(327 days)
No
The summary describes passive ECG electrodes and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is used for monitoring ECG, not for treating any condition. ECG monitoring is a diagnostic process, not a therapeutic one.
No
The device is described as an ECG monitoring electrode for short-term ECG monitoring. While ECG monitoring can provide data for diagnosis, the electrode itself is a data collection component, not a device that directly performs diagnosis or interprets the data to provide a medical conclusion.
No
The device description explicitly states it is comprised of pregelled electrodes, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The device described is an ECG monitoring electrode. It is applied to the surface of the body to measure electrical activity of the heart. This is an in vivo measurement, not an in vitro test on a sample.
- Intended Use: The intended use clearly states "ECG monitoring," which is a physiological measurement taken directly from the patient.
Therefore, this device falls under the category of a medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
As short-term (
§ 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
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
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.
V. INTENDED USE
As short-term (