(327 days)
Not Found
No
The 510(k) summary describes standard ECG monitoring electrodes and does not mention any AI or ML components or functionalities.
No
The device is described as "ECG monitoring electrodes," indicating it is used for diagnostic purposes (monitoring electrical activity of the heart), not for treating a condition.
No
Explanation: The device description states its use for "ECG monitoring," which is typically used to observe heart activity, not to diagnose a specific condition. Moreover, devices that are cleared under section 510(k) for monitoring are typically classified as Class II, which generally means they are not considered diagnostic devices.
No
The device description clearly states it is a pregelled electrode, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "ECG monitoring electrodes for short-term use (
N/A
Intended Use / Indications for Use
ECG monitoring electrodes for short-term use (
§ 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.
0
510 (k) SUMMARY
l. ADMINISTRATIVE
- Submitter: Maersk Medical A/S Niko Business Unit Enqmosen 1 DK-3540, Lynge Denmark Phone No .: 011 45 48 16 70 30
Contact Person: Mr. Christian Pelch
Date of Preparation: October 15, 1999
II. DEVICE NAME
Proprietary Name: Niko ECG Monitoring Electrodes Common Name: ECG Electrode Classification Name: Electrocardiograph Electrode
III. PREDICATE DEVICES
Disposable ECG Monitoring Electrode Models 4110 and 4140 (K950472); Nikomed USA, Inc.
IV. DEVICE DESCRIPTION
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 70 mm in diameter or rectangular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.
V. INTENDED USE
ECG monitoring electrodes for short-term use (