SDX · Neuromuscular Stimulator And Exercise Evaluation System

Neurology · 21 CFR 882.1871 · Class 2

Overview

Identification

The Myocene device is intended to provide objective measures of muscle fatigue to inform athletic training decisions by coaches and athletes. It is for applications in sport practice, to be used on healthy individuals (athletes), 15 years of age or older, to carry out tests of the extensor muscles of the knee by quantitatively measuring the force of contraction of the healthy quadriceps muscles generated by voluntary contractions and induced by a specific associated powered muscle stimulator, and by using these forces to compute objective measures of quadriceps muscle fatigue.

Classification Rationale

FDA has determined that, for the previously stated indications for use, the Myocene can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

Special Controls

In combination with the general controls of the FD&C Act, the neuromuscular stimulator and evaluation system is subject to the following special controls: (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Characterization of the neuromuscular stimulation parameters. For electrical stimulation, these parameters including the following: waveforms; output modes; maximum output voltage and maximum output current; pulse duration; frequency; net charge per pulse; maximum phase charge, maximum current density, maximum average current, and maximum average power density; and (ii) Characterization of the device sensor(s) used to quantify muscle response, including sampling frequency, accuracy, and measurement range. (2) Performance data must demonstrate the electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety of the device for its intended environment(s) of use. (3) Software verification, validation, and hazard analysis must be performed. (4) The tissue-contacting components of the device must be demonstrated to be biocompatible. (5) A human factors and usability evaluation, including a use-related risk analysis (URRA), must be performed. (6) Labeling must include: (i) Summaries of stimulation output and other performance parameters, and (ii) Interpretation of the device’s output measures.

Recent Cleared Devices (1 of 1)

Top Applicants

• Myocene — 1 clearance