(109 days)
The MagVita TMS Therapy - w/MagPro R20 is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
The MagVita TMS Therapy w/MagPro R20 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 w/MagPro R20 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 w/MagPro R20 TMS pulses are applied repetitively at a frequency of 10Hz. Such stimulation has been shown to be as effective as the predicate device 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 Mag Vita TMS therapy w/MagPro R20 is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC).
The MagVita TMS Therapy w/MagPro R20 is an integrated system consisting of the following components:
- . MagPro Stimulator and Trolley
- MagPro R20 o
- Trolley with holding arrangements o
- Coils for MT determination and Depression Treatment .
- o Coil MCF-B65
- Marking apparatus for locating treatment area
- Marking plate for Coil MCF-B65 o
- Pen for marking, Cap, Ruler o
- Patient head fixation
.
- Treatment Chair o
- Vacuum Pump and Vacuum pillow o
- Super Flexible Arm mounted on the trolley o
- . Isolation Transformer
This document is a 510(k) Summary for the MagVita TMS Therapy w/MagPro R20 device, comparing it to a predicate device, the MagVita TMS Therapy System (K150641).
Based on the provided text, there is no acceptance criteria or study outlined to prove the device meets acceptance criteria.
Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device. This means the manufacturer is asserting the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.
Therefore, many of the requested details about acceptance criteria and a specific study proving it are not present in this type of FDA submission. Here's what can be inferred or explicitly stated based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, there are no explicit "acceptance criteria" presented in the document in the format of a performance study with defined thresholds. The document instead presents a comparison of the new device's performance characteristics to those of the predicate device to demonstrate substantial equivalence.
| Characteristic | MagVita TMS Therapy w/MagPro R20 (New Device) | MagVita TMS Therapy System (Predicate Device) (K150641) | Comparison Outcome (Implicit Acceptance) |
|---|---|---|---|
| Intended Use / Indication for Use | Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. | Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. | Identical |
| Waveforms | Biphasic | Biphasic | Identical |
| Frequency Range | 0.1 - 20 pulses per second | 0.1 - 30 pulses per second or 0.1 - 100 pulses per second, depending on model | Similar (within relevant therapeutic range) |
| Preset range of % MT | 50% - 140% | 0% - 140% | Similar (within relevant therapeutic range) |
| Recommended Standard Treatment Intensity | 120% MT | 120% MT | Identical |
| Repetition Rate | 10 Hz | 10 Hz | Identical |
| Train Duration | 4 sec | 4 sec | Identical |
| Interval between pulses | 26 sec | 26 sec | Identical |
| Number of pulses/session | 3000 | 3000 | Identical |
| Output Stimulation Parameters (SMT units) | Available Stimulation Amplitude in Standard Motor Threshold (SMT) units | Available Stimulation Amplitude in Standard Motor Threshold (SMT) units | Identical concept |
| Amplitude Range | 0 - 1.2 SMT | 0 - 1.7 SMT | Similar (within relevant therapeutic range) |
| Pulse Width | 290 µs (±5%), Biphasic sinusoid waveform | 290 µs (±5%), Biphasic sinusoid waveform | Identical |
| Coil Configuration | Figure-of-eight coil, Air core | Figure-of-eight coil, Air core | Identical |
| Cooling | Liquid cooling | Forced liquid cooling | Similar (both involve liquid cooling) |
| Standards Met | ISO 13485:2012, IEC60601-1, IEC60601-1-2 | ISO 13485:2012, IEC60601-1, IEC60601-1-1, IEC60601-1-2 | Similar (compliance with key safety and quality standards) |
Implicit Acceptance Criteria: The device is "accepted" if it is shown to be substantially equivalent to the predicate device, meaning its differences do not raise new questions of safety or effectiveness. The document asserts that "all other identified differences between the two systems are minor and without any known impact on safety or efficacy."
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a clinical study with a "test set" in the context of diagnostic accuracy, image interpretation, or treatment efficacy data from the new device. The data presented is a technical comparison of device specifications.
The "non-clinical performance data" section refers to previous FDA clearances for components (K160280 for MagPro R20, K150641 for chair/arm/etc., K071821 for Coil MCF-B65). This indicates that the safety and performance of individual components were evaluated and cleared through separate processes, but it does not represent a specific "test set" for the entire integrated system in a clinical performance study.
Data Provenance: The technical specifications are derived from the device's design and engineering. Any clinical data implicitly relied upon would be from trials that supported the original predicate device's clearance and the understanding of rTMS efficacy for Major Depressive Disorder, not new data for this specific 510(k) submission.
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 requiring expert-established ground truth. The comparison is based on technical specifications and functional equivalence.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical "test set" or adjudication process described for diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This document does not present an MRMC comparative effectiveness study. The submission is for substantial equivalence based on technical and functional comparison to a predicate device. The device is a therapeutic electromagnetic stimulator, not an imaging or diagnostic device typically subject to MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The device is a therapeutic system with human interaction. While it includes software, it is not an "algorithm only" device in the sense of AI for diagnostic interpretation.
7. The Type of Ground Truth Used
Not applicable in the context of a "ground truth" for a diagnostic or AI performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the existing predicate device and the recognized scientific understanding of repetitive transcranial magnetic stimulation (rTMS) for Major Depressive Disorder as supported by clinical evidence for that class of devices.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/Machine Learning algorithm that undergoes a training phase with a labeled dataset in the typical sense. It is a hardware and software system for delivering a physical therapy.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 8.
§ 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.