(156 days)
The HORIZON™ 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 HORIZON™ 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 HORIZON™ Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from antidepressant medication in the current episode. The HORIZON™ Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings, including physicians' offices, clinics, and hospitals.
The HORIZON™ Therapy System is an integrated system consisting of a combination of hardware, software, and accessories.
This document is a 510(k) Pre-market Notification for the Magstim HORIZON™ Therapy System, a medical device used for the treatment of Major Depressive Disorder. The core of the submission is to demonstrate the substantial equivalence of the HORIZON™ system to a legally marketed predicate device, the Magstim Rapid² Therapy System.
Therefore, the "acceptance criteria" and "device performance" in this context are evaluated against the predicate device's performance and established safety standards, rather than generating new clinical efficacy data for the new device.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the acceptance criteria are largely defined by equivalence to the predicate device and compliance with relevant safety and performance standards. No novel acceptance criteria for clinical effectiveness are presented for the HORIZON™ system itself.
| Acceptance Criteria (Demonstration of Equivalence/Compliance) | Reported Device Performance (HORIZON™ Therapy System) |
|---|---|
| Functional Equivalence to Predicate | |
| Same Intended Use and Indications for Use | Identical: Treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. |
| Same Principle of Operation | Identical: 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. |
| Same Key Technological Characteristics | - Identical coil head geometry for both MT Remote Coil and Air Film Coil as predicate. |
- Identical Stimulus Frequency (10 Hz), Stimulus Train duration (4 sec), Inter-train interval (26 sec), Number of trains (75), Magnetic Pulses per Session (3000), Treatment Session Duration (37.5 min), Sessions/week (5), and Treatment Schedule (5 daily sessions for 6 weeks).
- Same brain area stimulated (Left Dorsolateral Prefrontal Cortex).
- Similar Stimulator Output Parameters (Amplitude, Frequency range, Pulse train duration, Inter-train interval, Max trains per session, Max pulses per session, MT Determination Method, Placement for stimulation).
- Minor modifications: increased thermal performance/reliability of mainframe/power supply, new coil-to-mainframe connector for reliability/usability. |
| Magnetic Field Characteristics | Identical to predicate device (Air Film Coil and D70mm MT Remote Coil cleared under K143531 and K162935) due to identical coil head geometry. Therefore, equivalent safety and performance is assured (no new testing needed for magnetic field characteristics). Values for Max output amplitude, Max magnetic field strength (at surface and 2cm depth), Max magnetic field gradient (at surface and 2cm depth), and Magnetic field strength gradient ratio are identical to predicate. |
| Basic Software Capabilities | Same as the predicate device related to treatment administration. |
| Safety and Performance Standards Compliance | |
| Electrical Safety | Compliant with IEC 60601-1 (Ed. 3.1.). |
| Electromagnetic Compatibility (EMC) | Compliant with IEC 60601-1-2 (2007). |
| Biocompatibility | Both coils meet ISO 10993-1 (2009) standards. |
| Acoustic Output Measurements | Conducted during IEC 60601-1 (Ed. 3.1) testing to demonstrate safety and performance. |
| Software Verification and Validation | Performed, demonstrating that the software performs as intended and in accordance with specifications. "Moderate" level of concern. |
| Risk Management | Potential risks identified and evaluated in compliance with ISO14971; risks determined acceptable or addressed with control measures. |
2. Sample size used for the test set and the data provenance
The document does not report any clinical test set data from human patients for efficacy or performance of the HORIZON™ Therapy System itself. The submission relies on non-clinical testing and substantial equivalence to the predicate device.
For non-clinical testing:
- Electrical safety and EMC testing: Conducted on "the system" (singular, implies one system tested).
- Biocompatibility evaluation: On "both coils."
- Acoustic output measurements: Conducted during IEC 60601-1 testing.
- Software verification and validation testing: Conducted for the software.
Data provenance: Not applicable in the context of clinical studies. The non-clinical testing was performed for the HORIZON™ device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical ground truth or expert evaluation of clinical outcomes for the HORIZON™ Therapy System is mentioned in this document as part of the substantial equivalence submission. The ground truth for the equivalence claim is based on engineering specifications, compliance with standards, and comparison to the predicate device's design.
4. Adjudication method for the test set
Not applicable. As no clinical test set for independent evaluation of the HORIZON™ device is presented.
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 Stimulation (TMS) system for treating depression, not an AI diagnostic imaging device. Therefore, MRMC studies are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware medical device with integrated software, not an AI algorithm. Its performance is inherent to its operation, not a separate "algorithm only" evaluation. The software functionality is verified and validated, but this is distinct from standalone AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the purpose of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence are:
- Predicate Device Specifications and Performance: The established, cleared characteristics and performance of the Magstim Rapid² Therapy System serve as the primary ground truth for the comparison.
- International Standards and Regulations: IEC 60601-1, IEC 60601-1-2, ISO 10993-1, and ISO14971 provide the "ground truth" for safety, EMC, biocompatibility, and risk management compliance.
- Engineering Specifications: The design parameters, such as coil winding parameters, inductance, pulse width, and physical dimensions, are considered the ground truth for comparing the technological characteristics to the predicate.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires training data for its core functionality. The "software" in question refers to control software, not an adaptive learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI algorithm. The ground truth for the correctness of the control software (functional specifications) would have been established during software development requirements gathering and design phases.
§ 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.