The ZOLL pedirpadz™ Reduced Energy Electrode is intended for defibrillation, ECG monitoring and noninvasive pacing of pediatric patients less than 8 year of age or weighing less than 55 Ibs (25 kg).

The ZOLL pedirpadz™ Reduced Energy Electrode is intended for use only with ZOLL M Series and ZOLL E Series Biphasic AED Defibrillator products. The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are intended to be used by personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.

The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are indicated for use on victims of cardiac arrest where there is apparent lack of circulation as indicated by:

. Unconsciousness
Absence of breathing .
Absence of pulse. .

Device Description

The disposable ZOLL pedrpadz™ Reduced Energy Electrode is specifically designed for use with ZOLL M Series and ZOLL E Series AED products on children less than 8 years of age or weighing less than 55 lbs (25 kg), to reduce the energy delivered by the device to levels within the range that has been identified as acceptable for the indicated patient population.

The ZOLL M Series and ZOLL E Series Defibrillator products are portable, batterypowered devices indicated for the defibrillation (manual and AED), Noninvasive Transcutaneous Pacing, and multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, End Tidal CO2, 12-Lead ECG Monitoring, Non Invasive Blood Pressure measurement and data printing and recording for resting patients in critical care and transport.

When analyzing a patient's heart-rhythm using the incorporated interpretive algorithm, the device 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.

AI/ML Overview

The ZOLL pedi·padz™ Reduced Energy Electrode is designed for use with ZOLL M Series and ZOLL E Series AED Defibrillator products on pediatric patients. The primary purpose of this device is to reduce the energy delivered by the defibrillator to levels appropriate for children less than 8 years old or weighing less than 55 lbs (25 kg).

Here’s an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list quantitative acceptance criteria in a table format with reported device performance. Instead, it describes functional requirements and performance specifications. The implicit acceptance criterion is that the device must maintain performance characteristics, features, and functions that are "very similar" to predicate devices and meet "all functional requirements and performance specifications with regard to safety and effectiveness."

Acceptance Criteria (Implied)	Reported Device Performance
Functional Requirements & Performance Specifications (Safety & Effectiveness) met	"Extensive testing of the ZOLL pedrpadz™ Reduced Energy Electrode with the ZOLL M Series and ZOLL E Series AED ensures that these products meet all functional requirements and performance specifications with regard to safety and effectiveness."
Substantial Equivalence to Predicate Devices (Cardiac Science Model 9730 Pediatric Attenuated Defibrillation Electrodes (K022929) with Cardiac Science PowerHeart® AED)	"The ZOLL pedirpadz™ Reduced Energy Electrode in conjunction with ZOLL E Series or ZOLL M Series AED products maintain performance characteristics, features and functions that are very similar to those of the Cardiac Science Model 9730 Pediatric Attenuated Defibrillation Electrodes (K022929) with the Cardiac Science PowerHeart® Automated External Defibrillator, Model 9200/9210." "Based on the results of the usability testing, the ZOLL pedirpadz™ Reduced Energy Electrode has demonstrated that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness."
Energy Reduction for Pediatric Use	"specifically designed for use with ZOLL M Series and ZOLL E Series AED products on children less than 8 years of age or weighing less than 55 lbs (25 kg), to reduce the energy delivered by the device to levels within the range that has been identified as acceptable for the indicated patient population." (This is a design feature, confirmed by "extensive testing").

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

The document mentions "extensive testing" and "usability testing" but does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

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

The document does not mention the number of experts or their qualifications used to establish ground truth for any test set.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method for a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers' improvement with AI assistance. The device in question is an electrode, not an AI diagnostic tool that assists human interpretation.

6. Standalone (Algorithm Only) Performance Study:

The document does not describe a standalone (algorithm only) performance study in the context of an interpretive algorithm. It refers to the electrode's function in conjunction with the AED's interpretive algorithm for detecting shockable rhythms, but the electrode itself is a passive component reducing energy, not an algorithm. The AED's interpretive algorithm (which analyzes ECG signals) is mentioned, but its standalone performance or the study of it is not detailed.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for any testing. Given the nature of the device (an electrode for defibrillation), the "ground truth" would likely relate to electrical performance (e.g., energy attenuation, impedance) and clinical outcomes (e.g., successful defibrillation with appropriate energy levels in an animal model or simulated environment) rather than expert consensus on image interpretation or pathology.

8. Sample Size for the Training Set:

The document does not refer to a training set or its sample size. This device is a hardware component (electrode), not a machine learning algorithm that requires a training set in the conventional sense. The "interpretive algorithm" mentioned for the AED would have a training set, but details are not provided.

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

As there is no mention of a training set for the electrode and limited information on the AED's internal algorithm, the document does not describe how ground truth for any training set was established.

Summary

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ZOLL Medical Corporation

Image /page/0/Picture/1 description: The image shows the address of a company's worldwide headquarters. The address is 269 Mill Road, Chelmsford, Massachusetts 01824-4105. The country is the U.S.A.

978 421-9655 978 421-0025 Main Fax

Image /page/0/Picture/3 description: The image shows the logo for ZOLL Medical Corporation. The word "ZOLL" is written in large, bold, black letters. Below the company name is the tagline "Advancing Resuscitation. Today."

510(k) Summary:

Submitter's Name and Address:

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

NOV 0 6 2007

Contact Person:

Sean Reynolds (978) 421-9386

Date Summary Prepared:

August 23, 2007

Device:

ZOLL pedirpadz™ Reduced Energy Electrode

Classification:

Electrode, Electrodcardiograph, Multi-Function; Class II (21 CFR 870.2360)

Substantial Equivalence:

The features and functions of the ZOLL pedirpadz™ Reduced Energy Electrode are substantially equivalent to those of the ZOLL pedirpadz™ Multifunction Electrode K915159A, cleared 02/07/1992, and the Cardiac Science Model 9730 Pediatric Attenuated Defibrillation Electrodes K022929, cleared 01/27/2003.

Description:

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Invasive Blood Pressure measurement and data printing and recording for resting patients in critical care and transport.

Indications for Use

The ZOLL pedroadz™ Reduced Energy Electrode is intended for defibrillation, ECG monitoring and noninvasive pacing of pediatric patients less than 8 year of age or weighing less than 55 lbs (25 kg).

The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are indicated for use on victims of cardiac arrest where there is apparent lack of circulation as indicated by:

. Unconsciousness
Absence of breathing
. Absence of pulse.

Comparison of Technological Characteristics

The ZOLL pedirpadz™ Reduced Energy Electrode in conjunction with ZOLL E Series or ZOLL M Series AED products maintain performance characteristics, features and functions that are very similar to those of the Cardiac Science Model 9730 Pediatric Attenuated Defibrillation Electrodes (K022929) with the Cardiac Science PowerHeart® Automated External Defibrillator, Model 9200/9210.

Testing

Extensive testing of the ZOLL pedrpadz™ Reduced Energy Electrode with the ZOLL M Series and ZOLL E Series AED ensures that these products meet all functional requirements and performance specifications with regard to safety and effectiveness.

Conclusion

Based on the results of the usability testing, the ZOLL pedirpadz™ Reduced Energy Electrode has demonstrated that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the staff and two snakes intertwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 6 2007

ZOLL Medical Corporation c/o Mr. Sean Reynolds Regulatory Affairs Engineer 269 Mill Road Chelmsford, MA 01824

Re: K072430

ZOLL pedi·padz™ Reduced Energy Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: MLN Dated: August 28, 2007 Received: August 29, 2007

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 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.

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 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

.S.U

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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INDICATIONS FOR USE

510(k) Number (if known):	K072430
---------------------------	---------

ZOLL pedi•padz™ Reduced Energy Electrode Device Name:

Indications for Use

The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are indicated for use on victims of cardiac arrest where there is apparent lack of circulation as indicated by:

. Unconsciousness
Absence of breathing .
Absence of pulse. .

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)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko 72430

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.