MEDI-TRACE 4103 NEONATAL ELECTRODE

• K Number: K981964
• Device Name: MEDI-TRACE 4103 NEONATAL ELECTRODE
• Manufacturer: GRAPHIC CONTROLS CORP.
• Date Cleared: 1998-11-13 ( 162 days)
• Product Code: DRX
• Regulation Number: 870.2360

Intended Use

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.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and electrical characteristics of an ECG electrode, with no mention of AI or ML.

Therapeutic

No
The device is described as an ECG monitoring electrode and its intended use is for cardiac monitoring, which is a diagnostic purpose, not a therapeutic one.

Diagnostic

No

Explanation: This device is described as an ECG monitoring electrode, used for "cardiac monitoring." While it collects data for cardiac monitoring, its primary function is to acquire signals rather than to interpret or diagnose medical conditions based on those signals. It's a component in the monitoring process, not a diagnostic tool itself.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components like conductive adhesive gel, eyelet, foam substrate, vinyl label, and a lead wire, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is for "cardiac monitoring of neonatal or pediatric patients." This describes a device used on the patient's body to monitor physiological signals, not a device used to test samples from the patient's body in a laboratory setting.
• Device Description: The description details an "ECG monitoring electrode" with components like conductive adhesive gel, eyelet, foam substrate, and lead wire. These are all external components designed for skin contact to pick up electrical signals from the heart.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.

Therefore, this device falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

74 DRX

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.

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

neonatal or pediatric patients / neonatal and pediatric patients

Intended User / Care Setting

trained medical or emergency personnel

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Graphic Controls Medi-Trace® 4103 Neonatal Electrode with Preattached Lead Wire

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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: [phone]

K981964

NOV 1 3 1998

510(k) SUMMARY

Graphic Controls

Date:	June 2, 1998
Manufacturing Facility:	Graphic Controls Corporation
Acadia Properties
Chase Street
Methuen, MA 01844
Registration Number: 12118874
Telephone:	[phone]
Contract Person:	Kathleen Selover
Regulatory Affairs Specialist
(71 6) 853-7500, ext 7630
Fax: [phone]
Device Trade Name:	Medi-Trace® 4103 Neonatal ECG
Electrode 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® 4103
Neonatal Electrode with Preattached Lead Wire

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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.

Intended Use:

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.

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 [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, 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 [phone] or [phone] 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:

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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)

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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

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