DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560

K990113 · Maersk Medical A/S · DRX · Dec 6, 1999 · Cardiovascular

Device Facts

• Record ID: K990113
• Device Name: DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560
• 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

Intended Use

ECG monitoring electrodes for short-term use.

Device Story

Niko ECG Monitoring Electrodes are pregelled, disposable devices used for short-term ECG signal acquisition. The device consists of an Ag/AgCl sensor element (10-20 mm diameter) and an adhesive backing (20-70 mm diameter or various shapes). Electrodes are applied to the patient's skin by a clinician to capture electrical cardiac signals, which are then transmitted to an external ECG monitoring system. The device is intended for use in clinical settings where continuous or intermittent heart rhythm monitoring is required. By providing a stable electrical interface between the patient and the monitoring equipment, the electrodes facilitate the observation of cardiac activity, aiding healthcare providers in diagnostic and monitoring decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

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

Indications for Use

Indicated for short-term ECG monitoring in patients requiring cardiac signal acquisition.

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 4500 (K950473)
• 4530 and 4540 (K950475)
• 4533 (K950474)
• 4539 (K950480)
• 4560 (K950477)

Submission Summary (Full Text)

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DEC - 6 1999

K990113

# 510 (k) SUMMARY

#### ADMINISTRATIVE 1.

- Maersk Medical A/S Submitter: 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: January 11, 1999

### ll. DEVICE NAME

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

### == PREDICATE DEVICES

Disposable ECG Monitoring Electrode Models 4500 (K950473), 4530 and 4540 (K950475), 4533 (K950474), 4539 (K950480) and 4560 (K950477); Nikomed USA, Inc.

## IV. DEVICE DESCRIPTION

Pregelled electrodes are of Aq/AqCl 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.

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# VI. COMPARISON TO PREDICATE DEVICES

The Niko ECG Monitoring Electrodes are identical in composition, function and design, and have the same intended use as the legally marketed disposable ECG monitoring electrodes Models 4500 (K950473), 4530 and 4540 (K950475), 4533 (K950474), 4539 (K950480) and 4560 (K950477); Nikomed USA, Inc. Accordingly Maersk Medical A/S concluded that the Niko ECG Monitoring Electrodes Models 4500, 4530, 4533, 4539, 4540 and 4560 are safe and effective for their intended use and perform at least as well as other disposable ECG monitoring electrodes.

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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 features the department's name arranged in a circular fashion around a symbol. The symbol consists of a stylized eagle or bird-like figure with three curved lines above it, representing the department's mission to protect and promote the health and well-being of Americans.

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 Ft. Worth, TX 76132

Re: K990113 Disposable ECG Monitoring Electrodes Models 4500, 4530, 4533, 4539, 4540 and 4560 Regulatory 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 requlations affecting your device can be found in the Code of Federal Regulations, 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 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 requlation 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 requlations.

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### Page 2 - Mr. Richard A. Hamer

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, "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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Don Vh Tilli

ia M. 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):

K990113

Niko ECG Monitoring Electrodes Device Name:

Indications for Use:

ECG monitoring electrodes for short term use.

(PLEASE DO NOT 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 ***_***__`K990113`

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

(Optional Format 1-2-96)