CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel

K150198 · Bio-Detek, Inc. · MKJ · May 2, 2015 · Cardiovascular

Device Facts

• Record ID: K150198
• Device Name: CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel
• Applicant: Bio-Detek, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: May 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic

Indications for Use

Defibrillation ECG Monitoring Cardioversion CPR Feedback The CPR Dura-padz Reusable Defibrillation Electrode is used in conjunction with Dura-padz Gel, and for use with the following ZOLL Biphasic-only defibrillators with max. energy setting of 200 Joules: AED Pro M Series E Series R Series The device will be used in pre-hospital, alternate care and hospital settings by trained personnel only, including: Physicians Nurses Paramedics Emergency Medical Technicians Cardiovascular Laboratory Technicians First Responders The CPR Dura-padz Reusable Defibrillation Electrodes are not for use with ZOLL AED Plus and/or any Public Access Defibrillators. The CPR Dura-padz Reusable Defibrillation Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

Device Story

Reusable defibrillation electrode system; used with Dura-padz Gel and compatible ZOLL biphasic defibrillators. Inputs: electrical signals for ECG monitoring and CPR compression data via integrated sensor. Device transforms inputs into real-time CPR feedback and cardiac monitoring data for display on host defibrillator. Used by trained clinicians (physicians, nurses, paramedics, EMTs) in clinical/pre-hospital settings. Output enables providers to monitor cardiac rhythm and optimize CPR compression quality. Benefits: facilitates effective resuscitation and monitoring. Reusable up to 100 patient uses.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing and verification/validation of functional requirements against recognized standards.

Technological Characteristics

Reusable multi-function electrode; includes integrated CPR sensor. Compatible with ZOLL biphasic defibrillators (max 200J). Materials: conductive electrode components and reusable gel. Connectivity: wired interface to host defibrillator. Reusable up to 100 patient uses.

Indications for Use

Indicated for adult patients (>= 8 years old, >= 55 lbs/25 kg) requiring defibrillation, cardioversion, ECG monitoring, or CPR feedback. Used with specific ZOLL biphasic defibrillators (AED Pro, M, E, R Series) by trained medical personnel in hospital, pre-hospital, or alternate care settings. Contraindicated for use with ZOLL AED Plus, public access defibrillators, or pediatric patients under 8 years/55 lbs.

Regulatory Classification

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.

Predicate Devices

• Dura-padz Reusable Defibrillation Electrode (K100565)
• ZOLL OneStep Adult Multi-Function Electrode (K110742)

Submission Summary (Full Text)

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Public Health Service

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

May 2, 2015

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

Re: K150198

Trade/Device Name: CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ, LIX Dated: April 13, 2015 Received: April 14, 2015

Dear Shannon Duhamel,

We have reviewed vour 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

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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 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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): K150198

# Device Name: CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel

Intended Use:

- Defibrillation
- ECG Monitoring
- Cardioversion ●
- CPR Feedback ●

The CPR Dura-padz Reusable Defibrillation Electrode is used in conjunction with Dura-padz Gel, and for use with the following ZOLL Biphasic-only defibrillators with max. energy setting of 200 Joules:

- AED Pro
- M Series ●
- E Series ●
- R Series ●

The device will be used in pre-hospital, alternate care and hospital settings by trained personnel only, including:

- . Physicians
- Nurses
- Paramedics
- Emergency Medical Technicians ●
- Cardiovascular Laboratory Technicians
- First Responders

The CPR Dura-padz Reusable Defibrillation Electrodes are not for use with ZOLL AED Plus and/or any Public Access Defibrillators.

The CPR Dura-padz Reusable Defibrillation Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

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 IF NEEDED)

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# 510(k) Summary:

| Submitter's Name and Address: | Bio-Detek, Inc.<br>525 Narragansett Park Drive<br>Pawtucket, RI 02861 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application Correspondent: | Shannon Duhamel<br>RA Specialist<br>[phone]<br>[e-mail] |
| Date Summary Prepared: | July 9, 2014 |
| Classification: | Class III |
| Device Name | CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel |
| Common Name | Automated External Defibrillator Multi-Function Electrodes |
| Classification Name | Automated External Defibrillators (MKJ;<br>21 CFR 870.5310)<br>Cardiopulmonary Resuscitation Aid (LIX;<br>21 CFR 870.5200) |
| Predicate Devices | K100565 - Dura-padz Reusable Defibrillation Electrode used in conjunction with Dura-padz Gel<br>K110742 - ZOLL OneStep Adult Multi-Function Electrode |

#### Substantial Equivalence - Non-Clinical Evidence:

The existing features and functions (defibrillation, cardioversion and ECG monitoring) of the CPR Dura-padz Reusable Defibrillation Electrode have been cleared per K100565. As with the cleared predicate (K100565), the subject device is intended for use on adult patients with the following ZOLL biphasic-only defibrillators: AED Pro, E Series, R Series and M Series. The CPR Feedback monitoring function is the same technology used in the predicate device cleared per K110742. Safety, efficacy and substantial equivalence was shown through verification and validation testing.

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# Substantial Equivalence - Clinical Evidence:

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

# Description:

As with the cleared predicate device (K100565), the CPR Dura-padz Reusable Defibrillation Electrode is intended for use with the following ZOLL biphasic-only defibrillators: AED Pro, E Series, R Series and M Series for ECG monitoring, defibrillation and cardioversion. The addition of a CPR sensor (cleared per K110742) to the subject device will enable CPR feedback. As with the currently marketed predicate device (K100565), the CPR Dura-padz electrode is intended for use in conjunction with Dura-padz Gel on adult patients, and the electrode is reusable up to 100 patient uses. The device Indications For Use are as follows:

- Defibrillation ●
- ECG Monitoring
- Cardioversion ●
- CPR Feedback ●

The CPR Dura-padz Reusable Defibrillation Electrode is used in conjunction with Dura-padz Gel, and for use with the following ZOLL Biphasic-only defibrillators with max. energy setting of 200 Joules:

- AED Pro
- M Series ●
- E Series ●
- R Series

The device will be used in pre-hospital, alternate care and hospital settings by trained personnel only, including:

- Physicians ●
- Nurses ●
- Paramedics ●
- Emergency Medical Technicians
- Cardiovascular Laboratory Technicians
- First Responders

The CPR Dura-padz Reusable Defibrillation Electrodes are not for use with ZOLL AED Plus and/or any Public Access Defibrillators.

The CPR Dura-padz Reusable Defibrillation Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

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# Comparison of Technological Characteristics:

The CPR Feedback, ECG monitoring, defibrillation and cardioversion functions of the CPR Dura-padz electrode cleared with the predicate devices K110742 and K100565 have remained unchanged in the proposed version of the device.

### Performance Testing:

The CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel 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.

## Conclusion:

The information provided in this 510(k) demonstrates that the CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel features and functions are substantially equivalent to those of the indicated commercially distributed devices with regard to performance, safety and effectiveness.