(160 days)
The Ultimate rTMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.
The Ultimate rTMS is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Major Depressive Disorder.
It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions.
The Ultimate rTMS principle of operation is based on the discharge of high voltage capacitor through stimulation coil; the pulsed magnetic field generated by the discharge current penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons.
Area of the brain to be simulated for MDD treatment is Left Dorsolateral Prefrontal Cortex.
This 510(k) clearance letter details the substantial equivalence of the Ultimate rTMS device to its predicate devices, Mag Vita TMS Therapy System. The provided information primarily focuses on non-clinical performance and technological comparisons, rather than a clinical trial with human subjects. Therefore, some information requested in your prompt regarding clinical study elements (like sample size for test sets, ground truth establishment for test sets, expert adjudication, or MRMC studies) is not explicitly detailed or applicable in the provided document.
Here's the breakdown of the acceptance criteria and the study (non-clinical performance tests) that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed in a separate table, but rather implied through the "Equivalence Comments" in the "Technological Comparison" and the "Non-clinical and/or Clinical Tests Summary & Conclusions" sections. The core acceptance criterion is substantial equivalence to the predicate devices, meaning the Ultimate rTMS device performs similarly and does not raise new safety or effectiveness concerns.
Here's a table summarizing the key performance metrics and their comparison to predicates, which serve as the "acceptance criteria" through equivalence:
| Criteria | Acceptance Criteria (Equivalent to Predicate) | Reported Ultimate rTMS Performance |
|---|---|---|
| Magnetic Field Intensity (SMT units) | Comparable to predicate (e.g., 0-2.1 to 0-2.4 SMT range, with 1 SMT achieved at similar % intensity settings). | BY90A, BF90A, BY90B Coils: 0 – 2.4 SMT (41% intensity → 1 SMT). |
| (Predicate MagVita: 0 – 2.1 SMT, 47% intensity → 1 SMT). | ||
| Comment: Slightly lower intensity setting needed for Ultimate rTMS to achieve same induced current, indicating favorable performance. | ||
| Waveform | Biphasic sinusoid. | Biphasic sinusoid. |
| Active Pulse Width (µs) | Comparable to predicate (e.g., 290 µs ± 5% for MagVita) within typical variations among cleared TMS devices. | BY90A, BF90A, BY90B Coils: 320 µs ± 10%. |
| (Predicate MagVita: 290 µs ± 5%). | ||
| Comment: Difference is comparable to other cleared devices. Higher pulse width means lower intensity needed to reach MT, aligned with SMT comparison. | ||
| Max Magnetic Field Strength 2 cm (T) | Comparable values to predicate across intensity settings, with equivalent slope and intercept values. | At 25% Intensity: BY90A: 0.172 T, BF90A: 0.182 T, BY90B: 0.117 T. |
| At 50% Intensity: BY90A: 0.291 T, BF90A: 0.287 T, BY90B: 0.244 T. | ||
| At 75% Intensity: BY90A: 0.403 T, BF90A: 0.395 T, BY90B: 0.369 T. | ||
| At 100% Intensity: BY90A: 0.498 T, BF90A: 0.494 T, BY90B: 0.481 T. | ||
| (Predicates values provided for comparison). | ||
| Comment: Values are in a narrow range and show equivalent behavior despite slight differences. | ||
| Max Initial dB/dt (kT/s) (near/2cm from coil) | Sufficiently close to predicate values. | Near Coil (z=0cm): BY90A: 13.44, BF90A: 13.76, BY90B: 12.10. |
| 2cm from Coil (z=2cm): BY90A: 3.59, BF90A: 4.27, BY90B: 6.78. | ||
| (Predicates values provided for comparison). | ||
| Comment: Considered equivalent; differences compensated by differing % power for 120% MT. | ||
| Output Intensity Stability within Burst | Max change |
§ 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.