Short-term (< 24 hrs) ECG monitoring of infants in operating room and emergency situations (Model 4570); short-term (< 24 hrs) ECG monitoring of infants and neonates in operating room and emergency situations (Model 4520); short-term (< 24 hrs) ECG monitoring of adults and infants under anesthesia (Model 4535).

Device Description

Pregelled electrodes are of Aq/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 describes a 510(k) submission for ECG electrodes, which are hardware devices, not AI/ML software. Therefore, many of the requested categories in the prompt are not applicable. The core of the submission is to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a study with the detailed elements requested for AI/ML.

Here's an attempt to address the prompt based on the available information, noting where information is not applicable:

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

The submission demonstrates substantial equivalence to predicate devices rather than meeting specific quantifiable performance metrics. The implicit "acceptance criteria" for a 510(k) are that the device is as safe and effective as a legally marketed predicate. The "reported device performance" is that it is identical in composition, function, and design, and has comparable biocompatibility.

Acceptance Criteria (Implied for 510(k) SE)	Reported Device Performance (as stated)
Safe for intended use	Biocompatibility established in standard safety tests.
Effective for intended use	Identical in composition, function, and design to predicate devices. Performs "at least as well as other disposable ECG monitoring electrodes."
Substantially equivalent to predicate device	Stated to be "identical in composition, function and design" and has the "same intended use" as legally marketed disposable ECG monitoring electrodes.

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

Not applicable. This is not a study assessing AI/ML software performance. The submission relies on demonstrating substantial equivalence through comparison of technological characteristics and biocompatibility testing, not clinical "test sets" in the AI/ML context.

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)

Not applicable. Ground truth establishment for a test set is not relevant for this type of device submission.

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

Not applicable. Adjudication for a test set is not relevant for this type of device submission.

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

Not applicable. This is a passive ECG electrode, not an AI/ML system designed to assist human readers.

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

Not applicable. This is a hardware device (ECG electrode), not an algorithm.

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

Not applicable. Ground truth is not a concept applied in this context for ECG electrodes. What is relevant is the established safety and efficacy of the predicate device, against which these electrodes are being compared for substantial equivalence.

8. The sample size for the training set

Not applicable. There is no AI/ML model to train for this device.

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

Not applicable. There is no AI/ML model to train for this device.

Summary

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DEC - 6 1999

510 (k) SUMMARY

l. 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: July 28, 1999

II. DEVICE NAME

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

lll. PREDICATE DEVICE

Disposable ECG Monitoring Electrode Models 4535 (K950470) and 4570 (K950478); Nikomed USA, Inc.

IV. DEVICE DESCRIPTION

V. INTENDED USE

As short-term (<24 hours) electrical conductor applied to the surface of the body of infants (Models 4520, 4535 and 4570), neonates (Model 4520) or adults (Model 4535) to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

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VI. TECHNOLOGICAL CHARACTERISTICS

The Niko ECG Monitoring Electrodes Models 4520, 4535 and 4570 are identical in composition, function and design, and have the same intended use as legally marketed disposable ECG monitoring electrodes, such as Models 4535 and 4570 (K950470 and K950478; Nikomed USA, Inc.) The biocompatibility of skin-contact components has been established in standard safety tests. Accordinqly, Maersk Medical A/S concluded that the Niko ECG Monitoring Electrodes Models 4520, 4535 and 4570 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 contains a black and white logo. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic of an eagle's head with three parallel lines extending from the back of the head, resembling feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 1999

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

Re: K990111 Disposable ECG Monitoring Electrodes Models 4520, 4535 and 4570 Requlatory Class: II (two) Product Code: DRX Dated: October 28, 1999 November 3, 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 Requlations, 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 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 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 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 (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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Daith

lia M. Witten, Ph.D., M.D. Actinq 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):

K990111

Niko ECG Monitoring Electrodes, Models 4520, 4535 and 4570 Device Name:

Indications for 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	K990111

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.