The disposable ZOLL stat padz™ MwP Multi-function Electrodes are designed to provide both patient ECG monitoring and therapeutic capabilities in a single set of multi-function electrode pads. The ZOLL statepadz™ MwP Electrodes will connect to ZQLL Medical Corporation defibrillator products for use on adult patients. The electrode pads include two therapy electrodes with permanently attached lead wires that join together in a proprietary ZOLL connector. Commonly used ECG monitoring electrodes are embedded within the anterior electrode backing but are electrically isolated from the therapy region. This configuration is designed to eliminate the need for, and time delay associated with, attaching up to 3 separate ECG electrodes.

AI/ML Overview

The provided text describes a 510(k) summary for the ZOLL stat-padz™ MwP Multi-function Electrodes. It states that "The ZOLL Stat padz™ MwP Multi-function Electrode 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." However, it does not provide specific details on the acceptance criteria, the actual results of the "extensive performance testing," or a study report with quantitative data.

Therefore, many of the requested details cannot be extracted from the given document.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states that "extensive performance testing" was done and that the device "meets all of its functional requirements and performance specifications," but it doesn't list the specific acceptance criteria or the reported performance data.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document mentions "performance testing" but does not specify sample sizes or data provenance.

3. 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)

Not applicable / Cannot be provided. The device is a multi-function electrode, not an AI diagnostic tool requiring expert ground truth establishment in this context. The testing mentioned appears to be performance and safety testing against engineering specifications and industry standards, not a clinical study involving expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Cannot be provided. As above, this type of adjudication is typically for clinical studies involving human interpretation or AI output, not for the performance testing of an electrode against engineering specifications.

5. 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

Not applicable. This is not an AI diagnostic device. The basis for substantial equivalence is comparison to predicate devices, not a human reader study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This describes an electrode, not an algorithm. The testing described is intrinsic device performance and safety.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For a device like an electrode, ground truth would refer to established engineering standards, electrical performance parameters, biocompatibility test results, and safety standards, rather than clinical ground truth obtained from experts or pathology.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable. As above, no training set is relevant here.

Summary of available information regarding compliance and testing:

Device Name: ZOLL stat-padz™ MwP Multi-function Electrodes
Purpose of Testing: To ensure the device meets all its functional requirements and performance specifications, and complies with applicable sections of recognized industry and safety standards.
Conclusion of Testing: Based on the results, the device demonstrated that its features and functions are substantially equivalent to indicated commercially distributed predicate devices with regard to performance, safety, and effectiveness.
Predicate Devices:
- ZOLL stat-padz™ Adult Multi-function Electrodes (K981802)
- Bio-Detek Tracerite ME40 SG ECG electrodes (K964213)
- Cardiotronics Systems, Inc. MODEL #918 Multi-Pads (K883375)

While the document confirms that testing occurred and met requirements for substantial equivalence, it does not provide the granular details of that testing, such as specific acceptance criteria or quantitative performance outcomes.

Summary

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Image /page/0/Picture/0 description: The image shows the text "K051076" in a bold, handwritten-like font, followed by the words "ZOLL Medical Corporation" in a smaller, sans-serif font. The text is black against a white background. The image appears to be a label or identifier, possibly related to a medical device or product from ZOLL Medical Corporation.

269 Mill Boar Chelmsford Massachusetts 01824-4105 978 421-9655

978 421-0025 Main Fax

ALY 1 3 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) 421-9386

Date Summary Prepared:

April 25, 2005

Device:

ZOLL stat padz™ MwP Multi-function Electrodes

Classification:

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

Substantial Equivalence:

The features and functions of the ZOLL stat-padz™ MwP Multi-function Electrodes are substantially equivalent to those of the ZQLL stat-padz™ Adult Multi-function Electrodes K981802, cleared 11/25/1998, the Bio-Detek Tracerite ME40 SG ECG electrodes K964213, cleared 10/22/1996 and the Cardiotronics Systems, Inc. MODEL #918 Multi-Pads K883375, cleared 08/30/1988.

Description:

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Intended Use

The ZOLL stat-padz™ MwP Multi-function Electrodes are intended for use by personnel who are trained in basic life support, or advanced life support, or other physician-authorized emergency medical response for external defibrillation, cardioversion, noninvasive pacing, and electrocardiograph monitoring. They are intended for use with all ZOLL Medical Corporation Defibrillator/Monitor/Pacemaker products.

Comparison of Technological Characteristics

The ZOLL Stat padz™ MwP Multi-function Electrodes maintain the same performance characteristics, features and functions to those of the ZOLL Stat-padz™ Adult Multi-function Electrodes (K981802), and the Bio-Detek Tracerite ECG monitoring electrodes (K964213) and are provided in a configuration that is very similar to that of the Cardiotronics, Inc. MODEL #918 Multi-Pads (K883375).

Testing

The ZOLL Stat padz™ MwP Multi-function Electrode 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 testing, the ZOLL Stat-padz™ MwP Multi-function Electrodes has demonstrated 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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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

MAY 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ZOLL Medical Corporation c/o Mr. Sean Reynolds Regulatory Affairs Engineer Worldwide Headquarters 269 Mill Road Chelmsford, Massachusetts 01824-4105

Re: K051076

K051070
Trade Name: ZOLL stat*padz™ MwP Multi-Function Electrodes Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrodes Regulatory Class: II (two) Product Code: MLN Dated: April 22, 2005 Received: April 27, 2005

Dear Mr. Reynolds:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally broker is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard the Medical Device Amedical Device American processes of to commence provision to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Costicule real (11ct) that do novement controls provisions of the Act. The 1 ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the riot riot 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 If your device is classified (soc aboro) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations Fi thay be subject to suell additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Ood of reading 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 I Teast of advised that I Driver is to the complies with other requirements of the Act that I DA has made a active and regulations administered by other Federal agencies. You must of any I catal statutes and registments, including, but not limited to: registration and listing (21 Comply with an the 11et brequirements)01); good manufacturing practice requirements as set CFR Part 807); adomig (21 CFR Part 820); and if applicable, the electronic form in the quant) byselling (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Section (Section ) our device as described in your Section 510(k) This letter wif anow you'ls ought and of substantial equivalence of your device to a legally prematication. The PDF intembly sification 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 specific acrievial 7 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 may be obtained from the Other general information of the mational 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,

Brimmer 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

Image /page/4/Picture/1 description: The image shows the text "K05/076" in a bold, handwritten font. The text appears to be a code or identifier, with the "K" possibly indicating a category or classification. A horizontal line is present beneath the text, possibly indicating that it is underlined or part of a form field.

510(k) Number (if known):

Device Name: ZOLL Stat·padz™ MwP Multi-function Electrodes

Indications for Use

ZOLL Stat-padz™ MwP Multi-function Electrodes are indicated for the following clinical applications:

ﺒ

Defibrillation .
Cardioversion ●
. Noninvasive Pacing
Electrocardiograph Monitoring

These disposable electrodes will be used with the following devices:

. ZOLL PD™ 1200 Pacemaker/Defibrillator
ZOLL PD™ 1400 Pacemaker/Defibrillator ●
ZOLL PD™ 2000 Pacemaker/Defibrillator .
. ZOLL D 900 Defibrillator
. ZOLL PD 1400 Defibrillator
. ZOLL D 2000 Defibrillator
ZOLL 1600 Pacemaker/Defibrillator
. ZOLL 1700 Pacemaker/Defibrillator
◆ ZOLL M Series Equipment
. Future ZOLL Devices, as defined by ZOLL Operators Manuals

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

D/OR
Ov
(2-

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)

B.J. Zimmerman

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K051076

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.