K Number
K980857
Device Name
MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
Date Cleared
1998-05-12

(68 days)

Product Code
Regulation Number
870.5310
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

Not Found

Not Found

No
The summary describes a passive electrode device and its electrical and simulated use testing, with no mention of AI or ML capabilities.

Yes.
The device is used for medical procedures such as defibrillation, cardioversion, and pacing, which are therapeutic interventions.

No
The device is described as an electrode for medical procedures like defibrillation, cardioversion, and pacing, which are therapeutic interventions rather than diagnostic ones. While it mentions ECG monitoring (which can be diagnostic), its primary stated intended uses are therapeutic.

No

The device description clearly describes a physical electrode with multiple layers and components, indicating it is a hardware device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for defibrillation, cardioversion, and pacing. These are therapeutic and monitoring procedures performed directly on the patient's body.
  • Device Description: The device is an electrode designed to conduct electrical signals to and from the patient's body.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are specifically designed to perform tests on biological samples outside of the body. This device is used on the body for direct electrical intervention and monitoring.

N/A

Intended Use / 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.

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

Product codes

74 MLN

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adults and pediatric patients weighing over 10kg.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

Physio Controls® Quik-Combo™ Pacing/Defibrillation/ECG Electrode

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.5310 Automated external defibrillator system.

(a)
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.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

0

MAY 1 2 1998

Date:

189 Van Rensselaer Street PO Box 1271 Buffalo, New York 14240-1271 USA 716853-7500 Fax: 716 849-6499

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: (716) 853-7500 Contact Person: Kathleen Selover Regulatory Affairs Specialist (716) 853-7500, extension 7630 Fax: (716) 847-7531 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.

1

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.

2

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,

3

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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.

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

Ship Shows (superior de Property) - All Printers (and Articles of the States of Street Articles (and Articles StationConcurrence of CDRH, Office of Device Evaluation (ODE)

ﺍﻟﻘﺎﻋﺪ ﺍ

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