(161 days)
Horizon 3.0 TMS Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and 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 depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Horizon® 3.0 TMS Therapy System is an integrated system consisting of a combination of hardware, software, and accessories.
The provided text is a 510(k) summary for the Magstim Horizon 3.0 TMS Therapy System. It states that the device is substantially equivalent to a predicate device and does not involve clinical data from a new study. Therefore, the information typically requested regarding acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance for a new study validating the device's performance against acceptance criteria is not present. Instead, the submission relies on demonstrating equivalence to previously cleared devices based on technological characteristics and existing clinical evidence for those predicates.
However, I can extract and format information regarding the basis for this substantial equivalence claim, particularly focusing on the non-clinical testing performed to show equivalence of the magnetic and electric fields, which serves as a proxy for meeting performance criteria for the extended indication.
Here's a breakdown of the information that can be extracted, and where the requested details are not applicable or provided:
1. A table of acceptance criteria and the reported device performance
The submission does not present a formal "acceptance criteria table" with numerical thresholds directly met by the subject device's performance. Instead, the performance is demonstrated by showing "equivalence" to a predicate device. The key performance metrics discussed are related to magnetic and electrical field characteristics.
Table: Comparative Performance Criteria (demonstrated by equivalence to predicate)
| Criteria | Acceptance Criteria (from Predicate Device K220127) | Reported Device Performance (Horizon 3.0) |
|---|---|---|
| Magnetic Field Characteristics | Consistent with FDA's guidance "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS)" Section 4. | Consistent with FDA's guidance "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS)" Section 4. |
| Magnetic Field Spatial Distribution | (Implicitly, equivalent to predicate) | Superimposed on T1-weighted MRI coronal, sagittal, and axial 1cm slices. |
| Magnetic Field Strength Gradients | (Implicitly, equivalent to predicate) | Provided. |
| Output Waveform | (Implicitly, equivalent to predicate) | Provided. |
| Magnetic Field Intensity | 120% of the MT (Motor Threshold) | 120% of the MT |
| Stimulus Frequency | 10 Hz | 10 Hz |
| Stimulus Train duration | 4 sec | 4 sec |
| Inter-train interval | 11-26 sec | 11-26 sec |
| Number of trains | 75 | 75 |
| Magnetic Pulses per Session | 3000 | 3000 |
| Treatment Session Duration | 18.8 min-37.5 min | 18.8 min-37.5 min |
| Sessions/week | 5 | 5 |
| Treatment Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks |
| Area of brain to be stimulated | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex |
| Electric Field Characteristics | E-field profiles equivalent to NeuroStar Advanced Therapy Coil. | Induced E-field profiles by the Horizon 3.0 Ez Cool Coil and NeuroStar Advanced Therapy Coil are equivalent and have an average difference of ±5% at distances of 1 to 4 cm from the coil surface (based on COMSOL modeling). |
2. Sample size used for the test set and the data provenance
- Non-clinical Testing:
- Sample Size for Magnetic/Electric Field Comparative Testing: Not specified in terms of "samples." This involves physical measurements and computational modeling of the devices themselves rather than a dataset of patient outcomes.
- Data Provenance: The testing was conducted by Magstim and involved direct comparison of their device (Horizon 3.0) with the predicate (NeuroStar Advanced Therapy System). No country of origin for a data set is specified as it's not a patient-based study. This was primary testing to support the submission (prospective, in a sense, as it was done for the 510(k)).
- Clinical Data (referenced for equivalence, not a new study): The submission explicitly states, "No new clinical data is being leveraged for this 510(k) submission." Instead, it relies on clinical data from previous clearances of the predicate devices (e.g., K220127 for anxiety indication of NeuroStar Advanced Therapy System) and the subject device itself for the MDD indication (K211389, K183376, etc.). A retrospective open-label study is mentioned (Oliveira-Maia, Garcia-Guarniz, et al.) comparing Magstim and NeuroStar treated patients, but details on its sample size or provenance are not provided within this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable for this type of 510(k) submission. Ground truth, in the direct sense of expert labels on clinical data, was not established for a new clinical test set. The submission relies on non-clinical comparative testing and the clinical validity established by the predicate device's existing clearances.
4. Adjudication method for the test set
Not applicable. No clinical test set requiring expert adjudication was part of this 510(k) submission.
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 system, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware/software medical device. While it contains software, its performance is evaluated as an integrated system for delivering TMS therapy, not as a standalone algorithm in the sense of AI for image analysis. The "standalone" performance here refers to the device's ability to generate the specified magnetic and electric fields, which was confirmed through non-clinical testing.
7. The type of ground truth used
For the non-clinical testing:
- The "ground truth" for the magnetic and electric field comparisons was established by direct physical measurements and finite element modeling (FEM) based on established scientific principles and FDA guidance.
- For the clinical indications, the "ground truth" (i.e., that the therapy is safe and effective for the stated indications) is based on the previously cleared clinical evidence for the predicate device (NeuroStar Advanced Therapy System K220127) and earlier clearances for the Magstim device for MDD. This is not "ground truth" generated by this submission directly, but rather relied upon from existing regulatory frameworks.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" in the context of machine learning or AI models within this 510(k) summary. The "training" for this device would refer to the engineering and design process, and the "data" would be the specifications and test results.
9. How the ground truth for the training set was established
Not applicable. As per point 8, there's no mention of a training set in the context this question implies.
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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 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.
March 16, 2023
Magstim Company Ltd. Daniel Gregory Head of Health Software Spring Gardens Whitland, Carmarthenshire SA340HR United Kingdom
Re: K223154
Trade/Device Name: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive transcranial magnetic stimulation system Regulatory Class: Class II Product Code: OBP Dated: October 6, 2022 Received: October 6, 2022
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 (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 located 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.
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely.
Robert Kang -S
for Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223154
Device Name Horizon 3.0 TMS Therapy System
Indications for Use (Describe)
Horizon 3.0 TMS Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
| 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) |
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Image /page/3/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 small registered trademark symbol to the right of the word.
K223154 Traditional 510(k) SUMMARY Magstim's Horizon® 3.0 TMS Therapv System
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 OHR, United Kingdom +44 (0) 1994 240798 Phone: Facsimile: +44 (0) 1994 240061 Contact Person: Daniel Gregory, Head of Health Software (Daniel.gregory@magstim.com)
Date Prepared: March 14, 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, product code OBP
Predicate Devices
K220127 NeuroStar Advanced Therapy, Neuronetics Inc. (Primary Predicate Device), 21 C.F.R § 882.5805, OBP K211389 Horizon® 3.0 TMS Therapy System, The Magstim® Company Limited (Secondary Predicate Device ), 21 C.F.R § 882.5805, OBP
Device Description
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 depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major
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Depressive Disorder (MDD) and who have failed to achieve satisfactory improvement from prior 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 and outpatient 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.
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 depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Technological Characteristics
Horizon® 3.0 TMS Therapy System and its technological characteristics remain almost identical to that cleared within K211389.
The proposed change to treat adult patients with MDD that may also exhibit comorbid anxiety symptoms are limited to updates to the IFU only. This change is made to facilitate safe and effective treatment of adult patients with MDD that exhibit comorbid anxiety symptoms and do not raise new or different questions of safety and effectiveness.
The coil positioning mechanism of action with Horizon 3.0 also remains unchanged from that earlier cleared in K211389, with two options available dependent on Horizon 3.0 configuration. Horizon 3.0 with StimGuide+ offers the ability to locate and determine MT and the location of the treatment location with the use of stereotactic navigation, where standard Horizon 3.0 uses the conventional manual measurement approach.
All other aspects of the device compared to the currently marketed Horizon 3.0 device remain unchanged and are identical.
Non-clinical Testing
Due to the minor nature of changes to the current Horizon 3.0 device, only a limited amount of non-clinical testing was necessary, which is later discussed in substantial equivalence.
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Magnetic and Electrical field comparative testing was performed to demonstrate the Horizon 3.0 stimulating coil to the Primary Predicate Device. The data provided is consistent with the FDA's guidance "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS)" Section 4.
Information has been provided about the magnetic field characteristics including output level linearity, maqnetic field spatial distribution, magnetic field strength gradients and the output waveform in accordance with the special controls guidance listed above. Magnetic field spatial distribution information was also superimposed on T1-weighted MRI coronal, sagittal, and axial 1cm slices. The Electric Field Distribution measurements were performed using a human phantom head model filled with a physiologic saline solution. The above testing was performed both on the subject Horizon 3.0 device as well as the predicate Neuronetics device.
The Horizon 3.0 Ez Cool Coil and the NeuroStar Advanced Therapy Coil electric field profiles have also been modeled in COMSOL and according to the finite element modelling (FEM) and statistical analysis, the induced E-field profiles by the Horizon 3.0 Ez Cool Coil and NeuroStar Advanced Therapy Coil are equivalent and have an average difference of ±5% at distances of 1 to 4 cm from the coil surface.
The testing performed is both described in the software section (Section XVIII) and performance testing section (Section XX).
No further testing for Electrical Safety, Mechanical Safety, Electromagnetic Compatibility, Alarm Systems, Human Factors, Software verification and Biocompatibility was necessary as previous data submitted as part of K211389 premarket notification remains valid to demonstrate safety and effectiveness and support a determination of substantial equivalence. This is re-iterated in Sections XII, XIV, XVII and XIX.
Clinical Testing
No new clinical data is being leveraged for this 510(k) submission and equivalence is being established through a comparison of technological characteristics. As described in the 'Nonclinical Testing' above the Horizon 3.0 including its figure of eight stimulating coil is technologically equivalent to the NeuroStar Advanced Therapy System cleared by the FDA under K220127.
Due to the differing stimulator output power levels between the Horizon 3.0 device and the Primary Predicate NeuroStar Advanced Therapy System (K220127) required to achieve the same stimulating effect, A post-market real-world data analysis, clinical literature review and feedback activity was used to determine that the tolerability profile for the Horizon 3.0 is equivalent to the primary predicate in terms of safety and tolerability even when the power levels are required to be increased to achieve stimulation depths such as 3cm. The observed result is that there was no change in the tolerability profile.
Clinical data that supports that the Horizon 3.0 is safe and effective for the treatment of Maior Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode was demonstrated under K211389, K183376, K182853 and also K180907, K171051, K162935, K171051, K143531.
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As discussed throughout this 510(k) notification, Horizon 3.0, including its figure of eight stimulating coil is technologically considered equivalent to the NeuroStar Advanced Therapy System cleared by the FDA under K221027.
As such, the clinical evidence to support the change to the Horizon 3.0 labelling to extend its indication for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) is supported by FDA clearance of the primary predicate device, the NeuroStar Advanced Therapy by Neuronetics Inc. (K221027).
Thus, the clinical data submitted under the above mentioned 510(k) clearances is valid to demonstrate the safety and effectiveness of the Horizon 3.0® TMS Therapy System which is the subject of this 510(k) submission.
Substantial Equivalence
The proposed change to treat adult patients with MDD that may also exhibit comorbid anxiety symptoms are limited to updates to the IFU only. This change is made to facilitate safe and effective treatment of adult patients with MDD that exhibit comorbid anxiety symptoms and do not raise new or different questions of safety and effectiveness.
Where the labelling has been updated, this has been performed appropriately to identify various contraindications and instructions relevant to the usage of the device as per special controls. Labelling can be found in Section XV.
The focus component of both the subject device and the primary predicate device when considering the extension to the indication for use is the stimulating coil.
Whilst the coil construction characteristics of the Ez Cool Coil and the NeuroStar Advanced Therapy are different, the magnetic field characteristics of the coils are equivalent which is pertinent to treatment delivery effectiveness. Earlier in K143531, the FDA determined that Magstim figure of eight stimulating coils are substantially equivalent to the NeuroStar Advanced Therapy System coil for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from medication in the current episode. This decision was later further substantiated in a retrospective open-label study titled "Comparative Efficacy of Repetitive Transcranial Magnetic Stimulation for Treatment of Depression Using 2 Different Stimulation Devices: A Retrospective Open-Label Study" where the authors Oliveira-Maia, Garcia-Guarniz, et al, conclude that there was no statistically significant differences between outcomes in Magstim and NeuroStar treated patients which is suggestive of equivalent antidepressant efficacy between devices.1
To further substantiate this argument, the Horizon 3.0 Ez Cool Coil and the NeuroStar Advanced Therapy Coil were modeled in COMSOL and according to the finite element modelling (FEM) and statistical analysis, the induced E-field profiles by the Horizon 3.0 Ez Cool Coil and NeuroStar Advanced Therapy Coil are equivalent and have an average difference of ±5% at distances of 1 to 4 cm from the coil surface. For further information on the modelling, please refer to Section XX.
1 (Garcia-Guarniz AL, Sinanis A, Pascual-Leone A, Press D. Comparative efficacy of repetitive transcranial magnetic stimulation for treatment of depression using 2 different stimulation devices: A refrospective open-label study. J Clin Psychiatry 2016;77:e743.)
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The conclusions taken from the COMSOL modelling were further qualified via magnetic field characteristics and electric field testing performed according to the requirements of FDA Guidance Document ""Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems". The testing performed further emphasized the substantial equivalence of the Horizon 3.0 compared to its primary predicate device, the NeuroStar Advanced Therapy System (K220127).
Thus, in summary, as a treatment of adult patients with MDD that may exhibit comorbid anxiety symptoms, the Horizon 3.0 figure of eight stimulating coil is considered equivalent to the NeuroStar Advanced Therapy System coil cleared by the FDA in K220127 and does not raise new or different questions of safety and effectiveness.
All other aspects of the device compared to the currently marketed Horizon 3.0 device remain unchanged and are identical.
Conclusion
In summary, the intended use and indications for use for Horizon 3.0 and it predicate devices are identical.
The minor modifications to Horizon 3.0 to extend the indications for use do not raise new or different questions regarding safety and effectiveness. Where non-clinical testing was performed, this was performed according to well established methods recognized either as an FDA recognized standard, FDA guidance document, scientific literature or via an approach previously accepted by the FDA.
Although the indications have been modified, the overall operating principles of TMS devices for stimulating the cerebral cortex remains the same. Regardless of indication, the same type of energy output is used and the same principles apply to determining a MT hotspot and positioning of the coil for delivery of brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex.
Non-clinical test data collected via well-established methods demonstrates that Horizon 3.0 is as safe and effective as its predicate devices (K211389 and K220127).
Thus, the information and data provided in this 510(k) premarket notification submission support a finding of substantial equivalence for the Horizon 3.0 for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
A tabular comparison of device characteristics can be found on the following page.
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Table 1: Substantial Equivalence Summary
| Criteria | Horizon 3.0 TMS TherapySystem(Subject of this submission) | HORIZON 3.0 TMS TherapySystem(K211389)(Secondary Predicate) | NeuroStar AdvancedTherapy System(K220127)(Primary Predicate) |
|---|---|---|---|
| Manufacturer | Magstim Company Limited | Magstim Company Limited | Neuronetics, Inc. |
| Device Name | Horizon 3.0 TMS TherapySystem | Horizon 3.0 TMS TherapySystem | NeuroStar TMS Therapy System |
| Clearance date | 09/14/2021 | 07/15/2022 | |
| 510(k) number | K211389 | K220127 | |
| Device code | OBP | OBP | OBP |
| Intended Use/Indications for Use | Horizon1 3.0 TMS Therapy System isindicated for the treatment ofdepressive episodes and for decreasinganxiety symptoms for those who mayexhibit comorbid anxiety symptoms inadult patients suffering from MajorDepressive Disorder (MDD) and whohave failed to achieve satisfactoryimprovement from prior antidepressantmedication in the current episode. | The Horizon 3.0 TMS Therapy System isindicated for the treatment of MajorDepressive Disorder in adult patientswho have failed to receive satisfactoryimprovement from prior antidepressantmedication in the current episode. | The NeuroStar Advanced TherapySystem is indicated for the treatmentof depressive episodes and fordecreasing anxiety symptoms for thosewho may exhibit comorbid anxietysymptoms in adult patients sufferingfrom Major Depressive Disorder (MDD)and who have failed to achievesatisfactory improvement from priorantidepressant medication in thecurrent episode. |
| Treatment Parameters | |||
| Magnetic Field Intensity | 120% of the MT | 120% of the MT | 120% of the MT |
| Stimulus Frequency | 10 Hz | 10 Hz | 10 Hz |
| Stimulus Train duration | 4 sec | 4 sec | 4 sec |
| Inter-train interval | 11-26 sec | 11-26 sec | 11-26 sec |
| Number of trains | 75 | 75 | 75 |
| Magnetic Pulses perSession | 3000 | 3000 | 3000 |
| Treatment SessionDuration | 18.8 min-37.5 min | 18.8 min-37.5 min | 18.8 min-37.5 min |
| Sessions/week | 5 | 5 | 5 |
| Treatment Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks |
| Area of brain to bestimulated | Left Dorsolateral PrefrontalCortex | Left Dorsolateral PrefrontalCortex | Left Dorsolateral PrefrontalCortex |
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| Coil Specifications | |||||||
|---|---|---|---|---|---|---|---|
| Horizon®MT Remote Coil | Horizon®3.0 E-zCool Coil | Horizon®3.0 E-zCool Coil(Nav) | Horizon®MT Remote Coil | Horizon®3.0 E-zCool Coil | Horizon® 3.0E-z CoolCoil (Nav) | NeuroStar Stimulating Coil | |
| Waveform | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic |
| Core Material | Air | Air | Air | Air | Air | Air | Ferromagnetic Core |
| Pulse Width | 330μs | 340μs | 340μs | 330μs | 340μs | 340μs | 180μs |
| System Specifications | |||||||
| Amplitude in SMT units(Standard Motor Threshold) | 0.28 - 1.9 | 0.28 - 1.9 | 0.22 - 2.08 | ||||
| Frequency range (Hz) at100% | 1 - 20 | 1 - 20 | 0.1 - 30 | ||||
| Pulse train durationrange (sec) | 0.1 - 600 | 0.1 - 600 | 1-20 | ||||
| Inter-train interval range(sec) | 1 - 540 | 1 - 540 | 10-60 | ||||
| Maximum # of pulses persession(cumulative exposure) | 60000 | 60000 | 5000 | ||||
| Maximum outputamplitude (V/m) at adepth of 2cm below thecoil surface | 150 V/m | 150 V/m | 135 V/m nominal | ||||
| Maximum magnetic fieldstrength (T) at coilsurface | 1.0T | 1.0T | 0.7T | ||||
| Maximum magnetic fieldstrength (T) at a depth of2cm | 0.4T | 0.4T | 0.5T | ||||
| Maximum magnetic fieldgradient (dB/dt) (kT/s) atcoil surface | 18 kT/s | 18 kT/s | 27 kT/s | ||||
| Maximum magnetic fieldgradient (dB/dt) (kT/s) ata depth of 2cm | 10 kT/s | 10 kT/s | 11 kT/s | ||||
| Coil Positioning | |||||||
| System Configuration | Horizon 3.0 | Horizon 3.0withStimGuide+ | Horizon 3.0 | Horizon 3.0withStimGuide+ | NeuroStar Advanced TherapySystem | ||
| Coil Position Principlefor MDD and ComorbidAnxiety Symptoms | Indirecttargeting oftreatmenttarget throughmeasureddistance anddirection(5.5cm) | Indirecttargeting oftreatmenttarget throughmeasureddistance anddirection(5.5cm)from MT | Indirecttargeting oftreatmenttarget throughmeasureddistance anddirection(5.5cm) | Indirecttargeting oftreatmenttarget throughmeasureddistance anddirection(5.5cm)from MT | Indirect targeting of treatmenttarget through measureddistance and direction (5.5cm)from MT Hotspot. Measurederived from statisticaldistance of DLPFC from MThotspot. |
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| from MTHotspot.Measurederived fromstatisticaldistance ofDLPFC fromMThotspot. | stereotacticnavigation.Measurederived fromstatisticaldistance ofDLPFCfrom MThotspot. | from MTHotspot.Measurederived fromstatisticaldistance ofDLPFC fromMThotspot. | stereotacticnavigation.Measurederived fromstatisticaldistance ofDLPFCfrom MThotspot. | ||
|---|---|---|---|---|---|
| MT Response Principlefor MDD and ComorbidAnxiety Symptoms | Visualqualitativemonitoring forAPB response | Option 1. EMGprovidesquantitativedata based onwhich userdefines MT.Option 2.Visualqualitativemonitoring forAPB response | Visualqualitativemonitoring forAPB response | Option 1.EMG providesquantitativedata based onwhich userdefines MT.Option 2.Visualqualitativemonitoring forAPB response | Visual qualitative monitoring forAPB response |
§ 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.