DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES

K033144 · Defibtech, LLC · MKJ · Nov 13, 2003 · Cardiovascular

Device Facts

• Record ID: K033144
• Device Name: DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES
• Applicant: Defibtech, LLC
• Product Code: MKJ · Cardiovascular
• Decision Date: Nov 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

FOR USE WITH DEFIBTECH ELECTRODES FOR AUTOMATIC AND MANUAL EXTERNAL DEFIBRILLATORS FOR MONITORING, PACING AND DEFIBRILLATION UP TO 360 JOULES.

Device Story

Defibtech Electrode Adapter serves as physical interface between Defibtech electrodes and various automatic/manual external defibrillators. Device is reusable; functions as standalone accessory or pre-attached to electrode package. Enables transmission of electrical signals for monitoring, pacing, and defibrillation up to 360 Joules. Used by clinicians in clinical settings to ensure compatibility between proprietary electrodes and third-party defibrillation equipment. Facilitates patient treatment by allowing use of Defibtech electrodes with existing defibrillator infrastructure.

Clinical Evidence

Bench testing only.

Technological Characteristics

Reusable physical interface adapter. Designed for compatibility with Defibtech electrodes and various external defibrillators. Supports energy delivery up to 360 Joules. No software or electronic components described.

Indications for Use

Indicated for use with Defibtech electrodes to facilitate monitoring, pacing, and defibrillation (up to 360 Joules) when using automatic and manual external defibrillators.

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

• Heartstream Electrode Adapter (K972418)

Submission Summary (Full Text)

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NOV 1 3 2003

Section E - 510(k) Summary

Date of Submission: September 26, 2003

| Establishment Registration | | |
|-------------------------------|-------------------------------------------------|---------------|
| Location<br>Company Name: | Defibtech, LLC | |
| | | |
| Address 1: | 753 Boston Post Road | |
| Address 2: | Suite 102 | |
| City, State, and Zip Code: | Guilford, CT 06437 | |
| Contact Information | | |
| Name: | Mr. John L. Rogers | |
| Telephone: | [phone] x13 | |
| Facsimile: | [phone] | |
| Trade (Proprietary) Name | Defibtech Electrode Adapter | |
| Model Number | DAC-300 Series | |
| Common Name | Defibrillation Electrode Adapter | |
| Classification | | |
| FDA Panel | Cardiovascular | |
| Class | Class III | |
| Regulation | 21 CFR 870.1025 - Arrhythmia detector and alarm | |
| Substantial Equivalence | | |
| Model | Manufacturer | 510(k) Number |
| Heartstream Electrode Adapter | Heartstream, Inc. | K972418 |

## Device Description

The Defibtech Electrode Adapter provides an interface between Defibtech electrodes and various automatic and manual external defibrillators. Each adapter is reusable and is either a stand-alone accessory or can be preattached to a Defibtech electrode package.

#### Intended Use

Intended for use with Defibtech electrodes to monitor, pace and defibrillate (up to 360 Joules) with automatic and manual defibrillators.

## Conclusion Summary of Safety and Effectiveness

Testing and performance evaluations demonstrate that the safety and effectiveness of the Defibtech Electrode Adapter is substantially equivalent to the predicate devices.

(0331444

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Image /page/1/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing segments and a flowing tail.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2003

Defibtech, LLC c/o Mr. John L. Rogers Director, Medical Device Compliance 753 Boston Post Road, Suite 102 Guilford, CT 06437

Re: K033144

Trade Name: Defibtech Electrode Adapter Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MKJ Dated: September 26, 2003 Received: September 30, 2003

#### Dear Mr. Rogers:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. John L. Rogers

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance 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 from the Division of Small Manufacturers, International 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 vours.

Diva Reinber
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 D - Statement of Indications of Use

| Ver/ 3 - 4/24/96 | Page 1 of 1 |
|------------------|-------------|
|------------------|-------------|

| Applicant: | Defibtech, LLC |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | Not Applicable |
| Device Name: | Defibtech Electrode Adapter |
| Indications For Use: | FOR USE WITH DEFIBTECH ELECTRODES FOR AUTOMATIC AND MANUAL EXTERNAL DEFIBRILLATORS FOR MONITORING, PACING AND DEFIBRILLATION UP TO 360 JOULES. |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

*Division Sign-Off*

Division of Cardiovascular Devices

| 510(k) Number | K033144 |
|---------------|---------|
|---------------|---------|

Defibtech LLC Electrode Adapter 510(k)

Proprietary & Confidential
9/26/03