INFANT/CHILD REDUCED ENERGY ELECTRODES

K022732 · Medtronic Physio-Control Corp. · MKJ · Dec 13, 2002 · Cardiovascular

Device Facts

• Record ID: K022732
• Device Name: INFANT/CHILD REDUCED ENERGY ELECTRODES
• Applicant: Medtronic Physio-Control Corp.
• Product Code: MKJ · Cardiovascular
• Decision Date: Dec 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

Use the Infant/Child defibrillation electrodes on an infant or child up to 8 years old or up to 25kg (55lbs). Do not delay therapy to determine child's exact age or weight. These electrodes are to be used only with LIFEPAK CR PLUS defibrillators and biphasic LIFEPAK® 500 AEDs configured with a pink cable connector. The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are indicated for use 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. The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are intended to be used by personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.

Device Story

Infant/Child Reduced Energy Electrodes consist of pediatric electrode pads, wires, connector, and attenuator assembly; attenuator contains resistors and surge protector on PCB in plastic case. Device connects to LIFEPAK CR PLUS or biphasic LIFEPAK 500 AEDs (pink connector models). Attenuator reduces standard adult AED energy output by ~4:1 ratio (e.g., 200J/300J/360J adult settings become 50J/75J/86J). Used by trained responders in emergency settings to deliver defibrillation therapy to pediatric patients. Packaging designed for intuitive selection and rapid deployment. Benefits include safe, effective energy delivery for smaller patients using existing adult AED infrastructure.

Clinical Evidence

Clinical testing of algorithm accuracy on pediatric rhythms; non-clinical testing of energy dosing; bench testing for electrode specifications; labeling usability validation.

Technological Characteristics

Attenuator assembly with resistors and surge protector on PCB in plastic case; pediatric electrode pads; compatible with LIFEPAK CR PLUS and biphasic LIFEPAK 500 AEDs (pink connector).

Indications for Use

Indicated for infants and children up to 8 years old or 25kg (55lbs) in cardiopulmonary arrest (unconscious, apneic, pulseless). For use with specific LIFEPAK AEDs.

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 Pediatric QUIK-COMBO electrodes (K979301)
• Heartstream Attenuated Defibrillation Pads (K003819)

Submission Summary (Full Text)

{0}------------------------------------------------

|<022732

## 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

DEC 1 3 2002

Contact Person:

Sherri L. Pocock [phone]

Date Summary Prepared:

August 12, 2002

Device:

Medtronic Physio-Control Infant / Child Reduced Energy Electrodes

Classification:

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

Description:

The attenuating electrode is designed to allow minimally trained responders to safely and effectively defibrillate infants and children under 8 using the LIFEPAK® CR Plus or biphasic LIFEPAK 500 AEDs manufactured after a certain date. (Compatible biphasic LIFEPAK 500 AEDs can be identified by the pink connector on the AED.)

The Infant / Child Reduced Energy Electrode assembly consists of currently marketed Pediatric QUIK-COMBO electrode pads, wires, a connector, and an attenuator. The attenuator is comprised of multiple resistors and a surge protector mounted on a PCB and installed in a flat plastic case.

The attenuator reduces the standard "adult" AED energy at a ratio of about 4 to 1. When used with the Infant / Child Reduced Energy electrodes, an AED set to deliver 200J first shock, 300J second shock,

{1}------------------------------------------------

and 360J third shock for adult patients, will instead deliver about 50, 75, and 86J.

Packaging and labeling have been designed to make it (1) readily apparent if Infant/Child electrodes are available, (2) intuitive that these electrodes are for infants and children only, (3) easy for the user to determine when to select the pediatric electrode, and (4) easy for the user to quickly deliver defibrillation therapy regardless of patient's age.

### Substantial Equivalence:

The features and functions of the Infant / Child Reduced Energv Electrodes are substantially equivalent to those of the Medtronic Physio-Control Pediatric QUIK-COMBO electrodes, 510(k) no, K979301. (cleared March 6, 1997) and the Heartstream Attenuated Defibrillation Pads, 510(k) no. K003819 (cleared May 2, 2001.)

Indications for Use:

Use the Infant/Child defibrillation electrodes on an infant or child up to 8 years old or up to 25kg (55lbs). Do not delay therapy to determine child's exact age or weight.

These electrodes are to be used only with LIFEPAK CR PLUS defibrillators and biphasic LIFEPAK 500 AEDs configured with a pink cable connector.

The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are indicated for use 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.

The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are intended to be used by personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.

Summary of Performance Information:

The 510(k) includes:

Clinical testing of algorithm accuracy on pediatric rhythms:

{2}------------------------------------------------

Non-Clinical testing of energy dosing;

Bench testing to verify electrodes meet their specifications; and

Labeling Usability Validation.

The information in this 510(k) demonstrates that the Infant / Child Reduced Energy Electrodes are substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance.

{3}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 3 2002

Medtronic Physio-Control Corporation c/o Ms. Sherri Pocock Regulatory Advisor 11811 Willows Road NE Redmond. WA 98073-9706

K022732 Re:

> Trade Name: Infant/Child Reduced Energy Electrodes Regulation Number: 21 CFR 870.1025 Regulation Name: Automated External Defibrillator Electrode Regulatory Class: Class III (three) Product Code: 74 MKJ, MLN Dated: November 25, 2002 Received: November 26, 2002

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.

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

{4}------------------------------------------------

#### Page 2 – Ms. Sherri Pocock

forth in the quality systems (OS) 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 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 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,

K. Karla Telen

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

Enclosure

{5}------------------------------------------------

Medtronic Physio Control

## SECTION D - STATEMENT OF INDICATIONS FOR USE

Ver/ 3 - 4/24/96

Applicant: Medtronic Physio-Control Corp.

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

K022732

Device Name: Infant / Child Reduced Energy Electrodes

Indications For Use:

Use the Infant/Child defibrillation electrodes on an infant or child up to 8 years old or up to 25kg (55lbs). Do not delay therapy to determine child's exact age or weight.

These electrodes are to be used only with LIFEPAK CR PLUS defibrillators and biphasic LIFEPAK® 500 AEDs configured with a pink cable connector.

The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are indicated for use 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.

The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are intended to be used by personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.

(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)

**Prescription Use**
(Per 21 CFR 801.109)

D-1

Division Sign-Off

Division of Cardiovascular
and Respiratory Devices

510(k) Number K022732