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K Number
K153019
Device Name
Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
Manufacturer
BIO PROTECH, INC.
Date Cleared
2016-03-21

(158 days)

Product Code
GXY
Regulation Number
882.1320
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Disposable Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potential sigmals (EP). The electrodes are non-sterile and for single use only.

Disposable Adhesive Surface (Ring) Electrodes are intended to be used with diagnostic electromyography equipment that deliver an electrical stimulus and record electromyography signals for neurodiagnostic purposes. The electrodes are nonsterile and for single use only.

Disposable/Reusable Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP).

Device Description

Not Found

AI/ML Overview

I am sorry, but this document contains general correspondence regarding an FDA 510(k) premarket notification for "Disposable Adhesive Surface Electrodes" and "Disposable/Reusable Cup Electrodes."

The document does not describe "acceptance criteria" for a study, nor does it present any "study that proves the device meets acceptance criteria" in the way one would analyze a medical device's performance in clinical or diagnostic tasks.

Instead, the document primarily focuses on:

  • Regulatory classification: Class II (Special Controls) for Cutaneous Electrodes.
  • Substantial equivalence: A determination that the device is substantially equivalent to legally marketed predicate devices.
  • General regulatory requirements: Information about annual registration, labeling, manufacturing practices, etc.
  • Indications for Use: What the electrodes are intended for (e.g., recording and monitoring biopotential signals like EEG, sEMG, EP).

Therefore, I cannot provide the requested information, which typically pertains to performance metrics (sensitivity, specificity, AUC), sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies for AI/CADe devices. This document is related to a much simpler, non-AI medical device.

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).