Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient.

Cardiac Science 9133 Defibrillation Electrodes are single use and intended to be used in conjunction with compatible automatic external defibrillators (AED) from Zoll or Physio-Control to monitor and deliver defibrillation energy to the patient, via brand-specific adapters. The brand-specific adapters are available for the AEDs specified in the product labeling.

The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging.

Device Description

The model 9131 and the 9133 Defibrillation Electrodes consists of a pair (2 each) of hydrogel polymeric self adhesive electrode pads of equal dimension. The outer dimension for each pad is 4.88in (12.4cm) by 4.88in (12.4 cm). Each electrode pad has a conductive hydrogel polymeric area of at least 50cm2 to comply with the AAMI DF-80 (AAMI DF-39) specifications. The total surface area of the two electrodes is greater or equal to 150cm2.

The electrodes pads are packaged in such a way that the two conductive hydrogel surfaces are in electrical contact. This feature enables the Cardiac Science AED to run diagnostic checks on the electrodes by checking the inter-electrode impedance when the electrode package is connected to and stored in the device.

The Cardiac Science 9133 defibrillation electrodes may be used in conjunction with adaptor cables that allow the electrodes to be used with compliant AEDs other than the Cardiac Science brands. These adaptor cables are provided as accessories to the Cardiac Science defibrillation electrodes.

AI/ML Overview

The provided document is limited in the information it provides regarding acceptance criteria and study details. It refers to a 510(k) summary for defibrillation electrodes, focusing on substantial equivalence to a predicate device rather than a comprehensive de novo validation study with specific acceptance criteria and detailed performance metrics of an AI component.

However, based on the text provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Functional and Safety	Meets system, safety, functional, and performance specifications (AAMI DF-80 (AAMI DF-39) specifications	"All samples successfully passed."
Equivalence to Predicate	"do not raise any new questions regarding the safety or effectiveness as compared with the predicate device."	"substantially equivalent to the Defibrillation Electrode cleared in K971149 in terms of indications for use, features and functions."

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

Sample Size: The document states, "Representative samples of the electrodes were tested." It does not specify the exact number of samples used in the "Functional and Safety Testing."
Data Provenance: Not specified. This document is a 510(k) summary, which typically reports on internal testing or testing required for regulatory submission. It does not provide details on the origin of the data beyond "representative samples." It is likely internal testing data.
Retrospective/Prospective: Not specified.

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

Not Applicable. The device (defibrillation electrodes) is a hardware component and accessory. Its "performance" is assessed through functional, electrical, and safety testing against engineering and regulatory standards (e.g., AAMI DF-80). It does not involve human interpretation of outputs that would require expert-established ground truth in the context of, for example, medical image analysis or diagnostic algorithms.

4. Adjudication Method for the Test Set

Not Applicable. As noted above, this is a hardware device. No adjudication method for expert consensus is relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes a 510(k) submission for defibrillation electrodes, which are passive medical devices. MRMC studies are typically performed for diagnostic devices (especially those involving AI or human interpretation) to assess improvements in human reader performance with computational assistance. This is not relevant here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is hardware. It does not have an "algorithm only" component in the sense of AI. Its function is to deliver electrical energy and monitor. The "testing" referred to is about its physical and electrical properties.

7. The Type of Ground Truth Used

Engineering and Regulatory Standards/Specifications. The "ground truth" for the device's performance is established by compliance with recognized industry standards (e.g., AAMI DF-80 (AAMI DF-39) specifications) and the device's own internal functional and safety specifications. For instance, impedance, adhesion, and energy delivery capabilities would be measured against predefined acceptable ranges derived from these standards.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of an AI/machine learning algorithm for this type of hardware device.

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

Not Applicable. No training set is involved.

Summary of Device and Study Type:

This 510(k) summary is for physical defibrillation electrodes. The "study" described is a series of functional and safety tests to demonstrate that the new models (9131 and 9133) meet established performance specifications and are substantially equivalent to a previously cleared predicate device (Survivalink-9130 Defibrillation Electrode, K971149). It is not a clinical efficacy study involving patient outcomes or a diagnostic AI validation study. The acceptance criteria are based on engineering and regulatory standards for defibrillation electrodes.

Summary

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III. 510(k) Summary

Submitter:	Cardiac Science Corporation3303 Monte Villa ParkwayBothell, WA 98021-8969	DEC 1 2 2008
Contact Person:	Beverly MagranePhone: (425) 402-2365Fax: (425) 402-2017
Date Prepared:	December 10, 2008
Trade Name:	9131 Defibrillation Electrode9133 Defibrillation Electrode
Common Name:	External defibrillation electrodes
ClassificationName and Number:	Automated External Defibrillator accessory (Electrode)Class III, 21CFR 870.5310
Product Code:	MKJ
PredicateDevice(s):	The 9131 and the 9133 Defibrillation Electrodesmanufactured by Cardiac Science, Inc are substantiallyequivalent to the Survivalink-9130 Defibrillation Electrode,K971149, (6/23/1997)
DeviceDescription:	The model 9131 and the 9133 Defibrillation Electrodesconsists of a pair (2 each) of hydrogel polymeric selfadhesive electrode pads of equal dimension. The outerdimension for each pad is 4.88in (12.4cm) by 4.88in (12.4cm). Each electrode pad has a conductive hydrogelpolymeric area of at least 50cm2 to comply with the AAMIDF-80 (AAMI DF-39) specifications. The total surface areaof the two electrodes is greater or equal to 150cm2.
	The electrodes pads are packaged in such a way that thetwo conductive hydrogel surfaces are in electrical contact.This feature enables the Cardiac Science AED to rundiagnostic checks on the electrodes by checking the inter-electrode impedance when the electrode package isconnected to and stored in the device.
	The Cardiac Science 9133 defibrillation electrodes maybe used in conjunction with adaptor cables that allow theelectrodes to be used with compliant AEDs other than theCardiac Science brands. These adaptor cables are

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Indications For Use:

provided as accessories to the Cardiac Science defibrillation electrodes.

The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging.

The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin. Representative samples of the electrodes were tested in accordance with the system, safety, functional and performance specifications. All samples successfully passed.

Based on the results of the testing described above, it is concluded that the modifications to the Cardiac Science, Defibrillation Electrode do not raise any new questions regarding the safety or effectiveness as compared with the predicate device. The Cardiac Science 9131 and the 9133 Defibrillation Electrodes are substantially equivalent to the Defibrillation Electrode cleared in K971149 in terms of indications for use, features and functions.

Functional and Safety Testing:

Conclusion:

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 12 2008

Cardiac Science Corporation c/o Ms. Beverly Magrane Sr. Manager RA/RC 3303 Monte Villa Parkway Bothell, WA 98021-8969

Re: K082090

Trade/Device Name: 9131 and 9133 Defibrillation Electrode Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: November 10, 2008 Received: November 12, 2008

Dear Ms. Magrane:

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

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Page 2 - Ms. Beverly Magrane

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

uma R.lo Ames

Bram D. Zuckerman, 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 Statement

510(k) Number:

Device Name: 9131 Defibrillation Electrode

Indications for Use:

The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging.

Prescription Use X (Per 21 CFR 801.109) OR

Over-The Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

suma R. la hines

(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices

540/k) Number_KO82090

Confidential

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.