ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES

K051076 · ZOLL Medical Corporation · MKJ · May 13, 2005 · Cardiovascular

Device Facts

• Record ID: K051076
• Device Name: ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES
• Applicant: ZOLL Medical Corporation
• Product Code: MKJ · Cardiovascular
• Decision Date: May 13, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic

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.

Device Story

Disposable multi-function electrode pads; provide ECG monitoring and therapeutic capabilities (defibrillation, cardioversion, pacing) in single set. Input: electrical signals from patient skin. Output: therapeutic electrical energy delivery and ECG signal transmission to ZOLL defibrillator/monitor/pacemaker. Used in emergency settings by trained BLS/ALS personnel or authorized responders. Electrodes feature two therapy pads with integrated lead wires and embedded ECG monitoring electrodes electrically isolated from therapy region. Design eliminates need for separate ECG electrode attachment, reducing time delay in emergency care. Benefits patient by streamlining setup for critical cardiac interventions.

Clinical Evidence

Bench testing only. Device subjected to extensive performance testing to ensure compliance with functional requirements and recognized industry safety standards.

Technological Characteristics

Disposable multi-function electrode pads; two therapy electrodes with proprietary connector; embedded ECG monitoring electrodes electrically isolated from therapy region. Connectivity: wired connection to ZOLL defibrillator/monitor/pacemaker products.

Indications for Use

Indicated for external defibrillation, cardioversion, noninvasive pacing, and ECG monitoring in adult patients. Used by trained BLS/ALS personnel or physician-authorized emergency responders with compatible ZOLL defibrillator/monitor/pacemaker products.

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

• ZOLL stat-padz™ Adult Multi-function Electrodes (K981802)
• Bio-Detek Tracerite ME40 SG ECG electrodes (K964213)
• Cardiotronics Systems, Inc. MODEL #918 Multi-Pads (K883375)

Submission Summary (Full Text)

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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 [phone]

Contact Person:

Sean Reynolds [phone]

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:

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.

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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 [phone]. 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 [phone] or [phone] 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

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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

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