(327 days)
Not Found
No
The 510(k) summary describes standard ECG monitoring electrodes and does not mention any AI or ML capabilities.
No.
The device is described as "ECG monitoring electrodes" and its intended use is for "ECG monitoring electrodes for short term use," indicating a diagnostic rather than therapeutic purpose.
Yes
Explanation: ECG monitoring is a diagnostic procedure used to assess heart health. Therefore, the electrodes used for this purpose are considered part of a diagnostic device.
No
The device description clearly states it is a physical electrode, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that these are "ECG monitoring electrodes." These electrodes are placed on the skin to detect electrical signals from the heart. They are used for external monitoring of a physiological process, not for analyzing a specimen taken from the body.
- Intended Use: The intended use is "ECG monitoring," which is a non-invasive procedure.
- Device Description: The description focuses on the physical characteristics of the electrodes and their packaging, consistent with an external medical device.
Therefore, based on the provided information, this device falls under the category of an external medical device used for physiological monitoring, not an In Vitro Diagnostic.
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
DEC - 6 1999
510 (k) SUMMARY
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: October 15, 1999
ll. DEVICE NAME
Proprietary Name: Niko ECG Monitoring Electrodes Common Name: ECG Electrode Classification Name: Electrocardiograph Electrode
III. PREDICATE DEVICES
Disposable ECG Monitoring Electrode Models 4420 and 4440 (K950476); 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 (