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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)

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.

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.

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