(25 days)
The Mag Vita TMS Therapy System is indicated for the treatment of Major Depressive Disorder who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
The Mag Vita TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents directed at regions of the cerebral cortex. The MagVita TMS Therapy System is indicated for Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neural tissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current are generated with a circuit containing a capacitor connected to the stimulating coil. With the capacitor charged to a certain level, the conducting state will cause the discharging of the capacitor through the coil. A magnetic field is generated proportional to this current. The rapid change in the magnetic field induces a current in conducting materials e.g. the body tissue. If the current induced in the human body is of sufficient amplitude and duration, it will excite neurons. In the MagVita TMS therapy system TMS pulses are applied repetitively at a frequency of 10Hz. Such stimulation has been shown to be effective in modulating cortical excitability. The observed and documented increase in cortical excitability after high frequency (10Hz) repetitive transcranial magnetic stimulation has been shown to persist beyond the duration of the train of stimulation. Repetitive Magnetic stimulation with the MagVita TMS therapy system is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC). The MagVita TMS Therapy System consists of the following components: MagPro Stimulator , Trolley and Super Flexible Arm . Coil for MT determination . Marking apparatus for locating treatment area . Coil for Depression Treatment . Isolation Transformer
This document, K171967, is a 510(k) summary for a modification to the MagVita TMS Therapy System, not a study presenting new clinical efficacy data for the device itself.
Therefore, the document does not present acceptance criteria or a study proving the device meets those criteria in the way a clinical trial would for a new device's efficacy.
Instead, this submission is to demonstrate substantial equivalence of a modified device (one without a proprietary treatment chair and head support) to a previously cleared device. The "acceptance criteria" here are essentially the demonstration that the modified device's performance characteristics are largely unchanged and that it adheres to relevant safety standards.
Here's how to interpret the provided information in the context of your request:
1. A table of acceptance criteria and the reported device performance:
The document provides a comparison table (pages 5 & 6) between the modified MagVita TMS Therapy System and its predicate device (MagVita TMS Therapy System K150641/171481), as well as other predicate devices regarding the treatment chair. The "acceptance criteria" are implied to be the characteristics of the predicate device, and the "reported device performance" is how the modified device compares.
| Criteria | Acceptance Criteria (Predicate Device K150641/171481) | Reported Device Performance (Modified MagVita TMS Therapy System) | Conclusion |
|---|---|---|---|
| Performance (Waveforms) | Biphasic; Frequency: 0.1 - 30 pulses/second or 0.1 - 100 pulses (depending on model) | Biphasic; Frequency: 0.1 - 30 pulses/second or 0.1 - 100 pulses (depending on model) | Identical |
| Performance (Treatment Parameters) | Stimulation Intensity: 120% MT; Repetition rate: 10 Hz; Train duration: 4 sec; Inter-train interval: 11-26 sec; Pulses/session: 3000; Treatment duration: 19-37 min; Sessions/week: 5; Treatment schedule: 5 daily sessions for 6 weeks | Stimulation Intensity: 120% MT; Repetition rate: 10 Hz; Train duration: 4 sec; Inter-train interval: 11-26 sec; Pulses/session: 3000; Treatment duration: 19-37 min; Sessions/week: 5; Treatment schedule: 5 daily sessions for 6 weeks | Identical |
| Performance (Output Stimulation Parameters) | Amplitude in SMT units: 0 - 1.7; Pulse width: 290 µs, Biphasic sinusoid waveform; Frequency Range: 0.1-30 pps or 0.1-100 pps (depending on model) | Amplitude in SMT units: 0 - 1.7; Pulse width: 290 µs, Biphasic sinusoid waveform; Frequency Range: 0.1-30 pps or 0.1-100 pps (depending on model) | Identical |
| Coil Configuration/Cooling Design | Figure-of-eight coil, air core, liquid cooling. System components: Mobile console, software, coil positioning system, coil for MT and treatment, coil fixture, treatment chair, head support system. | Figure-of-eight coil, air core, liquid cooling. System components: Mobile console, software, coil positioning system, coil for MT and treatment, coil fixture. (Treatment chair and pillow removed). | Identical (except for removed chair/support). Justified by stating that the modified system is identical to other predicates (MagStim K143531, Neurosoft K160309) which also require the user to provide a treatment chair and ensure patient comfort/head fixation. |
| Standards Met | ISO 13485:2012 | ISO 13485:2012 | Identical |
| Electrical Safety | Complies with IEC60601-1, IEC60601-1-1 and IEC60601-1-2 | Complies with IEC60601-1, IEC60601-1-1 and IEC60601-1-2 | Identical |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document does not describe a clinical study with a test set of patient data. It describes a technical and regulatory comparison for a device modification. The "data" here refers to the device's technical specifications and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not a study assessing clinical performance based on expert review of medical data. The ground truth for the device's technical specifications and safety compliance is established through engineering design, testing, and adherence to recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as there is no test set in the sense of patient data requiring adjudication.
5. 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 device is a Transcranial Magnetic Stimulator (TMS), not an AI-powered diagnostic imaging tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The MagVita TMS Therapy System is a physical medical device for treatment, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this 510(k) submission is the technical specifications, performance characteristics, and safety standards of the predicate device (MagVita TMS Therapy System K150641/171481) and recognized international standards (ISO, IEC). The aim is to demonstrate that the modified device is substantially equivalent to this established ground truth.
8. The sample size for the training set:
Not applicable. This document does not describe a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set mentioned in this document.
In summary: The K171967 document is a premarket notification for a modification to an existing device. It demonstrates substantial equivalence by comparing the modified device's technical specifications and adherence to safety standards against its predicate, rather than presenting a clinical study with patient data and performance metrics like sensitivity/specificity.
§ 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.