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 55 mm in diameter or rectanqular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.

AI/ML Overview

In this 510(k) summary, the device under review is the Niko ECG Monitoring Electrodes. The submission states that these electrodes are "identical in composition, function and design, and have the same intended use as the legally marketed disposable ECG monitoring electrodes Models 4600 and 4610 previously distributed by Nikomed USA, Inc. (K950479)."

Therefore, the submission does not present specific acceptance criteria or performance studies for the Niko ECG Monitoring Electrodes. Instead, it relies on substantial equivalence to the predicate device. This means that the device is deemed to meet the performance requirements by being equivalent to a device already cleared by the FDA.

Given this, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are detailed for the Niko ECG Monitoring Electrodes.
Sample sizes used for the test set and the data provenance: No test sets or data provenance are mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not applicable as no new studies were conducted.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a medical device (ECG electrodes), not an AI algorithm for diagnostic imaging.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The provided document describes a 510(k) submission for Niko ECG Monitoring Electrodes. The entire premise of this submission is predicated on substantial equivalence to a previously cleared predicate device: Disposable ECG Monitoring Electrode Models 4600 and 4610 (K950479) from Nikomed USA, Inc.

Therefore, the acceptance criteria are implicitly met because the device is stated to be "identical in composition, function and design" and to have "the same intended use" as the predicate device. No new studies were conducted to prove the current device meets specific acceptance criteria, as the regulatory pathway chosen (510(k)) allows for reliance on equivalence to a legally marketed device.

Summary

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DFC - 6 1999

K990112

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: October 15, 1999

II. DEVICE NAME
Proprietary Name: Niko ECG Monitoring Electrodes Common Name: ECG Electrode Classification Name: Electrocardiograph Electrode

PREDICATE DEVICES III.

Disposable ECG Monitoring Electrode Models 4600 and 4610 (K950479); Nikomed USA, Inc.

IV. DEVICE DESCRIPTION

V. INTENDED USE

ECG monitoring electrodes for short-term use ( < 24 hours) in adults (Model 4060) and infants (Model 4610).

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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 4600 and 4610 previously distributed by Nikomed USA, Inc. (K950479). Accordingly, Maersk Medical A/S concluded that the Niko ECG Monitoring Electrodes Models 4060 and 4610 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized emblem of a bird or eagle with three lines representing its wings or feathers.

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: K990112 Disposable ECG Monitoring Electrodes Models 4060 and 4610 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 requlation (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 begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 requlation (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,

Colia M. Witton, Ph.D.

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): K990112

Niko ECG Monitoring Electrodes Models 4060 and 4610 Device Name:

Indications for Use:

ECG monitoring electrodes for short-term use (<24 hours) in adults (Model 4060) and infants (Model 4610).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

N. Oa. K. Tittle

Military Sign Off

ovascular, Respiratory,

Prescription Use
(Per 21 CFR 801.109)

ાર

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.