MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE

K980857 · Graphic Controls Corp. · MKJ · May 12, 1998 · Cardiovascular

Device Facts

• Record ID: K980857
• Device Name: MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
• Applicant: Graphic Controls Corp.
• Product Code: MKJ · Cardiovascular
• Decision Date: May 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

Intended for use in defibrillation procedures, cardioversion and pacing. This device is intended for use on adults and pediatric patients weighing over 10kg.

Device Story

Medi-Trace 1310P is a self-adhesive, pre-gelled electrode for defibrillation, monitoring, and pacing. Construction includes a vinyl substrate, metal foil layer, conductive adhesive hydrogel, pressure-sensitive adhesive ring, and pre-attached leadwire. Packaged in pairs in heat-sealed pouches. Used in clinical settings by healthcare professionals to deliver electrical therapy and monitor ECG signals. Device functions as a passive interface between a defibrillator/pacer unit and the patient. Benefits include reliable electrical contact for life-saving therapy and continuous monitoring.

Clinical Evidence

Bench testing only. Device met AAMI DF-39 specifications for electrical performance, energy throughput, and simulated use (multiple defibrillation shocks, maximum current pacing, ECG monitoring). Biocompatibility testing per ISO-10993 confirmed the device is non-irritating, non-cytotoxic, and non-sensitizing. Accelerated shelf-life studies support claimed shelf life.

Technological Characteristics

Materials: vinyl substrate, metal foil, conductive adhesive hydrogel, pressure-sensitive adhesive ring. Connectivity: pre-attached leadwire for connection to defibrillator/pacer. Standards: AAMI DF-39 (electrical/energy testing), ISO-10993 (biocompatibility). Form factor: self-adhesive electrode pair.

Indications for Use

Indicated for use in defibrillation, cardioversion, and pacing procedures for adult and pediatric patients weighing over 10kg.

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

• Physio Controls Quik-Combo Pacing/Defibrillation/ECG Electrode (K980857)

Submission Summary (Full Text)

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MAY 1 2 1998

Date:

189 Van Rensselaer Street PO Box 1271 Buffalo, New York 14240-1271 USA 716853-7500 Fax: [phone]

K980857

# 510(k) SUMMARY

March 4, 1998

Graphic Controls Graphic Controls Corporation Manufacturing Facility: 189 Van Rensselaer Street P.O. Box 1271 Buffalo, NY 14240 Registration Number 1317188 Telephone: [phone] Contact Person: Kathleen Selover Regulatory Affairs Specialist [phone], extension 7630 Fax: [phone] Medi-Trace® 1310P Combination Defibrillation, Device Trade Name: Monitoring and Pacing Electrode Device Common Name: Self Adhesive Defibrillation and Monitoring Electrode Classification Name: Electrode, Electrocardiograph, Multifunction Regulatory Reference: 74 MLN Physio Controls® Quik-Combo™ Predicate Device: Pacing/Defibrillation/ECG Electrode Description: A pre-gelled conductive electrode consisting of a pre-attached leadwire, an insulating layer of a vinyl substrate, 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.

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510(k) Summary Page 2

### Intended/Indications for Use:

Intended for use in defibrillation procedures, cardioversion and pacing. This device is intended for use on adults and pediatric patients weighing over 10kg.

## Physical/Technical Comparison:

Medi-Trace® 1310P Electrode is replaceable with the Physio-Controls® Quick Combo™ Pacing/ Defibrillation/ECG Electrodes. Physical and technical characteristics, including materials used in construction, size, intended use and conductive gel type of these electrodes are comparable. Since the formulation of conductive gel is considered to be proprietary, exact chemical comparison could not be made.

## Performance Summary:

The device and the predicate were subject to AAMI electrical tests as described in DF-39, 3.3.19 and energy through put testing. Test results for both the device and the predicate meet the specifications as established in DF-39 for self adhesive electrodes for monitoring, defibrillation and pacing.

In addition, the device was subjected to simulated use testing consisting of multiple defibrillation shocks, maxium current pacing and ECG monitoring. Test results for the device met the specifications as established in DF-39 for self adhesive electrodes for monitoring, defibrillation and pacing.

# Biocompatibility Testing:

The device was subjected to biocompatibility testing as recommended in ISO-10993, Biological Evaluation of Medical Devices Part I: 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 were reviewed and found to substantiate our claimed shelf life.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 1998

Ms. Kathleen Selover Graphic Controls Corporation 189 Van Rensselaer Street P.O. Box 1271 Buffalo, NY 14240

Re: K980857 Medi Trace® 1310P Combination Defibrillation, Monitoring and Pacing Electrode Requlatory Class: III (three) Product Code: 74 MLN Dated: March 4, 1998 Received: March 5, 1998

Dear Ms. Selover:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions,

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### Page 2 - Ms. Kathleen Selover

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Area P

Sincerely yours,
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of low of of a love

510(k) Number, if known:

# Device Name: Medi-Trace® 1310P Combination Defibrillation, Monitoring and Pacing Electrode

Indications for Use:

Medi-Trace® 1310P Combination Defibrillation, Monitoring and Pacing Electrode is intended for use on adults and pediatric patients weighing over 10kg.

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Presecription Use

OR

Over-the-Counter

Use (Per 21CFR801.109)

M. Pyzik

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_ K980957