(156 days)
The HORIZON® 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.
The HORIZON® TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration 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.
The HORIZON® 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 antidepressant medication in the current episode. The HORIZON® 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 and outpatient settings, including physicians' offices, clinics, and hospitals.
The HORIZON® TMS Therapy System is an integrated system consisting of a combination of hardware, software, and accessories.
This document describes the Magstim HORIZON® TMS Therapy System, specifically focusing on K182853, which adds a new treatment protocol (iTBS) to a previously cleared device (K180907). The document demonstrates substantial equivalence to predicate devices, rather than presenting a de novo study with acceptance criteria and performance data for a novel device. Therefore, many of the requested sections (sample size, expert ground truth, adjudication, MRMC) are not applicable as they relate to clinical studies proving efficacy or diagnostic performance, which were not performed for this submission.
However, I can extract information related to the device's technical specifications and the basis for its safety and effectiveness claims.
Acceptance Criteria and Device Performance
Since this is a substantial equivalence submission for adding a treatment protocol, there aren't traditional "acceptance criteria" for performance that a new device would need to meet in a clinical trial. Instead, the acceptance criteria here are demonstrating that the addition of the iTBS protocol poses no new issues of safety or effectiveness, and that the device remains substantially equivalent to already cleared devices.
Table of "Acceptance Criteria" (demonstrated equivalency) and Reported Device "Performance" (characteristics for comparison):
| Criteria | HORIZON® TMS Therapy System (Subject Device - K182853) | Mag Vita TMS Therapy System w/Theta Burst Stimulation (Primary Predicate - K173620) | HORIZON® TMS Therapy System (Secondary Predicate - K180907) |
|---|---|---|---|
| Intended Use/Indications for Use | Identical: Treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. | Identical: Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. | Identical: Treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. |
| Technological Characteristics | Identical (basic design, mechanism of action, specifications) to K180907, with addition of iTBS protocol | Compared for iTBS protocol | Identical (basic design, mechanism of action, specifications) |
| Principles of Operation | Equivalent to predicates (system setup, patient prep, motor threshold determination, coil position, treatment administration) | Equivalent for iTBS protocol | Equivalent |
| Electrical Safety | Meets IEC 60601-1 | Yes | Meets IEC 60601-1 |
| EMC Standards | Meets EN 60601-1-2 | Yes | Meets EN 60601-1-2 |
| iTBS Treatment Protocol - Stimulation Intensity | 120% of the MT | 120% of the MT | N/A (not applicable to K180907 as a standard protocol) |
| iTBS Treatment Protocol - Repetition Rate | 50 Hz (5 pulses per sec) | 50 Hz (5 pulses per sec) | N/A |
| iTBS Treatment Protocol - Train Duration | 2 sec | 2 sec | N/A |
| iTBS Treatment Protocol - Inter-train Interval | 8 sec | 8 sec | N/A |
| iTBS Treatment Protocol - Burst Pulses | 3 | 3 | N/A |
| iTBS Treatment Protocol - Bursts | 200 | 200 | N/A |
| iTBS Treatment Protocol - Inter Pulse interval | 20 msec | 20 msec | N/A |
| iTBS Treatment Protocol - Number of trains | 20 | 20 | N/A |
| iTBS Treatment Protocol - Number of Pulses per Session | 600 | 600 | N/A |
| iTBS Treatment Protocol - Treatment Session Duration | 3.09 min | 3.09 min | N/A |
| iTBS Treatment Protocol - Sessions/week | 5 | 5 | N/A |
| iTBS Treatment Protocol - Treatment Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | N/A |
| iTBS Treatment Protocol - Area of brain to be stimulated | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex | N/A |
| Non-clinical performance testing for iTBS | Demonstrated that the intensity of individual stimuli in iTBS is equal and kept constant throughout delivery to ensure constant dose, equivalent to K173620. | Confirmed this principle is essential for clinical performance. | N/A |
Study Details (Not Applicable for this Submission Type):
As this is a 510(k) submission based on substantial equivalence for a minor modification (adding a treatment protocol) to an already cleared device, detailed clinical studies with the specific elements requested (sample sizes, expert ground truth, adjudication methods, MRMC studies) were not performed or required for this particular submission. The "study" here is primarily a comparative analysis to existing cleared devices and verification of the technical aspects of the new protocol addition.
- Sample size used for the test set and the data provenance: Not applicable. No new clinical test set was used for this 510(k) submission. The data provenance is implied by the predicate devices being legally marketed in the US.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical efficacy was established by the predicate devices' historical data or studies, not new data for this submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/diagnostic imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the original clearance of the predicate devices, clinical efficacy would have been established through clinical trials and outcomes data. For this specific submission, the ground truth for safety and effectiveness of the iTBS protocol is implicitly based on its successful clearance and clinical use in the primary predicate device (Mag Vita TMS Therapy System w/Theta Burst Stimulation, K173620) and the physical and electrical equivalence of the HORIZON system to its prior clearance (K180907).
- The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
§ 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.