QWD · Stimulator, Nerve, For Restless Legs Syndrome

Neurology · 21 CFR 882.5887 · Class 2

Overview

Identification

The NTX100 Tonic Motor Activation (ToMAc) System® is a non-surgical, non-implantable prescription device intended to reduce symptoms of primary moderate-severe Restless Legs Syndrome (RLS) and to improve sleep quality in adults refractory to medications. It uses external electrical stimulators and cutaneous electrodes to stimulate nerves in the lower extremity (e.g., peroneal nerves) and evoke tonic, sustained muscle activation in the legs.

Classification Rationale

Class II (special controls). The device is granted under De Novo classification (21 CFR 882.5887) and is subject to general controls and the identified special controls to mitigate risks such as adverse tissue reaction, skin discomfort, burns, electrical shock, pain, worsening of RLS symptoms, and user error or device failure.

Special Controls

In combination with the general controls of the FD&C Act, the external lower extremity nerve stimulator for Restless Legs Syndrome 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. This testing must include: (i) Characterization of the electrical stimulation parameters, including the following: waveforms; output modes; maximum output voltage and maximum output current (at 50002, 2k(2, and 10k(2 loads); pulse duration; frequency; net charge per pulse; maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω): Characterization of the therapy output across sudden and rapid changes in load (ii) impedance: and Characterization of electrode performance, including the electrical performance, (iii) adhesive integrity, shelf-life, reusability, and variation of impedance over the use of therapy. (2) The tissue-contacting components of the device must be demonstrated to be biocompatible. (3) Performance testing must demonstrate electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment. Software verification, validation, and hazard analysis must be performed. (4) (5) Physician and patient labeling must include the following: (i) Recommended treatment regimes, including frequency and duration of use, and identification of application site(s): (ii) Typical sensations experienced during treatment; (iii) Methods for identifying the appropriate stimulation intensity that is needed to reduce symptoms of Restless Legs Syndrome and is tolerable to patients: (iv) A shelf life for the electrode and reuse information; (v) Summaries of the electrical stimulation parameters and device technical parameters (including any wireless specifications); and (vi) Instructions on how to maintain the device, including all user-interface components.

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Top Applicants

• Noctrix Health, Inc. — 1 clearance