MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL

K955923 · Graphic Controls Corp. · MKJ · Oct 24, 1996 · Cardiovascular

Device Facts

• Record ID: K955923
• Device Name: MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL
• Applicant: Graphic Controls Corp.
• Product Code: MKJ · Cardiovascular
• Decision Date: Oct 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

Intended for use in defibrillation procedures. This device also allows for ECG monitoring. There are no population restrictions for the device except as noted in the directions for use.

Device Story

Medi-Trace 1110L is a pre-gelled, self-adhesive electrode; used for defibrillation and ECG monitoring. Components: cable attachment, vinyl insulating layer, metal foil, conductive adhesive hydrogel, pressure-sensitive adhesive ring, release liner. Packaged in pairs in heat-sealed pouches. Used by clinicians in clinical settings; provides electrical interface between defibrillator/monitor and patient skin. Facilitates energy delivery for defibrillation and signal acquisition for ECG monitoring.

Clinical Evidence

Bench testing only. Device met or exceeded ANSI/AAMI DF39-1993 specifications for electrical testing and labeling. Biocompatibility testing (ISO-10993) confirmed device is non-irritating, non-cytotoxic, and non-sensitizing. Accelerated shelf-life studies substantiated claimed shelf life.

Technological Characteristics

Materials: vinyl insulating layer, metal foil, conductive adhesive hydrogel, pressure-sensitive adhesive ring. Standards: ANSI/AAMI DF39-1993 (electrical/labeling), ISO-10993 (biocompatibility). Form factor: self-adhesive, pre-gelled electrode. Energy: passive electrical conductor for defibrillation/ECG.

Indications for Use

Indicated for patients requiring defibrillation procedures and ECG monitoring. No specific age or gender restrictions.

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

• Laerdal Heartstart® Defibrillation Electrode

Submission Summary (Full Text)

{0}

10/18/1996 15:32 71634

OCT 24 1996

510(k) SUMMARY; K955923

Date: October 18, 1996

Manufacturer: Graphic Controls Corporation
189 Van Rensselaer Street
PO Box 1271
Buffalo, NY 14240
Registration Number 1317188

Telephone: [phone]

Contact Person: Kathleen H. Selover
Regulatory Affairs Specialist
[phone], Extension 7630
Fax Number: [phone]

Device Trade Name: Medi-Trace® 1110L Combination Defibrillation and ECG Electrode

Common Name: Self Adhesive Electrode for Monitoring and Defibrillation

Classification Name: Accessory to an automatic or semiautomatic defibrillator

Regulatory Reference: 74 MKJ

Predicate Device: Laerdal Heartstart® Defibrillation Electrode

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10/18/1996 15:32 7168477531

## Description:

A pre-gelled conductive electrode consisting of a means of attaching the electrode to the cable, an insulating layer of vinyl, a layer of metal foil, a conductive adhesive hydrogel, a pressure sensitive adhesive ring and a release liner. Device is packaged in pairs in a heat sealed pouch, 10 pouches are packaged into one shelf-box/shipper.

## Intended Use:

Intended for use in defibrillation procedures. This device also allows for ECG monitoring. There are no population restrictions for the device except as noted in the directions for use.

## Physical/Technical Comparison:

Medi-Trace® 1110L Electrode is replaceable with the Laerdal Heartstart® Defibrillation Electrode. Physical and technical characteristics, including materials used in construction, size, intended use and conductive gel type of these electrodes are comparable. Since formulation of conductive gel is considered proprietary, exact chemical comparisons could not be made.

## Performance Summary:

The device was subjected to AAMI electrical tests as described in ANSI/AAMI DF39-1993 standard, part 3.3.19 and energy throughput testing. Test results indicated that this device meets or exceeds ANSI/AAMI specifications for electrical testing as established in DF39-1993, part 3.3.19 and labeling requirements as established in part 3.1.2 for self adhesive electrodes for monitoring and defibrillation.

## Biocompatibility Testing:

The device was subjected to biocompatibility testing as recommended in the May 1, 1995 FDA memorandum entitled: *Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"*. The device was found to be non-irritating, non-cytotoxic and non-sensitizing.

## Shelf Life:

Data obtained in accelerated shelf life studies was reviewed and found to substantiate our claimed shelf life.