The Multifunctional Electrodes, Models 9640 and 9650 are single use and intended to be used for defibrillation, synchronized cardioversion, ECG monitoring, and external pacing.

Device Description

The Multifunctional Electrodes consist of a pair of single-use, hydrogel polymeric selfadhesive electrode pads of equal dimension intended to be used for defibrillation, synchronized cardioversion, ECG monitoring and external pacing. The Multifunctional Electrodes are for use with the Powerheart® Cardiac Rhythm Module and the Powerheart® Automatic External Cardiac Defibrillator (AECD). The electrodes are packaged in a pouch to prevent the gel from drying out. The Model 9640 contains an additional small right leg drive (RLD) electrode on the sternum pad. The RLD electrode is used to eliminate the voltage potential between the patient and defibrillator's ground reference. Inside each electrode connector is an electrode ID chip. The ID chip allows the defibrillator to read the electrode specific information contained in the ID chip.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cardiac Science Multifunctional Electrodes:

Please note that the provided document is a 510(k) summary for a medical device. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than presenting extensive, detailed clinical trials with specific acceptance criteria, statistical power calculations, or human reader studies common in AI/software device submissions. Therefore, many of the requested points below may not be fully answerable based solely on this document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Defibrillation: Meet applicable requirements from ANSI/AAMI DF-2 and DF-39.	The Multifunctional Electrodes were found to perform as intended in accordance with industry standards ANSI/AAMI DF-2 and ANSI/AAMI DF-39. This implies they met the electrical, mechanical, and safety requirements specified in these standards for defibrillation electrodes.
ECG Monitoring: Meet applicable requirements from ANSI/AAMI EC-12.	The Multifunctional Electrodes were found to perform as intended in accordance with industry standard ANSI/AAMI EC-12. This implies they met the performance requirements for ECG monitoring electrodes.
Pacing: Meet applicable requirements from relevant standards (implied by overall performance for intended use).	The Multifunctional Electrodes were found to perform as intended. Specific pacing performance criteria are not explicitly detailed but are covered by the general statement of meeting intended use and implied by the industry standards for multi-functional electrodes.
Synchronized Cardioversion: Meet applicable requirements from relevant standards (implied by overall performance for intended use).	The Multifunctional Electrodes were found to perform as intended. Specific cardioversion performance criteria are not explicitly detailed but are covered by the general statement of meeting intended use and implied by the industry standards for multi-functional electrodes.
Biocompatibility: Meet requirements for components in contact with patient's skin.	Biocompatibility assessments were conducted on the components that come into contact with the patient's skin, and the electrodes were found to perform as intended. This implies the device met established biocompatibility standards.

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

Sample Size: Not specified in the provided document. The performance testing is described generally as "conducted to verify that the Multifunctional Electrodes meet the applicable requirements."
Data Provenance: Not specified. The testing described is likely laboratory-based and in-vitro, referring to the physical performance of the electrodes against engineering standards. It is not clinical data provenance.

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

This information is not applicable to the type of performance testing described. The "ground truth" for this device's performance would be the specifications and requirements outlined in the referenced ANSI/AAMI industry standards (DF-2, DF-39, EC-12), not expert clinical consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or clinical adjudication. The performance is assessed against predefined engineering and safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with AI vs. without AI

No, an MRMC comparative effectiveness study was not done, and this device is not an AI-powered diagnostic device, but rather a physical electrode. Therefore, this section is not applicable.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable. The device is a physical electrode system. Its "standalone performance" refers to its ability to meet the defined electrical, mechanical, and biocompatibility standards independently, which was indeed evaluated as described in Section 16.8.

7. The Type of Ground Truth Used

The ground truth used for performance validation was industry standards and specifications. Specifically, the device's performance was compared against the requirements stipulated in:

ANSI/AAMI DF-2 (Defibrillator Electrodes)
ANSI/AAMI DF-39 (Automatic External Defibrillators and Associated Defibrillator Electrodes)
ANSI/AAMI EC-12 (Disposable ECG Electrodes)
Biocompatibility standards (implied, not explicitly named)

8. The Sample Size for the Training Set

Not applicable. This device is a physical electrode, not a machine learning algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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K02210

OCT 0 4 2002

510K SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 16:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

16.1: ADMINSTRATIVE INFORMATION

Name and AddressSubmitted by:	Cardiac Science Incorporated16931 Millikan AveIrvine, CA 92606
Contact Person:	John Carline
Telephone No.:	952-939-4181, x2978
Facsimile No.:	952-939-4191
Email:	jcarline@cardiacscience.com

Date Prepared: July 1, 2002

DEVICE INFORMATION 16.2:

Common or Usual Name:	Disposable Polymer (Hydrogel) ExternalMonitoring, Pacing, Cardioversion andDefibrillation Electrode
Trade Name:	Powerheart® Multifunctional ElectrodesModels 9640 and 9650

16.3: DEVICE CLASSIFICATION

Classification Name:	Multifunctional Electrocardiograph Electrode
	21 CFR 870.2360
	MLN
Device Class:	III

16.4: DEVICE DESCRIPTION

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The Model 9640 contains an additional small right leg drive (RLD) electrode on the sternum pad. The RLD electrode is used to eliminate the voltage potential between the patient and defibrillator's ground reference.

Inside each electrode connector is an electrode ID chip. The ID chip allows the defibrillator to read the electrode specific information contained in the ID chip.

16.5: INDICATION FOR USE

The Multifunctional Electrodes, Models 9640 and 9650 are single use and intended to be used for defibrillation, synchronized cardioversion, ECG monitoring, and external pacing.

16.6: IDENTIFICATION OF PREDICATE DEVICE

Company	Device	510(k) No.	Date Cleared
Contour MedicalTechnology(Ludlow Co.)	Disposable HydrogelDefibrillation ElectrodeModel MFE-116	K960329	July 1, 2002

16.7: SUBSTANTIAL EQUIVALENCE

The Multifunctional Electrodes, Models 9640 and 9650 covered by this submission are substantially equivalent to other legally marketed electrodes for semi-automatic low power DC defibrillators. Specifically, the Multifunctional Electrodes are substantially equivalent to Contour Medical Technology (Ludlow Company) Disposable Hydrogel Defibrillation Electrode, Model MFE 116 cleared under premarket 510(k) notification, K960329 on July 2, 1996.

16.8: PERFORMANCE DATA

Performance testing was conducted to verify that the Multifunctional Electrodes meet the applicable requirements for single use hydrogel electrodes in accordance with industry standards ANSI/AAMI DF-2, ANSI AAMI DF-39, and. ANSV/AAMI EC-12. In addition, biocompatibility assessments were conducted on the components that come into contact with the patient's skin. The Multifunctional Electrodes, Models 9640 and 9650 were found to perform as intended.

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16.9: CONCLUSIONS

Cardiac Science has demonstrated through its evaluation and testing of the Multifunctional electrodes, Models 9640 and 9650 that the device is equivalent to the predicate device with respect to intended use, technological characteristics, materials, function and safety and effectiveness.

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a symbol that appears to be three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 4 2002

Cardiac Science, Inc. c/o Mr. John Carline Manager, Regulatory Affairs 16931 Millikan Avenue Irvine, CA 92606

Re: K022210

Trade Name: Multifunctional Electrodes, Models 9640 and 9650 Regulation Number: 21 CFR 870.1025 Regulation Name: Automated External Defibrillator Electrode Regulatory Class: Class III (three) Product Code: MKJ Dated: July 1, 2002 Received: July 8, 2002

Dear Mr. Carline:

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 - Mr. John Carline

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 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,

V
Bram D. Zuckerman, M.D.

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

Enclosure

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INDICATIONS FOR USE

510(k) Number:

Device Name:	Multifunctional Electrodes
	Models 9640 and 9650

The Multifunctional Electrodes are single use and intended to Indications for Use: be used for defibrillation, synchronized cardioversion, ECG monitoring and external pacing.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

XQ6712
Division of Cardiovascular & Respiratory Devices
510(k) Number K022210

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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.