(111 days)
The ECG electrode is intended to monitor patients. The electrode monitors and relates body functions through a monitoring device. The electrode senses functions in the body, gathers information, and relates that information to the device with which it is connected. The information gathered by the electrode can then be assessed by medical personnel in order to aid in determining the proper medical course of action.
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The provided text is a 510(k) clearance letter from the FDA for an "Electrode" device, identified by the trade name "FlectraMold". This document primarily focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance study results or acceptance criteria.
Therefore, the requested information regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, and ground truth establishment is not available within this document.
This type of FDA letter confirms that the device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different characteristics that do not raise different questions of safety and effectiveness. It does not typically include a detailed report of clinical or performance studies with specific acceptance criteria and their fulfillment.
To obtain the detailed information requested, one would need to refer to the original 510(k) submission (K050248) or the testing documentation submitted by Electramold.
§ 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.