The Powerheart AED is intended for use by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response.

The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrythmia recurs, the device will charge automatically and advise the operator to deliver therapy.

When the patient is a child or infant is up to 8 years of age, or up to 55 lbs (25kg), the Powerheart AED should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.

Device Description

The Powerheart AED is a portable, battery-operated, semi-automatic, low power DC defibrillator. It will diagnose the patient's cardiac rhythm and advise the operator if and when to deliver the shock energy.

The Model 9730 Pediatric Attenuated Defibrillation Electrodes are specially designed electrodes for operation with only the Powerheart AED biphasic waveform.

The Model 9730 pediatric electrode has been designed to reduce the energy delivered to the patient from a standard biphasic defibrillation waveforms generated by the Powerheart AED to levels applicable for use on children and infants up to 8 yrs of age or weighing less than 55 lbs (25 kg). This is performed though the use of an attenuating circuit that absorbs the excess energy during defibrillation without adversely affecting the electrode's performance during ECG monitoring.

The Model 9730 pediatric electrode is designed as a single use device and is intended for use to defibrillate and monitor of children.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powerheart AED with Model 9730 Pediatric Attenuated Defibrillation Electrodes:

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than setting specific numerical acceptance criteria and reporting performance against them in a detailed table.

Instead of explicit acceptance criteria, the document states:

Category	Acceptance "Criteria" (Implicit)	Reported Device Performance
General Performance	Designed in accordance with industry standards ANSI AAMI DF-39.	"The Powerheart AED with the Model 9730 electrodes were found to perform as intended."
Biocompatibility	Biocompatibility assessments conducted on components in contact with patient's skin.	"biocompatibility assessments were conducted... The Powerheart AED with the Model 9730 electrodes were found to perform as intended."
Substantial Equivalence	Equivalent to predicate device (Agilent Technologies FR2 AED with M3870A Pediatric Attenuated Defibrillation Electrodes) in intended use, technological characteristics, materials, function, safety, and effectiveness.	"Cardiac Science has demonstrated through its evaluation and testing... that the device is equivalent to the predicate device with respect to intended use, technological characteristics, materials, function and safety and effectiveness."

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

Sample Size for Test Set: The document does not specify a sample size for any clinical testing or specific test sets for performance evaluation. The performance section mentions "Performance testing" but does not detail the nature or scope of this testing in terms of sample size for patients or data.
Data Provenance: The document does not provide information on the country of origin of the data or whether it was retrospective or prospective. It primarily refers to "performance testing" and "evaluations and testing" without further detail.

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

The document does not mention the use of experts to establish ground truth for a test set. This type of detail is typically found in clinical trial reports or detailed validation studies, which are not included in this 510(k) summary. Given the nature of a defibrillator (delivering an electric shock rather than diagnosing a complex condition), the "ground truth" for its primary function (delivering a shock when indicated) would be based on its ability to classify rhythms accurately and deliver the correct energy, which is usually assessed through engineering and electrical performance testing against established standards, rather than expert interpretation of patient data in a "test set" paradigm as one might see for an AI diagnostic device.

4. Adjudication Method for the Test Set:

Since the document does not describe a clinical test set with human interpretation or expert evaluation, no adjudication method is mentioned or implied.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic AI devices where human interpretation is involved. The Powerheart AED is a device that autonomously analyzes rhythms and advises on shock delivery, so an MRMC study comparing human readers with and without AI assistance would not be applicable in this context.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study in the traditional sense of an AI algorithm (i.e., algorithm only without human-in-the-loop performance) was not explicitly described in terms of a separate clinical study. However, the "Performance testing" conducted to verify compliance with ANSI AAMI DF-39 would have essentially evaluated the device's (including its embedded algorithm's) ability to diagnose rhythms and deliver appropriate therapy without human intervention in terms of the core defibrillation function. The summary itself does not detail the methodology or results of this testing.

7. Type of Ground Truth Used:

The primary "ground truth" for a defibrillator typically comes from:

Physiological/Electrical Standards: The ability to accurately detect shockable rhythms (e.g., ventricular fibrillation, ventricular tachycardia) and non-shockable rhythms, and to deliver energy within specified parameters. This is governed by industry standards like ANSI AAMI DF-39.
Predicate Device Equivalence: The performance of a legally marketed predicate device (Agilent Technologies FR2 AED with M3870A Pediatric Attenuated Defibrillation Electrodes).

The document states that performance testing was conducted according to ANSI AAMI DF-39, implying that the "ground truth" for this testing would be based on the requirements and test methods outlined in that standard to ensure the device performs its intended functions correctly.

8. Sample Size for the Training Set:

The document does not specify a training set sample size. This is expected as the Powerheart AED is not a machine learning or AI algorithm in the contemporary sense that requires a "training set" to develop its diagnostic capabilities. Its rhythm analysis is based on pre-programmed algorithms and signal processing, not on learning from a dataset.

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

As there is no mention of a training set in the context of machine learning, there is no information on how a "ground truth for the training set" was established. The device's functionality is verified against established engineering and medical device standards.

Summary

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IC022929

SECTION 17. 510K SUMMARY OF SAFETY AND EFFECTIVENESS

JAN 2 7 2003

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

17.1 Adminstrative Information

Name and AddressSubmitted by:	Cardiac Science Incorporated16931 Millikan AveIrvine, CA 92606
Contact Person:Telephone No.:Facsimile No.:Email:	Kenneth Olson952-939-4181952-939-4191kolson@cardiacscience.com
Date Prepared:	January 15, 2003

Device Information 17.2

Common or Usual Name:	Automated External Defibrillator
Trade Name:	Powerheart® AED Model 9200/9210Use with Models 9730 Pediatric AttenuatedDefibrillation Electrode.

Device Classification 17.3

Automatic External Defibrillator Classification Name: 21 CFR 870.1025 MKJ Device Class: III

Multifunctional Electrocardiograph Electrode 21 CFR 870.2360 MLN Device Class: III

17.4 Device Description

The Powerheart AED is a portable, battery-operated, semi-automatic, low power DC defibrillator. It will diagnose the patient's cardiac rhythm and advise the operator if and

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when to deliver the shock energy.

The Model 9730 Pediatric Attenuated Defibrillation Electrodes are specially designed electrodes for operation with only the Powerheart AED biphasic waveform.

The Model 9730 pediatric electrode is designed as a single use device and is intended for use to defibrillate and monitor of children.

17.5 Indication for use

The Powerheart AED is intended for used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response.

When the patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the Powerheart AED should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.

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17.6 Identification of Predicate Device

Company	Device	510(k) #	Date Cleared
Agilent Technologies(Philips MedicalSystem)	FR2 AED with Model M3870A PediatricAttenuated Defibrillation Electrodes.	K003819	May 2, 2001
Survivalink(Wholly OwnedSubsidiary of CardiacScience)	Powerheart AED	K011901	Feb 1, 2002

Substantial Equivalence 17.7

The Powerheart AED with the Model 9730 Pediatric Attenuated Defibrillation Electrodes covered by this submission is substantially equivalent to other legally marketed AED and pediatric attenuated defibrillation electrodes. Specifically, the Powerheart AED with the Model 9730 electrode is substantially equivalent to Agilent Technologies (acquired by Philips Medical System) FR2 AED with model M3870A pediatric attenuated defibrillation cleared under premarket 510(k) notification, K0038198 on May 2, 2002.

17.8 Performance Data

Performance testing was conducted to verify that the Powerheart AED with the Model 9730 Pediatric Attenuated Defibrillation Electrodes has been designed in accordance with industry standards ANSI AAMI DF-39. In addition, biocompatibility assessments were conducted on the components that come into contact with the patient's skin. The Powerheart AED with the Model 9730 electrodes were found to perform as intended.

17.9 Conclusions

Cardiac Science has demonstrated through its evaluation and testing of the Powerheart AED with the model 9730 Pediatric Attenuated Defibrillation Electrodes 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 U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2003

Cardiac Science Incorporated Mr. Kenneth Olson Chief technology Officer 16931 Millikan Avenue Irvine, CA 92606

Re: K022929

Trade/Device Name: Powerheart AED Model 9200/9210 with Model 9730 Pediatric Attenuated Defibrillation Electrodes Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm. Regulatory Class: Class III Product Code: MKJ, MLN Dated: December 13, 2002 Received: December 16, 2002

Dear Mr. Olson:

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

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Page 2 -- Mr. Kenneth Olson

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) 594-4586. 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 vours.

K.G. Tell

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

Enclosure

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INDICATIONS FOR USE

K022929 510(k) Number:

Device Name:

Powerheart AED Model 9200/9210 Us Ha Model 9730 Pediating Cetternated Efectrodes

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	K022929
---------------	---------

Prescription Use		OR	Over-The-Counter Use
(Per 21 CFR 801.109)

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.