(141 days)
The Rapid2 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 Rapid2 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 Rapid2 Therapy System is an integrated system consisting of a combination of hardware, software, and accessories.
This document (K162935) is a 510(k) premarket notification for a modification to an existing device, the Magstim Rapid2 Therapy System. The modification involves the introduction of a new optional handheld remote coil (D70mm MT Remote Coil) for determining the motor threshold level. It is important to note that this document is not a clinical study proving the device meets primary efficacy acceptance criteria for Major Depressive Disorder (MDD) treatment. Instead, it demonstrates substantial equivalence to a previously cleared predicate device (K143531) for this specific modification.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present "acceptance criteria" in the traditional sense of clinical efficacy endpoints or performance goals for MDD treatment. Instead, it relies on demonstrating that the modified device (with the new coil) maintains parity in safety and technical performance with the predicate device. The "performance" reported is primarily in the form of non-clinical testing results and a comparison of technical specifications.
| Criteria | Acceptance Criteria (Implied from Predicate Equivalence) | Reported Device Performance (with D70mm MT Remote Coil) |
|---|---|---|
| Intended Use/Indications for Use | Remain the same as the predicate device (treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode). | Identical to the predicate device. |
| Technological Characteristics & Principles of Operation | Should not introduce new questions of safety or effectiveness compared to the predicate. | The document states "does not change the intended use and indications for use nor does it change the technological characteristics and principles of operation." Table 1 shows very similar (or identical where applicable) specifications. |
| Electrical Safety | Compliant with IEC 60601-1 (Ed. 3.1.). | Demonstrated compliance with IEC 60601-1 (Ed. 3.1.). |
| Electromagnetic Compatibility (EMC) | Compliant with IEC 60601-1-2 (2007). | Demonstrated compliance with IEC 60601-1-2 (2007). |
| Environmental Testing | Compliant with IEC 60601-1. | Demonstrated compliance with IEC 60601-1. |
| Biocompatibility | Both coils (Air Film Coil and D70mm MT Remote Coil) meet ISO 10993-1 (2009) standards. | Demonstrated compliance with ISO 10993-1 (2009) for both coils. |
| Magnetic Field Characteristics | Consistent with predicate device and FDA guidance "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems". | Maximum output amplitude, frequency range, pulse train duration range, inter-train interval range, maximum trains per session, and maximum pulses per session are identical to the predicate. Magnetic field strength and gradient also compared and shown to be similar. |
| Software Verification & Validation | Software performs as intended and in accordance with specifications (for a "moderate" level of concern). | Software verification and validation testing completed, demonstrating performance as intended. Basic software capabilities related to treatment administration are unchanged. |
| Risk Management | Identified and evaluated risks in compliance with ISO14971, with acceptable or addressed risks. | Risks identified and evaluated per ISO14971, with risks determined acceptable or addressed. |
| Safety and Effectiveness Comparability (Overall) | As safe and effective as the predicate device. | Performance data demonstrate that the Rapid Therapy System is "as safe and effective as the predicate" with the new coil. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: This document does not describe a clinical "test set" in the context of patient data for efficacy or safety comparisons. The testing described is non-clinical for technical specifications (electrical, EMC, environmental, biocompatibility, magnetic field characteristics, and software). Therefore, patient sample sizes are not applicable to the scope of this 510(k) submission.
- Data Provenance: The data provenance is primarily from non-clinical laboratory testing conducted by the manufacturer (Magstim Company Limited) in the United Kingdom.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not applicable as the document describes non-clinical testing for device specifications and substantial equivalence, not a clinical study requiring expert ground truth establishment for patient outcomes. "Ground truth" in this context would be engineering specifications and standards.
4. Adjudication Method for the Test Set
- This information is not applicable as the document describes non-clinical testing, not a clinical study that would typically involve adjudication of patient outcomes or image interpretations.
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
- No, an MRMC comparative effectiveness study was not done. This document pertains to a Repetitive Transcranial Magnetic Stimulation (rTMS) System, which is a therapeutic device, not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is not applicable. The Rapid2 Therapy System is a medical device for treatment delivery, not an algorithm, and it explicitly requires "prescription only under the supervision of a licensed physician" (human-in-the-loop for operation and treatment). The software mentioned is for device control and operation, not for standalone diagnostic performance.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical testing described would be the established international standards (IEC, ISO) for electrical safety, EMC, environmental performance, and biocompatibility, as well as the engineering specifications and design requirements of the device itself (e.g., magnetic field parameters, coil inductance, pulse width). The comparison to the predicate device's cleared specifications also serves as a form of "ground truth" for demonstrating equivalence.
8. The Sample Size for the Training Set
- This information is not applicable. The device is not an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns from data. The software within the device is control software, verified and validated against its specifications, but not "trained" on a dataset.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reasons as #8. There is no training set for this type of device.
§ 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.