ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE

K110526 · ZOLL Medical Corporation · MKJ · Mar 25, 2011 · Cardiovascular

Device Facts

• Record ID: K110526
• Device Name: ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
• Applicant: ZOLL Medical Corporation
• Product Code: MKJ · Cardiovascular
• Decision Date: Mar 25, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The AED Pro unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of at least 2 inches (5 cm) for adult patients.

Device Story

Portable, battery-powered AED; acquires/analyzes patient ECG signals; detects shockable rhythms; provides voice/visual prompts for defibrillation and CPR guidance. Used by trained rescuers/emergency personnel in semi-automatic mode or qualified medical personnel in manual mode. Software update aligns prompts with 2010 AHA guidelines: 2.0-inch compression depth threshold; 'push harder' prompts; 'fully release' chest reminders. Metronome encourages 100 compressions/minute. Output informs clinical decision-making regarding shock delivery and CPR quality; benefits patient by standardizing resuscitation efforts to current guidelines.

Clinical Evidence

Bench testing only. No clinical data presented. Performance testing verified that the software update correctly implements the 2010 AHA guideline prompts and thresholds.

Technological Characteristics

Portable, battery-powered AED. Sensing: ECG signal acquisition. Energy: Defibrillation shock. Connectivity: Not specified. Software: Rule-based algorithm for rhythm analysis and CPR feedback. Sterilization: Not applicable. Form factor: Portable unit with visual display and voice prompts.

Indications for Use

Indicated for cardiac arrest victims (unconscious, apneic, pulseless) requiring defibrillation. Pediatric use (<8 years or <55 lbs) requires pediatric electrodes. Also indicated for ECG monitoring to evaluate heart rate/morphology. Contraindicated if patient is conscious, breathing, or has a pulse. CPR monitoring is not for patients under 8 years old.

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

• ZOLL AED Pro (K041892)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for ZOLL Medical Corporation. The logo features the company name in bold, black letters. Below the name is the tagline "Advancing Resuscitation. Today."

K 110526

ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824 U.S.A

# 510(k) Summary:

Submitter's Name and Address:

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 [phone]

Contact Person:

Eileen M. Boyle

[phone], Ext. 9171

Date Summary Prepared:

February 11, 2011

Device:

ZOLL AED Pro® with 2010 AHA Guidelines Software Update

Classification:

Defibrillator, Low-energy - DC: Class III (21 CFR 870.5310)

Automatic External Defibrillators have been considered Class III devices by FDA.

Cardiac Monitors (including Cardiotachometers and Rate alarms): Class II (21 CFR 870.2300)

Description:

The ZOLL AED Pro® is a portable, battery powered automated external defibrillator (AED) that uses voice prompts and visual messages to provide feedback to a user attempting a cardiac arrest rescue. The AED Pro acquires and analyzes an adult or pediatric patient's ECG signal and, if a shockable rhythm is detected, recommends delivery of a defibrillation shock via voice and visual prompts.

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# K110526

The recent 2010 American Heart Association Guidelines for CPR and ECC changed previous recommendations from 1.5"-2.0" inches compression depth of a depth of at least 2.0". The Guidelines also advise caregivers to allow full recoil of the patient's chest during CPR. As a result, we are proposing modifying the device's software to prompt caregivers to perform CPR in accordance with the new AHA quidelines.

### Description of Software Changes

The ZOLL AED Pro software, which currently supports the 2005 American Heart Association Guidelines for CPR and ECC, has been revised to optionally support the 2010 American Heart Association Guidelines for CPR and ECC. The specific changes include:

The specific changes include:

- changing the depth indicator on the device screen from 1.5 inches to 2.0 inches .
- prompting the user to "push harder" when compressions are less than 2.0 inches . instead of less than 1.5 inches in the previous release
- adding a text prompt to remind the rescuer to "Fully Release" the patient's . chest during CPR

### Intended Use

The AED Pro unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of at least 2 inches (5 cm) for adult patients.

### Indications for Use

Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by

- Unconsciousness
- · Absence of breathing, and
- · Absence of pulse and other signs of circulation.

When the victim is less than 8 years old or weighs less than 55 lb. (25 kg), use ZOLL pedirpadz® II pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight.

The device is also intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology.

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Never use the AED Pro unit for defibrillation when the patient

- Is conscious
- · Is breathing, or
- · Has a detectable pulse or other sign of circulation.

### CPR Monitoring

The CPR monitoring function is not intended for use on patients under 8 years of age.

### Intended Users

In semiautomatic mode, the AED Pro unit is intended to be used by rescuers and emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the operator controls delivery of shocks to the patient. In manual mode, the AED Pro unit is intended to be used only by qualified medical personnel trained in Advanced Life Support skills.

In ECG monitoring mode, the AED Pro unit is intended to be used by personnel who are qualified by training in the use of the AED Pro device, basic life and/or advanced life support, or other physician-authorized emergency medical training.

# Substantial Equivalence:

The features and functions of the proposed ZOLL AED Pro (with 2010 AHA Guidelines software update) are substantially equivalent to the currently marketed ZOLL AED Pro (K041892, cleared for use on 2/4/2005).

## Comparison of Technological Characteristics

The technological characteristics of the proposed ZOLL AED Pro (with 2010 AHA Guidelines software update) are substantially equivalent to the currently marketed ZOLL AED Pro (K041892, cleared for use on 2/4/2005).

### Performance Testing:

Extensive performance testing ensures that the ZOLL AED Pro Defibrillator meets all of its functional requirements and performance specifications.

### Conclusion

. Performance testing of the ZOLL AED Pro Defibrillator demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ZOLL Medical Corporation c/o Mr. Chuck Kolifrath Regulatory Affairs Manager Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824-4105

MAR 2 5 2011

Re: K110526

Trade/Device Name: ZOLL AED Pro with 2010 AHA Guidelines Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: January 26, 2011 Received: February 24, 2011

Dear Mr. Kolifrath:

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. Please note: CDRH does not evaluate information related to contract hability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Chuck Kolifrath

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

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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#### SECTION 4-INDICATIONS FOR USE

#### 510(k) Number (if known): K110526

#### Device Name: ZOLL AED Pro with 2010 AHA Guideline Update

#### Indications for Use

Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by

- Unconsciousness .
- Absence of breathing, and .
- Absence of pulse and other signs of circulation. .

When the victim is less than 8 years old or weighs less than 55 lb. (25 kg), use ZOLL pediatric defibrillation electrodes: Do not delay therapy to determine the patient's exact age or weight.

The device is also intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology.

#### Contraindications for Use Defibrillation

Never use the AED Pro unit for defibrillation when the patient

- ls conscious
- . Is breathing, or
- Has a detectable pulse or other sign of circulation.

#### CPR Monitoring

The CPR monitoring function is not intended for use on patients under 8 years of age.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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BDZ

lovascular Devices

510(k) Number K110526