As with the cleared predicate device (K110742), the OneStep CPR II MFE is intended for use with ZOLL R Series defibrillators for ECG Monitoring, Defibrillation, External Noninvasive Pacing, Cardioversion and CPR Feedback for adult patients in either the hospital or pre-hospital environment. The currently marketed OneStep 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".

The proposed device incorporates a second motion sensor on the posterior electrode which will allow rescuers to obtain accurate depth compression feedback when CPR is performed on soft/ compressible surfaces. The dual sensor technology works by detecting motion in the posterior sensor and communicating it to the anterior sensor to allow for compensation for a compressible surface underneath the patient. The accelerometers in each CPR sensor work in series to provide a signal to the defibrillator which interprets that signal to determine actual chest compression depth when compressions are performed on a compressible surface. The dual sensor technology can also be used on a solid surface as the design of the posterior sensor is not influenced by lack of movement.

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 CPR II electrode will also have the ability to perform a defibrillation self test and expiration date identification with the ZOLL R Series Defibrillator. 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

I am sorry, but the provided text does not contain the requested information about acceptance criteria and a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter and summary for a medical device (OneStep CPR II Adult Multi-Function Electrode).

It describes the device, its intended use, and states that it 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." However, it does not provide the specific acceptance criteria, the results of the performance testing, the study design, sample sizes, ground truth establishment, or any details about multi-reader multi-case studies or standalone algorithm performance.

To answer your request, I would need a different document, likely a detailed study report or validation protocol (e.g., from Section 18 mentioned in the text).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.

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

October 10, 2014

Bio-Detek, Inc. Shannon Duhamel Regulatory Affairs Specialist 269 Mill Road Chelmsford, Massachusetts 01824-4105

Re: K133441 Trade/Device Name: OneStep CPR II Adult Multi-Function Electrode Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: August 28, 2014 Received: August 29, 2014

Dear Shannon Duhamel,

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

Kenneth J. Cavanaugh -S

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): K133441

Device Name: OneStep CPR II Adult Multi-Function Electrode

Intended Use:

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

For use on adult patients with ZOLL® R Series® defibrillator by trained personnel only, including:

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

The OneStep CPR II Adult Electrodes are not 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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Image /page/3/Picture/0 description: The image shows the logo for BIO-DETEK INCORPORATED. The words BIO-DETEK are in red, with a hyphen between BIO and DETEK. The word INCORPORATED is in gray and is located below BIO-DETEK. The number K133441 is in black and is located in the upper right corner of the image.

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: Shannon Duhamel Regulatory Affairs Specialist Tel. (978) 421-9574 sduhamel@zoll.com

Date Summary Prepared: October 10, 2014

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

RequlationCommon Name: Automated External Defibrillator Multi-Function Electrodes

Classification Name: Multi-Function Electrode, with CPR Aid Accessory to an Automated External Defibrillator

Substantial Equivalence:

The ZOLL OneStep CPR II Multi-Function Electrode (MFE) is substantially equivalent to the predicate ZOLL OneStep CPR MFE that was FDA cleared per K110742 on 04/13/2011. The proposed electrode introduces the addition of a second sensor on the posterior pad which allows users to obtain accurate compression depth feedback while performing CPR on soft/ compressible surfaces. As with the predicate device, the OneStep CPR II MFE is intended for use with the ZOLL R Series Defibrillator. Both the predicate and the proposed OneStep CPR II Electrodes are presently in FDA Regulatory Class III category.

Description of Device:

As with the cleared predicate device (K110742), the OneStep CPR II MFE is intended for use with ZOLL R Series defibrillators for ECG Monitoring, Defibrillation, External

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K133441

Noninvasive Pacing, Cardioversion and CPR Feedback for adult patients in either the hospital or pre-hospital environment. The currently marketed OneStep 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".

Device Name: OneStep CPR II Adult Multi-Function Electrode

Intended Use:

Defibrillation
Cardioversion ●
Noninvasive Pacing
ECG Monitoring ●
CPR Sensor .

For use with ZOLL® R Series® defibrillator by trained personnel only, including:

Physicians ●
Nurses
Paramedics
Emergency Medical Technicians ●

1 Meaney, P. A., et al. CPR Quality: Improving Cardiac Resuscitation Outcomes Both Inside and Outside the Hospital: A Consensus Statement From the American Heart Association. Circulation by AHA. 2013: 5.

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K133441

. Cardiovascular Laboratory Technicians
The OneStep CPR II Adult Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

Comparison of Technological Characteristics:

The intended use of the OneStep Multi-Function Electrodes as described in the Indications For Use and labeling has not changed as a result of this submission. The OneStep CPR II MFE that is the subject of this submission as compared to the ZOLL OneStep predicate electrode cleared in submission K110742 uses the same conductive materials, acrylic adhesive closed cell foam, and has a conductive area of the same dimensional size.

Testing:

The OneStep CPR II 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. Performance testing is provided in Section 18 of this submission.

The proprietary name is ZOLL OneStep CPR II Adult MFE which was formerly identified as OneStep Adult Dual Sensor. Testing and performance evaluations demonstrate that the safety and effectiveness of the OneStep CPR II Adult MFE is substantially equivalent to the predicate device.

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.