ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO

K071025 · Zoll Medical Corporation, World Wide Headquarters · MKJ · Jun 22, 2007 · Cardiovascular

Device Facts

• Record ID: K071025
• Device Name: ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO
• Applicant: Zoll Medical Corporation, World Wide Headquarters
• Product Code: MKJ · Cardiovascular
• Decision Date: Jun 22, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

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. (25kg), use 20LL pedi-padz® Il pediatric. The device is also intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology.

Device Story

Portable, battery-powered AED for cardiac arrest rescue; operates via voice/visual prompts. Acquires ECG signals and CPR compression data via CPR-D-padz electrodes. Features 'See-Thru CPR' technology: uses a filter to correlate CPR compressions with ECG signals to remove CPR-related artifacts, allowing clinicians to view underlying ECG rhythm during manual CPR. Filtering stops when compressions cease. Used by rescuers in various settings to guide defibrillation decisions; provides visual/audible feedback to improve resuscitation quality.

Clinical Evidence

Bench testing only. Functional testing was conducted to ensure software modifications for the See-Thru CPR feature did not impact other product features, functions, or performance specifications.

Technological Characteristics

Portable, battery-powered AED. Uses CPR-D-padz electrodes for ECG acquisition and CPR compression sensing. Employs a digital filter algorithm to correlate compression data with ECG signals to remove motion artifacts. Software-based signal processing.

Indications for Use

Indicated for cardiac arrest victims (unconscious, apneic, pulseless) requiring defibrillation. Pediatric use (under 8 years or <55 lbs) requires specific pediatric electrodes. Monitoring function is contraindicated for patients under 8 years of age. Defibrillation is contraindicated if the patient is conscious, breathing, or has a detectable pulse.

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.

Submission Summary (Full Text)

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07/025 pg 1 of 2
ZOLL Medical Corporation

Worldwide Headquarters 269 Mill Road Chelmsford, Massachusetts 01824-4105 U.S.A.

978 421-9655

978 421-0025 Main Fax

JUN 2 2 2007

Image /page/0/Picture/5 description: The image shows the logo for ZOLL Medical Corporation. The logo consists of the word "ZOLL" in large, bold, black letters. Below the company name is the tagline "Advancing Resuscitation. Today.", and below the tagline is a curved line.

# 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 14, 2007

Device:

ZOLL AEDPRO® with See-Thru CPR™

Classification:

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

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 AEDPRO with See-Thru CPR enables the user to see a close approximation of the patient's underlying ECG rhythm while performing CPR in conjunction with ZOLL CPR-D•padz™ electrodes in manual mode.

The ZOLL AEDPRO® with See-Thru CPR™ 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 AEDPRO acquires and andlyzes an adult or attemption is but nation fessue. "The AcDerico acquires and recommends of poulatio pation o EOG Signal and, if a shockable migri
recommends delivery of a defibrillation shock via voice and visual prompts.

See-Thru CPR uses a filter that relies on the correlation between CPR compressions, as detected by the ZOLL CPR-Dypadz electrodes, and the CPR artifact to remove CPR artifact to remove CPR related antiact from the ECG signal. See-Thru CPR filtering continues as long as the CPR-Drom the Lock agains. See-Thu OFF illiening communism are detected, filtering stops, unfiltered ECG signals are displayed, and the unit removes the CPR FLTR message from the LCD screen.

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K071025 pg 2 of 2

## Intended Use:

The functionality (See-Thru CPR) being added to the ZOLL AEDPRO uses a filter to help remove the artifact from the ECG signal.

## Substantial Equivalence:

The features and functions of the ZOLL AEDPRO with See-Thru CPR are identical to other ZOLL Defibrillators equipped with this technology.

## Comparison of Technological Characteristics

The ZOLL AEDPRO with See-Thru CPR uses a filter that relies on the correlation between the CPR compressions, as detected by the ZOLL CPR-Drpadz electrodes, and the ECG signal to remove CPR related artifact from the ECG signal.

## Performance Testing:

Extensive performance testing ensures that the ZOLL AEDPRO with See-Thru CPR performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications.

Functional testing of the device's features and functions was conducted to ensure that the modifications to the software did not degrade or impact other product features, functions or performance specifications.

### Conclusion

Testing of the ZOLL AEDPRO with See-Thru CPR demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed device with regard to performance, safety and effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ZOLL Medical Corporation c/o Ms. Eileen M. Boyle Regulatory Affairs Specialist 269 Mill Road Chelmsford, MA 01824-4105

JUN 2 2 2007

Re: K071025

Trade Name: ZOLL AEDPO® with See-Thru CPR™ Regulation Number: 21 CFR 870.5310 Regulation Name: Automated external defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: April 13, 2007 Received: May 22, 2007

Dear Ms. Boyle:

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.

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Page 2 - Ms. Eileen M. Boyle

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050, This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 [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 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,

Blymmma 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): K071025

#### ZOLL AEDPRO® with See-Thru CPR™ Device Name:

# Indications for use

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. (25kg), use 20LL pedi-padz® Il pediatric When the victim is less than o years one of weight food than bo 121 (2005), we shart 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 AEDPRO unit for defibrillation when the patient:

ls conscious s breathing, or Has a detectable pulse or other sign of circulation

## Nonitoring

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

801 Subpart D)

AND/OR

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

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

ffice of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K071025