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 less than 8 years of age, or weighs less thank 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 device will analyze the electrocardiographic (ECG) rhythm of the patient and detect whether the rhythm is shockable or non-shockable. If the device detects a shockable rhythm, the device charges the capacitor, enables the treatment button and prompt the user to deliver the defibrillation energy to the patient. If the device detects a non-shockable rhythm, the device will prompt the user to begin CPR. The electrodes used with the device incorporates an accelerometer that mesures 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 American Heart Association (AHA) Guidelines. The device provides feedback in the form of a metronome (to encourage the proper CPR frequency of 100 compressions per minute) and a visual depth indicator on the display (to encourage the recommended compression depth).

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the ZOLL AED Plus with the 2010 AHA Guidelines Software Update, based on the provided text.

Based on the provided text, the device in question is a software update for an existing Automatic External Defibrillator (AED), the ZOLL AED Plus. The update primarily changes the CPR compression depth feedback to align with the 2010 AHA Guidelines.

It is critical to understand that this submission is a 510(k) for a software update to an already cleared device, not a new device requiring extensive clinical trials for a de novo clearance. This means the performance testing primarily focuses on demonstrating that the updated software maintains the safety and effectiveness of the predicate device and meets the new CPR depth recommendations.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format that would typically be seen for a new device's diagnostic performance (e.g., sensitivity, specificity for a diagnostic algorithm). Instead, the "acceptance criteria" implicitly relate to adhering to the new AHA guidelines and demonstrating substantial equivalence to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
CPR Compression Depth Feedback
- Prompt user to "push harder" when compressions are < 2.0 inches	The device's software is modified to prompt "push harder" when compressions are less than 2.0 inches.
- Display CPR depth indicator as 2.0 inches minimum	The depth indicator on the device screen is changed from 1.5 inches to 2.0 inches.
CPR Chest Recoil Feedback
- Add text prompt to remind user to "Fully Release" chest	An additional text user prompt to remind users to "Fully Release" the patient's chest during CPR is added.
Overall Device Safety and Effectiveness
- Maintain safety and effectiveness of predicate device	"Performance and safety testing... 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."
- Compliance with applicable sections of recognized industry and safety standards	Safety testing assures that the device complies with applicable sections of recognized industry and safety standards.

Study Details

Given the nature of a software update for an already cleared device, the "study" described is a performance testing and safety testing regimen, rather than a clinical trial validating a novel diagnostic algorithm.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify a sample size for a "test set" in the context of diagnostic accuracy.
- The "performance testing" and "safety testing" mentioned are likely internal engineering and validation tests, not typically involving "test sets" of patient data in the same way a diagnostic AI would. Details on the data provenance (country, retrospective/prospective) are also not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This information is not applicable/not provided. The "ground truth" for this device's performance relates to its ability to accurately measure and provide feedback on CPR depth and frequency according to the new AHA guidelines and to perform its core defibrillation function as per the predicate device. This would be validated through engineering and functional testing, not expert consensus on medical images or physiological signals.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable/not provided. Adjudication methods are typically used in clinical studies involving human interpretation or uncertain outcomes, which is not the primary focus of this software update.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI systems that aid human interpretation (e.g., radiologists reading scans). The ZOLL AED Plus is a device that provides direct feedback based on physiological measurements (CPR depth, rhythm analysis), not an AI assisting a human "reader" in a diagnostic task.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device's core functions (rhythm analysis, CPR feedback) operate "standalone" in the sense that the algorithm processes inputs (ECG, accelerometer data) and provides outputs (shock/no shock, CPR prompts). The performance testing would have validated these algorithmic modifications. However, it's crucial to note that an AED always requires a human operator to physically administer CPR and deliver the shock, so "standalone performance" here refers to the algorithm's accuracy in its functions, not that the device operates without human interaction during a rescue.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for rhythm analysis is well-established through clinical standards and validated algorithms.
- For the CPR feedback, the ground truth is based on engineering measurements of compression depth (e.g., using a force plate or sensor to verify the accelerometer's accuracy) and frequency, adhering to the specified 2010 AHA Guidelines.
- The overall safety and effectiveness rely on demonstrating equivalence to the predicate device, which itself would have been validated against established medical standards.
The sample size for the training set:
- This information is not provided and is largely not applicable in the context of this specific regulatory submission. Modern AI systems often require large training datasets, but this device's algorithms for rhythm analysis and CPR feedback are likely based on established physiological principles and signal processing, rather than deep learning requiring extensive "training sets" in the contemporary AI sense. If any machine learning was used for the accelerometer-based CPR feedback, the training data details are not disclosed.
How the ground truth for the training set was established:
- Not explicitly described. For the core functions of an AED, the ground truth for algorithms is typically established through:
  - Physiological models: Simulations and testing with controlled inputs.
  - Clinical data from previous generations/studies: ECG databases with adjudicated rhythms.
  - Engineering validation: Direct measurement of physical parameters (e.g., force, depth) using calibrated equipment.
- For the CPR feedback, the "ground truth" for the desired performance parameters is objectively defined by the 2010 AHA Guidelines (e.g., 2.0 inches minimum depth, 100 compressions/minute, full recoil). The training of the device, if any, would involve calibrating its sensors to accurately reflect these physical parameters.

Summary Takeaway:

This 510(k) submission is for a minor software update to an already cleared Class III medical device (AED). The "performance testing" described is primarily focused on verifying that the software changes correctly implement the updated CPR guidelines (specifically compression depth and recoil feedback) and that these changes do not adversely affect the overall safety and effectiveness of the device compared to its predicate. It is not a submission for a new diagnostic AI system, and therefore, many of the typical AI study parameters (e.g., large test/training sets of patient data, expert adjudication, MRMC studies) are not present or not relevant to this specific regulatory review. The safety and functional performance tests would be internal validation studies, not clinical trials in the traditional sense.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for ZOLL Medical Corporation. The logo features the word "ZOLL" in large, bold, black letters. Below the word "ZOLL" is the tagline "Advancing Resuscitation. Today." in a smaller font. There is a curved line below the tagline.

K110154

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

FFB 17 201

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) 421-9171

Date Summary Prepared:

January 14, 2011

Device:

ZOLL AED Plus with 2010 AHA Guidelines Software Update

Classification:

Automatic External Defibrillators: Class III (21 CFR 870,5310) Cardiopulmonary Resuscitation Aid: Class III (21 CFR 870.5200)

Description:

The ZOLL AEDPlus was cleared by the agency under 510(k) application K033474. 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 device will analyze the electrocardiographic (ECG) rhythm of the patient and detect whether the rhythm is shockable or non-shockable. If the device detects a shockable rhythm, the device charges the capacitor, enables the treatment button and prompt the user to deliver the defibrillation energy to the patient. If the device detects a non-shockable rhythm, the device will prompt the user to begin CPR. The electrodes used with the device incorporates an accelerometer that mesures the depth of CPR compressions. This information is used by the device to provide feedback to the user and encourage

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the user to administer CPR in compliance with the American Heart Association (AHA) Guidelines. The device provides feedback in the form of a metronome (to encourage the proper CPR frequency of 100 compressions per minute) and a visual depth indicator on the display (to encourage the recommended compression depth).

The recent American Heart Association (AHA) 2010 Guidelines (see attached) changed it's previous recommendation for a minimum depth of CPR compressions from 1.5 inches to a depth of at least 2.0 inches. The Guidelines also advise caregivers to allow full recoil of the patient's chest during CPR. As a result we are modifying the device's software from it's current CPR depth monitoring of 1.5" to at least 2.0" and provide an additional text user prompt to remind users to fully release the patient's chest during CPR.

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 user to "Fully Release" the patient's chest . during CPR

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 ●

When a victim is less than 8 years of age, or weighs less thank 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:

The features and functions of the proposed ZOLL AED Plus (with 2010 AHA Guidelines for CPR software update) are substantially equivalent to the currently marketed ZOLL AED Plus (K033474, cleared for use on 5/21/2004).

Comparison of Technological Characteristics

The technological characteristics of the proposed ZOLL AED Plus (with 2010 AHA Guidelines software update) are substantially equivalent to the currently marketed ZOLL AED Plus (K033474, cleared for use on 5/21/2004).

Performance Testing:

Extensive performance testing ensures that the ZOLL AED Plus (with 2010 AHA Guidelines software update) 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:

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Conclusion

Performance and safety testing of the ZOLL AED Plus (with 2010 AHA · Guidelines software update) 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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Public Health Service

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

Ms. Eileen M. Boyle Regulatory Affairs Specialist Zoll Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105

FEB 17 20:1

Re: K110154

Trade/Device Name: Zoll AED Plus with 2010 AHA Guidelines Software Update Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: January 14, 2011 Received: January 19, 2011

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. 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 omrois:

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Page 2 - Ms. Eileen M. Boyle

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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,
W.M.

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

KITOS

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

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)

W.Moe

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K110154

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.