QGT · Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Neurology · 21 CFR 882.5899 · Class 2

Overview

Identification

A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.

Classification Rationale

Class II (special controls). The special controls for this device are:

Special Controls

In combination with the general controls of the FD&C Act, the trunk and limb electrical stimulator to treat headache 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: a) Characterization of the electrical stimulation, including the following: waveforms; output modes; maximum output voltage and maximum output current (at 500Ω , 2kQ. and 10k≤2 loads); pulse duration; frequency; net charge per pulse; and maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω); b) Characterization of the impedance monitoring system; and c) Characterization of the electrode performance including the electrical performance, adhesive integrity, shelf-life, reusability, and current distribution of the electrode surface area. 2) The patient-contacting components of the device must be demonstrated to be biocompatible. 3) Performance testing must demonstrate electromagnetic compatibility and electrical, mechanical and thermal safety in the intended use environment. 4) Software verification, validation, and hazard analysis must be performed. 5) Labeling must include the following: a) Instructions for use, including the typical sensations experienced during treatment: b) A detailed summary of the electrical stimulation output, and the device technical parameters, including any wireless specifications; c) A shelf life for the electrodes and reuse information; and d) Instructions on care and cleaning of the device.

*Classification.* Class II (special controls). The special controls for this device are:(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, including the following: Waveforms; output modes; maximum output voltage and maximum output current (at 500Ω, 2kΩ, and 10kΩ loads); pulse duration; frequency; net charge per pulse; and maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω); (ii) Characterization of the impedance monitoring system; and (iii) Characterization of the electrode performance including the electrical performance, adhesive integrity, shelf-life, reusability, and current distribution of the electrode surface area. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance testing must demonstrate electromagnetic compatibility and electrical, mechanical, and thermal safety in the intended use environment. (4) Software verification, validation, and hazard analysis must be performed. (5) Labeling must include the following: (i) Instructions for use, including the typical sensations experienced during treatment; (ii) A detailed summary of the electrical stimulation output, and the device technical parameters, including any wireless specifications; (iii) A shelf life for the electrodes and reuse information; and (iv) Instructions on care and cleaning of the device.

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• Theranica Bioelectronics , Ltd. — 4 clearances
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