MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS
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
Indications for Use
Intended for use in defibrillation procedures, cardioversion and pacing. This device is intended for use on adults. Not for use on children or infants.
Device Story
Pre-gelled conductive electrode; consists of cable attachment, vinyl insulating layer, metal foil, conductive adhesive hydrogel, pressure-sensitive adhesive ring, and release liner. Used in clinical settings for defibrillation, cardioversion, and pacing. Operates as interface between patient skin and defibrillator/pacing equipment; facilitates electrical energy delivery and ECG signal monitoring. Packaged in pairs in heat-sealed pouches. Healthcare providers apply electrodes to patient chest to deliver therapeutic shocks or pacing pulses; output affects clinical management of cardiac arrhythmias.
Clinical Evidence
Bench testing only. Device met AAMI DF-39 specifications for electrical performance, energy throughput, and simulated use (multiple defibrillation shocks and maximum current pacing). Biocompatibility testing (ISO-10993) confirmed non-irritating, non-cytotoxic, and non-sensitizing properties. Accelerated shelf-life studies performed.
Technological Characteristics
Materials: vinyl insulating layer, metal foil, conductive adhesive hydrogel, pressure-sensitive adhesive ring. Sensing/actuation: conductive electrode for ECG monitoring, defibrillation, and pacing. Standards: AAMI DF-39 (electrical/energy testing), ISO-10993 (biocompatibility). Form factor: pre-gelled, self-adhesive, packaged in pairs.
Indications for Use
Indicated for adult patients requiring defibrillation, cardioversion, or pacing. Contraindicated for children and infants.
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.
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10/24/1996 09:59 7168477531 GRAPHIC CONTROLS PAGE 04
OCT 24 1996
510(k) SUMMARY; K955882
Date: October 24, 1996
Manufacturer: Graphic Controls Corporation
189 Van Rensselaer Street
PO Box 1271
Buffalo, NY 14240
Registration Number 1317188
Telephone: (716) 853-7500
Contact Person: Kathleen H. Selover
Regulatory Affairs Specialist
(716) 853-7500, Extension 7630
Fax Number: (716) 847-7531
Device Trade Name: Medi-Trace® 1210H Combination Defibrillation, Pacing and ECG Electrode
Common Name: Self Adhesive Electrode for Monitoring and Defibrillation, optional Pacing
Classification Name: Multi-Purpose Electrocardiograph Electrode
Regulatory Reference: 74 MLN
Predicate Device: Hewlett® Packard M1749A Multifunction Adult Electrode
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10/24/1996 09:59 7168477531 GRAPHIC CONTROLS PAGE 05
## 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, cardioversion and pacing. This device is intended for use on adults. Not for use on children or infants.
## Physical/Technical Comparison:
Medi-Trace® 1210H Electrode is replaceable with the Hewlett® Packard M1749A Multifunction Adult 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 and the predicate were subjected to AAMI electrical tests as described in DF-39, 3.3.19 and energy throughput testing. Test results for both the device and the predicate met the specifications as established in DF-39 for self adhesive electrodes for monitoring, and defibrillation and pacing.
In addition, the device was subjected to simulated used testing consisted of multiple defibrillation shocks and maximum current pacing. Test results for the device met the specifications as established in DF-39 for self adhesive electrodes for monitoring, and defibrillation and pacing.
## 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.
