ZOLL AED PLUS

K033474 · Zoll Medical Corp · MKJ · May 21, 2004 · Cardiovascular

Device Facts

• Record ID: K033474
• Device Name: ZOLL AED PLUS
• Applicant: Zoll Medical Corp
• Product Code: MKJ · Cardiovascular
• Decision Date: May 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The ZOLL AED Plus external defibrillator is intended to be used by personnel who are qualified by training in basic life support, advanced life support, or other physician-authorized emergency medical response to defibrillate victims of cardiac arrest.

Device Story

ZOLL AED Plus is a portable, battery-powered semi-automatic external defibrillator; provides voice prompts and visual icons to guide rescuers through cardiac arrest treatment. Device inputs: patient ECG rhythm via electrodes. Operation: device analyzes ECG to detect shockable rhythms; if detected, charges capacitor and prompts user to press treatment button for defibrillation using ZOLL Rectilinear Bi-Phasic waveform. Used by trained emergency responders in various settings. Device performs automatic periodic self-tests to ensure readiness. Pediatric electrodes allow use on children <8 years. Output affects clinical decision-making by providing automated rhythm analysis and therapy delivery, potentially improving survival outcomes in cardiac arrest.

Clinical Evidence

No clinical trials in humans were required. Evidence includes bench testing for functional requirements and safety standards (EN60601-1, EN60601-1-2, IEC 601-2-4, AAMI DF39), electrode performance testing, animal studies for defibrillation energy dosing, and validation of the rhythm classification algorithm using a pediatric database.

Technological Characteristics

Lightweight, portable, battery-powered AED. Utilizes ZOLL Rectilinear Bi-Phasic defibrillation waveform. Includes pediatric electrode system for patients <8 years/55 lbs. Complies with EN60601-1, EN60601-1-2, IEC 601-2-4, and AAMI DF39 standards. Features automated periodic self-testing and voice/visual guidance.

Indications for Use

Indicated for victims of cardiac arrest exhibiting unconsciousness, absence of normal breathing, and absence of pulse/signs of circulation. Pediatric use (age <8 years or weight <55 lbs/25kg) requires ZOLL AED Plus Pediatric Electrodes. Contraindicated for patients who are conscious, breathing, or have a detectable pulse/signs of circulation.

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 Infant / Child Reduced Energy Electrodes used with the LIFEPAK CR Plus or biphasic LIFEPAK 500 AEDs (K022732)

Submission Summary (Full Text)

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K033474

# 510(K) SUMMARY

### Applicant's Name and Address

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824

### Contact Person

Paul Dias [phone]

### Date Summary Prepared

October 17, 2003

#### Device

ZOLL AED Plus

### Device Classification

Automatic External Defibrillator 21 CFR 870.1025 Device Class: 111

Multifunction Electrocardiograph Electrode 21 CFR 870.2360 MLN Device Class: 111

### Device Description

The ZOLL AED Plus is a lightweight, portable, battery powered semi-automatic external defibrillator that uses voice prompts and visual icons to quide a user through a cardiac The device utilizes the ZOLL Rectilinear Bi-Phasic defibrillation arrest rescue. waveform. The device is designed to be used by trained emergency responders for the treatment of cardiac arrest.

When connected with ZOLL AED Plus defibrillation electrodes to a patient, the device will analyze the electrocardiographic (ECG) rhythm of the patient and detect whether the rhythm is shockable or not shockable. If the device detects a shockable rhythm, the device charges the capacitor, enables the treatment button and issues the audio warning "Don't Touch Patient, Press Treatment Button". The user can then press the treatment button to deliver defibrillation therapy to the patient. If the patient is not responsive to treatment, additional shocks may be advised and administered after automatically repeated analyses of the patient's heart rhythm.

The ZOLL AED Plus is lightweight. It can easily be transported to any rescue site. It is designed to hang on the wall in an area where it is easily accessible and ready to use at a moment's notice. The device automatically performs a periodic self-test and continually indicates its state of readiness to the user.

^· ZOLL AED Plus Pediatric Electrode System

^{· 510(}k) Summary

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When the ZOLL AED Plus is used in conjunction with the ZOLL AED Plus Pediatric Electrodes the device can be used on patients less than 8 years of age. Labeling and packaging of the electrodes is designed to promote a clear visual distinction between adult and pediatric electrodes.

### Indications for Use

The ZOLL AED Plus external defibrillator is intended to be used by personnel who are qualified by training in basic life support, or advanced life support, or other physicianauthorized emergency medical response to defibrillate victims of cardiac arrest.

Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by:

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

When a victim is a child or infant less than 8 years of age, or less than 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

## Substantial Equivalence

ZOLL AED Plus and ZOLL AED Plus Pediatric Electrodes are substantially equivalent to other legally marketed AED and pediatric defibrillation electrode combinations. Specifically, the ZOLL AED Plus with the ZOLL AED Plus Pediatric Electrodes is substantially equivalent to the Medtronic Physio-Control Infant / Child Reduced Energy Electrodes used with the LIFEPAK CR Plus or biphasic LIFEPAK 500 AEDs cleared under premarket 510(k) notification k022732.

### Performance Data

The ZOLL AED Plus external defibrillator was subject to extensive safety and performance testing prior to release. Final testing for the system included various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety testing was performed to ensure the device complies with applicable sections of the following industry and safety standards.

- EN60601-1, Medical Electrical Equipment Part 1: General Requirements for . Safety.
- EN60601-1-2, Medical Electrical Equipment Part 1: General Requirements . for Safety; Electromagnetic Compatibility.
- IEC 601-2-4, Medical Electrical Equipment Part 2: Particular Requirements . for the Safety of Cardiac Defibrillators and Cardiac Defibrillator-Monitors.
- . AAAMI DF39, AED and Remote Control Defibrillators.

In addition the premaket 510(k) notification includes:

^· ZOLL AED Plus Pediatric Electrode System

^{· 510(}k) Summary

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- Electrode performance testing, .
- . Animal testing of defibrillation energy dosing, and
- Rhythm classification algorithm performance testing on a pediatric database. .

### Conclusion

The information in this premarket notification demonstrates that the ZOLL AED Plus used in conjunction with the ZOLL AEP Plus Pediatric Electrodes is substantially equivalent to the predicate device with respect to safety, effectiveness, and performance.

^· ZOLL AED Plus Pediatric Electrode System

^{· 510(}k) Summary

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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 depiction of an eagle or bird-like figure with three horizontal lines forming its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 2004

Zoll Medical Corporation c/o Mr. Paul Dias Director, Quality Assurance and Regulatory Affairs World Wide Headquarters 269 Mill Road Chelmsford, MA 01824

Re: K033474

Trade Name: ZOLL AED Plus Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillators Regulatory Class: III (three) Product Code: MLN, MKJ Dated: April 27, 2004 Received: April 29, 2004

Dear Mr. Dias:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalled the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surved in the encreases 1976, the enactment date of the Medical Device Amendments, or to conniner of the to 1725 20, 2019 11:12 provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmeter For (110) lear the device, subject to the general controls provisions of the Act. The r ou may, mererere, manns of the Act include requirements for annual registration, listing of general controls pro receive, 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. Paul Dias

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that + + + + + + + = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = or any I cocur statues and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of R Fart 877) its systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualisms wys would be (Sections 531-542 of the Act); 21 CFR 1000-1050. product radially w you to begin marketing your device as described in your Section 510(k) I mis letter will and in you to cuba finding of substantial equivalence of your device to a legally premaired predicated 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 if you desire spoonly arriver 9 % [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 other general mionmation 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,

Neil R. Poole

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 6 - Indications for Use

510(k) Number (if known): __________________________________________________________________________________________________________________________________________________

ZOLL AED Plus Device Name:

### Indications for Use:

Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by:

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

When a victim is less than 8 years of age, or weighs less than 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

### Contraindications:

Do NOT use the AED when patient is:

- Consciousness; or .
- . breathing; or
- has a detectable pulse or other signs of circulation. .

#### Intended Use:

The ZOLL AED Plus external defibrillator is intended to be used by personnel who are qualified by training in basic life support, advanced life support, or other physician-authorized emergency medical response to defibrillate victims of cardiac arrest.

Net RPOgden for BDZ
(Division Sign-Off)
Division of Cardiovascular Devices

233474 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

or

Over-The-Counter-Use

(Optional Format 1-2-96)