The Nikomed TRACE 1™ ECG Electrode is indicated for use on the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. (CFR 870.2360)

Device Description

The ECG electrode labels will have the TRACE 1™ name and will use pictographic instructions for use. This change applies to all currently marketed and any previously cleared (via premarket-notification) electrodes sold or distributed by NIKOMED USA, Inc.

AI/ML Overview

This 510(k) submission (K022909) is a Special 510(k) for labeling changes for Nikomed ECG Electrodes. As such, it does not contain a study or data to prove device performance against acceptance criteria in the way a traditional premarket notification for a new or modified device might.

The entire submission is focused on the administrative notification of a change to the trade name (TRACE 1™) and the adoption of pictographic instructions for use on the labels of already-cleared ECG electrodes. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the substantial equivalence is based on the previously cleared devices, not on new performance data for these specific labeling changes.

Therefore, most of the requested information regarding acceptance criteria and performance studies is not applicable to this specific submission.

Here's a breakdown based on the provided text:

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

Not Applicable. This Special 510(k) is solely for labeling changes to an already-cleared device. There are no new performance claims or studies reported in this document to establish new acceptance criteria or demonstrate device performance. The performance relies on the previous clearance of the predicate devices.

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

Not Applicable. No new test set data was generated or submitted for this labeling change. The performance of the underlying ECG electrodes was established during their initial premarket clearance.

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. No test set requiring expert ground truth was created for this labeling change.

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

Not Applicable. No test set requiring adjudication was created for this labeling change.

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 device is an ECG electrode, not an AI-powered diagnostic or interpretive system. No MRMC study was conducted.

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

Not Applicable. This is a passive medical device (ECG electrode), not an algorithm.

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

Not Applicable. No new ground truth was established for this labeling change.

8. The sample size for the training set

Not Applicable. No new training set was used or required for this labeling change.

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

Not Applicable. No new training set or ground truth for a training set was established for this labeling change.

Summary

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K022909

JAN 0 9 2003

510(k) Summary

SUBMITTER:

Submitted on behalf of:

Company Name:	Nikomed U.S.A., Inc.
Address:	206 Airport Blvd.Doylestown, PA 18901
Telephone:	215-230-8455
Fax:	215-230-8446

bv: Elaine Duncan, M.S.M.E., RAC

President, Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082 715-549-6035 Telephone: 715-549-5380

CONTACT PERSON: Elaine Duncan

DATE SUMMARY PREPARED: August 26, 2002

NIKOMED TRACE 1™ ECG Electrodes TRADE NAME: COMMON NAME: ECG Electrodes

SUBSTANTIALLY EQUIVALENT TO: All currently 510(k) cleared NIKOMED ECG Electrodes. This special 510(k) is only for labeling changes.

DESCRIPTION of the DEVICE:

Fax:

INDICATIONS FOR USE: No change

CLINICAL INFORMATION and SAFETY and EFFECTIVENESS:

This special 510(k) just concerns labeling changes.

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of three curved lines that converge to form the body and wings.

JAN 0 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nikomed U.S.A., Inc. c/o Ms. Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082

Re: K022909

Trade Name: Nikomed ECG Electrodes Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: December 9, 2002 Received: December 10, 2002

Dear Ms. Duncan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA). it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FLA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Elaine Duncan, M.S.M.E., RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 5944646. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 vours.

V. Qalattell
Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)	K022909
Device Name:	Nikomed ECG Electrodes

Indications for Use:

(Please Do Not Write Below This Line-Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over -The-Counter Use
			(Optional Format 1-2-96)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number	K022909
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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.