A pre-gelled conductive elecrode 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

AI/ML Overview

This 510(k) summary describes a medical device, the Medi-Trace® 1510M Combination Defibrillation, Monitoring and Pacing Electrode, and its performance against established standards. However, it does not describe an AI device. The document predates widespread AI in medical devices and focuses on physical and electrical device performance rather than algorithmic performance.

Therefore, many of the requested criteria related to AI/algorithm performance (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not applicable to this submission.

Here's an analysis based on the provided text, focusing on what is available:

Acceptance Criteria and Reported Device Performance

Acceptance Criterion (from relevant standards)	Reported Device Performance (as stated in the document)
AAMI DF-39, 3.3.19 (Electrical Tests)	Met the specifications.
Energy Throughput Testing	Met the specifications.
AAMI DF-39 (for self-adhesive electrodes for monitoring, defibrillation and pacing) - Simulated Use Testing (multiple defibrillation shocks)	Met the specifications.
AAMI DF-39 (for self-adhesive electrodes for monitoring, defibrillation and pacing) - Simulated Use Testing (maximum current pacing)	Met the specifications.
AAMI DF-39 (for self-adhesive electrodes for monitoring, defibrillation and pacing) - Simulated Use Testing (ECG monitoring)	Met the specifications.
Biocompatibility (ISO-10993, Part 1)	Found to be non-irritating, non-cytotoxic, and non-sensitizing.
Shelf Life (Accelerated Shelf Life Studies)	Data substantiated the claimed shelf life.

Study Details (where applicable to a non-AI device):

Sample size used for the test set and the data provenance: Not explicitly stated as this is a physical device. The testing was done on the device and its predicate. The provenance would be the manufacturing facility, Graphic Controls Corporation, in Buffalo, New York, USA. The testing would be prospective, as new devices were manufactured and tested.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device performance is typically established by established engineering standards and validated test methods, not expert clinical consensus in the way an AI algorithm might be.
Adjudication method for the test set: Not applicable. The "ground truth" for electrical and physical performance is defined by the AAMI DF-39 standard specifications. A pass/fail determination against these specifications would be direct, not requiring expert adjudication in the classic sense.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, not applicable. This is not an AI device.
The type of ground truth used: Engineering standards (AAMI DF-39) and established biocompatibility testing protocols (ISO-10993).
The sample size for the training set: Not applicable. This is not an AI device, so there is no "training set."
How the ground truth for the training set was established: Not applicable.

Summary

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189 Van Rensselaer Street PO Box 1271
Buffalo, New York 14240-1271 USA
716 853-7500
Fax: 716 849-6499

K972970

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510(k) SUMMARY

AUG 27 1997

Graphic Controls

Date:	August 6, 1997
Manufacturing Facility:	Graphic Controls Corporation189 Van Rensselaer StreetPO Box 1271Buffalo, NY 14240Registration Number 1317188
Telephone:	(716) 853-7500
Contract Person:	Kathleen SeloverRegulatory Affairs Specialist(71 6) 853-7500, ext 7630Fax: (716) 847-7531
Device Trade Name:	Medi-Trace® 1510M CombinationDefibrillation, Monitoring and PacingElectrode
Device Common Name:	Self Adhesive Electrode for Monitoringand Defibrillation, optional Pacing
Classification Name:	Multi-function ElectrocardiographElectrode
Regulatory Reference:	74 MLN
Predicate Device	Marquette ElectronicsDefibrillation/Pacing Pads

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Description:

Intended/Indications for Use:

Intended for use in defibrillation procedures, cardioversion and This device is intended for use on adults. Not for use on pacing. children or infants.

Physical/Technical Comparison

Medi-Trace® 1510M Electrode is replaceable with Marquette Electronics Defibrillation/Pacing Pads. 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 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 mointoring, defibrillation and pacing.

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

Shelf Life:

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

AUG 27 1997

Susan A. Krasny, Ph.D. Graphic Controls Corporation 189 Van Rensselaer Street P.O. Box 1271 14240-1271 Buffalo, New York

Re: K972970 Medi-Trace® 1510M Combination Defibrillation, Monitoring and Pacing Electrodes Regulatory Class: III (three) Product Code: 74 MLN Dated: August 6, 1997 Received: August 11, 1997

Dear Dr. Krasny:

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, Drug, 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 regulations 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 Requlation (QS) for Medical Devices: General requlation (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 GME regulation may result in requlatory 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, or other Federal laws or regulations.

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Page 2 - Susan A. Krasny, Ph.D.

・

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 requlation (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".

Sincerely yours,

A.A. Licht

As 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 _________________________________________________________________________________________________________________________________________________________________________

510(k) Number, if known: _____________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: MediTrace® 1510M Combination Defibrillation, Monitoring and Pacing Electrode

Indications for Use:

Medi-Trace 1510M Combination Defibrillation, Monitoring and Pacing Electrode is intended for use on adults. Not for use on children or infants.

(PLEASE DP MPT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K972970

Prescription Use (Per 21CFR 801.109) OR Over-the-Counter
Use

Regulation Number and Section

§ 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.