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.

AI/ML Overview

The provided text is a 510(k) summary for the Niko ECG Monitoring Electrodes. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and specific performance metrics for the new device.

Therefore, the document does not contain the information required to populate the table of acceptance criteria and device performance or to describe a study proving the device meets those criteria, as typically understood for a new product performance study.

Specifically, the text states: "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... Accordingly Maersk Medical A/S concluded that the Niko ECG Monitoring Electrodes Models... are safe and effective for their intended use and perform at least as well as other disposable ECG monitoring electrodes."

This is a statement of self-assessment based on identity to predicate devices, not a study performing specific tests against predetermined acceptance criteria.

To address the prompt as accurately as possible given the provided text, I will state that the product is claiming substantial equivalence to predicate devices, rather than establishing new performance criteria.

Here's a breakdown of what can and cannot be extracted from the provided text according to your request:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not specify quantitative acceptance criteria or reported performance metrics for the Niko ECG Monitoring Electrodes in a study. It asserts that the device is "identical in composition, function and design" to predicate devices and therefore "perform at least as well."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. No test set or study is described for the Niko ECG Monitoring Electrodes. The claim is based on substantial equivalence to existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. No test set or ground truth establishment process is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No test set or adjudication method is described.

5. 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

Cannot be provided. This is not an AI device, and no MRMC study or comparative effectiveness study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be provided. This is not an AI algorithm; it is an electrode. No standalone performance study is mentioned.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Cannot be provided. No ground truth is established for the Niko ECG Monitoring Electrodes as no distinct performance study is detailed.

8. The sample size for the training set

Cannot be provided. This is not a machine learning device, and no training set is mentioned.

9. How the ground truth for the training set was established

Cannot be provided. This is not a machine learning device, and no training set or its ground truth establishment is mentioned.

Summary based on the provided text:

The submission K990113 for the Niko ECG Monitoring Electrodes does not involve a study to prove the device meets specific acceptance criteria. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. The core argument is that the Niko ECG Monitoring Electrodes are "identical in composition, function and design" and have "the same intended use" as several legally marketed predicate devices from Nikomed USA, Inc. Therefore, the conclusion is that the Niko electrodes "perform at least as well as other disposable ECG monitoring electrodes."

No specific quantitative acceptance criteria, performance data, test sets, expert reviews, ground truth establishment, or training sets are described in the provided sections of the 510(k) summary. This type of 510(k) submission typically leverages existing data and regulatory approvals of the predicate devices.

Summary

{0}------------------------------------------------

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

v. INTENDED USE

ECG monitoring electrodes for short-term use.

{1}------------------------------------------------

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.

{2}------------------------------------------------

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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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](https://510k.innolitics.com/search/K990113)

Prescription Use
(Per 21 CFR 801.109)
OR
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.