When the victim is less than 8 years of age or weighs less than 55 lbs (25 kg), the AED Pro unit should with the with ZOLL pedi-padz™ II defibiliation electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

At the discretion of the rescuer, the Monitoring Mode feature can be used with the AED Pro ECG Cable At the ulscretion of the resource and meathing or responsive patient's ECG rhythm, regardless of their to provide a not-olaghostic display of a broaking of Nosperiorms a background analysis of the patient's rhythm and disables its defibrillator feature.

Device Description

The ZOLL AED Pro External Defibrillator 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 AED Pro acquires and analyzes an adult or pediatric patient's ECG signal and, if a shockable rhythm is detected, recommends delivery of a defibrillation shock via voice and visual prompts. Defibrillation therapy is provided by using defibrillation electrode products specifically designed to be attached to the ZOLL AED Pro. ZOLL pedirpadz™ II defibrillation electrodes enable users to provide therapy to children less than 8 years of age. When used in conjunction with ZOLL CPR-D-padz™, the AED Pro provides CPR compression performance feedback to the user through voice prompts. The ZOLL AED Pro also provides a non-diagnostic ECG monitoring feature and manual override capabilities for physicians and appropriately trained healthcare providers. A high-resolution LCD Screen will display ECG Data, Visual Prompts, Shock Count and CPR compression performance.

AI/ML Overview

The ZOLL AED Pro External Defibrillator is a portable, battery-powered automated external defibrillator (AED) that uses voice prompts and visual messages. It acquires and analyzes an adult or pediatric patient's ECG signal and, if a shockable rhythm is detected, recommends defibrillation. It also provides a non-diagnostic ECG monitoring feature and manual override capabilities for trained healthcare providers.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria in terms of sensitivity and specificity as is common for diagnostic devices. Instead, it relies on demonstrating substantial equivalence to predicate devices through various performance and safety tests. The "reported device performance" is broadly stated as meeting functional requirements and performance specifications, and complying with industry and safety standards to prove substantial equivalence.

Acceptance Criteria (Implicit)	Reported Device Performance
Functional Requirements and Performance Specifications:	The ZOLL AED Pro External Defibrillator has been subjected to extensive performance testing to ensure that the device meets all of its functional requirements and performance specifications. This includes acquiring and analyzing ECG signals, providing shock advisory determinations for adult and pediatric patients, advising users to deliver a shock, perform CPR or conduct patient assessment through audible and visual prompts. The AED Pro ECG monitoring feature and manual override capability were deemed substantially equivalent to the Philips Heartstart FR2+ defibrillator.
Safety and Effectiveness:	Safety testing was performed to assure the device complies with applicable sections of recognized industry and safety standards. Based on the results of the performance and safety testing, the ZOLL AED Pro has demonstrated that its features, functions, and incorporated interpretive algorithm are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety, and effectiveness.
Substantial Equivalence to Predicate Devices:	The ZOLL AED Pro design characteristics are the same as those of the indicated predicate devices: ZOLL AED Plus with CPR Aid (K011541), ZOLL AED Plus (K033474), and Philips Medical Systems Heartstart FR2+ (K013425). The technology is very similar to the ZOLL AED Plus. The AED Pro advises users through audible and visual prompts identical to those used by the ZOLL AED Plus. The ECG monitoring feature and manual override capability are substantially equivalent to the Philips Heartstart FR2+. The device is intended to be used by personnel trained in basic life support, advanced life support, or other physician-authorized emergency medical response, aligning with the intended use of comparable AEDs.
CPR Compression Performance Feedback (CPR-D-padz™):	When used in conjunction with ZOLL CPR-D-padz™, the AED Pro provides CPR compression performance feedback to the user through voice prompts. (No specific performance metrics are provided for this feature in the summary).
Pediatric Defibrillation (pedi-padz™ II):	ZOLL pedirpadz™ II defibrillation electrodes enable users to provide therapy to children less than 8 years of age. (No specific performance metrics are provided for this feature in the summary, other than its availability and enabling of pediatric use). The CPR monitoring function is noted as not intended for use on patients under 8 years of age.
Non-Diagnostic ECG Monitoring and Manual Override:	The AED Pro also provides a non-diagnostic ECG monitoring feature and manual override capabilities for physicians and appropriately trained healthcare providers. This feature, along with manual override, is considered substantially equivalent to the Philips Heartstart FR2+.

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

The provided 510(k) summary does not specify the sample size of any test set used or the provenance of data (e.g., country of origin, retrospective/prospective). It broadly states "extensive performance testing." This level of detail is typically not included in a public 510(k) summary document but would be part of the full submission to the FDA.

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

The 510(k) summary does not mention the use of experts to establish a ground truth for a test set. The evaluation seems to rely on performance and safety testing against established standards and comparisons to predicate devices, rather than a clinical study with expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

No adjudication method is described, as the summary does not detail a study involving expert review of a test set.

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

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance is present in the provided text. The device is an AED, which provides advisories for human users, but the "AI" component (the interpretive algorithm) is the core of the device's decision-making, not an assistant to human readers interpreting ECGs.

6. Standalone (Algorithm Only Without Human-in-the Loop) Performance

The summary explicitly states that the device "acquires and analyzes an adult or pediatric patient's ECG signal and, if a shockable rhythm is detected, recommends delivery of a defibrillation shock via voice and visual prompts." This describes the standalone performance of the algorithm in detecting shockable rhythms and providing advisories. The "Performance Testing" section also refers to the "incorporated interpretive algorithm" demonstrating substantial equivalence regarding performance. Therefore, a standalone performance assessment of the algorithm's ability to detect shockable rhythms was implicitly conducted as part of the "extensive performance testing" to demonstrate equivalence.

7. Type of Ground Truth Used

The type of ground truth used for evaluating the device's interpretive algorithm is not explicitly stated. For AEDs, the "ground truth" for a shockable rhythm is typically established by using a database of ECGs classified by cardiologists or based on known clinical outcomes that definitively identify shockable rhythms (e.g., ventricular fibrillation, ventricular tachycardia) versus non-shockable rhythms (e.g., asystole, normal sinus rhythm). The summary's reliance on "performance and safety testing" and "comparison of technological characteristics" to predicate devices suggests that the algorithm's performance was validated against established benchmarks for rhythm analysis in AEDs.

8. Sample Size for the Training Set

The provided 510(k) summary does not mention any training set or its sample size. This information is typically proprietary to the manufacturer and not included in public summaries, especially for devices where the core technology might have been developed over many iterations prior to this specific product.

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

Since no training set is mentioned, the method for establishing its ground truth is also not provided. For such devices, if machine learning was used (which is implied by an "interpretive algorithm"), the ground truth for training data would typically be established by expert cardiologists or electrophysiologists classifying ECG waveforms.

Summary

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K041892

FEB - 4 2005

510(k) Summary:

Submitter's Name and Address:

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

Contact Person:

Sean Reynolds (978) 421-9655, Ext. 9386

Date Summary Prepared:

June 28, 2004

Device:

ZOLL AED Pro External Defibrillator

Classification:

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

Automatic External Defibrillators; Class III (21 CFR 870.5310)

Cardiac Monitors (including Cardiotachometers and Rate Alarms): Class II (21 CFR 870.2300

Substantial Equivalence:

The features and functions of the ZOLL AED Pro External Defibrillator are substantially equivalent to those of the ZOLL AED Plus with CPR Aid: 510(k) No. K011541, cleared 4/11/2002, the ZOLL AED Plus: 510(k) No. K033474, cleared 5/21/2004 and the Philips Medical Systems, Heartstart FR2+ (formerly Heartstream ForeRunner), 510(k) No. K013425, cleared 1/14/2002.

Description:

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510(k) Summarv

Defibrillation therapy is provided by using defibrillation electrode products specifically designed to be attached to the ZOLL AED Pro. ZOLL pedirpadz™ II defibrillation electrodes enable users to provide therapy to children less than 8 years of age. When used in conjunction with ZOLL CPR-D-padz™, the AED Pro provides CPR compression performance feedback to the user through voice prompts.

The ZOLL AED Pro also provides a non-diagnostic ECG monitoring feature and manual override capabilities for physicians and appropriately trained healthcare providers. A high-resolution LCD Screen will display ECG Data, Visual Prompts, Shock Count and CPR compression performance.

Intended Use

The ZOLL AED Pro External Defibrillator is a portable, ruggedized, automated external defibrillator intended for use by personnel who are trained in basic life support, advanced life support, or other physician-authorized emergency medical response who must respond to emergency situations, to deliver defibrillation therapy and to display ECG rhythms of patients during treatment.

Comparison of Technological Characteristics:

The ZOLL AED Pro design characteristics are the same as those of the indicated predicate devices; the technology is very similar to that of the ZOLL AED Plus. The ZOLL AED Pro acquires and analyzes ECG signals and provides shock advisory determinations for adult and pediatric patients. The ZOLL AED Pro advises users to deliver a shock, perform CPR or conduct patient assessment through audible and visual prompts identical to those used by the ZOLL AED Plus. The AED Pro ECG monitoring feature and manual override capability are substantially equivalent to that of the Philips Heartstart FR2+ defibrillator.

Performance Testing:

The ZOLL AED Pro External Defibrillator has been subjected to extensive performance testing to ensure that the device meets all of its functional requirements and performance specifications. Safety testing was performed to assure the device complies with applicable sections of recognized industry and safety standards.

Conclusion

Based on the results of the performance and safety testing, the ZOLL AED Pro has demonstrated that its features, functions and incorporated interpretive algorithm are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

FEB - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Sean Reynolds Regulatory Affairs Engineer Zoll Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105

K041892 Re:

Trade/Device Name: ZOLL AED Pro External Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automatic External Defibrillator Regulatory Class: III Product Code: MJK Dated: December 3, 2004 Received: December 6, 2004

Dear Mr. Reynolds:

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 ass ontale an 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 - Mr. Sean Reynolds

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 DX 3 issumost of our device complies with other requirements of the Act or that FDA nas mude a determilations administered by other Federal agencies. You must comply with all 1 Coords statutes and regendating, but not limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements) incolares, none manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 801), good 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Connor provisions (Socure to begin marketing your device as described in your Section 510(k) This letter will and in yours Finding of substantial equivalence of your device to a legally prematics notification: "The PDF missing site and thus, permits 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 in you attire Office of Compliance at (240) 276-0120. 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 Echeral international 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,

Bhimnica for

Bram D. Zuckerman, M.D. Division of Cardiovacsular 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): ____________________________________________________________________________________________________________________________________________________ K041892

Device Name: ZOLL AED Pro External Defibrillator

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, and .
Absence of normal breathing, and .
Absence of a pulse or signs of circulation. .

Contraindications for Use - Defibrillation

Do not use the AED Pro unit for defibrillation when the patient

. ls conscious; or
Is breathing; or .
Has a detectable pulse or other signs of circulation. .

Contraindications for Use - CPR Monitoring

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

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)

ummuma Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)

Division of Cardiovascular Devices
510(k) Number k 041892

Page 1 of 1 _

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.