When the victim is less than 8 years old or weighs less than 55 lb. (25 kg), use ZOLL pediatric defibrillation electrodes: Do not delay therapy to determine the patient's exact 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.

Device Description

The ZOLL AED Pro® 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.

The ZOLL AED Pro software, which currently supports the 2005 American Heart Association Guidelines for CPR and ECC, has been revised to optionally support the 2010 American Heart Association Guidelines for CPR and ECC. The specific changes include:

changing the depth indicator on the device screen from 1.5 inches to 2.0 inches .
prompting the user to "push harder" when compressions are less than 2.0 inches . instead of less than 1.5 inches in the previous release
adding a text prompt to remind the rescuer to "Fully Release" the patient's . chest during CPR

AI/ML Overview

The provided document describes a 510(k) premarket notification for a software update to the ZOLL AED Pro, aligning it with the 2010 American Heart Association Guidelines for CPR and ECC. The focus is on CPR monitoring and defibrillation.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a pass/fail quantifiable manner for the software update, but rather describes the changes made to comply with new guidelines and implies that the device meets these new guideline requirements. The performance testing section states that the device "meets all of its functional requirements and performance specifications" and "demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness."

Acceptance Criteria (Implied)	Reported Device Performance
CPR Compression Depth:
Prompt for adults to "push harder" when compressions are less than 2.0 inches (5 cm).	Software revised to prompt "push harder" when compressions are < 2.0 inches (instead of < 1.5 inches previously).
Device screen indicator for compression depth at 2.0 inches.	Screen indicator changed from 1.5 inches to 2.0 inches.
CPR Chest Recoil:
Prompt for full chest recoil during CPR.	Text prompt added to remind rescuer to "Fully Release" the patient's chest during CPR.
CPR Rate:
Metronome to encourage 100 compressions per minute. (This was present in the prior version and maintained/verified).	CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute.
Defibrillation Performance:
Substantially equivalent to predicate device (K041892) for defibrillation accuracy and safety.	Performance testing of the ZOLL AED Pro Defibrillator demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness.

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

The document broadly mentions "Extensive performance testing," but does not provide any specific sample sizes for test sets used to validate the software changes. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any testing performed.

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

The document does not mention the use of experts to establish ground truth for a test set related to this software update. The basis for the software changes is the 2010 American Heart Association Guidelines, which are consensus-based expert recommendations, but not a specific ground truth determination for device testing.

4. Adjudication Method for the Test Set:

Since there is no mention of a test set where ground truth was independently established by experts, no adjudication method is described in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus of this 510(k) is a software update to align with new guidelines, not an assessment of human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

The document states "Extensive performance testing ensures that the ZOLL AED Pro Defibrillator meets all of its functional requirements and performance specifications." While this implies algorithm-only testing to ensure it correctly implements the new guidelines, it does not explicitly detail a standalone performance study with specific metrics for the algorithm's performance. The context is a software change to a device that has "human-in-the-loop" by design (an AED).

7. The Type of Ground Truth Used:

The ground truth for the design criteria of the software update is the 2010 American Heart Association Guidelines for CPR and ECC recommendations. For the device's overall performance validation, the ground truth is implicitly related to "functional requirements and performance specifications" and comparison to "commercially distributed predicate devices" to establish substantial equivalence. However, no specific ground truth (like pathology, outcomes data, or expert consensus on specific cases) for a test set is explicitly described in the context of this software update.

8. The Sample Size for the Training Set:

The document does not mention a training set or its sample size. This is a software update to an existing device based on updated clinical guidelines, not the development of a new AI/machine learning model that typically requires a training set.

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

Since there is no mention of a training set, this information is not applicable and not provided in the document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for ZOLL Medical Corporation. The logo features the company name in bold, black letters. Below the name is the tagline "Advancing Resuscitation. Today."

K 110526

ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824 U.S.A

510(k) Summary:

Submitter's Name and Address:

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

Contact Person:

Eileen M. Boyle

(978) 421-9655, Ext. 9171

Date Summary Prepared:

February 11, 2011

Device:

ZOLL AED Pro® with 2010 AHA Guidelines Software Update

Classification:

Defibrillator, Low-energy - DC: Class III (21 CFR 870.5310)

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:

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K110526

The recent 2010 American Heart Association Guidelines for CPR and ECC changed previous recommendations from 1.5"-2.0" inches compression depth of a depth of at least 2.0". The Guidelines also advise caregivers to allow full recoil of the patient's chest during CPR. As a result, we are proposing modifying the device's software to prompt caregivers to perform CPR in accordance with the new AHA quidelines.

Description of Software Changes

The specific changes include:

changing the depth indicator on the device screen from 1.5 inches to 2.0 inches .
prompting the user to "push harder" when compressions are less than 2.0 inches . instead of less than 1.5 inches in the previous release
adding a text prompt to remind the rescuer to "Fully Release" the patient's . chest during CPR

Intended Use

The AED Pro unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of at least 2 inches (5 cm) for adult patients.

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. (25 kg), use ZOLL pedirpadz® II pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact 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.

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Never use the AED Pro unit for defibrillation when the patient

Is conscious
· Is breathing, or
· Has a detectable pulse or other sign of circulation.

CPR Monitoring

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

Intended Users

In semiautomatic mode, the AED Pro unit is intended to be used by rescuers and emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the operator controls delivery of shocks to the patient. In manual mode, the AED Pro unit is intended to be used only by qualified medical personnel trained in Advanced Life Support skills.

In ECG monitoring mode, the AED Pro unit is intended to be used by personnel who are qualified by training in the use of the AED Pro device, basic life and/or advanced life support, or other physician-authorized emergency medical training.

Substantial Equivalence:

The features and functions of the proposed ZOLL AED Pro (with 2010 AHA Guidelines software update) are substantially equivalent to the currently marketed ZOLL AED Pro (K041892, cleared for use on 2/4/2005).

Comparison of Technological Characteristics

The technological characteristics of the proposed ZOLL AED Pro (with 2010 AHA Guidelines software update) are substantially equivalent to the currently marketed ZOLL AED Pro (K041892, cleared for use on 2/4/2005).

Performance Testing:

Extensive performance testing ensures that the ZOLL AED Pro Defibrillator meets all of its functional requirements and performance specifications.

Conclusion

. Performance testing of the ZOLL AED Pro Defibrillator demonstrates that its features and functions 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/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. 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.

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

ZOLL Medical Corporation c/o Mr. Chuck Kolifrath Regulatory Affairs Manager Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824-4105

MAR 2 5 2011

Re: K110526

Trade/Device Name: ZOLL AED Pro with 2010 AHA Guidelines Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: January 26, 2011 Received: February 24, 2011

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 hability 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. Chuck Kolifrath

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 vours,

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): K110526

Device Name: ZOLL AED Pro with 2010 AHA Guideline Update

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. (25 kg), use ZOLL pediatric defibrillation electrodes: Do not delay therapy to determine the patient's exact 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 AED Pro unit for defibrillation when the patient

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

CPR Monitoring

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

Prescription Use × (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)

Page 1 of 1
BDZ

lovascular Devices

510(k) Number K110526

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.