(90 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 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 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 provided document is a 510(k) Premarket Notification from the FDA for the Magstim®Horizon® 3.0 TMS Therapy System. It describes the device, its intended use, and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Key Takeaway: The device discussed is the Magstim®Horizon® 3.0 TMS Therapy System, and the submission is a 510(k) to demonstrate substantial equivalence to a previously cleared version (K222171). The testing described is primarily non-clinical bench testing focused on changes made to the device's camera tracking system and EMG amplifier, ensuring these changes do not raise new questions of safety or effectiveness and that the performance is equivalent or better than the predicate device. No clinical studies or human reader studies (MRMC) were conducted or mentioned as a requirement for this particular submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on demonstrating performance equivalent to or better than the predicate device, especially for the modified components (camera tracking and EMG). The performance metrics are largely quantitative measurements from bench testing.
| Acceptance Criteria (Expected Result) | Reported Device Performance (Actual Results) |
|---|---|
| Stress Testing - Sample Rate: Tracking remains stable under load to support sampling rates of 20Hz and 50Hz. (These rates are the highest for FDA cleared protocols - OCD Protocol and iTBS Protocol). | Actual Results: Maintains a constant sample rate above 50Hz. 50Hz chosen as that is the fastest rate of delivery out of cleared protocols. Under Abnormal PC Load: 52Hz min recorded. Average Capture Rate in Normal Conditions: 120Hz. Equivalent to Predicate Device. |
| Stress Testing - Data Storage: 1000 rMT positions can be stored and 10,000 stimuli positions can be stored. | Actual Results: Supports recording of 1000 Simultaneous MT Locations for Motor Hotspot procedures and recording of up to 12,000 Stimuli which is sufficient for treatment (Maximum stimuli from FDA protocol is 3000) – Equivalent to Predicate Device. |
| Positional and Volumetric Accuracy - Camera Accuracy: <= 0.25mm Root Mean Squared (RMS) Positional Accuracy. | Actual Results: 0.16mm RMS Positional Accuracy – Equivalent to Predicate Device. |
| Landmark Registration Accuracy (Rigid Body Testing): <= 1mm RMS Rigid-body Positional Accuracy. | Actual Results: 0.45mm RMS Rigid-body Positional Accuracy - Equivalent to Predicate Device. |
| Orientational Accuracy: <= 5.5 degrees RMS Orientational Accuracy. | Actual Results: 1.8 degrees RMS Orientational Accuracy. Equivalent to Predicate Device, provides an equivalent level of rotational accuracy. |
| Treatment Delivery Performance on Phantom Head: Pickup coil should detect a reading of the same voltage induced at the MT hotspot and Treatment Target (+/- 5%). | Actual Results: Over 20 samples (repeat of 10 tests for MDD and 10 tests for OCD) there was an average difference of 1.02% for MDD and 1.92% for OCD of the induced voltage when measured at the expected treatment target following the principles of operation. Resulting in a combined average difference of 1.47% from the voltage induced in a search coil at the MT location compared to when it is placed at the treatment location following the Navigation software. The treatment location was determined to be the location presented by Navigation software and when the software indicated it was in the position (green). Equivalent to Predicate Device. When following the same principles of operation as the predicate device – the new tracking system results in equivalent output. |
| Direct Accuracy Comparison to Manual Method and Predicate Device - Overall System Accuracy: The mean difference between the manual method and the subject device navigation method is equivalent or better than the predicate device navigation method compared to the same manual method (< 4.0mm). | Actual Results: MDD Mean Difference to Manual Method (5.5cm forward from MT Hotspot): 1.51mm (Std. Dev 1.14mm)OCD Mean Difference to Manual Method (4cm forward from MT Hotspot): 1.66mm (Std. Dev 0.76mm)Compared to the results of the predicate device:Predicate – 3.0mm Mean Delta (Std. Dev 1.8mm)Subject – 1.5mm (Std. Dev 1.1mm)Equivalent to Predicate Device – subject device offers better approximation/guidance to the treatment target in accordance with the principles of operation. |
| EMG Performance - Timing Jitter: < 5ms Jitter (TMS Pulse to EMG Capture). | Actual Results: Timing Jitter Measured: Maximum of 3.25ms and mean of 1.68ms over samples. Equivalent to Predicate Device. All measured values of the system are within tolerance. |
| EMG Performance - Noise Level: < 5uV RMS. | Actual Results: Noise Level Measured: 3.03uV RMS. Equivalent to Predicate Device. All measured values of the system are within tolerance. |
| EMG Performance - Waveform Accuracy: error of < 10% in Amplitude and Time. | Actual Results: Waveform Accuracy Measured: Maximum Amplitude Error - 6.5%, Maximum Pulse Width Error - 3%, Maximum Frequency Error - 3.16%. Equivalent to Predicate Device. All measured values of the system are within tolerance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Positional and Volumetric Accuracy - Camera Accuracy: "A reflective marker is stepped through 1000 different positions (ground truths) with 30 samples taken at each position."
- Treatment Delivery Performance on Phantom Head: "Over 20 samples (repeat of 10 tests for MDD and 10 tests for OCD)."
- Other tests like "Stress Testing," "Landmark Registration Accuracy," "Orientational Accuracy," "Direct Accuracy Comparison," and "EMG Performance" indicate "samples" but do not specify a precise number for each measurement run, though the methods imply multiple measurements were taken (e.g., "moved along rotational axes by known amounts," "known waveforms are input," which suggests a range of conditions).
- Data Provenance: The tests are described as non-clinical testing using simulated settings and phantom heads. The data is thus synthetic/experimental, not from human patients. The company is based in the United Kingdom.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The ground truth for the non-clinical bench tests appears to be established by the physical and measurable setup of the experiments themselves (e.g., "known positions," "known waveforms," "precisely positioned and secured pickup coil"). Expert consensus is not relevant for this type of engineering performance testing.
4. Adjudication Method for the Test Set
This is not applicable as the tests are non-clinical, quantitative bench tests with direct measurements against pre-defined engineering specifications. There is no human interpretative element requiring 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
No MRMC comparative effectiveness study was done or required. The submission explicitly states: "There is no clinical testing required to support this submission." The device modifications are to the tracking camera, EMG, and associated software, and the testing focuses on ensuring their fundamental performance characteristics are equivalent or better than the predicate. This is not an AI diagnostic algorithm that assists human readers in interpreting medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The "standalone" performance closest to what might be inferred is the performance of the camera tracking system and EMG amplifier in isolation, as tested in the bench assessments. The results detailed in the table (e.g., positional accuracy, orientational accuracy, EMG jitter, noise, waveform accuracy) are essentially "algorithm only" or component-level performance metrics, demonstrating the technical capabilities of the new components. However, this is not a diagnostic AI algorithm in the traditional sense that "stands alone" to provide a clinical output.
7. The type of Ground Truth Used
The ground truth used for these non-clinical tests is based on engineering measurements and pre-defined physical parameters.
- For positional accuracy tests: reflective markers are stepped through "1000 different positions (ground truths)".
- For treatment delivery performance: "known position on the phantom head" and "precisely positioned and secured pickup coil at the ideal location."
- For EMG performance: "known waveforms are input into the EMG interface using a function generator."
8. The Sample Size for the Training Set
This information is not applicable / not provided. This submission is for a medical device (TMS system) with updated hardware and software components, not for a deep learning or AI model trained on a large dataset of patient data. The "software" updates mentioned are related to integrating the new hardware and improving user interaction, not for training a predictive model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable / not provided for the same reasons as #8. No "training set" in the context of an AI/ML model for clinical tasks is mentioned or implied.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 25, 2023
The Magstim Company Ltd. Daniel Gregory Principal Systems Engineer Spring Gardens Whitland, Carmarthenshire SA340HR United Kingdom
Re: K232235
Trade/Device Name: Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro Regulation Number: 21 CFR 882.5805. 21 CFR 882.5802 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP, QCI Dated: July 27, 2023 Received: July 27, 2023
Dear Daniel Gregory:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
{2}------------------------------------------------
Sincerely,
Robert Kang -S
for Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K232235
Device Name Horizon 3.0 TMS Therapy System
Indications for Use (Describe)
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).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the word "magstim" in a bold, blue font. The "i" in "magstim" is dotted with a light blue circle. The "m" in "magstim" has a curved line underneath it.
K232235 Traditional 510(k) Summary Magstim's Horizon® 3.0 TMS Therapy System
Prepared according to the requirements outlined in 21 CFR 807.92
Prepared according to the requirements outlined in 21 CFR 807.92
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Magstim® Company Limited Spring Gardens, Whitland, Carmarthenshire SA34 0HR, United Kingdom +44 (0) 1994 240798 Phone: Facsimile: +44 (0) 1994 240061 Contact Person: Daniel Gregory, Principal Systems Engineer (daniel.gregory@magstim.com)
Date Prepared: October 25, 2023
Trade Name of Device
Horizon® 3.0 TMS Therapy System
Common or Usual Name
Transcranial Magnetic Stimulation System for Neurological and Psychiatric Disorders and Conditions
Classification
21 C.F.R. § 882.5805, Class II, primary product code OBP 21 C.F.R. § 882.5802, Class II, subsequent product code QCI
Predicate Devices
Primary Predicate Device: Horizon 3.0® TMS Therapy System, The Magstim® Company Limited (K222171)
Product Code: 21 C.F.R. § 882.5805 OBP,
Subsequent Product Code: 21 C.F.R. § 882.5802 QCI
Device Description
The Horizon® 3.0 TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation 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 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. Its technological characteristics are described in further detail below.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the word "magstim" in a bold, blue font. There is a blue dot above the "i" in "magstim". To the right of the word "magstim" is the registered trademark symbol.
Intended Use & Indications for Use
The Horizon® 3.0 TMS Therapy System is intended to produce and deliver 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.
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).
Technological Characteristics
Horizon® 3.0 TMS Therapy Systems are offered in two system configurations: Horizon® 3.0 and Horizon® 3.0 with StimGuide Pro. These system configurations are comprised of the following physical components:
| Horizon® 3.0 | Horizon® 3.0 with StimGuide Pro |
|---|---|
| 1. Horizon® 3.0 Stimulatora. Horizon® 3.0 Mainframe;b. Horizon® 3.0 PSU (Power Supply Unit);c. Horizon® 3.0 Interface Unit;d. Horizon® 3.0 User Interface2. Horizon® 3.0 Coil for MT Determinationa. Horizon® MT Coil;3. Horizon® 3.0 Coil for Treatmenta. Horizon® 3.0 E-z Cool Coil4. Horizon® 3.0 Cart and Coil Holdera. Horizon® 3.0 E-z Cartb. Horizon® 3.0 Coil Holder5. Accessoriesa. Horizon® 3.0 Accessory Kit | 1. Horizon® 3.0 Stimulatora. Horizon® 3.0 Mainframe;b. Horizon® 3.0 PSU (Power Supply Unit);c. Horizon® 3.0 Interface Unit;d. Horizon® 3.0 User Interface2. Horizon® 3.0 Coil for MT Determinationa. Horizon® MT Coil;3. Horizon® 3.0 Coil for Treatmenta. Horizon® 3.0 E-z Cool Coil (Nav)4. Horizon® 3.0 Cart and Coil Holdera. Horizon® 3.0 E-z Cart;b. Horizon® 3.0 Coil Holder5. Accessoriesa. Horizon® 3.0 Accessory Kit;b. StimGuide Pro Camera & Horizon® 3.0Camera Standc. StimGuide Pro Accessory Kit |
The following technological changes are proposed for the Horizon® 3.0 TMS Therapy System which is the subject of this 510(k):
-
- The Horizon 3.0 Ul Software and StimGuide+ Navigation software have been combined onto a single screen to give a more integrated feel to the entire device. This has resulted in the minor rebranding of the StimGuide name to "StimGuide Pro".
-
- The StimGuide® Camera has been replaced, previously using an NDI Polaris Vicra Camera, with an OptiTrack V120:Duo Camera. The new camera has equivalent performance characteristics as the camera used on the predicate device. Testing of the tracking system with the new camera is described in the "Non-Clinical Testing" section below.
-
- The EMG amplifier used within the predicate device the StimGuide® Eego amplifier has been replaced with an amplifier with equivalent performance characteristics, co-developed between Magstim and MentaLab GmbH. Testing of the EMG device is described in the "Non-Clinical Testing" section below.
-
- Tracker Tools, which are sets of reflective spheres to help identify objects such as the Patient Head and Applicating Coil, have been modified to have slightly different arrangements to support the new camera system.
-
- As a result of the Camera and EMG Amplifier changing, it was necessary to make some additional technological changes to support the integration of the above components:
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the word "magstim" in a bold, sans-serif font. The word is dark blue, except for a small, light blue circle above the "i". A small registration mark is to the right of the "m".
- a. The Horizon 3.0 UI Software and StimGuide+ Navigation software have been updated to integrate with the new Camera and EMG components. This includes the interpretation of the new Tracker Tools sphere placements to identify tracked rigid bodies. The updated StimGuide software has been rebranded as StimGuide Pro.
- ﻒ Modification to the pointer tool to allow remote interaction with the touchscreen to facilitate the landmarks registration process via Bluetooth, acting as a Human Interface Device (HID).
- i. Previously one hand would need to be placed on a landmark with the pointer tool and the other used to interact with the touchscreen. The remote function allows a user to use both hands for stabilizing the tool and register landmarks without needing to interact with the touchscreen.
- ii. The Bluetooth stack and chips used for communication were analyzed and not found to be vulnerable to exploits such as SweynTooth. This is documented further in Section XVIII.I.
- c. The Camera Stand holding the camera has been slightly modified to support the new OptiTrack camera.
- d. The Interface Unit which previously housed the StimGuide® Eego amplifier now houses the amplifier co-developed by Magstim and MentaLab GmbH.
- Device labels and instructions for use updated to cover modified components. e
-
- This has resulted in a minor change in rebranding from 'StimGuide+' to 'StimGuide Pro'.
-
- A Coil winding temperature interlock using solid state temperature sensors has been placed within the Horizon E-z Cool Coil 3.0 and Horizon E-z Cool Coil 3.0 (Nav) variant. This has been implemented due to the previous implementation of thermal fuses which may, under rare circumstances, activate as a result of mechanical shock when the coil is discharged. This addresses the issue whilst still providing the same level of safety as the predicate device. Performance testing has been documented in Appendix 06.C.3.
Please note that the MentaLab EMG Amplifier is manufactured as a component to be used in the manufacture and assembly of the updated Horizon 3.0 device.
Non-clinical Testing
Non-clinical testing was conducted to validate the performance of the subject Horizon® 3.0 TMS Therapy System and to ensure that the device performs as intended and meets the design specifications, consistent with the FDA's guidance "Class II Special Control Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS)."
As part of the update, Electrical Safety and Electromagnetic Compatibility ("EMC") testing were conducted on the subject device to demonstrate that the device remains compliant with IEC 60601-1 (Ed. 3.2), IEC 60601-1-2 (Ed. 4.1) and IEC 60601-1-8 (Ed. 2.2) following its modifications.
Human Factors Usability testing in accordance with IEC 62366-1 (Ed. 1.1) and AAMI/ANSI HE75:2009/(r)2018 was performed on the updated device with modifications to confirm that the subject device with its modifications continue to be safe and effective for the intended users, uses and use environments.
Biocompatibility testing from previous submissions (K222171) is leveraged for this 510(k) as the materials of the patient-contacting components of the system have not been modified and have been found to be compliant to the requirements of ISO 10993-1 (Ed. 5), ISO 10993-5 (Ed. 3) and ISO 10993-10 (Ed. 3). For completeness, the testing from the previous submission and a recent biological evaluation and gap analysis can be found in Appendix 03.
To evaluate the replacement of the Camera Tracking System, performance testing was performed to compare the modified system within the subject device to that used on the currently marketed predicate device. The performance testing included:
- . Stress Testing to ensure maintained system performance and sampling rates under worst-case scenarios.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the word "magstim" in a bold, blue font. The "i" in "magstim" is dotted with a blue circle. The word is likely a logo or brand name. There is a registered trademark symbol to the right of the word.
- . Positional, Volumetric and Orientational Accuracy for tracked reflective spheres and rigid bodies.
- Evaluation that the new tracking system with a simulated Motor Threshold and Treatment procedure maintains the appropriate level of induced voltage when used to navigate to a treatment target from a Motor Threshold Hotspot.
- Direct Evaluation of Performance when used as a full system. The tracking system used with the currently marketed Horizon® 3.0 TMS Therapy System has previously been evaluated for performance against the manual method. This was repeated on the modified tracking system of the subject device and compared against that of the predicate device.
- Evaluation of EMG Amplifier performance characteristics compared to the predicate device.
A summary of the non-clinical testing performed on the subject Horizon® 3.0 TMS Therapy System is provided in Table 2.
A summary of the non-clinical performance testing used to evaluate the performance characteristics of the modified tracking system can be found in Table 3.
| Test | Method | Results/ Comment |
|---|---|---|
| Electrical SafetyMechanical SafetyThermal Safety | ANSI/AAMI ES60601-1 (incl. AMD2:2021)Medical electrical equipment - Part 1:General requirements forbasic safety and essential performance;FDA Recognition Number: 19-46 | A sample Horizon® 3.0 TMS TherapySystem (specifically Horizon® 3.0 withStimGuide Pro) has been tested andfound to be compliant to therequirements of ANSI/AAMI ES 60601-1by independent test laboratory BSIAppliances, to demonstrate safety andeffectiveness of the system followingincorporation of new/ differentcharacteristics as compared to thepredicate device. |
| ElectromagneticCompatibility | IEC 60601-1-2 (2020) -Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance -Collateral standard: Electromagneticcompatibility -Requirements and tests;FDA recognition number: 19-36 | A sample of the Horizon® 3.0 TMSTherapy System (specifically Horizon®3.0 with StimGuide Pro) has been testedand found to be compliant to therequirements of IEC 60601-1-2 byindependent test laboratory EurofinsHursley, to demonstrate safety andeffectiveness of the system followingincorporation of new/ differentcharacteristics as compared to thepredicate device. |
| Alarm Systems | IEC 60601-1-8 (2020) -Medical electrical equipment - Part 1-8:General requirements for basic safety andessential performance - CollateralStandard: General requirements, tests andguidance for alarm systems in medicalelectrical equipment and medical electricalsystems; FDA Recognition Number: 5-131 | A sample Horizon® 3.0 TMS Therapy System(specifically Horizon® 3.0 with StimGuide Pro)Horizon has been tested and found to becompliant to the requirements of IEC 60601-1-8 by independent test laboratory BSIAppliances, thus demonstrating the subjectHorizon® 3.0 TMS Therapy System issubstantially equivalent to the legallymarketed predicate device. |
| Risk Management | ISO 14971 (2019) - Medical Devices –Application of risk management to medicaldevices; FDA Recognition Number: 5-125.AAMI TIR57 (2016 reaffirmed 2019) –Principles for medical device security –Risk Management; FDA RecognitionNumber: 13-83.AAMI TIR97:2019 - Principles for medicaldevice security – Postmarket riskmanagement for device manufacturers;FDA Recognition Number: 13-112 | The potential risks of Horizon 3.0 havebeen identified and evaluated incompliance with ISO 14971, and the riskswere determined to be acceptable, orhave been addressed with risk controlmeasures. In addition to ISO14971:2019, AAMI TIR57:2016/(R)2019and AAMI TIR97:2019 were also appliedto evaluate and control cyber securityrisks associated with the Horizon 3.0device and the risks were determined tobe acceptable. |
| Software | IEC 62304 (2015) – Medical DeviceSoftware – Software life cycle processes;FDA Recognition Number: 13-79 | The Software lifecycle process inaccordance with IEC 62304, whichincludes verification and validationtesting assures that the modifiedsoftware performs as intended and inaccordance with specifications. |
| Biocompatibility | ISO 10993-1 (2018) - Biological Evaluationof Medical Devices - Part 1: Evaluation andtesting within a risk management process;FDA Recognition Number: 2-258ISO 10993-5 (2009) - Biological evaluationof medical devices -- Part 5: Tests for invitro cytotoxicity; FDA RecognitionNumber: 2-245ISO 10993-10 (2010) - Biologicalevaluation of medical devices - Part 10:Tests for irritation and skin sensitization;FDA Recognition Number: 2-174 | Patient-contacting components of theHorizon® 3.0 TMS Therapy Systeminclude:• Enclosure of the Horizon® MT Coil;• Enclosure of the Horizon® Ez CoolCoil 3.0;• Enclosure of Horizon® Ez Cool Coil(Nav) 3.0,These components are unchanged fromthe predicate device.All these have limited contact durationwith skin (surface contacting, less than24-hour duration).Samples of these materials have beentested and found to be compliant to therequirements of ISO 10993-1, ISO10993-5 and ISO 10993-10 by anindependent test laboratory. |
| Cybersecurity Testing | AAMI TIR57 (2016 reaffirmed 2019) –Principles for medical device security –Risk Management; FDA RecognitionNumber: 13-83.AAMI TIR97:2019 - Principles for medicaldevice security - Postmarket riskmanagement for device manufacturers;FDA Recognition Number: 13-112 | AAMI TIR57:2016/(R)2019 and AAMITIR97:2019 were also applied toevaluate and control cyber security risksassociated with the Horizon 3.0 deviceand the risks were determined to beacceptable.Penetration testing has been performedon the Azure Infrastructure and PatientData Management items the systemintegrates with.Finally, the addition of the Bluetoothclicker tool was analyzed for Bluetoothvulnerabilities such as SweynTooth andwas found not to be vulnerable to anyknown exploits. Off-the-shelf softwarepackages used with the Horizon 3.0devices have been updated to addressany known vulnerabilities. |
| Human Factors Testing | AAMI/ANSI HE75 (2018) - Human FactorsEngineering - Design of Medical Devices;FDA Recognition Number: 5-57IEC 62366-1 (2020) - Medical Devices -Part 1: Application of Usability EngineeringTo Medical Devices; FDA RecognitionNumber: 5-129 | Usability testing was performed on thesubject Horizon® 3.0 TMS TherapySystem.The Human Factors Engineering reportverifies the subject Horizon® 3.0 TMSTherapy System, to be safe andeffective for the intended users, uses,and use environments thusdemonstrating the subject Horizon® 3.0TMS Therapy System is substantiallyequivalent to the legally marketedpredicate devices. |
Table 2: Summary of Non-Clinical Testing
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Magstim. The logo is in a dark blue font. There is a blue dot above the "i" in the logo.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the word "magstim" in a bold, sans-serif font. The letters are all lowercase, and the color is a dark blue. There is a small, light blue circle above the "i" in "magstim". There is a registered trademark symbol to the right of the word.
Non-clinical Testing – Tracking System:
As the updated Horizon® 3.0 TMS Therapy system replaces the tracking camera, EMG, updates the tracking tools and results in modifications to associated software systems – the following performance testing was performed to confirm that the changes in technological characteristics do not raise any new or differing questions of safety or effectiveness.
Expected results to evaluate equivalence were obtained from the tracking system used on the currently marketed Horizon® 3.0 TMS Therapy System (K222171):
Table 3: Summary of Non-Clinical Testing for Tracking System Update
| Test | Method | Results/ Comment |
|---|---|---|
| Stress Testing - SampleRate | System is set up to continuously sampleusing the camera while the host PCrunning the software is put under heavyload.Expected Result: Tracking remains stableunder load to support sampling rates of20Hz and 50Hz. 20Hz and 50Hz arechosen as this is the highest rate of | Actual Results:Maintains a constant sample rate above50Hz.50Hz chosen as that is the fastest rateof delivery out of cleared protocols.Under Abnormal PC Load: 52Hz minrecorded. |
| Test | Method | Results/ Comment |
| delivery for an FDA cleared protocol (OCDProtocol and iTBS Protocol). | Average Capture Rate in NormalConditions: 120Hz/Equivalent to Predicate Device. | |
| Stress Testing - DataStorage | System is placed in a state for definingmotor threshold and treatment delivery.Random points are then injected into thesoftware to identify limits.Expected Result: 1000 rMT positions canbe stored and 10,000 stimuli positions canbe stored. | Actual Results:Supports recording of 1000Simultaneous MT Locations for MotorHotspot procedures and recording of upto 12,000 Stimuli which is sufficient fortreatment (Maximum stimuli from FDAprotocol is 3000) – Equivalent toPredicate Device. |
| Positional and VolumetricAccuracy - CameraAccuracy | At 25C temperature, A reflective marker isstepped through 1000 different positions(ground truths) with 30 samples taken ateach position.Expected Result: <= 0.25mm Root MeanSquared (RMS) Positional Accuracy | Actual Results:0.16mm RMS Positional Accuracy –Equivalent to Predicate Device. |
| Landmark RegistrationAccuracy (Rigid BodyTesting) | At 25C temperature, A rigid body is definedusing sets of reflective markers and areplaced at known points (ground truths)where they are sampled.Expected Result: <= 1mm RMS Rigid-body Positional Accuracy | Actual Results:0.45mm RMS Rigid-body PositionalAccuracy - Equivalent to PredicateDevice. |
| Orientational Accuracy | At 25C temperature, A rigid body is definedusing sets of reflective markers and aremoved along rotational axes by knownamounts (ground truths) for Yaw, Pitch andRoll where the orientation of the body isthen sampled.Expected Result: <= 5.5 degrees RMSOrientational Accuracy | Actual Results:1.8 degrees RMS OrientationalAccuracyEquivalent to Predicate Device,provides an equivalent level ofrotational accuracy. |
| Treatment DeliveryPerformance on PhantomHead. | An MT workflow is performed in asimulated setting with a built-up systemand tracker tools attached to the phantomhead and coils. A stimuli is delivered at50% machine output at a known positionon the phantom head that is defined as theMT hotspot. The induced voltage wasdetected using a precisely positioned andsecured pickup coil within the phantomhead. The magnitude of this voltage wasrecorded.Subsequently, the new software andtracking system is used to navigate 5.5cmforward for MDD, 4cm forward for OCD inaccordance with the principles of operationand a stimuli at the same power isdelivered at the anticipated treatmenttarget where there is another preciselypositioned and secured pickup coil at theideal location.Expected Result: Pickup coil shoulddetect a reading of the same voltage | Actual Results:Over 20 samples (repeat of 10 tests forMDD and 10 tests for OCD) there wasan average difference of 1.02% for MDDand 1.92% for OCD of the inducedvoltage when measured at the expectedtreatment target following the principlesof operation.Resulting in a combined averagedifference of 1.47% from the voltageinduced in a search coil at the MTlocation compared to when it is placedat the treatment location following theNavigation software.The treatment location was determinedto be the location presented byNavigation software and when thesoftware indicated it was in the position(green).Equivalent to Predicate Device. Whenfollowing the same principles of |
| Test | Method | Results/ Comment |
| induced at the MT hotspot and TreatmentTarget (+/- 5%). | operation as the predicate device –the new tracking system results inequivalent output. | |
| Actual Results: | ||
| Treatment targets are defined using themanual method as described in thePredicate Device operating manual. | MDD Mean Difference to ManualMethod (5.5cm forward from MTHotspot): | |
| These points are then used as reference tocompare to treatment targets generatedusing the tracking system of the PredicateDevice and the tracking system of the | 1.51mm (Std. Dev 1.14mm) | |
| Direct Accuracy Comparisonto Manual Method andPredicate Device - OverallSystem Accuracy | Subject Device. | OCD Mean Difference to ManualMethod (4cm forward from MT Hotspot): |
| This test takes into account all sources oferror and is completed on a full system set-up. | 1.66mm (Std. Dev 0.76mm) | |
| Expected Result: The mean differencebetween the manual method and thesubject device navigation method is | Compared to the results of the predicatedevice: | |
| equivalent or better than the predicatedevice navigation method compared to thesame manual method (< 4.0mm). | Predicate – 3.0mm Mean Delta (Std.Dev 1.8mm)Subject – 1.5mm (Std. Dev 1.1mm) | |
| Equivalent to Predicate Device –subject device offers betterapproximation/guidance to thetreatment target in accordance withthe principles of operation. | ||
| EMG Performance. | Using a function generator, knownwaveforms are input into the EMGinterface on the Horizon 3.0 device. Apulse is then delivered to trigger an EMG | Timing Jitter Measured: Maximum of3.25ms and mean of 1.68ms oversamples. |
| capture. The capture data collected by theamplifier and stored on the system is then | Noise Level Measured: 3.03uV RMS | |
| compared to the known waveforms usingthe function generator. | Waveform Accuracy Measured:Maximum Amplitude Error - 6.5%, | |
| Expected Result: Timing Jitter betweenTMS Pulse and EMG Capture: < 5ms. | Maximum Pulse Width Error - 3%,Maximum Frequency Error - 3.16% | |
| Noise Level <5uV RMS. | Equivalent to Predicate Device. Allmeasured values of the system arewithin tolerance. | |
| EMG Waveform Accuracy: error of < 10%in Amplitude and Time. |
{10}------------------------------------------------
magstim
{11}------------------------------------------------
Further details on the testing can be found in the Section XX – Performance Testing – Bench
Clinical Testing
There is no clinical testing required to support this submission.
Substantial Equivalence
The Horizon® 3.0 TMS Therapy System - in both configurations, Horizon 3.0 and Horizon 3.0 with StimGuide Pro, which is the subject of this submission is substantially equivalent to the primary predicate device cleared under K222171. A full comparison table of characteristics can be found at the bottom of this summary.
The intended use and indications for use of the subject device when compared to the predicate device are identical, this is:
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the word "magstim" in a bold, sans-serif font. The letters are a dark blue color, and there is a small, light blue circle above the "i" in "magstim". To the right of the word is a small, circled R, indicating that the word is a registered trademark. The word is centered in the image and takes up most of the space.
"The 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 basic design of the subject Horizon® 3.0 TMS Therapy System is substantially equivalent to the design of the predicate device K222171, as both systems are based on applying transcranial magnetic stimulation by means of repetitive pulse trains at a predetermined frequency. All systems use the same mechanism of action. i.e., an electromechanical instrument that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the prefrontal cortex.
The technological characteristics of the device remain substantially equivalent to the predicate device. The camera tracking system and EMG amplifier components exhibit equivalent or better performance characteristics as described in Table 4. The modifications have been successfully tested to the requirements of IEC 60601-1. IEC 60601-1-2 and IEC 60601-1-8 standards maintain the same level of Electrical, Mechanical and Thermal safety as the predicate device. The changes to the user interface have also been evaluated in accordance with IEC 62366-1 and ANSI/AAMI HE75 confirming no unacceptable use risks. Patient contacting parts remain identical to the predicate device, as well as their materials and formulation. As a result, it can be determined that none of the changes to the device raise any new or differing questions of safety and effectiveness.
The coil head geometry of the Horizon 3.0 MT Coil and E-z Cool Coil are identical to the predicate device. For this reason, the magnetic field characteristics of the system are identical to the predicate device, therefore equivalent safety and performance is assured. Consequently, no additional testing of the maqnetic field characteristics of the system is necessary to meet the requirement of FDA's guidance document "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems" in order to demonstrate safety and performance.
The principles of operation of the subject Horizon® 3.0 TMS Therapy System are equivalent to the primary predicate device. The method for determining Motor Threshold both with and without EMG and the coil positioning principle for treatment in both navigated and non-navigated device configurations for both MDD and OCD treatments remain unchanged compared to the predicate device. The recommended treatment protocols, the standard rTMS protocol, iTBS protocol, and OCD protocol are identical to those of the predicate devices.
Conclusion
The intended use and indications for use are identical between the subject Horizon® 3.0 TMS Therapy System and the primary predicate device cleared under K222171.
Although the technological characteristics of the subject device differ slightly following the update of the associated tracking camera and EMG device, non-clinical testing demonstrates that the subject device is as safe and effective compared to its primary predicate device, the Horizon® 3.0 TMS Therapy System (K222171).
Furthermore, despite the changes in technological characteristics - the principles of operation remain unchanged between the subject Horizon® 3.0 TMS Therapy System and its primary predicate, with the predicate recommending the options of using the Standard Treatment Protocol, iTBS Treatment Protocol and OCD Protocol. The method for MT Response Detection and the principle for Coil Position also remain the same as the primary predicates.
Thus, the information and data provided in this 510(k) premarket notification submission support a finding of substantial equivalence for the subject device, the updated Horizon® 3.0 TMS Therapy System, namely the Horizon 3.0 and Horizon 3.0 with StimGuide Pro.
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the word "magstim" in a bold, sans-serif font. The word is a dark blue color, and there is a small, light blue circle above the "i" in "magstim". There is a registered trademark symbol to the right of the word.
Table 4: Substantial Equivalence Summary
| Criteria | Horizon 3.0 TMS Therapy SystemHorizon 3.0 and Horizon 3.0 withStimGuide Pro(Subject of this submission) | HORIZON 3.0 TMS TherapySystemHorizon 3.0 and Horizon 3.0 withStimGuide+(Primary Predicate) | Evaluation ofDifferences |
|---|---|---|---|
| Manufacturer | Magstim Company Limited | Magstim Company Limited | |
| Device Name | Horizon 3.0 TMS Therapy System | Horizon 3.0 TMS Therapy System | |
| 510(k)number(s) | K232235 | K222171 | |
| Device code | OBP, QCI | OBP, QCI | No Difference |
| Intended Use/Indications forUse | Horizon 3.0 TMS Therapy System is indicated forthe treatment of Major Depressive Disorder inadult patients who have failed to achievesatisfactory improvement from priorantidepressant medication in the currentepisode, as well as an adjunct for the treatmentof adult patients suffering from Obsessive-Compulsive Disorder (OCD). | Horizon 3.0 TMS Therapy System isindicated for the treatment of MajorDepressive Disorder in adult patients whohave failed to achieve satisfactoryimprovement from prior antidepressantmedication in the current episode, as wellas an adjunct for the treatment of adultpatients suffering from Obsessive-Compulsive Disorder (OCD). | No Difference |
| OCD Treatment Protocol | |||
| Magnetic FieldIntensity | 100% of the MT | 100% of the MT | No Difference |
| StimulusFrequency | 20 Hz | 20 Hz | No Difference |
| Stimulus Trainduration | 2 sec | 2 sec | No Difference |
| Inter-traininterval | 20 sec | 20 sec | No Difference |
| Number oftrains | 50 | 50 | No Difference |
| MagneticPulses perSession | 2000 | 2000 | No Difference |
| TreatmentSessionDuration | 18.3 min | 18.3 min | No Difference |
| TreatmentSchedule | 5 daily sessions for 5 weeks, 4 dailysessions for 1 week. | 5 daily sessions for 5 weeks, 4daily sessions for 1 week. | No Difference |
| Area of brainto bestimulated | Dorsomedial Prefrontal Cortex | Dorsomedial Prefrontal Cortex | No Difference |
| Standard Treatment Protocol | |||
| Magnetic FieldIntensity | 120% of the MT | 120% of the MT | No Difference |
| StimulusFrequency | 10 Hz | 10 Hz | No Difference |
| Stimulus Trainduration | 4 sec | 4 sec | No Difference |
| Inter-traininterval | 11-26 sec | 11-26 sec | No Difference |
| Number oftrains | 75 | 75 | No Difference |
| MagneticPulses perSession | 3000 | 3000 | No Difference |
| TreatmentSessionDuration | 18.8 min-37.5 min | 18.8 min-37.5 min | No Difference |
| Sessions/week | 5 | 5 | No Difference |
| TreatmentSchedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | No Difference |
| Area of brainto bestimulated | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex | No Difference |
| iTBS Treatment Protocol | |||
| StimulationIntensity | 120% of the MT | 120% of the MT | No Difference |
| RepetitionRate | 50 Hz (5 pulses per sec) | 50 Hz (5 pulses per sec) | No Difference |
| Train Duration | 2 sec | 2 sec | No Difference |
| Inter-trainInterval | 8 sec | 8 sec | No Difference |
| Burst Pulses | 3 | 3 | No Difference |
| Bursts | 200 | 200 | No Difference |
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the word "magstim" in a bold, sans-serif font. The word is colored in a dark blue. There is a small, light blue circle above the "i" in "magstim". There is a registered trademark symbol to the right of the word.
{15}------------------------------------------------
magstim
| Inter Pulseinterval | 20 msec | 20 msec | No Difference | ||||
|---|---|---|---|---|---|---|---|
| Number oftrains | 20 | 20 | No Difference | ||||
| Number ofPulses perSession | 600 | 600 | No Difference | ||||
| TreatmentSessionDuration | 3.09 min | 3.09 min | No Difference | ||||
| Sessions/week | 5 | 5 | No Difference | ||||
| TreatmentSchedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | No Difference | ||||
| Area of brainto bestimulated | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex | No Difference | ||||
| Horizon®MT Remote Coil | Horizon®3.0 E-zCool Coil | Horizon® 3.0E-z Cool Coil(Nav) | Horizon®MT RemoteCoil | Horizon®3.0 E-zCool Coil | Horizon® 3.0E-z Cool Coil(Nav) | ||
| Waveform | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | No Difference |
| Core Material | Air | Air | Air | Air | Air | Air | No Difference |
| Pulse Width | 330μs | 340μs | 340μs | 330μs | 340μs | 340μs | No Difference |
| Amplitude inSMT units(Standard MotorThreshold) | 0.28 - 1.9 | 0.28 - 1.9 | No Difference | ||||
| Frequencyrange (Hz) at100% | 1 - 20 | 1 - 20 | No Difference | ||||
| Pulse trainduration range(sec) | 0.1 - 600 | 0.1 - 600 | No Difference | ||||
| Inter-traininterval range(sec) | 1 - 540 | 1 - 540 | No Difference | ||||
| Maximum # ofpulses persession(cumulativeexposure) | 60000 | 60000 | No Difference |
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the word "magstim" in a bold, sans-serif font. The word is colored in a dark blue hue. There is a small, light blue circle above the "i" in "magstim". There is a registered trademark symbol to the right of the word.
| Maximumoutputamplitude(V/m) at adepth of 2cmbelow the coilsurface | 150 V/m | 150 V/m | No Difference |
|---|---|---|---|
| Maximummagnetic fieldstrength (T) atcoil surface | 1.0T | 1.0T | No Difference |
| Maximummagnetic fieldstrength (T) ata depth of 2cm | 0.4T | 0.4T | No Difference |
| Maximummagnetic fieldgradient(dB/dt) (kT/s)at coil surface | 18 kT/s | 18 kT/s | No Difference |
| Maximummagnetic fieldgradient(dB/dt) (kT/s)at a depth of2cm | 10 kT/s | 10 kT/s | No Difference |
| Camera Tracking System and EMG Performance Characteristics | |||
| TrackingSystemAccuracy(defined asaccuracy of theCamera system) | 0.16mm RMS | 0.25mm RMS | Equivalent.Subject devicecamera trackingsystem exhibitsequivalentperformancecharacteristics. |
| OverallSystemAccuracy(defined as theaccuracy of the overallsystem, accounting fortracking tools, rigidbodies and LandmarkRegistration) | < 4mm | < 10mm | Equivalent.Subject devicecamera trackingsystem exhibitsequivalentperformancecharacteristics. |
| EMGPerformance | < 5ms Jitter (TMS Pulse to EMGCapture)< 5uV Noise RMS | < 5ms Jitter (TMS Pulse toEMG Capture)< 5uV Noise RMS | Equivalent.Subject deviceEMG Amplifierexhibits |
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image shows the word "magstim" in a bold, sans-serif font. The word is colored in a dark blue. There is a small, light blue circle above the "i" in "magstim". There is a registered trademark symbol to the right of the word.
| < 10% Error in Amplitude and Time | < 10% Error in Amplitude and Time | equivalentperformancecharacteristics. | |||
|---|---|---|---|---|---|
| Coil Positioning and MT Determination Principle for OCD | |||||
| SystemConfiguration | Horizon 3.0 | Horizon 3.0 withStimGuide Pro | Horizon 3.0 | Horizon 3.0 withStimGuide+ | |
| Coil PositionPrinciple forOCD | Indirecttargeting oftreatmenttargetthroughmeasureddistance anddirection(4cmanterior)from Leg MTHotspot.Measurederived fromstatisticaldistance ofDMPFC/ACCfrom MThotspot. | Indirect targeting oftreatment targetthrough measureddistance and direction(4cm) from Leg MTHotspot usingstereotactic navigation.Measure derived fromstatistical distance ofDMPFC/ACC from MThotspot. | Indirecttargeting oftreatmenttargetthroughmeasureddistance anddirection(4cmanterior) fromLeg MTHotspot.Measurederived fromstatisticaldistance ofDMPFC/ACCfrom MThotspot | Indirect targeting oftreatment targetthrough measureddistance anddirection (4cm)from Leg MTHotspot usingstereotacticnavigation.Measure derivedfrom statisticaldistance ofDMPFC/ACC fromMT hotspot. | Equivalent.Thetechnologicalcharacteristicsthat supportthese principles(the StimGuide+Camera, EMGDevice andassociatedsoftware) havebeen modified -but theprinciplesremain identicalbetween boththe subject andprimary predicate. |
| MT ResponsePrinciple forOCD | Visual qualitative monitoring for APBresponse | Visual qualitative monitoring forAPB response | |||
| Coil Positioning and MT Determination Principle for MDD | |||||
| Coil PositionPrinciple forMDD | Horizon 3.0 | Horizon 3.0 withStimGuide Pro | Horizon 3.0 | Horizon 3.0 withStimGuide+ | |
| Coil PositionPrinciple forMDD | Indirecttargeting oftreatmenttargetfrom MTHotspot.Measurederived fromstatisticaldistance ofDLPFC fromMThotspot. | Indirect targeting oftreatmenttarget throughmeasureddistance and direction(5.5cm)from MT Hotspot usingstereotactic navigation.Measure derived fromstatistical distance ofDLPFCfrom MT hotspot. | Indirecttargeting oftreatmenttargetthroughmeasureddistance anddirection(5.5cm)from MTHotspot.Measurederived fromstatisticaldistance ofDLPFC fromMThotspot. | Indirect targeting oftreatmenttarget throughmeasureddistance anddirection (5.5cm)from MT Hotspotusingstereotacticnavigation.Measure derivedfromstatistical distanceof DLPFCfrom MT hotspot. | Equivalent.Thetechnologicalcharacteristicsthat supportthese principles(the StimGuide+Camera, EMGDevice andassociatedsoftware) havebeen modified -but theprinciplesremain identicalbetween boththe subject and |
| MT ResponsePrinciple forMDD | |||||
| Visualqualitativemonitoringfor APBresponse | Option 1. EMGprovidesquantitative data basedonwhich user defines MT.Option 2. Visualqualitativemonitoring for APBresponse | Visualqualitativemonitoringfor APBresponse | Option 1. EMGprovidesquantitative databased onwhich user definesMT.Option 2. Visualqualitativemonitoring for APBresponse | primarypredicate. |
{18}------------------------------------------------
magstim
§ 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.