(89 days)
The Relivion® transcutaneous electrical nerve stimulator is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older. It is a prescription device to be self-used at home.
The Relivion® is an external non-invasive neurostimulator designed for transcutaneous electrical nerve stimulation. The Relivion® headset integrates three pairs of output electrodes which come in contact with the subject's scalp at the forehead and occiput. The electrodes deliver the stimulation pulses produced by the headset's stimulation unit to the subject's scalp. The frontal electrodes stimulate the trigeminal (supraorbital and supratrochlear) nerve branches and the posterior electrodes stimulate the greater occipital nerve branches.
The Relivion® includes single-use replaceable electrode pads that are positioned on-top of the electrodes prior to treatment and are wetted by the user before use, in order to provide proper conductivity between the electrodes and the scalp.
The Relivion® is powered by a rechargeable battery and the headset incorporates an on-board user interface that enables the user to activate/deactivate the device and to adjust the stimulation intensity. Upon treatment activation, the treatment automatically runs and ends after 60 minutes or alternatively, the user can stop the treatment when desired.
The Relivion® can communicate via a low energy Bluetooth link with the Relivion® dedicated mobile application on the user's smartphone. The Relivion® mobile application is optional and it is used to display the device status and provide indications and alerts.
The provided document is a 510(k) premarket notification for the Relivion® device, a transcutaneous electrical nerve stimulator for the acute treatment of migraine. It details the device's characteristics, performance data, and comparison to a predicate device (Cefaly® Acute).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Relivion® device, as derived from the RIME study (the pivotal clinical trial for the commercial version of the device), focused on the efficacy of pain relief.
| Acceptance Criteria (Primary Endpoint) | Reported Device Performance (RIME Study) |
|---|---|
| Proportion of subjects reporting reduction of migraine headache pain (i.e., pain relief) 2 hours post-treatment initiation from severe or moderate to mild or no pain, or from mild to no pain. | Active Group: 60% of subjects met the primary endpoint. |
| Sham Group: 37% (mITT) / 36% (PP) of subjects met the primary endpoint. (p-value = 0.0180 (mITT) / 0.0135 (PP)) | |
| Secondary Endpoints (Superiority demonstrated for all three) | |
| Pain Freedom rate at 2 hours post-treatment initiation without use of rescue medication. | Active Group: 46.00% |
| Sham Group: 11.86% (p-value |
§ 882.5891 Transcutaneous electrical nerve stimulator to treat headache.
(a)
Identification. A transcutaneous electrical nerve stimulator to treat headache is a device used to apply an electrical current to a patient's cranium through electrodes placed on the skin.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Appropriate analysis/testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety.
(3) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (µC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm
2 , r.m.s.), maximum average current (mA), maximum average power density (W/cm2 ), and the type of impedance monitoring system must be fully characterized.(4) Electrical performance, adhesive integrity, shelf life, reusability, and current distribution testing of the electrodes must be conducted.
(5) Appropriate software verification, validation, and hazard analysis must be performed.
(6) Clinical performance data must demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population.
(7) Labeling must include the following:
(i) Appropriate contraindications such as not for use in subjects with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator.
(ii) Appropriate warnings such as not to apply the device on the neck or chest, not to use the device in the presence of electronic monitoring equipment, not to use in the bath or shower, not to use while sleeping, not to use while driving, not to use while operating machinery.
(iii) Appropriate precautions such as the long-term effects of chronic use of the device are unknown.
(iv) A summary of the expected risks and benefits of using the device.
(v) A summary of the clinical performance data, including information on the patient population for which the device has and has not been demonstrated to be effective, and any adverse events and complications.
(vi) Information on how the device operates and the typical sensations experienced during treatment.
(vii) A detailed summary of the device technical parameters.
(viii) An expiration date/shelf life for the electrodes and the number of times they can be reused.
(ix) Disposal instructions.