ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE

K091561 · ZOLL Medical Corporation · MKJ · Sep 23, 2010 · Cardiovascular

Device Facts

• Record ID: K091561
• Device Name: ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE
• Applicant: ZOLL Medical Corporation
• Product Code: MKJ · Cardiovascular
• Decision Date: Sep 23, 2010
• 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, 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.

Device Story

Lightweight, portable, battery-powered semi-automatic external defibrillator; used by trained emergency responders for cardiac arrest treatment. Device inputs: ECG signals via defibrillation electrodes. Operation: device analyzes ECG rhythm to detect shockable vs. non-shockable rhythms; if shockable, charges capacitor and prompts user to press shock button. Output: defibrillation therapy. Features periodic self-tests for readiness. Pediatric use enabled via specific electrodes. Benefits: provides guided resuscitation therapy to patients in cardiac arrest.

Clinical Evidence

Bench testing only. Performance and safety testing confirmed the device meets functional requirements and industry safety standards, demonstrating substantial equivalence to the predicate device.

Technological Characteristics

Portable, battery-powered external defibrillator. Utilizes ZOLL Rectilinear Bi-Phasic waveform. Includes pediatric electrode compatibility. Performs automated periodic self-tests. Software version 5.32.

Indications for Use

Indicated for victims of cardiac arrest exhibiting unconsciousness, absence of normal breathing, and absence of pulse/signs of circulation. Suitable for adults and pediatric patients (infants/children <8 years or <55 lbs) when used with appropriate pediatric electrodes.

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 (K033474)

Submission Summary (Full Text)

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## 510(k) Summary:

SEP 2 3 2010

Submitter's Name and Address:

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

Contact Person:

Charles W. Kolifrath [phone]

Date Summary Prepared:

May 22, 2009

Device:

ZOLL AED Plus (V5.32 Software Release)

Classification:

Automatic External Defibrillators: Class III (21 CFR 870.5310) Cardiopulmonary Resuscitation Aid: Class III (21 CFR 870.5200)

Description:

The ZOLL AED Plus is a lightweight, portable, battery-powered semi-automatic external The ZOLL AED Fids is a lightwolght, portually cons to guide a user through a cardiac ochbhilator that about willized the ZOLL Rectilinear Bi-Phasic defibrillation arrest reseat. 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 will analyze the clestroomale. If the device detects a shockable rhythm, the rifythin is shockable of non onbonable." device charges the oupdoiter, chables in the ment Button". The user can then press the warning "Dort Frodor Fration," Toution therapy to the patient. If the patient is not treathent button to dolliver donamalism 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 The ZOLL AED Plus is lightweight. Tt our outly bo transported in and ready to use at a

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K091561 pg 2 of 2

moment's notice. The device automatically performes a periodic self-test and continually indicates its state of readiness to the user.

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.

#### Intended 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:

The features and functions of the proposed ZOLL AED Plus (with software version 5.32) are substantially equivalent to the currently marketed ZOLL AED Plus (K033474, cleared for use on 4/7/2005).

## Comparison of Technological Characteristics

The technological characteristics of the proposed ZOLL AED Plus (with software version 5.32) are substantially equivalent to the currently marketed ZOLL AED Plus (K033474, cleared for use on 4/7/2005).

### Performance Testing:

Extensive performance testing ensures that the ZOLL AED Plus (with software version 5.32) performs as well as the indicated predicated predicate device and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards.

#### Conclusion

Performance and safety testing of the ZOLL AED Plus (with software version 1 enomance and bullety tooling on the functions are substantially equivalent to 5.02) domonotices the indicated commercially distributed predicate device with regard to performance, safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a bird or eagle in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.

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

Zoll Medical Corporation c/o Mr. Charles W. Kolifrath Regulatory Affairs Manager 269 Mill Road Chelmsford, MA 01824

SEP 2 3 2010

Re: K091561

Trade/Device Name: Zoll AED Plus Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: September 3, 2010 Received: September 8, 2010

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 liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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## Page 2 - Mr. Charles W. Kolifrath

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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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K09 1561 as.1 ofl

## Indications for Use

510(k) Number (if known):

2 3 2010 SEP

Device Name: ZOLL AED Plus

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 physician authorized 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.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| AND/OR | |

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K091561

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