MODIFICATION TO POWERHEART ECD

K060934 · Cardiac Science Corporation · MKJ · May 15, 2006 · Cardiovascular

Device Facts

• Record ID: K060934
• Device Name: MODIFICATION TO POWERHEART ECD
• Applicant: Cardiac Science Corporation
• Product Code: MKJ · Cardiovascular
• Decision Date: May 15, 2006
• Decision: SESE
• Submission Type: Special
• 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, multi-functional device combining defibrillator, monitor, and pacemaker; operated by trained personnel in clinical settings. Inputs include ECG signals (3/5-lead), SpO2 data, and transthoracic impedance. Device processes ECG via RHYTHMx software for rhythm analysis; delivers impedance-compensated STAR Biphasic energy (2-270 Joules). Features include manual/semi-automatic defibrillation, fixed/demand pacing, and pulse oximetry. Output displayed on 320x240 TFT color screen; event history stored internally; thermal printer provides hard copies. Remote synchronization to bedside monitors supported. Clinicians use real-time monitoring and automated rhythm analysis to guide therapeutic interventions (defibrillation, cardioversion, pacing). Device benefits patients by providing rapid, impedance-adjusted therapy for life-threatening arrhythmias and continuous physiological monitoring.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by system, safety, and bench testing of hardware and software components to demonstrate functional and performance characteristics.

Technological Characteristics

Portable defibrillator/monitor/pacemaker; 320x240 TFT color display. Power: AC or internal rechargeable Li-Ion battery. Therapy: STAR Biphasic impedance-compensated waveform (2-270J). Monitoring: 3/5-lead ECG, SpO2. Features: 60mm thermal printer, internal event storage, remote sync. Software: RHYTHMx rhythm analysis. Sterilization: N/A (external device).

Indications for Use

Indicated for termination of fatal arrhythmias (ventricular fibrillation, symptomatic ventricular tachycardia) and treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and stable ventricular tachycardia via synchronized energy delivery. Semi-automatic advisory mode for cardiac arrest in patients ≥8 years old (must be unconscious, pulseless, apneic). ECG monitoring for rhythm/dysrhythmia identification and heart rate calculation. Noninvasive pacing for symptomatic bradycardia or asystole. Pulse oximetry for continuous monitoring of arterial oxygen saturation and pulse rate in 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

• Powerheart ECD (K052316)

Submission Summary (Full Text)

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Ko60934i|500

MIY 1 5 2005

#### IX. 510(k) Summary

| Submitter: | Cardiac Science Corporation<br>3303 Monte Villa Parkway<br>Bothell, WA 98021-8969 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cheryl Shea<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | April 4, 2006 |
| Trade Name: | Powerheart ECD™ |
| Classification<br>Name and Number: | Automated External Defibrillator<br>Class III, 21CFR 870.5310 |
| Product Code: | MKJ |
| Predicate<br>Device(s): | The Powerheart ECD™ manufactured by Cardiac<br>Science, Inc is substantially equivalent to the Cardiac<br>Science Powerheart ECD - K052316 (1/3/2006) |
| Device<br>Description: | The Powerheart® ECD is a defibrillator/monitor/<br>pacemaker intended for use by personnel trained in its<br>operation. The device is lightweight, portable, easy to<br>use and reliable. It incorporates a 320 x 240 transmissive<br>TFT color display for wide viewing angles in all light<br>conditions. The device operates using either an AC power<br>supply or internal rechargeable Li-Ion battery. The device<br>provides continuous ECG monitoring and three types of<br>therapies: defibrillation, cardioversion and external<br>pacing. Defibrillation can be applied manually or semi-<br>automatically. Pacing therapy can be either fixed or<br>demand. The device employs patented RHYTHMx®<br>software which provides ECG rhythm analysis. STAR®<br>Biphasic waveform delivers impedance-compensated<br>energy ranging from 2-270 Joules. Features and options<br>include external paddles, spoons, disposable pads, 3-<br>and 5-lead ECG, pulse oximetry (SpO2), built-in 60 mm<br>thermal printer, internal storage of event history and<br>remote synchronization to bedside monitor. |
| Indications For 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. |
| Functional and Safety Testing: | Representative samples of the device components underwent system, safety and bench testing on both hardware and software to demonstrate appropriate functional and performance characteristics. |
| Conclusion: | Based on the results of the testing described above, it is concluded that the modifications to the Powerheart ECD do not raise any new questions regarding the safety or effectiveness as compared with the predicate device. The Cardiac Science, Inc. Powerheart ECD is substantially equivalent to the Powerheart ECD cleared in K052316 in terms of indications for use, features and functions. |

Confidential

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Confidential

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 15 2006

Cardiac Science Corporation C/O Ms. Cheryl L. Shea, RAC VP-RA/QA 3303 Monte Villa Parkway Bothell, WA 98021-8969

Re: K060934

Trade/Device Name: Powerheart ECD Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: May 3, 2006 Received: May 5, 2006

Dear Ms. Shea:

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 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mb letter natification. The FDA finding of substantial equivalence of your device to a legally premainer modicate 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-__. 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 yours,

Bymmuma for

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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### 510(k) Number:

## Device Name: Powerheart ECD™

### Indications for 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, The Townson LED illation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation, atrial energy in the cyntillion 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 y on overy 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.

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Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use

Alumuma

riston Sian-Division of Cardiovascular Devices 510(k) Number