Intended for use whenever cardiac monitoring of neonatal or pediatric patients is deemed or desirable by trained medical or emergency personnel. This electrode is for use on neonatal and pediatric patients.

Device Description

A neonatal ECG monitoring electrode consisting of a conductive adhesive gel, a silver/silver chloride plated eyelet, a foam substrate and vinyl label and a 24 inch lead wire terminating in a 0.059" DIN standard safety socket.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Graphic Controls Corporation Medi-Trace® 4103 Neonatal ECG Electrode with Preattached Lead Wire, based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
AAMI electrical tests (ANSI/AAMI DF-12, 1991)	Met specifications established in DF-12-1991
ECG trace quality	Found comparable to the predicate device
Biocompatibility (ISO-10993 Part 1)	Non-irritating, non-cytotoxic, and non-sensitizing
Shelf life	Data substantiated claimed shelf life

Note: The document states that the modified device was found "comparable" to the predicate for ECG trace quality. Specific quantitative metrics for ECG trace quality or a detailed comparison are not provided.

Study Details

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size for the test set used in the performance summary. It broadly states that "the device and the predicate were subjected to AAMI electrical tests" and implies a comparison.
- The data provenance is not explicitly mentioned (e.g., country of origin). The testing seems to have been conducted by the manufacturer, Graphic Controls Corporation.
- The nature of the data (retrospective or prospective) is not indicated, but given the context of device testing for a premarket notification, it would typically be prospective testing conducted by the manufacturer.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The performance tests appear to be objective electrical and biocompatibility assessments against standards rather than expert-derived ground truth. For "ECG trace quality," it's mentioned as comparable to the predicate, but the methodology for this comparison (e.g., expert review vs. automated measurement) is not detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- There is no mention of an adjudication method. The reported performance is based on meeting voluntary standards for electrical characteristics and biocompatibility testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is an ECG electrode, not an AI-powered diagnostic tool, so such a study would not be applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device (an electrode) and does not involve an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the electrical tests and biocompatibility was defined by the specifications of the ANSI/AAMI DF-12, 1991 voluntary standard and the recommendations in the ISO-10993 Biological Evaluation of Medical Devices Part 1. For "ECG trace quality," the ground truth was the performance of the legally marketed predicate device.
The sample size for the training set:
- Not applicable. This device is a physical electrode and does not utilize a training set in the context of machine learning or algorithms.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

Summary

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Graphic Controls Corporation

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

Customer Relations: 800 669-1009 Fax: 800-347-2421

K981964

NOV 1 3 1998

510(k) SUMMARY

Graphic Controls

Date:	June 2, 1998
Manufacturing Facility:	Graphic Controls CorporationAcadia PropertiesChase StreetMethuen, MA 01844Registration Number: 12118874
Telephone:	(716) 853-7500
Contract Person:	Kathleen SeloverRegulatory Affairs Specialist(71 6) 853-7500, ext 7630Fax: (716) 847-7531
Device Trade Name:	Medi-Trace® 4103 Neonatal ECGElectrode with Preattached Lead Wire
Device Common Name:	Neonatal ECG Monitoring Electrode
Classification Name:	Electrocardiograph Electrode
Regulatory Reference:	74 DRX
Predicate Device	Graphic Controls Medi-Trace® 4103Neonatal Electrode with Preattached Lead Wire

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Description:

Intended Use:

Physical/Technical Comparison

The modified Medi-Trace® 4103 electrode is equivalent to the Medi-Trace® 4103 electrode currently marketed by Graphic Controls Corporation. Physical and technical characteristics, including materials used in construction, size, intended use, indications for use for the modified device and the predicate are comparable.

Performance Summary:

The device and the predicate were subjected to AAMI electrical tests as described in ANSI/AAMI voluntary standard, DF-12, 1991, Disposable ECG Electrodes. Test results for both the device and the predicate met the specifications as established in DF-12-1991/

In addition to the requirements of DF-12-1991, the modified device was found comparable to the predicate for ECG trace quality.

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, noncvtotoxic and non-sensitizing.

Shelf Life:

ﮨﮯ

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/2 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 three human profiles facing to the right, stacked on top of each other.

NOV 1 3 1998

Susan Krasny, Ph.D. Graphic Controls Corporation P.O. Box 1274 189 Van Rensselaer Street Buffalo, NY 14240

Re: K981964 Meditrace® 4103 Neonatal Electrode Regulatory Class: II (two) Product Code: 74 DRX Dated: August 25, 1998 Received: August 26, 1998

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 legally marketed predicate 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 Reqister. 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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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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, 2 Misbranding by reference to premarket notification? (21CFR 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.gov/cdrh/dsma/dsmamain.html".

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 _________________________________________________________________________________________________________________________________________________________________________

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

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Whenever cardiac monitoring is deemed necessary or desirable by trained medical or wherever ears as morely is for use on neonatal and pediatric patients.

(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	K981964
Prescription Use (Per 21 CFR 801.109)	X
OR Over-the-Counter Use

Regulation Number and Section

§ 870.2360 Electrocardiograph electrode.

(a)
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.(b)
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.