MEDI-TRACE 200, MEDI-TRACE 200-30

K960968 · Graphic Controls Corp. · DRX · Oct 28, 1996 · Cardiovascular

Device Facts

• Record ID: K960968
• Device Name: MEDI-TRACE 200, MEDI-TRACE 200-30
• Applicant: Graphic Controls Corp.
• Product Code: DRX · Cardiovascular
• Decision Date: Oct 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Intended Use

Intended for use in general electrocardiograph procedures where ECG monitoring is deemed necessary and is ordered by a physician.

Device Story

Disposable ECG monitoring electrode; conductive wet gel interface; silver/silver chloride plated ABS eyelet; nickel plated brass stud; adhesive foam substrate; vinyl label; polystyrene release liner. Used in clinical settings for ECG monitoring; applied to patient skin by healthcare personnel to acquire electrical signals for diagnostic/monitoring equipment. Benefits include reliable signal acquisition for cardiac monitoring.

Clinical Evidence

Bench testing only. Device tested per AAMI EC12-1991 standards for electrical performance, labeling, shelf life, packaging, and safety. Biocompatibility testing performed per ISO-10993; results confirmed non-irritating, non-cytotoxic, and non-sensitizing. Real-time shelf life studies substantiated.

Technological Characteristics

Conductive wet gel electrode. Materials: silver/silver chloride plated ABS eyelet, nickel plated brass stud, adhesive foam substrate, vinyl label, polystyrene release liner. Complies with AAMI EC12-1991 standards.

Indications for Use

Indicated for patients requiring general electrocardiograph (ECG) monitoring as ordered by a physician.

Regulatory Classification

Identification

An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.

Predicate Devices

• Medi-Trace® 500 Electrodes

Submission Summary (Full Text)

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10/25/1996 14:58 7168477531 GRAPHIC CONTROLS PAGE 04

Graphic Controls Corporation
189 Van Rensselaer Street
PO Box 1274
Buffalo, New York 14240-1274 USA
716 853-7500

Customer Relations: 900 609 1009
Fax: [phone]

K960968

OCT 28 1996


## 510(k) SUMMARY; K960968

## Graphic Controls

Date: October 25, 1996

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

Manufacturing Location: Graphic Controls, Canada, Ltd.
215 Herbert Street
Gananoque, Ontario
Canada, K7G 2Y7

Telephone: [phone]

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

Device Trade Name: Medi-Trace® 200 and Medi-Trace® 200-30 ECG Electrodes

Common Name: Disposable ECG Monitoring Electrode

Classification Name: Electrocardiograph Electrode

Regulatory Reference: 74 DRX

Predicate Device: Medi-Trace® 500 Electrodes

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## Description:

A conductive wet gel electrode consisting of a conductive adhesive gel, a silver/silver chloride plated ABS eyelet, nickel plated brass stud, an adhesive foam substrate, vinyl label and polystyrene release liner. Electrodes are packaged either as 100 per pouch (Medi-Trace® 200) or 30 per pouch (Medi-Trace® 200-30); pouches are heat sealed.

Unit of sale for each packaging is a case of either 600 or 1000 electrodes.

## Intended Use:

Intended for use in general electrocardiograph procedures where ECG monitoring is deemed necessary and is ordered by a physician.

## Physical/Technical Comparison:

Medi-Trace® 200 is equivalent to the predicate device. Physical and technical characteristics, including materials used in construction, size, intended use and conductive gel type of device and the predicate are comparable.

## Performance Summary:

The device and the predicate were subjected to AAMI electrical performance tests as described in EC12-1991. Test results indicate that this device meet or exceeds the performance specifications as established in EC12-1991 for Disposable ECG Electrodes. In addition, the device was found to meet EC12-1991 AAMI standard for labeling, shelf life, packaging and safety and Graphic Controls' internal specifications for trace performance.

## 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 real time shelf life studies was reviewed and found to substantiate our claimed shelf life.