ZOLL AED PRO EXTERNAL DEFIBRILLATOR

K041892 · ZOLL Medical Corporation · MKJ · Feb 4, 2005 · Cardiovascular

Device Facts

• Record ID: K041892
• Device Name: ZOLL AED PRO EXTERNAL DEFIBRILLATOR
• Applicant: ZOLL Medical Corporation
• Product Code: MKJ · Cardiovascular
• Decision Date: Feb 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The ZOLL AED Pro External Defibrillator is a portable, ruggedized, automated external defibrillator intended for use by personnel who are trained in basic life support, advanced life support, or other physician-authorized emergency medical response who must respond to emergency situations, to deliver defibrillation therapy and to display ECG rhythms of patients during treatment.

Device Story

Portable, battery-powered AED for emergency cardiac arrest rescue. Inputs: ECG signals via defibrillation electrodes or ECG cable. Operation: Device analyzes ECG rhythm; if shockable, provides voice/visual prompts for defibrillation. Includes manual override and non-diagnostic ECG monitoring for trained providers. Features high-resolution LCD displaying ECG, shock count, and CPR compression performance (via CPR-D-padz). Used by BLS/ALS personnel in emergency settings. Output: Defibrillation shock and visual/audible feedback. Benefits: Facilitates rapid rhythm analysis and CPR quality improvement to increase survival chances.

Clinical Evidence

Bench testing only. Device subjected to extensive performance and safety testing to ensure compliance with functional requirements and recognized industry standards. No clinical data presented.

Technological Characteristics

Portable, battery-powered, ruggedized AED. Features high-resolution LCD. Uses proprietary defibrillation electrodes (pedi-padz II for pediatrics, CPR-D-padz for CPR feedback). Includes manual override and non-diagnostic ECG monitoring. Software-based interpretive algorithm for shock advisory. Connectivity via ECG cable for monitoring mode.

Indications for Use

Indicated for cardiac arrest victims exhibiting unconsciousness, absence of normal breathing, and absence of pulse/signs of circulation. Pediatric use (<8 years or <55 lbs) requires pedi-padz II electrodes. Monitoring mode indicated for non-diagnostic ECG display in breathing/responsive patients. Contraindicated for defibrillation if patient is conscious, breathing, or has a pulse. CPR monitoring contraindicated for patients under 8 years.

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 Plus with CPR Aid (K011541)
• ZOLL AED Plus (K033474)
• Philips Medical Systems, Heartstart FR2+ (K013425)

Submission Summary (Full Text)

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K041892

FEB - 4 2005

## 510(k) Summary:

Submitter's Name and Address:

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

Contact Person:

Sean Reynolds [phone], Ext. 9386

Date Summary Prepared:

June 28, 2004

#### Device:

ZOLL AED Pro External Defibrillator

Classification:

Defibrillator, Low-energy - DC: Class II (21 CFR 870.5300)

Automatic External Defibrillators; Class III (21 CFR 870.5310)

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

Substantial Equivalence:

The features and functions of the ZOLL AED Pro External Defibrillator are substantially equivalent to those of the ZOLL AED Plus with CPR Aid: 510(k) No. K011541, cleared 4/11/2002, the ZOLL AED Plus: 510(k) No. K033474, cleared 5/21/2004 and the Philips Medical Systems, Heartstart FR2+ (formerly Heartstream ForeRunner), 510(k) No. K013425, cleared 1/14/2002.

Description:

The ZOLL AED Pro External Defibrillator 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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#### 510(k) Summarv

Defibrillation therapy is provided by using defibrillation electrode products specifically designed to be attached to the ZOLL AED Pro. ZOLL pedirpadz™ II defibrillation electrodes enable users to provide therapy to children less than 8 years of age. When used in conjunction with ZOLL CPR-D-padz™, the AED Pro provides CPR compression performance feedback to the user through voice prompts.

The ZOLL AED Pro also provides a non-diagnostic ECG monitoring feature and manual override capabilities for physicians and appropriately trained healthcare providers. A high-resolution LCD Screen will display ECG Data, Visual Prompts, Shock Count and CPR compression performance.

#### Intended Use

The ZOLL AED Pro External Defibrillator is a portable, ruggedized, automated external defibrillator intended for use by personnel who are trained in basic life support, advanced life support, or other physician-authorized emergency medical response who must respond to emergency situations, to deliver defibrillation therapy and to display ECG rhythms of patients during treatment.

#### Comparison of Technological Characteristics:

The ZOLL AED Pro design characteristics are the same as those of the indicated predicate devices; the technology is very similar to that of the ZOLL AED Plus. The ZOLL AED Pro acquires and analyzes ECG signals and provides shock advisory determinations for adult and pediatric patients. The ZOLL AED Pro advises users to deliver a shock, perform CPR or conduct patient assessment through audible and visual prompts identical to those used by the ZOLL AED Plus. The AED Pro ECG monitoring feature and manual override capability are substantially equivalent to that of the Philips Heartstart FR2+ defibrillator.

#### Performance Testing:

The ZOLL AED Pro External Defibrillator has been subjected to extensive performance testing to ensure that the device meets all of its functional requirements and performance specifications. Safety testing was performed to assure the device complies with applicable sections of recognized industry and safety standards.

#### Conclusion

Based on the results of the performance and safety testing, the ZOLL AED Pro has demonstrated that its features, functions and incorporated interpretive algorithm 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/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. 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.

Public Health Service

FEB - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Sean Reynolds Regulatory Affairs Engineer Zoll Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105

K041892 Re:

Trade/Device Name: ZOLL AED Pro External Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automatic External Defibrillator Regulatory Class: III Product Code: MJK Dated: December 3, 2004 Received: December 6, 2004

Dear Mr. Reynolds:

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 ass ontale an 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. Sean Reynolds

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 DX 3 issumost of our device complies with other requirements of the Act or that FDA nas mude a determilations administered by other Federal agencies. You must comply with all 1 Coords statutes and regendating, but not limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements) incolares, none manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 801), good 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Connor provisions (Socure to begin marketing your device as described in your Section 510(k) This letter will and in yours Finding of substantial equivalence of your device to a legally prematics notification: "The PDF missing site and thus, permits 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 in you attire 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 Echeral international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bhimnica for

Bram D. Zuckerman, M.D. Division of Cardiovacsular 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): ____________________________________________________________________________________________________________________________________________________ K041892

Device Name: ZOLL AED Pro External Defibrillator

### 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, and .
- Absence of normal breathing, and .
- Absence of a pulse or signs of circulation. .

When the victim is less than 8 years of age or weighs less than 55 lbs (25 kg), the AED Pro unit should with the with ZOLL pedi-padz™ II defibiliation electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

At the discretion of the rescuer, the Monitoring Mode feature can be used with the AED Pro ECG Cable At the ulscretion of the resource and meathing or responsive patient's ECG rhythm, regardless of their to provide a not-olaghostic display of a broaking of Nosperiorms a background analysis of the patient's rhythm and disables its defibrillator feature.

### Contraindications for Use - Defibrillation

Do not use the AED Pro unit for defibrillation when the patient

- . ls conscious; or
- Is breathing; or .
- Has a detectable pulse or other signs of circulation. .

## Contraindications for Use - CPR Monitoring

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

Prescription Use X (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)

ummuma Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)

Division of Cardiovascular Devices
510(k) Number k 041892

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