The Powerheart AECD is intended to acquire the electrocardiograph rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of in-hospital patients who are at risk of Sudden Cardiac Arrest.

Device Description

The Powerheart monitors a patient's cardiac electrical activity and detects and treats ventricular tachyarrhythmias. The patient is connected to the device by a patient cable which is attached to both a set of ECG electrodes and a set of defibrillation electrodes. The defibrillation electrodes can be positioned on the patient sternum- apex or anterior-posteriorly. The operator can program the device during set up to use either the ECG electrodes or the defibrillator electrodes to sense ECG. The Powerheart uses a combination of rate and, if programmed by the physician, morphology to determine the presence of shockable arrhythmias. When a shockable arrhythmia is detected, the system delivers cardioversion and/or defibrillation energy through defibrillator electrodes to restore normal cardiac rhythm. Should the arrhythmia continue, the Powerheart will deliver additional electrical countershocks after each subsequent evaluation and programmed delay. Depending upon the programmed parameters as prescribed by the physician, the Powerheart may deliver a maximum of nine pulse sequences. In the event that nine pulse sequences have been delivered, the Powerheart will not automatically deliver any further therapy until: 1) a new shockable rhythm is detected after 60 consecutive seconds of non-shockable rhythm is presented, or 2) the device is reset manually. The energy levels for each individual countershock are also programmed into the device per the physician's prescription.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific pass/fail acceptance criteria values (e.g., "sensitivity must be > X%", "specificity must be > Y%"). Instead, it confirms that the device was deemed "as safe based on the non-chilical performance tosting, and the predicate device." This suggests a comparative approach where the performance of the new device was evaluated against the established performance of the predicate device (Powerheart® AECD® cleared under K970741).

The study lists a series of non-clinical tests performed, implying that successful completion of these tests serves as the "acceptance criteria" for demonstrating safety and effectiveness comparable to the predicate.

Acceptance Criteria Category (Implied)	Reported Device Performance
System Validation	Concluded as safe and as effective as the predicate device.
Observation of Requirements Implementation	Concluded as safe and as effective as the predicate device.
Analysis Tests	Concluded as safe and as effective as the predicate device.
Battery System Tests	Concluded as safe and as effective as the predicate device.
Defibrillation Related Performance	Concluded as safe and as effective as the predicate device.
Alarm System Tests	Concluded as safe and as effective as the predicate device.
Environmental Testing	Concluded as safe and as effective as the predicate device.
Electrical Safety Testing	Concluded as safe and as effective as the predicate device.
Functional Safety Testing	Concluded as safe and as effective as the predicate device.
Electromagnetic Compatibility (EMC) Testing	Concluded as safe and as effective as the predicate device.
ECG Channel/Defibrillator Pad ID	Concluded as safe and as effective as the predicate device.
Quality and Reliability	Concluded as safe and as effective as the predicate device.
Human Factors	Concluded as safe and as effective as the predicate device.
System Software Validation and Verification	Concluded as safe and as effective as the predicate device.
Arrhythmia Detection Software Verification and Validation	Concluded as safe and as effective as the predicate device.

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

The document does not explicitly state the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only lists categories of non-clinical tests.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any test set. Given the non-clinical nature of the listed tests, it's possible that internal engineering and validation teams were involved rather than external clinical experts for the direct evaluation of the device's
arrhythmia detection software.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1).

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device itself and its comparison to a predicate device, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, a standalone performance evaluation of the "Arrhythmia Detection Software" was performed, as indicated by "Arrhythmia Detection Software Verification and Validation" under non-clinical tests. The document implies that the software's performance (specifically its detection capabilities) was deemed equivalent to the predicate device's software.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. For arrhythmia detection software validation, it would typically involve a reference standard derived from expert-annotated ECG recordings, often from established arrhythmia databases.

8. Sample Size for the Training Set

The document does not provide information on the sample size for the training set.

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

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

Summary

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4 2000

K993533

Attachment F

510 (k) Summary

Date	October 15, 1999
Submitter and Contact Person	Cardiac Science, Inc.1176 Main Street, Building "C"Irvine, CA 92614	Contact: Stan Tillman, Dir. RA/QAPhone: 949/587-0357, ext. 238

Device Name	Trade Name	Common/Classification Name
	Powerheart® AECD®	Defibrillator, Automatic, External

Predicate Device	Powerheart® AECD® (K970741).
------------------	------------------------------

Device Description	The Powerheart monitors a patient's cardiac electrical activity and detects and treats ventricular tachyarrhythmias. The patient is connected to the device by a patient cable which is attached to both a set of ECG electrodes and a set of defibrillation electrodes. The defibrillation electrodes can be positioned on the patient sternum- apex or anterior-posteriorly. The operator can program the device during set up to use either the ECG electrodes or the defibrillator electrodes to sense ECG. The Powerheart uses a combination of rate and, if programmed by the physician, morphology to determine the presence of shockable arrhythmias. When a shockable arrhythmia is detected, the system delivers cardioversion and/or defibrillation energy through defibrillator electrodes to restore normal cardiac rhythm. Should the arrhythmia continue, the Powerheart will deliver additional electrical countershocks after each subsequent evaluation and programmed delay. Depending upon the programmed parameters as prescribed by the physician, the Powerheart may deliver a maximum of nine pulse sequences. In the event that nine pulse sequences have been delivered, the Powerheart will not automatically deliver any further therapy until: 1) a new shockable rhythm is detected after 60 consecutive seconds of non-shockable rhythm is presented, or 2) the device is reset manually. The energy levels for each individual countershock are also programmed into the device per the physician's prescription.
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Device Description

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Intended Use The Powerheart AECD is intended to acquire the electrocardiograph rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of in-hospital patients who are at risk of Sudden Cardiac Arrest.

The modified Powerhear® has the same technological characteristics as the
unmodified device which previously received 510(k) clearance as shown in the table Comparison Table below:

Feature	Predicate Device	Candidate Device
PrimaryComponent	Powerheart proprietary AECD®Arrhythmia Detection Software(cleared under K970741 andalso cleared separately underK982710)	Same
MajorComponents	11. defibrillator12. defibrillation electrodes13. ECG electrodes (off-the-shelf)14. patient cable15. computer system16. control panel17. display monitor18. chart recorder (printer)19. event recorder20. ECG out cable	Same
Input Data	Electrocardiogram (ECG)	Same
Output	Delivery of shock	Same
MaximumEnergy	360 Joules	Same
DefibrillationWaveformand ChargingTime	Per AAMI DF2-1996	Same
ECG SignalInput	Defibrillation electrodes orbipolar ECG electrodes	Same
OperatingModes	5. Automatic,6. Advisory,7. Manual and8. Program	Same
PhysicianProgrammableParameters	4. Patient ID number5. Detection criteria, and6. Therapy criteria	Same

Continued on next page

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Non-clinical Tests

Based on the non-clinical performance testing, the device was concluded is as safe Based on the non-chilical performance tosting, and the predicate device.

Summary of Performance Testing

System Validation .
Observation of Requirements . Implementation
Analysis Tests .
Battery System Tests .
Defibrillation Related Performance .
. Alarm System Tests
Environmental Testing .
Electrical Safety Testing .
Functional Safety Testing ●
Electromagnetic Compatibility . Testing (EMC)
ECG Channel/Defibrillator Pad ID .
. Quality and Reliability
Human Factors .
System Software Validation and . Verification
Arrhythmia Detection Software . Verification and Validation

END

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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming a protective shape. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

MAR 2 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardiac Science, Inc. c/o Mr. Stan E. Tillman 16931 Millikan Avenue Irvine, CA 92606

Re: K993533

Trade/Device Name: Powerheart External Cardioverter Defibrillator with RHYTHMx ECD Software Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (Three) Product Code: MKJ, LDD Dated: January 13, 2000 Received: January 14, 2000

Dear Mr. Tillman:

This letter corrects our substantially equivalent letter of January 24, 2000.

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 (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 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. Stan E. Tillman

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 continue 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

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(if known)	K993533
Device Name	Powerheart® AECD®
Indications forUse	The Powerheart AECD is intended to acquire the electrocardiographrhythm for the detection of, and to provide treatment for, ventriculartachyarrhythmias of in-hospital patients who are at risk of Sudden CardiacArrest.

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

Clearance of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number
Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

122

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.