(27 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 modified Relivion® is an external non-invasive neurostimulator designed for transcutaneous electrical nerve stimulation. The modified 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 modified 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 modified Relivion® is powered by a rechargeable battery and the headset incorporates an onboard 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 modified Relivion® can communicate via a low energy Bluetooth link with the modified Relivion®'s dedicated mobile application on the patient's smartphone. The modified Relivion®'s mobile application is optional, and it is used by the patient to display the device status and provide indications and alerts. Additionally, the modified Relivion® mobile application also enables the patient to report their migraine headache status.
The main modification introduced in the Relivion® Device compared to the cleared predicate device (K203419) is an added optional Physician Interface that enables physicians to remotely follow-up on the patient's migraine attacks status and the treatments they performed using the Relivion device, based on the data transferred to it via the modified mobile application.
Both the modified Relivion®'s mobile application (for patients) and added physician interface (for physicians) are referred together as the optional "Patient Management Interface" (PMI) of the modified Relivion® Device.
This document is a 510(k) premarket notification from Neurolief Ltd. for their Relivion® device, seeking clearance for a modified version. The primary modification is the addition of an optional Physician Interface to the existing mobile application. This is not a study proving a device meets acceptance criteria, but rather a document seeking clearance by demonstrating substantial equivalence to a previously cleared predicate device based on bench testing and software validation.
Therefore, the requested information, specifically regarding acceptance criteria and performance data for a clinical study, cannot be extracted from this document, as it outlines bench testing and software validation for modifications to an already cleared device, not a new clinical study with specific performance acceptance criteria for human efficacy.
The document explicitly states: "Because the modification to the device impacted only the software, no further testing was required." This indicates that no new clinical study was performed.
The "Performance Data" section solely refers to:
- Bench testing for the modifications (output parameters meeting specifications).
- Software testing for the Patient Management Interface (PMI) and Physician Interface (verification and validation, cybersecurity).
It does not provide details of a clinical study, acceptance criteria for clinical performance, sample sizes for a test set or training set, expert adjudication, MRMC studies, or specific ground truth methodologies for clinical outcomes.
Therefore, I am unable to fulfill the request for this specific information based on the provided text.
§ 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.