DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440

K990115 · Maersk Medical A/S · DRX · Dec 6, 1999 · Cardiovascular

Device Facts

• Record ID: K990115
• Device Name: DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440
• Applicant: Maersk Medical A/S
• Product Code: DRX · Cardiovascular
• Decision Date: Dec 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

ECG monitoring electrodes for short-term use (<24 hours) in adults (Model 4440) and infants (Model 4420).

Device Story

Niko ECG Monitoring Electrodes are disposable, pregelled sensors used to acquire cardiac electrical signals for monitoring purposes. The device consists of an Ag/AgCl sensor element (10-20 mm diameter) and an adhesive backing (20-70 mm diameter or rectangular/square). Electrodes are applied to the patient's skin by clinical staff to facilitate ECG signal transmission to monitoring equipment. The device is intended for short-term use (<24 hours) in clinical settings. By providing a stable electrical interface between the patient's skin and the monitoring system, the electrodes enable continuous observation of cardiac activity, assisting healthcare providers in clinical decision-making regarding patient heart health.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Ag/AgCl sensor construction; sensor element 10-20 mm diameter; adhesive backing 20-70 mm diameter or rectangular/square; bulk packaged in OPP/PE laminated pouches; non-sterile.

Indications for Use

Indicated for short-term (<24 hours) ECG monitoring in adults (Model 4440) and infants (Model 4420).

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

• Disposable ECG Monitoring Electrode Models 4420 and 4440 (K950476)

Submission Summary (Full Text)

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## DEC - 6 1999

K990115

### 510 (k) SUMMARY

#### ADMINISTRATIVE -

Submitter: Maersk Medical A/S Niko Business Unit Engmosen 1 DK-3540, Lynge Denmark Phone No.: 011 45 48 16 70 30

Contact Person: Mr. Christian Pelch

Date of Preparation: October 15, 1999

#### ll. DEVICE NAME

Proprietary Name: Niko ECG Monitoring Electrodes Common Name: ECG Electrode Classification Name: Electrocardiograph Electrode

#### III. PREDICATE DEVICES

Disposable ECG Monitoring Electrode Models 4420 and 4440 (K950476); Nikomed USA, Inc.

### IV. DEVICE DESCRIPTION

Pregelled electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 70 mm in diameter or rectangular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.

#### V. INTENDED USE

ECG monitoring electrodes for short-term use (<24 hours) in adults (Model 4440) and infants (Model 4420).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 1999

Maersk Medical A/S c/o Mr. Richard A. Hamer Consultant to Maersk Medical A/S Richard Hamer Associates, Inc. P.O. Box 16598 76132 Ft. Worth, TX

Re : K990115 Disposable ECG Monitoring Electrodes Models 4420 and 4440 Requlatory Class: II (two) Product Code: DRX Dated: October 15, 1999 Received: October 18, 1999

Dear Mr. Hamer:

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 regulations affecting your device can be found in the Code of Federal Regulations, 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 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 - Mr. Richard A. Hamer

This letter will allow you to beqin 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 Also, please note the regulation entitled, [phone]. "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,

Dea K. Willi

Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of

510(k) Number (if known): K990115

Niko ECG Monitoring Electrodes Models 4420 and 4440 Device Name:

# Indications for Use:

ECG monitoring electrodes for short term use (<24 hours) in adults (Model 4440) and infants (Model 4420).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

NS. Dack V. Tilli

Cardiovascular, Respiratory, and Neurological Dev 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use _

(Optional Format 1-2-96)