacemaker; internal paddles capability; 50 mm printer; automated external defibrillator mode; built in AC power with NiMH battery backup; digital remote synchronization to bedside monitor; and an infrared and serial ports for data download.

Substantial Equivalence:

The features and functions of the LIFEPAK 20 defibrillator/monitor are substantially equivalent to those of the Medtronic Physio-Control LIFEPAK 9P defibrillator/monitor: 510(k) no. K902288, cleared 5/21/90, and the LIFEPAK 12 defibrillator/monitor: 510(k) nos. K973486, cleared 1/9/98; and K991910, cleared 9/3/99.

Indications for Use:

Defibrillation is a means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. A direct current defibrillator applies a brief, intense pulse of electricity to the heart muscle. 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.

The biphasic waveform has only been clinically studied on adults; it has not been studied on pediatric patients.

The Automated External Defibrillation mode is for use on patients in cardiopulmonary arrest. It is not intended for use on patients less than 8 vears old.

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Noninvasive pacing is used as a means of treating symptomatic bradycardia and asystole.

3-lead (3 wire), 6-lead (4 wire), and 7-lead (5 wire) ECG monitoring allows for identification or interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate.

Pulse Oximetry is used to check the saturation of oxygen in arterial blood (SpQs). It is indicated for use in any patient who is at risk of developing hypoxemia.

Summary of Performance Information:

The 510(k) includes documentation related to the compliance of the LIFEPAK 20 device with AAMI, IEC, and ISO defibrillator, monitor, and pulse oximeter standards.

The information in this 510(k) demonstrates that the LIFEPAK 20 defibrillator/monitor is substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle are three stylized lines that resemble an abstract symbol, possibly representing an eagle or a similar bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 5 2002

Ms. Sherri L. Pocock Regulatory Advisor Medtronic Physio-Control Corporation 11811 Willows Road NE P.O. Box 97006 Redmond, WA 98073-9706

Re: K012274

Trade Name: LifePak® 20 Defibrillator/Monitor Regulation Number: 21 CFR 870.1025, 870.5300, 870.5550 Regulation Name: Arrhythmia Detector, Defibrillator, External Transcutaneous Cardiac Pacemaker Regulatory Class: Class III (three) Product Code: MKJ, LDD, DRO Dated: November 6, 2001 Received: November 7, 2001

Dear Ms. Pocock:

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.

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Page 2 - Ms. Sherri L. Pocock

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 or any I vith 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 OFF fat 607); adoming (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 promated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Ouvision of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dork Tith

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ver/ 3 - 4/24/96

Applicant: Medtronic Physio-Control Corp.

510(k) Number (if known): 510(k) Number Not yet assigned

Device Name: LIFEPAK 20 Defibrillator

Indications For Use:

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.

The biphasic waveform has only been clinically studied on adults; it has not been studied on pediatric patients.

The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm.

In AED mode, the LIFEPAK 20 defibrillator/monitor is not intended for use on pediatric patients less than eight years old.

Noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.

Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012274

Prescription Use
(Per 21 CFR 801.109)