MEDI-TRACE 4103 NEONATAL ELECTRODE

K981964 · Graphic Controls Corp. · DRX · Nov 13, 1998 · Cardiovascular

Device Facts

• Record ID: K981964
• Device Name: MEDI-TRACE 4103 NEONATAL ELECTRODE
• Applicant: Graphic Controls Corp.
• Product Code: DRX · Cardiovascular
• Decision Date: Nov 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2
• Attributes: Pediatric

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 Story

Medi-Trace 4103 is a neonatal ECG monitoring electrode; consists of conductive adhesive gel, silver/silver chloride plated eyelet, foam substrate, vinyl label, and 24-inch lead wire with 0.059" DIN safety socket. Used in clinical settings by medical/emergency personnel for cardiac monitoring. Device interfaces with standard ECG monitoring equipment to capture electrical signals from patient skin. Output is an ECG trace used by clinicians to assess cardiac activity and inform clinical decisions. Benefits include reliable signal acquisition for neonatal/pediatric patient monitoring.

Clinical Evidence

Bench testing only. Device performance evaluated against ANSI/AAMI DF-12-1991 standards for disposable ECG electrodes, confirming electrical specifications. Biocompatibility testing conducted per ISO-10993 standards confirmed the device is non-irritating, non-cytotoxic, and non-sensitizing. Accelerated shelf-life studies substantiated the claimed shelf life.

Technological Characteristics

Conductive adhesive gel; silver/silver chloride plated eyelet; foam substrate; vinyl label; 24-inch lead wire with 0.059" DIN safety socket. Electrical performance compliant with ANSI/AAMI DF-12-1991. Biocompatibility compliant with ISO-10993.

Indications for Use

Indicated for cardiac monitoring of neonatal and pediatric patients when deemed necessary by trained medical or emergency personnel.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Graphic Controls Medi-Trace® 4103 Neonatal Electrode with Preattached Lead Wire (K981964)

Submission Summary (Full Text)

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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: [phone]

K981964

NOV 1 3 1998

#

## 510(k) SUMMARY

# Graphic Controls

| Date: | June 2, 1998 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Manufacturing Facility: | Graphic Controls Corporation<br>Acadia Properties<br>Chase Street<br>Methuen, MA 01844<br>Registration Number: 12118874 |
| Telephone: | [phone] |
| Contract Person: | Kathleen Selover<br>Regulatory Affairs Specialist<br>(71 6) 853-7500, ext 7630<br>Fax: [phone] |
| Device Trade Name: | Medi-Trace® 4103 Neonatal ECG<br>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<br>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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### 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) | <div style="text-align:left;">X</div> |
| OR Over-the-Counter Use | |

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