(93 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, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
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 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 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 and outpatient settings, including physicians' offices, clinics, and hospitals.
The Horizon® 3.0 TMS Therapy System configurations are an integrated system consisting of a combination of hardware, software, and configurations:
- Horizon 3.0 Inspire (Subject of this submission).
- Horizon 3.0 (Previously cleared under K232235, K223154, K222171 and K211389).
- Horizon 3.0 with StimGuide Pro (Cleared under K232235).
All three configurations, including the subject Horizon 3.0 Inspire configuration, have identical intended use/indications for use, common specifications, equivalent performance and equivalent composition. All three devices share equivalent technological characteristics and principles of operation.
All configurations are composed from the following main components:
- Stimulating Unit & Power Supply
- User Interface
- Applicating Coil for Motor Threshold
- Applicating Coil for Treatment Delivery
- System and Applicating Coil Cart and Holding Arm
The Horizon 3.0 with StimGuide Pro specifically includes a stereotactic infrared tracking system for aiding coil positioning.
The provided text is a 510(k) summary for the Horizon 3.0 TMS Therapy System, specifically introducing the "Horizon 3.0 Inspire" configuration. This document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (K232235, Horizon 3.0 TMS Therapy System) rather than presenting a standalone study with defined acceptance criteria and performance metrics against a specific clinical outcome.
Therefore, the requested information, particularly regarding acceptance criteria for clinical performance, sample sizes for test sets where ground truth was established by experts, and effect sizes for MRMC studies, is not present in this document. The document describes non-clinical testing to demonstrate that the new configuration is as safe and effective as the predicate device.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes compliance with various safety and performance standards, but does not present a table of acceptance criteria with corresponding performance results in a way that would typically be seen for a new clinical efficacy study. Instead, it refers to demonstrating equivalence to a predicate device through non-clinical testing.
| Acceptance Criteria Category | Description of Compliance/Performance |
|---|---|
| Electromagnetic Compatibility (EMC) | Compliant "to the requirements of IEC 60601-1-2 to demonstrate an equivalent level of Electromagnetic Compatibility as the primary predicate device." Test plan utilized the same performance criteria as the primary predicate. |
| Electrical & Mechanical Safety | Compliant "to the requirements of IEC 60601-1 (including IEC 60601-1-8) to demonstrate an equivalent level of Electrical and Mechanical safety as the primary predicate device." |
| Thermal Safety | Compliant "to the requirements of IEC 60601-1 (including IEC 60601-1-6 and IEC 60601-1-8) to demonstrate an equivalent level of Thermal safety as the primary predicate device." Additional testing ensured the Horizon Air Film Coil could execute OCD, iTBS, and rTMS protocols at worst-case ambient conditions without excessive temperatures. The system can perform recommended protocols safely and effectively under worst-case simulated ambient conditions (80%-100% machine output, 30°C ambient). |
| Software Verification & Validation | Software developed following IEC 62304. Documentation demonstrates appropriate function and that software cannot contribute to unacceptable risk. Changes for "Inspire" configuration verified for correctness and no negative impact on predicate configurations. Cybersecurity testing performed to ensure "Inspire" configuration is as secure as the primary predicate. |
| Usability/Human Factors Engineering | Evaluation demonstrates appropriate human factors and usability for intended use, free from unacceptable use-related risks (IEC 60601-1-6, IEC 62366-1, ANSI/AAMI HE75). Consistency of workflows, UIs, and components from predicate contribute to a healthy usability profile. |
| Magnetic Pulse Output Testing and Magnetic & Electrical Field Testing | Electric field distribution measured in a human head phantom filled with physiologic saline solution. Values of Magnetic and Electric field obtained by measuring induced voltage. Results demonstrated "equivalent Power Outputs, Electric Fields between the subject device configuration applicating coil and the primary predicate device configuration applicating coil." Key characteristics (stimulator output, field spatial distribution, E-Field decay, output waveforms, rate of change) were equivalent, especially at clinically relevant depths. |
| Safety Feature Testing | IEC 60601-1 testing of fault scenarios to ensure appropriate safety features. System-level testing (software verification) exercised various interlocks. Testing introduced failure modes to confirm hardware backup interlocks. Demonstrates substantial equivalence of safety features. |
| Acoustic Testing | In simulated use scenarios (OCD Protocol at maximum machine output), the Horizon 3.0 "Inspire" configuration demonstrated equivalent acoustic properties to the predicate and fell below safe exposure limits. |
2. Sample size used for the test set and the data provenance:
- Test Set: No patient-specific test set for clinical performance is mentioned. The testing described is non-clinical/bench testing.
- Data Provenance: The data provenance is from laboratory testing performed by the manufacturer, comparing the new configuration's performance to the primary predicate device and relevant standards. This is retrospective in the sense that it relies on existing standards and predicate device data, but the tests themselves were conducted on the new device configuration.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable as the document describes non-clinical testing against engineering standards and comparison to a predicate device, not a human reader study where experts establish ground truth for a clinical dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the same reasons as point 3.
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 MRMC comparative effectiveness study was done or described. This is a device for Transcranial Magnetic Stimulation, not typically an imaging AI device that aids human readers in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone medical device for delivering TMS therapy. The described testing is of the device's technical specifications and safety profile, not of an "algorithm only" in the context of an AI diagnostic. The software components were verified and validated as part of the overall device system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical tests described, the "ground truth" (or reference) used were:
- International standards: (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 62366-1, ANSI/AAMI HE75, ISO 10993-1, ISO 10993-10, ISO 14971, IEC 62304, AAMI TRS7, AAMI TIR97).
- Performance of the legally marketed predicate device (K232235): The goal was to demonstrate "equivalent" safety and effectiveness.
- Phantom head model: For Magnetic and Electrical Field Testing, a human head phantom model filled with physiologic saline solution was used to measure induced voltage.
8. The sample size for the training set:
This information is not applicable. This document does not describe the development or training of a machine learning algorithm; it describes a hardware and software system for TMS therapy.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason 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.