(87 days)
Concentric, Monopolar, Hook Wire and Hypodermic EMG Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.
EMG electrodes are applied in the study of biopotentials such as electromyograph (EMG), nerve conduction and stimulation/response. Electrodes are invasive as they are placed in contact with nerve or muscle tissue.
The electrodes consist of a needle with a connector/lead wire attached. The connector/lead wires terminate in a safety connector that cannot be connected to an AC power outlet.
The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physician.
The EMG electrodes consist of a needle with a connector or lead wire attached. The connector or lead wires terminate in a safety connector that cannot be connected to an AC power outlet. The EMG Electrodes are provided sterile and for single patient use.
This document is a 510(k) summary for Sterile EMG Electrodes by Nicolet Biomedical Incorporated. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving device performance against such criteria.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway that typically does not involve new clinical performance studies or specific acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.
§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).(b)
Classification. Class II (performance standards).