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.

AI/ML Overview

The provided text is a 510(k) summary for the Niko ECG Monitoring Electrodes and a letter from the FDA regarding its clearance. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria.

The document only states that the device is substantially equivalent to legally marketed predicate devices. This means that the FDA determined the device has the same intended use and technological characteristics as a predicate device, or if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness. The 510(k) process typically relies on demonstrating substantial equivalence rather than requiring a full clinical trial with defined acceptance criteria and detailed performance studies in the way a PMA (Premarket Approval) might.

Therefore, I cannot provide the requested information from the given text. The text does not describe:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for test sets.
Number or qualifications of experts for ground truth.
Adjudication methods.
MRMC comparative effectiveness study or effect size.
Standalone performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Summary

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K990110

510 (k) SUMMARY

l. ADMINISTRATIVE

Submitter: Maersk Medical A/S Niko Business Unit Enqmosen 1 DK-3540, Lynge Denmark Phone No .: 011 45 48 16 70 30
Contact Person: Mr. Christian Pelch

Date of Preparation: October 15, 1999

II. DEVICE NAME

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

III. PREDICATE DEVICES

Disposable ECG Monitoring Electrode Models 4110 and 4140 (K950472); Nikomed USA, Inc.

IV. DEVICE DESCRIPTION

V. INTENDED USE

ECG monitoring electrodes for short-term use (< 24 hours) in adults (Model 4110) and infants (Model 4140).

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

K990110 Re: Disposable ECG Monitoring Electrodes Models 4110 and 4140 Requlatory Class: II (two) Product Code: DRX October 15, 1999 Dated: October 18, 1999 Received:

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 to 895. A substantially equivalent determination assumes compliance 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

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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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "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,

L. Ruth Tiller

lia 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 of 1 1

510(k) Number (if known): K990110

Niko ECG Monitoring Electrodes Model 4110 and 4140 Device Name:

Indications for Use:

ECG monitoring electrodes for short-term use (< 24 hours) in adults (Model 4110) and infants (Model 4140).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dan K. Miller

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

Prescription Use
(Per 21 CFR 801.109)

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Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2 96)

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.