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.

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 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.

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.

AI/ML Overview

The ZOLL AED Plus device is a semi-automatic external defibrillator designed for use by trained emergency responders. The provided documentation primarily addresses substantial equivalence for market clearance rather than detailed performance reporting from specific clinical studies to establish acceptance criteria. Therefore, much of the requested information about acceptance criteria and study particulars for device performance as typically understood for AI/algorithm-driven devices (accuracy, sensitivity, specificity, etc.) is not explicitly available in the provided text.

However, based on the information provided, here's a breakdown of what can be extracted and what is not explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on a declaration of substantial equivalence based on safety and functional performance meeting established standards, rather than providing specific numerical performance metrics (like sensitivity/specificity for rhythm classification against a ground truth).

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Safety Standards Compliance	EN60601-1 (Medical Electrical Equipment Part 1: General Requirements for Safety)	Meets applicable sections of the standard.
	EN60601-1-2 (Medical Electrical Equipment Part 1: General Requirements for Safety; Electromagnetic Compatibility)	Meets applicable sections of the standard.
	IEC 601-2-4 (Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Cardiac Defibrillators and Cardiac Defibrillator-Monitors)	Meets applicable sections of the standard.
	AAMI DF39 (AED and Remote Control Defibrillators)	Meets applicable sections of the standard.
**Functional Requirements/	Rhythm classification algorithm Performance Specifications**	"Rhythm classification algorithm performance testing on a pediatric database."
Electrode Performance	Electrode performance testing	Testing was performed (no specific metrics provided).
Defibrillation Energy Dosing	Animal testing of defibrillation energy dosing	Testing was performed (no specific metrics provided).

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

Sample Size: Not explicitly stated for any specific test set, including the "pediatric database" used for rhythm classification.
Data Provenance: Not specified (e.g., country of origin). The terms "retrospective" or "prospective" are not used.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The document mentions "rhythm classification algorithm performance testing on a pediatric database" but does not describe how the ground truth for that database was established or by whom.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not discussed or reported in the provided text. The document focuses on the device's functional and safety performance relative to standards and its predicate device. This type of study (human readers with/without AI assistance) is typically relevant for interpretative AI devices, which this AED system is not described as in the sense of directly assisting human interpretation of complex medical images or data beyond basic rhythm analysis in an emergency.

6. Standalone (Algorithm Only) Performance

A standalone performance evaluation was implied for the "rhythm classification algorithm performance testing on a pediatric database." However, specific metrics (e.g., sensitivity, specificity, PPV, NPV) from this standalone performance are not reported in the document. The document states that final testing included "various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications," but the details of these are not provided.

7. Type of Ground Truth Used

The type of ground truth used for the "pediatric database" rhythm classification algorithm testing is not explicitly stated. For ECG rhythm analysis, ground truth is typically established by expert cardiologists reviewing the ECG tracings. Without explicit mention, it's assumed to be expert consensus, but this is not confirmed.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. The focus is on the device's final performance and adherence to standards for substantial equivalence.

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

Since a training set is not mentioned, the method for establishing its ground truth is also not provided.

Summary

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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 (978) 421-9413

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

· ZOLL AED Plus Pediatric Electrode System

· 510(k) Summary

· Page 1 of 3

{1}------------------------------------------------

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

· Page 2 of 3

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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

· Page 3 of 3

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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 % (301) 594-4648. 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 (800) 638-2041 or (301) 443-6597 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. .

Contraindications:

Do NOT use the AED when patient is:

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

Intended Use:

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)

Over-The-Counter-Use

(Optional Format 1-2-96)

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.