Defibrillation
Cardioversion
Noninvasive Pacing
ECG Monitoring
CPR Feedback
For use with ZOLL® Defibrillators, such as:
R Series
X Series
Trained Personnel only, Including:
Physicians
Nurses
Paramedics
Emergency Medical Technicians
Cardiovascular Laboratory Technicians
The OneStep Pediatric CPR electrodes are indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

Device Description

As with the currently marketed OneStep Pediatric CPR Multi-Function Electrode (reviewed and cleared with K120907), the modified OneStep Pediatric CPR Multi-Function Electrode (MFE) is intended for use with ZOLL R Series and ZOLL X Series defibrillators for ECG Monitoring, Defibrillation, External Noninvasive Pacing, Cardioversion and CPR Feedback for use on patient less than 8 years of age or weighing less than 55lbs (25kg) in either the hospital environment. The currently marketed OneStep Pediatric CPR MFE provides users with accurate depth compression feedback when CPR is performed on a firm surface – a known recommended practice. A recent publication by the AHA acknowledges that "accelerometers are insensitive to mattress compression" and stresses the need for "continued development of optimal and widely available CPR monitoring." So. with the current submission. we are proposing to modify the OneStep Pediatric CPR MFE to incorporate a second motion sensor on the posterior electrode thereby allowing rescuers to obtain accurate depth compression feedback when CPR is performed on soft/ compressible surfaces. Dual sensor technology, utilized in the proposed OneStep Pediatric CPR MFE. has been reviewed and cleared by the agency with OneStep CPR II MFE (K133441).
As with the predicate device, the proposed electrode and wire harness with a ZOLL proprietary connector will have a pre-connect feature that enhances the user's ability to deliver immediate therapy. And like the predicate device, the OneStep Pediatric CPR electrode is also designed to support the defibrillator's self test and expiration date identification. Each electrode pad is structurally comprised of a solid hydrogel with a pure tin electrical conductive element having a polyethylene terephtalate (PET) backing with an adhesive perimeter suitable for coupling to patient skin during rescue and/or treatment.

AI/ML Overview

The provided text is a 510(k) summary for the ZOLL OneStep Pediatric CPR Multi-Function Electrode (MFE). It describes a modified device that incorporates a second motion sensor for improved CPR depth feedback on soft surfaces. However, it does not explicitly provide a table of acceptance criteria or detailed results of a study proving the device meets specific performance metrics in the way that would typically be presented for image-based diagnostic or AI-driven medical devices.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical evidence and performance testing against recognized standards. There is no mention of a study involving human readers or AI in the context of diagnostic accuracy.

Therefore, many of the requested elements cannot be extracted directly from this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with numerical performance targets (e.g., sensitivity, specificity, accuracy) for a diagnostic outcome, nor does it present device performance in that manner. Instead, it states that the device was subjected to "extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards."

The performance testing listed consists of categories rather than specific metrics:

EMC Testing in accordance with IEC 60601-1-2.
Electrical, mechanical, bio-compatibility and simulated use testing per the applicable requirement of international recognized standards IEC 60601-1, IEC 60601-2-4, ISO 10993-1, ISO 10993-5 and ISO 10993-10.
Testing to qualify the use of the electrode with R Series and X Series devices.
Usability testing.

The "reported device performance" is essentially that these tests were conducted and the device met its functional requirements and specifications, allowing it to be deemed substantially equivalent.

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

The document does not refer to a "test set" in the context of diagnostic performance data (e.g., medical images or patient records). The "testing" mentioned refers to engineering and safety performance tests of the device itself (electrical, mechanical, usability). Therefore, sample sizes for such a test set and data provenance (country, retrospective/prospective) are not applicable or provided in this context.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable. The device is a multi-function electrode for CPR and defibrillation, not an interpretative diagnostic tool. Ground truth in the sense of expert consensus on diagnostic findings is not relevant to the described testing.

4. Adjudication Method:

Not applicable, as there's no diagnostic ground truth being established.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is compared with and without AI assistance. This document describes a physical medical device (electrodes) and its substantial equivalence based on engineering and safety performance, not a diagnostic algorithm.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone algorithm performance study was not done. The device in question is a hardware component with a function to provide feedback (CPR depth), not an independent algorithm for diagnostic interpretation.

7. Type of Ground Truth Used:

The "ground truth" for the performance testing described would be the verifiable measurements and standards for electrical safety, biocompatibility, mechanical integrity, and functional performance (e.g., accurate depth compression feedback as measured by a calibrated system). It is not expert consensus, pathology, or outcomes data in the diagnostic sense.

8. Sample Size for the Training Set:

Not applicable. The device is not an AI/ML algorithm that requires a training set of data.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary regarding acceptance criteria and study in the context of the provided document:

The provided document describes the ZOLL OneStep Pediatric CPR Multi-Function Electrode and seeks 510(k) clearance by demonstrating substantial equivalence to existing predicate devices.

Instead of providing a typical "acceptance criteria" table with specific performance metrics for a diagnostic claim, the document indicates that acceptance was based on the device meeting functional requirements and performance specifications as defined by applicable National/International recognized standards.

The study (or rather, "performance testing") used to demonstrate this involved:

EMC Testing: In accordance with IEC 60601-1-2.
Electrical, Mechanical, Biocompatibility, and Simulated Use Testing: Per IEC 60601-1, IEC 60601-2-4, ISO 10993-1, ISO 10993-5, and ISO 10993-10.
Device Qualification Testing: To ensure compatibility with ZOLL R Series and X Series defibrillators.
Usability Testing.

The primary change being approved is the addition of a second motion sensor to improve CPR depth feedback on soft surfaces, a technology already cleared in a similar predicate device (OneStep CPR II MFE, K133441). Clinical evidence was explicitly stated as "N/A - Clinical evidence was not necessary to show substantial equivalence." This indicates that the regulatory decision was based on engineering and performance testing against established standards for physical devices, rather than a clinical trial or diagnostic performance study.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with a triple-line design above them.

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

May 2, 2015

Bio-Detek, Inc. % Tanmay Shukla Sr. Regulatory Affairs Specialist Zoll Medical Corporation 269 Mill Road Chelmsford, Massachusetts 01824-4105

Re: K150055

Trade/Device Name: OneStep Pediatric CPR Multi-function Electrode Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ, LIX Dated: April 3, 2015 Received: April 6, 2015

Dear Tanmay Shukla:

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 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

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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 of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Arthrell Stein

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):

Device Name: OneStep Pediatric CPR Multi-Function Electrode

Intended Use:

Defibrillation ●
Cardioversion ●
Noninvasive Pacing o
ECG Monitoring ●
CPR Feedback .

For use with ZOLL® Defibrillators, such as:

R Series ●
X Series .

Trained Personnel only, Including:

Physicians ●
Nurses ●
Paramedics ●
Emergency Medical Technicians ●
Cardiovascular Laboratory Technicians ●

The OneStep Pediatric CPR electrodes are indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

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)

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INCORPORATED

510(k) Summary:

Submitter's Name and Address: Bio-Detek, Inc. A Subsidiary of ZOLL®Medical Corporation 525 Narragansett Park Drive Pawtucket, RI 02861 Tel. (401) 729-1400

Contact Person: Tanmay Shukla Sr. Regulatory Affairs Specialist ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824 Tel. (978) 421-9171 tshukla@zoll.com

Date Summary Prepared: January 9, 2015

Device Name / Proprietary Name: ZOLL OneStep Pediatric CPR Multi-Function Electrode (MFE)

Common Name: Automated External Defibrillator Multi-Function Electrodes

Classification Name: Multi-Function Electrode, with CPR Aid Accessory to an Automated External Defibrillator (21 CFR 870.5310 - Product Code MKJ)

Substantial Equivalence: ZOLL OneStep Pediatric CPR MFE (K120907) OneStep CPR II MFE (K133441)

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Description of Device:

As with the predicate device, the proposed electrode and wire harness with a ZOLL proprietary connector will have a pre-connect feature that enhances the user's ability to deliver immediate therapy. And like the predicate device, the OneStep Pediatric CPR electrode is also designed to support the defibrillator's self test and expiration date identification. Each electrode pad is structurally comprised of a solid hydrogel with a pure tin electrical conductive element having a polyethylene terephtalate (PET) backing with an adhesive perimeter suitable for coupling to patient skin during rescue and/or treatment.

Device Name: OneStep Pediatric CPR Multi-Function Electrode

Intended Use:

Defibrillation
Cardioversion
Noninvasive Pacing ●
ECG Monitoring o
CPR Feedback ●

For use with ZOLL® Defibrillators, such as:

R Series ●
X Series .

By Trained Personnel only. Including:

Physicians ●
Nurses ●
Paramedics

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Emergency Medical Technicians 0
o Cardiovascular Laboratory Technicians

The OneStep Pediatric CPR electrodes are indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

Substantial Equivalence - Non-Clinical Evidence:

The proposed ZOLL OneStep Pediatric CPR Multi-Function Electrode (MFE) is identical to the currently marketed ZOLL OneStep Pediatric CPR MFE (K120907) except that the proposed electrode introduces an additional motion sensor on the posterior pad which allows the users to obtain accurate compression depth feedback while performing CPR on soft/ compressible surfaces. The change is similar to one implemented for OneStep CPR II MFE (K133441).The intended use of the OneStep Pediatric CPR Multi-Function Electrodes as described in the Indications for Use and labeling has not changed as a result of this submission.

Substantial Equivalence - Clinical Evidence:

N/A - Clinical evidence was not necessary to show substantial equivalence

Comparison of Technological Characteristics

From a technological standpoint, the only difference between the proposed ZOLL OneStep Pediatric CPR Multi-Function Electrode (MFE) and the currently marketed ZOLL OneStep Pediatric CPR MFE (K120907) is the introduction of the dual sensor technology in the proposed device. Dual sensor technology, utilized in the proposed OneStep Pediatric CPR MFE, has been reviewed and cleared by the agency with OneStep CPR II MFE (K133441).

Performance Testing:

The proposed OneStep Pediatric CPR Multi-Function Electrode has been subjected to extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards.

EMC Testing in accordance with IEC 60601-1-2. .
Electrical, mechanical, bio-compatibility and simulated use testing per the o applicable requirement of international recognized standards IEC 60601-1, IEC 60601-2-4, ISO 10993-1, ISO 10993-5 and ISO 10993-10.
Testing to qualify the use of the electrode with R Series and X Series devices. ●
Usability testing ●

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Conclusion:

The information provided in this 510(k) demonstrates that the proposed ZOLL OneStep Pediatric CPR Multi-Function Electrode (MFE) is substantially equivalent to indicated commercially distributed devices with regard to performance, safety and effectiveness.

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.