POWERHEART ECD

K052316 · Cardiac Science, Inc. · MKJ · Jan 3, 2006 · Cardiovascular

Device Facts

• Record ID: K052316
• Device Name: POWERHEART ECD
• Applicant: Cardiac Science, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: Jan 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The Powerheart ECD defibrillator system is intended to be used by personnel who have been trained in its operation. The Powerheart ECD is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia. The semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. The Powerheart ECD 3-lead and 5-lead ECG monitoring allows for identification or interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate. The Powerheart ECD noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole. The Powerheart ECD pulse oximetry is intended for the continuous external monitoring of arterial oxygen saturation and pulse rate and is indicated for use in any patient who is at risk of developing hypoxemia.

Device Story

Powerheart ECD is a portable, battery/AC-powered defibrillator/monitor/pacemaker for use by trained personnel. Device inputs include ECG signals (3/5-lead), SpO2, and impedance. RHYTHMx software analyzes ECG rhythms; STAR Biphasic waveform delivers impedance-compensated energy (2-270 Joules). Therapies include manual/semi-automatic defibrillation, cardioversion, and fixed/demand pacing. Output displayed on 320x240 TFT color screen; event history stored internally; thermal printer provided. Clinicians use output to guide resuscitation and cardiac therapy; device facilitates rhythm identification, heart rate calculation, and oxygen saturation monitoring. Benefits include rapid intervention for life-threatening arrhythmias and continuous patient monitoring.

Clinical Evidence

No clinical data. Bench testing, system testing, and safety testing were performed on hardware and software components to demonstrate functional and performance characteristics.

Technological Characteristics

Portable defibrillator/monitor/pacemaker; 320x240 TFT color display; AC or Li-Ion battery power. Delivers impedance-compensated biphasic energy (2-270J). Features 3/5-lead ECG, SpO2 monitoring, and 60mm thermal printer. Software-based rhythm analysis (RHYTHMx).

Indications for Use

Indicated for termination of fatal arrhythmias (ventricular fibrillation, symptomatic ventricular tachycardia) in patients; synchronized mode for atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and stable ventricular tachycardia. Semi-automatic advisory mode for cardiac arrest in patients ≥8 years old (unconscious, pulseless, apneic). Noninvasive pacing for symptomatic bradycardia or asystole. Pulse oximetry for patients at risk of hypoxemia.

Regulatory Classification

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.

Predicate Devices

• Medtronic Physio-Control LIFEPAK 20 Defibrillator (K012274)

Submission Summary (Full Text)

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#### JAN 3 2006

### SECTION 2. SUMMARY AND CERTIFICATION

| 2.1. 510(k) Summary | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Cardiac Science, Inc.<br>5474 Feltl Road<br>Minnetonka, MN 55343 |
| Contact Person: | Kenneth Olson<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | August 22, 2005 |
| Trade Name: | Powerheart ECD™ |
| Classification Name<br>and Number: | Automated External Defibrillator<br>Class III, 21CFR 870.5310 |
| Product Code: | MKJ |
| Predicate Device(s): | The Powerheart ECD™ manufactured by Cardiac Science, Inc<br>is substantially equivalent to Medtronic Physio-Control<br>LIFEPAK® 20 Defibrillator (K012274). |
| Device Description: | The Powerheart® ECD is a defibrillator/monitor/pacemaker<br>intended for use by personnel trained in its operation. The<br>device is lightweight, portable, easy to use and reliable. It<br>incorporates a 320 x 240 transmissive TFT color display for<br>wide viewing angles in all light conditions. The device operates<br>using either an AC power supply or internal rechargeable Li-Ion<br>battery. The device provides continuous ECG monitoring and<br>three types of therapies: defibrillation, cardioversion and<br>external pacing. Defibrillation can be applied manually or<br>semi-automatically. Pacing therapy can be either fixed or<br>demand. The device employs patented RHYTHMx® software<br>which provides ECG rhythm analysis. STAR® Biphasic<br>waveform delivers impedance-compensated energy ranging<br>from 2-270 Joules. Features and options include external<br>paddles, spoons, disposable pads, 3- and 5-lead ECG, pulse<br>oximetry (SpO2), built-in 60 mm thermal printer, internal<br>storage of event history and remote synchronization to bedside<br>monitor. |
| Indications For Use: | The Powerheart ECD defibrillator system is intended to be used<br>by personnel who have been trained in its operation.<br><br>The Powerheart ECD is indicated for the termination of certain<br>fatal arrhythmias, such as ventricular fibrillation and<br>symptomatic ventricular tachycardia. Delivery of energy in the<br>synchronized mode is a method for treating atrial fibrillation,<br>atrial flutter, paroxysmal supraventricular tachycardia and in |
| | |
| | relatively stable patients, ventricular tachycardia. |
| | The semi-automatic advisory mode is for use in cardiac arrest in<br>patients of at least 8 years of age. The patient must be<br>unconscious, pulseless, and not breathing spontaneously before<br>using the defibrillator to analyze the patient's ECG rhythm. |
| | The Powerheart ECD 3-lead and 5-lead ECG monitoring allows<br>for identification or interpretation of cardiac rhythms or<br>dysrhythmias and calculation of heart rate. |
| | The Powerheart ECD noninvasive pacing as a therapy is<br>indicated for patients with symptomatic bradycardia or asystole. |
| | The Powerheart ECD pulse oximetry is intended for the<br>continuous external monitoring of arterial oxygen saturation and<br>pulse rate and is indicated for use in any patient who is at risk of<br>developing hypoxemia. |
| Functional and<br>Safety Testing: | Representative samples of the device components underwent<br>system, safety and bench testing on both hardware and software<br>to demonstrate appropriate functional and performance<br>characteristics. |
| Conclusion: | Based on the results of the testing described above, it is<br>concluded that the Powerheart ECD does not raise any different<br>questions regarding the safety or effectiveness as compared<br>with the predicate device. The Cardiac Science, Inc. Powerheart<br>ECD is substantially equivalent to the Medtronic Physio-<br>Control LIFEPAK 20 in terms of indications for use, features<br>and functions. |

#### 2.1 510(k) Summarv

510(k) Premarket Submission Cardiac Science, Inc.

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#### 2.2. 510(k) Checklist

# Traditional 510(k) Premarket Notification Checklist for Class III Device

| No. | Item | Included | Location |
|-----|------------------------------------------------------------------------|----------|--------------|
| 1 | Cover letter clearly identifying submission as<br>"Traditional 510(k)" | Yes | Cover Letter |
| 2 | Table of Contents | Yes | TOC |
| 3 | Indication for Use | Yes | IFU page |
| 4 | Manufacturer name and address | Yes | Section I |
| 5 | Contact person, phone number, fax number | Yes | Section 1 |
| 6 | Device common name and trade name | Yes | Section 1 |
| 7 | Establishment registration number | Yes | Section 1 |
| 8 | Device classification and product code | Yes | Section 1 |
| 9 | 510(k) Summary | Yes | Section 2.1 |
| 10 | Identification of predicate device | Yes | Section 2.1 |
| 11 | Truthful and Accurate Statement | Yes | Section 2.4 |
| 12 | Class III Certification and Summary | Yes | Section 2.5 |
| 13 | Proposed labeling | Yes | Section 3 |
| 14 | Description of the device | Yes | Section 4 |
| 15 | Substantial equivalence comparison | Yes | Section 5 |
| 16 | Performance testing | Yes | Section 6 |
| 17 | System Hazard Analysis | Yes | Section 6.1 |
| 18 | Clinical evaluation | Yes | Section 6.6 |
| 19 | Biocompatibility data | Yes | Section 7 |
| 20 | Sterilization information | Yes | Section 8 |
| 21 | Software documentation | Yes | Section 9 |
| 22 | Compliance with performance standards | Yes | Section 10 |

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#### 2.3. Premarket Notification Statement

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In lieu of a Pre Market Notification Statement, a 510(k) Summary is provided in Section 2.1. of this 510(k) Premarket Notification.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 2006

Cardiac Science, Inc. c/o Mr. Kenneth F. Olson Chief Technical Officer 5474 Feltl Road Minnetonka, MN 55343-7982

Re: K052316 Trade Name: Powerheart ECD Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: December 20, 2005 Received: December 21, 2005

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.

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Page 2 - Mr. Kenneth F. Olson

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), please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Bheminar for

Bram D. Zuckerman, M.D. Director Division of Cardiovacsular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Powerheart ECD TM

The Powerheart ECD defibrillator system is intended to be used by personnel who have been trained in its operation.

The Powerheart ECD is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.

The semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm.

The Powerheart ECD 3-lead and 5-lead ECG monitoring allows for identification or interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate.

The Powerheart ECD noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.

The Powerheart ECD pulse oximetry is intended for the continuous external monitoring of arterial oxygen saturation and pulse rate and is indicated for use in any patient who is at risk of developing hypoxemia.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page I of l

Blammymer

(Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K052316

510(k) Premarket Submission Cardiac Science, Inc.

Powerheart ECD CONFIDENTIAL

August 23, 2005

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