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

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Medtronic Physio-Control Infant/Child Reduced Energy Electrodes, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on substantial equivalence to predicate devices rather than explicit, quantitative acceptance criteria for all performance metrics. However, it does outline the energy reduction ratio, which is a key performance characteristic.

Acceptance Criteria / Performance Metric	Reported Device Performance
Energy Reduction Ratio (Standard "adult" AED energy to delivered energy)	About 4 to 1
Example:	When an AED is set to deliver 200J (1st shock), 300J (2nd shock), and 360J (3rd shock) for adult patients, the Infant/Child Reduced Energy Electrodes will deliver about 50J, 75J, and 86J respectively.
Substantial Equivalence to Predicate Devices (Safety, Effectiveness, Performance)	The 510(k) submission states that the information demonstrates the device is substantially equivalent to the Medtronic Physio-Control Pediatric QUIK-COMBO electrodes (K979301) and the Heartstream Attenuated Defibrillation Pads (K003819) with respect to safety, effectiveness, and performance. This is the overarching acceptance criterion for 510(k) clearance.
Clinical testing of algorithm accuracy on pediatric rhythms	Performed (Result: Implies adequate accuracy for pediatric rhythms to support substantial equivalence). Specific numerical acceptance criteria or performance metrics for algorithm accuracy are not provided in the text.
Non-Clinical testing of energy dosing	Performed (Result: Implies successful verification of energy dosing in line with specifications and substantial equivalence). Specific numerical acceptance criteria or performance metrics for energy dosing are not provided in the text.
Bench testing to verify electrodes meet specifications	Performed (Result: Implies electrodes meet their specifications). Specific numerical acceptance criteria or performance metrics are not provided in the text.
Labeling Usability Validation	Performed (Result: Implies favorable usability). Specific acceptance criteria or metrics for usability are not provided in the text.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms" and "Non-Clinical testing of energy dosing" but does not specify:

The exact sample size used for the test set in either category.
The country of origin of the data.
Whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms" but does not specify:

The number of experts used to establish ground truth.
The qualifications of those experts.

4. Adjudication Method for the Test Set

The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms" but does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was NOT mentioned or described in the provided text. The submission focuses on the performance of the device itself and its substantial equivalence to predicate devices, rather than measuring the improvement of human readers with AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms," which suggests a standalone evaluation of the algorithm's performance in analyzing ECG rhythms. However, further details on how this was conducted (e.g., specific metrics, comparison to human interpretation) are not provided. The primary focus seems to be the algorithm's ability to accurately identify pediatric rhythms for the defribrillator.

7. Type of Ground Truth Used

The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms." For ECG rhythm analysis, the ground truth is typically established by expert consensus of cardiologists or electrophysiologists on the rhythm strips. However, the document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. Sample Size for the Training Set

The document does NOT provide any information regarding the sample size used for the training set for the algorithm.

9. How the Ground Truth for the Training Set Was Established

The document does NOT provide any information on how the ground truth for the training set was established.

Summary

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|<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 (425) 867-4332

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:

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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.

Summary of Performance Information:

The 510(k) includes:

Clinical testing of algorithm accuracy on pediatric rhythms:

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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.

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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

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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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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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.

(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

Regulation Number and Section

§ 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.