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.

Device Description

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

When connected with ZOLL AED Plus defibrillation electrodes to a patient, the predicate device will analyze the electrocardiographic (ECG) ihythm of the patient and detect whether the rhythm is shockable or non-shockable. If the device detects a nonshockable rhythm, the device will prompt the user to begin CPR. The electrodes used with the device incorporates an accelerometer that measures the depth of CPR compressions. This information is used by the device to provide feedback to the user and encourage the user to administer CPR in compliance with the 2010 American Heart Association (AHA) Guidelines. If the device detects a shockable rhythm, the semiautomatic configuration of the device charges the capacitor, enables the treatment button and prompt the user to deliver the defibrillation energy to the patient. The user would then press the treatment (shock) button to deliver the defibrillation shock to the patient. The new fully automatic configuration would deliver the shock to the patient without the need for the user (rescuer) to press the shock button.

AI/ML Overview

The ZOLL Fully Automatic AED Plus is a semi-automatic external defibrillator that has been updated to deliver a shock automatically without the user pressing a button, following appropriate prompts and a warning tone.

Here's an analysis of the provided information concerning acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or specific performance metrics for the new fully automatic feature of the ZOLL Fully Automatic AED Plus. Instead, it relies on a comparison to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Device (K110154) in:	The new device's features and functions are "substantially equivalent" to the predicate ZOLL AED Plus (K110154).
- Features and Functions	All other functions and Indications for Use have remained "unchanged." The proposed change is implemented through software.
- Technological Characteristics	Technological characteristics are "substantially equivalent" to the predicate.
- Performance	"Extensive performance testing ensures that the ZOLL Fully Automatic AED Plus performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications."
- Safety	"Safety testing assures that the device complies with applicable sections of recognized industry and safety standards."
- Effectiveness	Performance, safety, and effectiveness are substantially equivalent to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific sample sizes for any test sets related to the fully automatic feature. It broadly mentions "Extensive performance testing" and "Safety testing." There is no information on data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study described does not appear to involve human expert ground truth determination in the conventional sense for algorithmic performance, but rather focuses on functional and safety equivalency.

4. Adjudication Method for the Test Set

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is present. The focus is on the device's functional equivalence and safety, not on human reader improvement with or without AI assistance. The device is an automated external defibrillator, where the "AI" (algorithm) is designed to act on its own, not to assist human readers in interpreting information.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The study described primarily assesses the standalone performance of the algorithm in the context of its new fully automatic shock delivery. The product is an "Automatic External Defibrillator," implying standalone algorithmic function. The document states:

"When a shockable rhythm has been detected defibrillation energy is delivered by the device without the need for the user (rescuer) to depress the treatment (shock) button following a sequence of appropriate prompts and a warning tone."
"All other functions of the device and its Indications for Use have remained unchanged."

This indicates that the core rhythm analysis and shock advisory/delivery mechanism, which is the heart of the algorithm's standalone function, is the primary subject of evaluation for the change.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance testing. However, given it's an AED, the ground truth for rhythm analysis (shockable vs. non-shockable) would typically be established based on:

Electrophysiological standards (e.g., specific ECG waveform characteristics recognized as ventricular fibrillation or ventricular tachycardia).
Potentially, expert ECG review.

For the fully automatic shock delivery, the ground truth would be whether a shockable rhythm was correctly identified according to established criteria, and whether the device then proceeded to deliver the shock as designed.

8. Sample Size for the Training Set

This information is not provided. The document focuses on regulatory submission and substantial equivalence, not the details of algorithm development or training data.

9. How the Ground Truth for the Training Set Was Established

This information is not provided.

Summary

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510(k) Summary:

OCT 2 6 2012

Submitter's Name and Address:

ZOLL Medical Corporation 269 Mill Road Chelmsford. MA 01824-4105 (978) 421-9655

Contact Person:

Tanmay B. Shukla (978) 421-9171

Date Summary Prepared:

February 8, 2012

Device:

ZOLL Fully Automatic AED Plus

Classification:

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

Description:

The predicate ZOLL AED Plus with 2010 AHA Guideline software update was cleared by the agency under 510(k) application K110154. The device is a lightweight, portable, battery-powered semi-automatic external defibrillator that uses voice prompts and visual icons to guide a user through a cardiac arrest rescue. The device utilized the ZOLL Rectilinear Bi-Phasic defibrillation waveform. The device is designed to be used by trained responders for the treatment of cardiac arrest.

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patient. The new fully automatic configuration would deliver the shock to the patient without the need for the user (rescuer) to press the shock button.

The following is a comparison summary of the new Fully Automatic AED Plus when compared to the predicate device:

When a shockable rhythm has been detected defibrillation energy is delivered by the device without the need for the user (rescuer) to depress the treatment (shock) button following a sequence of appropriate prompts and a warning tone.
All other functions of the device and its Indications for Use have remained . unchanged.
. The proposed change is implemented in the device through software.

Intended 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

Substantial Equivalence:

The features and functions of the new ZOLL Fully Automatic AED Plus are substantially equivalent to the predicate ZOLL AED Plus (K110154, cleared for use on 2/17/2011).

Comparison of Technological Characteristics

The technological characteristics of the new ZOLL Fully Automatic AED Plus are substantially equivalent to the predicate ZOLL AED Plus (K110154, cleared for use on 2/17/2011).

Performance Testing:

Extensive performance testing ensures that the ZOLL Fully Automatic AED Plus performs as well as the indicated 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 Fully Automatic AED Plus demonstrates that its features and functions are substantially equivalent to those of 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 consists of a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

OCT 2 6 2012

Zoll Medical Corporation c/o Mr. Tanmay Shukla Regulatory Affairs Specialist 269 Mill Road Chelmsford, MA 01824

Re: K120406

Trade/Device Name: Zoll AED Plus Fully Automatic Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: October 17, 2012 Received: October 18, 2012

Dear Mr. Shukla:

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.

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. Tanmay Shukla

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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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Section 4 - Indications for Use

510(k) Number (if known): ZOLL Fully Automatic AED Plus Device Name:

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

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

non

(Division/Sign-Off) Division of Cardiovascular Devices 510/k) Numb

Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
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.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.