LIFEPAK 12, 20, 500, CR PLUS

K033275 · Medtronic Physio-Control Corp. · MKJ · Nov 6, 2003 · Cardiovascular

Device Facts

• Record ID: K033275
• Device Name: LIFEPAK 12, 20, 500, CR PLUS
• Applicant: Medtronic Physio-Control Corp.
• Product Code: MKJ · Cardiovascular
• Decision Date: Nov 6, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The LIFEPAK 500, LIFEPAK CR Plus, and the LIFEPAK 12 and LIFEPAK 20 in automated external defibrillation mode are intended for use on patients in cardiac arrest.

Device Story

Portable, battery-operated defibrillators (LIFEPAK 12, 20, 500, CR Plus) treat cardiac arrest. Devices input patient ECG via disposable chest electrodes; patented software algorithm analyzes rhythm to detect shockable states. LIFEPAK 500 and semi-automatic CR Plus prompt operator to deliver shock; fully automatic CR Plus delivers shock without interaction. LIFEPAK 12 and 20 include additional clinical features: manual defibrillation, pacing, ECG monitoring, pulse oximetry, synchronized cardioversion, and (LIFEPAK 12) blood pressure/CO2 monitoring. Used in clinical or emergency settings by healthcare providers or lay rescuers. Output informs clinical decision-making regarding defibrillation, potentially restoring cardiac rhythm and improving patient survival.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design controls and comparison to legally marketed predicate devices.

Technological Characteristics

Portable, battery-operated defibrillators. Sensing via disposable chest electrodes. Energy delivery via biphasic waveform. Software-based ECG analysis algorithm. LIFEPAK 12/20 include multi-parameter monitoring (ECG, SpO2, NIBP, IBP, CO2) and pacing. Connectivity and specific material standards not detailed.

Indications for Use

Indicated for patients in cardiopulmonary arrest who are unconscious, pulseless, and not breathing normally. LIFEPAK 500 and CR Plus are indicated for pediatric use (up to 8 years or 25kg) with specific reduced energy electrodes. LIFEPAK 12 and 20 AED mode contraindicated for pediatric patients under 8 years.

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

• Medtronic Physio-Control LIFEPAK 12 Defibrillator (K991910, K010918)
• Medtronic Physio-Control LIFEPAK 20 Defibrillator (K012274)
• Medtronic Physio-Control LIFEPAK 500 AED (K983393, K012428)
• Medtronic Physio-Control LIFEPAK CR Plus AED (K011144)

Submission Summary (Full Text)

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## 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:

Michelle Ackermann [phone]

Date Summary Prepared:

September 22nd, 2003

Devices:

Medtronic Physio-Control LIFEPAK® 12, 20, 500, and CR Plus Defibrillators

Classification:

Low Energy DC-Defibrillator: Class II Automatic External Defibrillator: Class III

Substantial Equivalence:

The features and functions of the LIFEPAK 12, LIFEPAK 20, LIFEPAK 500, and LIFEPAK CR Plus are substantially equivalent to the previously cleared version of each device listed in the table below.

| Device | 510(k) Information |
|------------------------------------------------------|------------------------------------------|
| Medtronic Physio-Control LIFEPAK 12<br>Defibrillator | K991910 (09/03/99)<br>K010918 (08/23/01) |
| Medtronic Physio-Control LIFEPAK 20<br>Defibrillator | K012274 (02/05/02) |
| Medtronic Physio-Control LIFEPAK 500<br>AED | K983393 (05/05/99)<br>K012428 (09/28/01) |
| Medtronic Physio-Control LIFEPAK CR<br>Plus AED | K011144 (12/03/01) |

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## Description:

The LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators are small, portable, battery operated devices intended for treatment of cardiac arrest. Both devices use a patented software algorithm to analyze the patient's electrocardiogram (ECG) to determine if a shockable rhythm is present. The LIFEPAK 500 and the semi-automatic version of the LIFEPAK CR Plus will then inform the operator if it detects a shockable rhythm and the operator can then press the shock button to deliver energy. The energy is delivered via disposable defibrillation electrodes applied to the chest. The LIFEPAK CR Plus is also available in a fully automatic version which does not require operator interaction to charge and discharge.

The LIFEPAK 12 and LIFEPAK 20 devices use the same shock advising software algorithm as the devices described above. Features available in addition to automated external defibrillation include manual external defibrillation, noninvasive pacing, ECG monitoring, pulse oximetry, and synchronized cardioversion. The LIFEPAK 12 also offers noninvasive blood pressure monitor, invasive blood pressure monitor, and end-tidal CO2 monitor features.

Intended Use:

The LIFEPAK 500, LIFEPAK CR Plus, and the LIFEPAK 12 and LIFEPAK 20 in automated external defibrillation mode are intended for use on patients in cardiac arrest.

Technological characteristics of new and predicate devices:

The features and functions of the LIFEPAK 12, LIFEPAK 20, LIFEPAK 500, and LIFEPAK CR Plus are the same as those of the currently marketed versions of each device.

Summary of Design Controls:

This 510(k) includes a summary of design control activities and a declaration of conformity to design controls.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

NOV - 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Physio-Control Corp. c/o Ms. Michelle Ackermann Regulatory Affairs Specialist 11811 Willows Road NE P.O. Box 97006 Redmond, WA 98073-9706

Re: K033275

Trade Name: LIFEPAK® 12, 20, 500 and CR Plus Defibrillators Regulation Number: 21 CFR 870.1025 Regulation Name: Automatic External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: October 9, 2003 Received: October 10, 2003

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.

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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); 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Dng Leiseher for
Brent D. Zuckerman, M.D.

ram D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION D: STATEMENT OF INDICATIONS FOR USE

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

Device Name: LIFEPAK 12 and LIFEPAK 20 Defibrillator/Monitor/Pacemakers

Indications for AED Use:

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 12 and LIFEPAK 20 defibrillator/monitors are not intended for use on pediatric patients less than 8 years old.

Device Name: LIFEPAK 500 Automated External Defibrillator

Indications for Use:

The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, not breathing normally, and showing no signs of circulation (for example, no pulse, and/or no coughing, no movement) before the device is used to analyze the patient's ECG rhythm. With Infant/Child Reduced Energy Defibrillation Electrodes, the specially configured biphasic LIFEPAK 500 AED may be used on children up to 8 years old or 25kg (55 lb).

Device Name: LIFEPAK CR Plus Automated External Defibrillator

Indications for Use:

The LIFEPAK CR Plus defibrillator is indicated for use on patients in cardiac arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK CR Plus defibrillator may be used on children up to 8 years old of 25kg (55 lb).

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

fice of Device Evaluation (ODE)

(Optional Format 3-10-98)

Ana Luna
Division Sign-Off

5 iu(K) number K03275