(327 days)
ECG monitoring electrodes for short-term use (
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.
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.
§ 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.