(132 days)
Horizon® 3.0 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.
The Horizon® 3.0 TMS 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. ("TMS")
The Horizon® 3.0 TMS 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® 3.0 TMS Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient settings, including physicians' offices, clinics, and hospitals.
Horizon® 3.0 TMS Therapy System is an integrated system consisting of a combination of hardware, software, and accessories.
The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below. It is important to note that this document primarily focuses on non-clinical testing for substantial equivalence to predicate devices, rather than a clinical effectiveness study against a gold standard.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes non-clinical testing conducted to validate the performance of the Horizon® 3.0 TMS Therapy System and to ensure it meets design specifications and relevant FDA guidance. The "acceptance criteria" here are generally compliance with recognized standards and demonstration of substantial equivalence to predicate devices. The "reported device performance" is the outcome of these compliance tests.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Electrical Safety (Compliance with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012) | A sample Horizon® 3.0 TMS Therapy System (specifically Horizon® 3.0 with StimGuide+) was tested by independent test laboratory BSI Appliances and found to be compliant with the requirements of ANSI/AAMI ES 60601-1, demonstrating safety and effectiveness following incorporation of new/different characteristics compared to the predicate device. |
| Mechanical Safety (Implicit in ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012) | (Covered by Electrical Safety compliance above) |
| Electromagnetic Compatibility (EMC) (Compliance with IEC 60601-1-2: 2014) | A sample of the Horizon® 3.0 TMS Therapy System (specifically Horizon® 3.0 with StimGuide+) was tested by independent test laboratory Eurofins Hursley and found to be compliant with the requirements of IEC 60601-1-2, demonstrating safety and effectiveness following incorporation of new/different characteristics compared to the predicate device. |
| Alarm Systems (Compliance with IEC 60601-1-8) | A sample Horizon® 3.0 TMS Therapy System was tested by independent test laboratory BSI Appliances and found to be compliant with the requirements of IEC 60601-1-8, demonstrating substantial equivalence to the legally marketed predicate device. |
| Biocompatibility (Compliance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010) | Patient-contacting components (Enclosure of Horizon® MT Coil, Enclosure of Horizon® E-z Cool Coil 3.0, Enclosure of Horizon® E-z Cool Coil (Nav) 3.0) were tested by an independent test laboratory and found, for materials with limited skin contact duration (surface contacting, less than 24-hour duration), to be compliant with the requirements of ISO 10993-1, ISO 10993-5, and ISO 10993-10, demonstrating substantial equivalence to the legally marketed predicate devices. |
| Human Factors Testing (Compliance with AAMI/ANSI HE75 and IEC 62366-1) | Usability testing was performed on the Horizon® 3.0 TMS Therapy System. The Human Factors Engineering report verifies the system is safe and effective for the intended users, uses, and use environments, demonstrating substantial equivalence to the legally marketed predicate devices. |
| Software Lifecycle Process (Verification & Validation, ISO 14971, AAMI TIR57:2016/(R)2019 for Cybersecurity) | The software lifecycle process, including verification and validation testing, assures that the software performs as intended and in accordance with specifications. Potential risks were identified and evaluated in compliance with ISO 14971 (Ed 2.0) and determined acceptable or addressed with risk control measures. AAMI TIR57:2016/(R)2019 was applied to evaluate and control cybersecurity risks, which were determined acceptable. |
| Substantial Equivalence to Predicate Devices | The Horizon® 3.0 TMS Therapy System was found substantially equivalent to the Horizon® TMS Therapy System (K182853) and Horizon® TMS Therapy System with Navigation (K183376) in terms of intended use, indications for use, basic design, mechanism of action, coil head geometry, magnetic field characteristics, and treatment protocols (standard rTMS and iTBS). Minor differences (upgraded mainframe, PSU design change, new interface unit, improved touch panels/GUI, upgraded cart/arm, StimGuide+ updates, Magstim Connect integration) were evaluated through the non-clinical testing listed above, demonstrating that the Horizon® 3.0 is as safe and effective as the predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of patient data or clinical trials. The testing described is primarily non-clinical bench testing and verification/validation activities on the device itself.
- For tests like Electrical Safety, EMC, and Alarm Systems, a "sample Horizon® 3.0 TMS Therapy System (specifically Horizon® 3.0 with StimGuide+)" was used.
- For Biocompatibility, "samples of these materials" (patient-contacting components) were tested.
- For Human Factors, "Usability testing was performed to Horizon® 3.0 TMS Therapy System."
Data Provenance: This is not applicable to the non-clinical testing described, as it does not involve patient data. The tests were performed by independent test laboratories (BSI Appliances, Eurofins Hursley) and internally by Magstim.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable as the study involves non-clinical engineering and systems testing, not the establishment of a medical 'ground truth' based on expert consensus for diagnostic or prognostic purposes. Compliance with standards and direct measurement against specifications serve as the "ground truth."
4. Adjudication Method for the Test Set
This is not applicable, as the study does not involve expert adjudication of medical cases. The tests are objective measurements and compliance checks performed by qualified testing laboratories and the manufacturer.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states that the submission relies on non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than a clinical trial of effectiveness. There is no mention of human readers or AI assistance in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physical medical system (Transcranial Magnetic Stimulation Therapy System), not primarily an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not directly apply in the typical sense of AI diagnostics. However, the software components of the device were a subject of extensive verification and validation testing, including assessing cybersecurity risks, as part of the overall system. This can be seen as an evaluation of the system's inherent performance, albeit for a complex electro-mechanical system rather than a purely diagnostic algorithm.
7. The Type of Ground Truth Used
For this submission, the "ground truth" for the non-clinical testing is:
- Recognized International and National Standards: e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 10993 series, AAMI/ANSI HE75, IEC 62366-1.
- Design Specifications and Intended Performance: The device was tested to ensure it performs as intended and meets its internal design specifications.
- FDA Guidance: "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS)."
- Predicate Device Characteristics: Comparison of the new device's technical specifications and performance to legally marketed predicate devices to establish substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable. The document describes a 510(k) submission based on non-clinical testing for substantial equivalence. It does not involve machine learning models that require training sets of data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as no machine learning training set is described in the document.
§ 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.