(90 days)
Horizon 3.0 TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
The Horizon® 3.0 TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation. ("TMS").
The Horizon® 3.0 TMS Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
The Horizon® 3.0 TMS Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient settings, including physicians' offices, clinics, and hospitals.
Horizon® 3.0 TMS Therapy System is an integrated system consisting of a combination of hardware, software, and accessories.
The provided document is a 510(k) Premarket Notification from the FDA for the Magstim®Horizon® 3.0 TMS Therapy System. It describes the device, its intended use, and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Key Takeaway: The device discussed is the Magstim®Horizon® 3.0 TMS Therapy System, and the submission is a 510(k) to demonstrate substantial equivalence to a previously cleared version (K222171). The testing described is primarily non-clinical bench testing focused on changes made to the device's camera tracking system and EMG amplifier, ensuring these changes do not raise new questions of safety or effectiveness and that the performance is equivalent or better than the predicate device. No clinical studies or human reader studies (MRMC) were conducted or mentioned as a requirement for this particular submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on demonstrating performance equivalent to or better than the predicate device, especially for the modified components (camera tracking and EMG). The performance metrics are largely quantitative measurements from bench testing.
| Acceptance Criteria (Expected Result) | Reported Device Performance (Actual Results) |
|---|---|
| Stress Testing - Sample Rate: Tracking remains stable under load to support sampling rates of 20Hz and 50Hz. (These rates are the highest for FDA cleared protocols - OCD Protocol and iTBS Protocol). | Actual Results: Maintains a constant sample rate above 50Hz. 50Hz chosen as that is the fastest rate of delivery out of cleared protocols. Under Abnormal PC Load: 52Hz min recorded. Average Capture Rate in Normal Conditions: 120Hz. Equivalent to Predicate Device. |
| Stress Testing - Data Storage: 1000 rMT positions can be stored and 10,000 stimuli positions can be stored. | Actual Results: Supports recording of 1000 Simultaneous MT Locations for Motor Hotspot procedures and recording of up to 12,000 Stimuli which is sufficient for treatment (Maximum stimuli from FDA protocol is 3000) – Equivalent to Predicate Device. |
| Positional and Volumetric Accuracy - Camera Accuracy: |
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.