(263 days)
The Monarch external Trigeminal Nerve Stimulation (eTNS) System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
The Monarch external Trigeminal Nerve Stimulation (eTNS) System is a non-invasive device that uses electrical signals to therapeutically stimulate the Trigeminal nerve. The primary components of the device are:
- The Monarch external pulse generator
- The Monarch NS-2 external (cutaneous) electrical patches, which are single use disposable patches worn on the forehead.
The device has two primary components A) an external pulse generator approximately the size of a cell phone, and B) the non-invasive electrical patch that patients apply to their forehead to receive therapy.
The Monarch eTNS System underwent two clinical studies to establish its effectiveness and safety.
1. Acceptance Criteria and Reported Device Performance
The primary acceptance criteria for effectiveness were based on the change in ADHD-IV Rating Scale (ADHD-RS) scores.
| Acceptance Criteria (Implicit from Study 2 Primary Endpoint) | Reported Device Performance (Study 2, Active Group vs. Sham) |
|---|---|
| Statistically significant improvement in ADHD-IV RS total score in the active group compared to the sham group after 4 weeks of treatment. | ADHD-RS Total Score: |
| Active Group: Decreased from 34.1 at baseline to 23.4 at Week 4 (mean change of -10.7). | |
| Sham Group: Decreased from 33.7 at baseline to 27.5 at Week 4 (mean change of -6.2). | |
| The difference between active and sham groups was clinically meaningful and statistically significant (p |
§ 882.5898 Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.
(a)
Identification. A transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.(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) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be performed:
(i) Electrical performance testing must validate electrical output and duration of stimulation;
(ii) Battery performance testing must be performed; and
(iii) Adhesive integrity testing of the electrodes must be conducted.
(4) The technical parameters of the device including waveform, maximum output current and voltage, pulse duration, frequency, net charge per pulse, maximum current density, maximum average current, and maximum average power density must be fully characterized.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Shelf life testing of the electrodes must be performed to demonstrate continued package integrity and component functionality over the labeled shelf life.
(7) Labeling must include the following:
(i) A contraindication for patients with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator;
(ii) A warning that the device is only for use on clean, intact skin;
(iii) Information on how the device operates and the typical sensations experienced during treatment;
(iv) A detailed summary of the device technical parameters;
(v) A shelf life for the electrodes;
(vi) Instructions for use, including placement of the device on the patient; and
(vii) Cleaning instructions.