(268 days)
No
The summary describes a standard TMS device with software for treatment and data management. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
Explanation: The device is indicated for the "treatment of Major Depressive Disorder in adult patients" and delivers "magnetic field to the cerebral cortex in order to activate neurons". This indicates a therapeutic function.
No
The device is indicated for the treatment of Major Depressive Disorder, not for diagnosis. It delivers a magnetic field to activate neurons for therapeutic purposes.
No
The device description explicitly lists hardware components such as the Main Unit, Stimulation Coil, and Coil Positioning System, in addition to the software.
Based on the provided information, the Apollo TMS Therapy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Apollo TMS Therapy System Function: The description clearly states that the Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a magnetic field to the cerebral cortex. It directly interacts with the patient's brain for therapeutic purposes (treating Major Depressive Disorder).
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient.
Therefore, the Apollo TMS Therapy System falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Apollo 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.
Product codes
OBP
Device Description
The Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS).
The Apollo TMS Therapy System is comprised of the following principal components:
- User Interface
- Main Unit (with or without housing)
- Stimulation Coil
- Coil Positioning System
The operator controls the Apollo TMS Therapy System via the user interface (application software "Stimware"). "Stimware" is a treatment and data management software that administrates treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. Stimulation is applied via the stimulation coil which is positioned to the left dorsolateral prefrontal cortex (DLPFC) by means of a coil positioning system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral cortex, left dorsolateral prefrontal cortex (DLPFC)
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing was performed according to the standards listed above, including electrical safety, electromagnetic compatibility and biocompatibility as required and already cleared by the FDA earlier in K180313. To establish substantial equivalence for the additional coils PMD70-pCool, HANS-aCool, PMD70-aCool and the HANS-Coil cleared by the FDA earlier in K180313, a comparative testing of the technological characteristics has been performed. Configuration, technological characteristics, and magnetic field characteristics are substantially equivalent to the predicate devices.
The clinical performance of iTBS depends on the stimuli being delivered at equal intensity, to ensure that a constant dose of stimuli is maintained during treatment. Clinical data on treatment efficacy of the iTBS protocol has already been demonstrated in Summary K173620. Additional verification testing has demonstrated that the intensity of the individual stimuli in iTBS is equal and kept constant throughout the delivery of the full treatment. This was successfully demonstrated for the pCool coils and aCool coils of the subject device and therefore, is substantially equivalent to the primary predicate HORIZON ® TMS Therapy System (cleared in K182853). Additional clinical performance data is not required to demonstrate safety and effectiveness of the iTBS treatment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
HORIZON ® TMS Therapy System (K182853), Apollo TMS Therapy System (K180313)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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May 24, 2024
MAG & More GmbH Juliane Rieß Regulatory Affairs Manager Machtlfinger Straße 13 Munich, 81379 Germany
Re: K232639
Trade/Device Name: Apollo TMS Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: April 30, 2024 Received: April 30, 2024
Dear Juliane Rieß:
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.
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).
1
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).
Sincerely,
Pamela D. Scott -S
Pamela Scott, MS 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
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Indications for Use
Submission Number (if known)
Device Name
Apollo TMS Therapy System
Indications for Use (Describe)
The Apollo 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.
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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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
| 510(k) Owner: | MAG & More GmbH
Machtlfinger Straße 13
81379 Munich, Germany
Phone: +49 (0)89 998 292 300
Fax: +49 (0)89 998 292 301 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Juliane Rieß |
| Date Prepared: | 30-Apr-2024 |
| Proprietary Name: | Apollo TMS Therapy System |
| Common/Usual Name: | Repetitive Transcranial Magnetic Stimulation (rTMS) System |
| Classification Name: | Repetitive Transcranial Magnetic Stimulation Device
21 CFR 882.5805, Product Code OBP |
| Predicate Device: | HORIZON ® TMS Therapy System (K182853)
Apollo TMS Therapy System (K180313) |
Intended Use
The Apollo 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.
Device Description and Function
The Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS).
The Apollo TMS Therapy System is comprised of the following principal components:
- User Interface
- Main Unit (with or without housing)
- Stimulation Coil
- Coil Positioning System
The operator controls the Apollo TMS Therapy System via the user interface (application software "Stimware"). "Stimware" is a treatment and data management software that administrates treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. Stimulation is applied via the stimulation coil which is positioned to the left dorsolateral 510(k) Summary Page 1 of 9
4
prefrontal cortex (DLPFC) by means of a coil positioning system. The observed and documented increase in cortical excitability after high frequency (10Hz) rTMS has been shown to persist beyond the duration of the train of stimulation.
Performance Standards
The Apollo TMS Therapy System conforms to the following recognized consensus standards:
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a ● risk management process
- IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- . IEC 62304 Medical device software - Software life cycle processes
Further Applicable Standards
The Apollo TMS Therapy System complies with applicable requirements of the following additional standards:
- -ISO 14971 Medical devices - Application of risk management to medical devices
- -ISO 15223 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements
- -IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
Non-Clinical and Clinical Performance Data
The contents of this 510(k) complies with the FDA Guidance Document: "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems - Guidance for Industry and Food and Drug Administration Staff." Non-clinical performance testing was performed according to the standards listed above, including electrical safety, electromagnetic compatibility and biocompatibility as required and already cleared by the FDA earlier in K180313. To establish substantial equivalence for the additional coils PMD70-pCool, HANS-aCool, PMD70-aCool and the HANS-Coil cleared by the FDA earlier in K180313, a comparative testing of the technological characteristics has been performed. Configuration, technological characteristics, and magnetic field characteristics are substantially equivalent to the predicate devices.
The clinical performance of iTBS depends on the stimuli being delivered at equal intensity, to ensure that a constant dose of stimuli is maintained during treatment. Clinical data on treatment efficacy of the iTBS protocol has already been demonstrated in Summary K173620. Additional verification testing has demonstrated that the intensity of the individual stimuli in iTBS is equal and kept constant throughout the delivery of the full treatment. This was successfully demonstrated for the pCool coils and aCool coils of the subject device and therefore, is substantially equivalent to the primary predicate
5
HORIZON ® TMS Therapy System (cleared in K182853). Additional clinical performance data is not required to demonstrate safety and effectiveness of the iTBS treatment.
Software Verification and Validation Testing
Software verification and validation testing was conducted and documented in accordance with IEC 62304 and the documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
The software documentation for this device is considered as "basic documentation" (supported by Special Controls Guidance "rTMS Class Il"), since a failure or flaw of any device software function(s) could not present a hazardous situation with a probable risk of death or serious injury, either to a patient, user of the device, or others in the environment of use.
Risk Management
Risk assessment is applied throughout the product development lifecycle process in accordance with the requirements set forth under the Agency recognized consensus standards ISO 14971 and IEC 62304. The results of the comprehensive risk analysis for the device indicate that there are no new hazards, harms, or safety risks introduced when compared to the predicate devices. Furthermore, the iTBS protocol is a well-established stimulation protocol, that has shown similar side-effects and safety compared to the standard stimulation protocol (Blumberger et al. 2018-).
Substantial Equivalence
The Apollo TMS Therapy System is substantially equivalent to its predicate devices, the HORIZON® TMS Therapy System (K182853) and Apollo TMS Therapy System (K180313). The intended use and indications for use for the Apollo TMS Therapy System and predicate devices are identical.
The Apollo TMS Therapy System and the secondary predicate device have equivalent system components, consisting of a main unit (available in two variants 918001 Apollo and 918010 Apollo Light) including the stimulation coil, a coil positioning system, and the application software. The basic operational procedure is identical consisting of system setup, patient preparation, coil positioning, determination of patient's motor threshold, and administration of treatment at predefined treatment stimulation parameters.
Treatment efficacy depends on the applied treatment protocol of the subject device Apollo TMS Therapy System is identical to that of the primary predicate device HORIZON ® TMS Therapy System cleared in K182853. The clinical performance of iTBS depends on the stimuli being delivered at equal intensity, to ensure that a constant dose of stimuli is maintained during treatment. The equal and constant intensity of individual stimuli being delivered was successfully demonstrated for the pCool coils (510570 HANS-pCool, 510565 PMD70-pCool) and aCool coils (510580 HANS-aCool, 510575 PMD70-aCool) of the subject device throughout the full iTBS treatment. Therefore, the subject device is substantially equivalent to the primary predicate HORIZON ® TMS Therapy System (K182853) in terms of iTBS treatment.
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The HANS-coil already cleared in K180313 is identical to the HANS-pCool and to the PMD70-pCool (PMD70-pCool without the exterior plastic adapter). Both, the pCool and aCool coils of the subject device Apollo TMS Therapy System have the identical coil winding configuration compared to the HANS-Coil cleared in K180313 and thus can be considered as substantially equivalent. The minor difference in the cooling technology between the aCool coils of the subject device, and the HANS-Coil of the Apollo TMS Therapy System cleared in K180313 does not alter the electromagnetic field profile or the stimulation efficacy.
Conclusions
The indication for use, the target population, the treatment procedure, and the treatment spot are all 100 % identical for the Apollo TMS Therapy System and the predicate devices HORIZON ® TMS Therapy System (K182853) and Apollo TMS Therapy System (K180313).
The performance and the clinical effectiveness are substantially equivalent and the iTBS treatment parameters are identical to those of the primary predicate device HORIZON ® TMS Therapy System (K182853). Non-clinical performance testing has demonstrated that the technological characteristics of the aCool-coils (HANS-aCool and PMD70-aCool) and the PMD70-pCool of the subject device are substantially equivalent to the HANS-coil of the secondary predicate Apollo TMS Therapy System (K180313). Additional verification testing has demonstrated that the intensity of the individual stimuli in iTBS is equal and kept constant throughout the delivery of the full treatment with the Apollo TMS Therapy System. This provides a consistent treatment dose that is clinically effective when treating patients with the Apollo TMS Therapy System. This demonstrates that the Apollo TMS Therapy System is as safe and effective for use in treatment of Major Depressive Disorder as the primary predicate device.
All identified differences between the subject device Apollo TMS Therapy System and its predicate devices are minor and without any impact on safety or effectiveness. The subject device Apollo TMS Therapy System does not introduce any new safety considerations.
Therefore, the Apollo TMS Therapy System can be considered to be substantially equivalent to its predicate devices HORIZON ® TMS Therapy System (K182853) and Apollo TMS Therapy System (K180313).
² Daniel M Blumberger, Fidel Vila-Rodriguez, Kir Feffer, Yoshihiro Noda, Peter Giacobbe, Yuliya Knyahnytska, Sidney H Kennedy, Raymond W Lam, Zafrirs I Daskalakis, Jonathan Downar: Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial; The Lancet 391:10131, 1637-1748
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Substantial Equivalence Comparison
| Characteristic | Subject Device | Predicate Device | Secondary Predicate |
|---|---|---|---|
| 510(k) Number | K232639 | K182853 | K180313 |
| Device Trade | |||
| Name | Apollo TMS Therapy System | HORIZON ® TMS Therapy System | Apollo TMS Therapy System |
| 510(k) submitter | MAG & More GmbH | ||
| Machtlfinger Straße 13 | |||
| 81379 Munich, Germany | Magstim Company Limited | ||
| Spring Gardens, Whitland, | |||
| Carmarthenshire | |||
| SA34 OHR, United Kingdom | MAG & More GmbH | ||
| Machtlfinger Straße 13 | |||
| 81379 Munich, Germany | |||
| Indications for use | The Apollo TMS Therapy System is | ||
| indicated for the treatment of | |||
| Major Depressive Disorder in adult | |||
| patients who have failed to achieve | |||
| satisfactory improvement from | |||
| prior antidepressant medication in | |||
| the current episode. | The HORIZON® TMS Therapy System | ||
| is indicated for the treatment of | |||
| Major Depressive Disorder in adult | |||
| patients who have failed to achieve | |||
| satisfactory improvement from prior | |||
| antidepressant medication in the | |||
| current episode. | The Apollo 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. | |||
| Product Code | OBP | OBP | OBP |
| Classification | 21 CFR 882.5805 | 21 CFR 882.5805 | 21 CFR 882.5805 |
| Standard Treatment Stimulation Parameters | |||
| Area of brain to be | |||
| stimulated | Left DLPFC | Left DLPFC | Left DLPFC |
| Stimulation | |||
| intensity | 120% of MT | 120% of MT | 120% of MT |
| %MT range | 50% to 150% MT | 0% to 200% MT | 50% to 150% MT |
| Characteristic | Subject Device | Predicate Device | Secondary Predicate |
| Stimulation | |||
| frequency | 10 Hz | 10 Hz | 10 Hz |
| Pulse train | |||
| duration | 4 sec | 4 sec | 4 sec |
| Inter-train interval | 11 – 26 sec | 11 – 26 sec | 11 – 26 sec |
| Trains per session | 75 | 75 | 75 |
| Max No. of Pulses | 3,000 | 3,000 | 3,000 |
| Output Stimulation Parameters | |||
| Amplitude in SMT | |||
| units | 0 – 2.0 SMT | 0.28 – 1.9 SMT | 0 – 2.0 SMT |
| Pulse width (± | |||
| accuracy) | pCool coils: | ||
| HANS-pCool | |||
| PMD70-pCool | |||
| $162 \mu s \pm 1.9 \mu s$ | aCool coils: | ||
| HANS-aCool | |||
| PMD70-aCool | |||
| $163 \mu s \pm 2.5 \mu s$ | HORIZON® | ||
| MT Remote | |||
| Coil | |||
| $330 \mu s$ | |||
| HORIZON® | |||
| E-z Cool | |||
| Coil | |||
| $340 \mu s$ | HORIZON® | ||
| AFC | |||
| $300 \mu s$ | |||
| HANS-Coil | |||
| $167 \mu s (\pm 10%)$ | |||
| Frequency (± | |||
| accuracy) | 30-100 Hz (± 2%) | 1 – 20 Hz | 30-100 Hz (± 2%) |
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9
| Characteristic | Subject Device | Predicate Device | Secondary Predicate | |||
|---|---|---|---|---|---|---|
| Stimulation Coil Parameters | ||||||
| Coil | pCool coils: | |||||
| HANS-pCool | ||||||
| PMD70-pCool | aCool coils: | |||||
| HANS-aCool | ||||||
| PMD70-aCool | HORIZON® | |||||
| MT Remote | ||||||
| Coil | HORIZON® | |||||
| E-z Cool | ||||||
| Coil | HORIZON® | |||||
| AFC | HANS-Coil | |||||
| Configuration | figure-of-eight coil | figure-of-eight coil | figure-of-eight coil | |||
| Output waveform | biphasic | biphasic | biphasic | |||
| Cooling | passive cooling | active air- | ||||
| cooling | air | passive cooling | ||||
| Coil winding: N | 10 on each side | 9 on each | ||||
| side | 3x23 on | |||||
| each side | 3x19 on | |||||
| each side | 10 on each side | |||||
| Coil winding: inner | ||||||
| diameter | 20 mm | 55 mm | 37.5 mm | 43 mm | 20 mm | |
| Coil winding: outer | ||||||
| diameter | 80 mm | 92 mm | 97 mm | 92 mm | 80 mm | |
| Coil winding: wire | ||||||
| diameter | 6.4 mm * 2.9 mm | - | - | - | 6.4 mm * 2.9 mm | |
| Surface tempera- | ||||||
| ture at max output | iTBS Treatment Protocol | - | - | - | ||
| Area of brain to be | ||||||
| stimulated | Left DLPFC | Left DLPFC | - | |||
| Stimulation | ||||||
| Intensity | 120% of the MT | 120% of the MT | - | |||
| Repetition Rate | 50 Hz (5 pulses per sec) | 50 Hz (5 pulses per sec) | - | |||
| Train Duration | 2 sec | 2 sec | - | |||
| Inter-train Interval | 8 sec | 8 sec | - | |||
| Burst Pulses | 3 | 3 | - | |||
| Bursts | 200 | 200 | - | |||
| Inter Pulse interval | 20 ms | 20 ms | - | |||
| Number of trains | 20 | 20 | - | |||
| Number of Pulses | ||||||
| per Session | 600 | 600 | - | |||
| Characteristic | Subject Device | Predicate Device | Secondary Predicate | |||
| Treatment Session Duration | 3.09 min | 3.09 min | - | |||
| Sessions/week | 5 | 5 | - | |||
| Treatment | ||||||
| Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | - |
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