(276 days)
The Apollo 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, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
The Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS).
The Apollo TMS Therapy System is comprised of the following principal components:
- User Interface
- Main Unit (with or without housing)
- Stimulation Coil
- Coil Positioning System
The operator controls the Apollo TMS Therapy System via the user interface (application software "Stimware"). "Stimware" is a treatment and data management software that administrates treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. Stimulation is applied via the stimulation coil. For the treatment of major depressive disorder, the stimulation coil is positioned to the left dorsolateral prefrontal cortex (DLPFC) by means of the coil positioning system. The observed and documented increase in cortical excitability after high frequency rTMS has been shown to persist beyond the duration of the train of stimulation. For treatment of OCD, the stimulation coil is positioned to the dorsomedial prefrontal cortex (DMPFC).
The provided FDA 510(k) clearance letter and summary for the Apollo TMS Therapy System (K243539) indicate that the device is substantially equivalent to predicate devices. This clearance is based on non-clinical performance data and a comparison to existing cleared devices rather than a de novo clinical comparative effectiveness study.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices, particularly for the extended indication of Obsessive-Compulsive Disorder (OCD) treatment. The criteria are therefore focused on matching or being demonstrably similar to the predicate device's performance, especially for the OCD treatment parameters, and adhering to recognized safety and performance standards.
| Acceptance Criteria (Inferred from 510(k) Summary) | Reported Device Performance (Apollo TMS Therapy System K243539) |
|---|---|
| Intended Use Equivalence: Identical intended use as predicate devices. | The Apollo 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, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). This matches the intended use of the primary predicate device (HORIZON® 3.0 TMS Therapy System K222171) for OCD, and the secondary predicate (Apollo TMS Therapy System K232639) for MDD. |
| OCD Treatment Stimulation Parameters Equivalence: Identical brain area, intensity (100% leg MT), frequency (20 Hz), pulse train duration (2 sec), inter-train interval (20 sec), trains per session (50), max no. of pulses (2000), and treatment schedule (5 daily sessions for 5 weeks, 4 daily sessions for 1 week) as the primary predicate device. | Area of brain to be stimulated: DMPFC (Identical to predicate) |
| Stimulation intensity: 100 % of leg MT (Identical to predicate) | |
| Stimulation frequency: 20 Hz (Identical to predicate) | |
| Pulse train duration: 2 sec (Identical to predicate) | |
| Inter-train interval: 20 sec (Identical to predicate) | |
| Trains per session: 50 (Identical to predicate) | |
| Max no. of pulses: 2000 (Identical to predicate) | |
| Treatment schedule: 5 daily sessions for 5 weeks, 4 daily sessions for 1 week (Identical to predicate) | |
| Consistent Intensity of Individual Stimuli during OCD Protocol: The intensity of each stimulus during the OCD protocol is equal and kept constant throughout the delivery of the full treatment. | Successfully demonstrated for the subject device. |
| Safety Temperature Limits Adherence: Remaining within recognized safety temperature limits at maximum output. | Remaining within recognized safety temperature limits. (Identical to predicates) |
| Electrical Safety: Conformance to IEC 60601-1. | Conforms to IEC 60601-1. |
| Electromagnetic Compatibility (EMC): Conformance to IEC 60601-1-2. | Conforms to IEC 60601-1-2. |
| Usability: Conformance to IEC 60601-1-6. | Conforms to IEC 60601-1-6. |
| Software Life Cycle Processes: Conformance to IEC 62304 and FDA guidance for software. | Software verification and validation testing conducted and documented in accordance with IEC 62304 and internal quality procedures. Software documentation considered "basic documentation" (supported by Special Controls Guidance "rTMS Class II"). |
| Risk Management: Application of ISO 14971 and IEC 62304 throughout the product development lifecycle with no new hazards/harms compared to predicates. | Risk assessment applied. Results indicate no new hazards, harms, or safety risks introduced when compared to the predicate devices. |
| Output Stimulation Parameters: Adequately similar output stimulation parameters (amplitude, pulse width, frequency, pulse train duration, ITI range, max # of pulses per session) to enable substantial equivalence determination. | Detailed comparison provided in the summary. While pulse width differs, the output stimulation is considered "adequately similar" to the primary predicate for OCD treatment. Other parameters within acceptable ranges or directly comparable. |
| Stimulation Coil Parameters: Similar coil configuration (figure-of-eight), output waveform (biphasic), E-Field at 1.0 SMT (130 V/m). | All identical to predicates. |
| Coil Positioning System: Comparable in function and method to predicate devices. | Integrated into Head-and-Neck-Support System (HANS), Landmark-Aided Coil Placement, TMS Cap for standardized 10-20-EEG Positioning with Coil Positioning Arm. Considered comparable or improved over predicate. |
2. Sample size used for the test set and the data provenance
The submission does not detail a specific "test set" sample size with patient data for efficacy, as it claims substantial equivalence primarily through non-clinical performance testing and direct comparison of specifications and treatment parameters to already cleared devices.
The "study" relies on:
- Non-clinical performance testing: This would involve engineering and laboratory testing for electrical safety, EMC, usability, temperature, and stimulation intensity, rather than a sample size of patients.
- Leveraged data from prior clearances (K180313 and K232639): This indicates that data from previously cleared versions of the Apollo TMS Therapy System was used as a basis.
- Primary predicate device (HORIZON® 3.0 TMS Therapy System K222171): The effectiveness of the OCD treatment protocol is derived from the established effectiveness of this predicate device, which was itself cleared based on its own clinical or non-clinical data.
Data Provenance: Not specified in terms of country of origin or retrospective/prospective for patient data, as direct clinical effectiveness data for the subject device was not required for this 510(k) clearance due to the substantial equivalence claim. The non-clinical testing would have been conducted by the manufacturer (MAG & More GmbH, Germany).
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 submission does not describe a clinical study where experts established ground truth for a test set of patient data. The clearance is based on comparison to a predicate device and non-clinical engineering tests.
4. Adjudication method for the test set
This information is not applicable as there was no clinical test set requiring expert 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
This information is not applicable. The Apollo TMS Therapy System is a therapeutic device that directly applies magnetic stimulation, not an imaging analysis or diagnostic AI device that involves "human readers" or AI assistance in interpretation. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable in the context of an "algorithm only" performance study. The Apollo TMS Therapy System is a hardware device with controlling software. Its performance is always "standalone" in the sense that the device itself (hardware+software) delivers the therapy; there isn't a separate "human-in-the-loop" performance associated with its direct therapeutic action, but rather clinical oversight and operation by a healthcare professional. The software verification and validation are noted, but this is for the control system's reliability, not an "algorithm-only performance" in the diagnostic AI sense.
7. The type of ground truth used
For the effectiveness of the OCD treatment, the "ground truth" is essentially the established clinical efficacy of the primary predicate device (HORIZON® 3.0 TMS Therapy System K222171), whose OCD treatment protocol the Apollo TMS Therapy System replicates. The substantial equivalence claim means that because the subject device's treatment parameters are identical and its output stimulation is adequately similar, it can be expected to achieve the same therapeutic effect.
For the safety and performance of the device itself (e.g., electrical safety, temperature limits, consistent stimulus delivery), the "ground truth" is established through adherence to recognized consensus standards (e.g., IEC 60601-1) and successful non-clinical engineering tests.
8. The sample size for the training set
This information is not applicable. The Apollo TMS Therapy System is not an AI/ML device in the sense of requiring a large "training set" of patient data for its primary function. Its software (Stimware) manages protocols and patient data, but it's not "trained" on patient outcomes to learn or adapt therapeutic delivery in an AI sense.
9. How the ground truth for the training set was established
This information is 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.