Brainsway Deep TMS System

K203735 · Brainsway , Ltd. · OBP · Apr 23, 2021 · Neurology

Device Facts

• Record ID: K203735
• Device Name: Brainsway Deep TMS System
• Applicant: Brainsway , Ltd.
• Product Code: OBP · Neurology
• Decision Date: Apr 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5805
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BrainsWay Deep TMS System is indicated for the treatment of depressive episodes in adult patients suffering from Major Depressive Disorder who failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode.

Device Story

Brainsway Deep TMS System is an electromechanical device for non-invasive neuromodulation. It uses an electromagnetic coil (H1-Coil) placed against the patient's scalp to deliver brief, rapidly alternating magnetic pulses. These pulses induce electric fields in the prefrontal cortex, causing localized axonal depolarization and neuronal activation. The system includes a mobile cart, neurostimulator, cooling system, positioning arm, and helmet. It is operated by clinicians in hospitals or clinics. The device now supports an intermittent theta-burst (iTBS) stimulation protocol, which delivers 600 pulses in approximately 3 minutes. By providing a shorter treatment duration compared to traditional high-frequency protocols, it improves clinical workflow efficiency while maintaining therapeutic efficacy for MDD patients.

Clinical Evidence

Non-inferiority study comparing iTBS protocol (n=66) to High Frequency (HF) protocol (n=80) using the BrainsWay Deep TMS device. Primary endpoint: change in HDRS-21 score from baseline to 5 weeks. Results showed the upper limit of the confidence interval for the difference between groups was less than the 3-point non-inferiority margin, confirming non-inferiority of iTBS to HF stimulation.

Technological Characteristics

Electromechanical TMS system; air-cooled electromagnetic H1-coil; biphasic waveform; 120% motor threshold intensity. Complies with IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993-5/10, and ISO 14971. Connectivity: Standalone system. Software: IEC 62304 compliant.

Indications for Use

Indicated for adult patients (≥18 years) with Major Depressive Disorder (MDD) who have failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MagVita TMS Therapy System w/ Theta Burst Stimulation (K173620)
• BrainsWay Deep TMS System (K122288)
• BrainsWay Deep TMS System (K173540)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

April 23, 2021

Brainsway Ltd. % Ahava Stein Regulatory Consultant A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 Israel

Re: K203735

Trade/Device Name: Brainsway Deep TMS System (with iTBS Protocol) Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: January 19, 2021 Received: January 25, 2021

Dear Ahava Stein:

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.

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

{1}------------------------------------------------

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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Pamela Scott, M.S. 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K203735

Device Name Brainsway Deep TMS System

Indications for Use (Describe)

The BrainsWay Deep TMS System is indicated for the treatment of depressive episodes in adult patients suffering from Major Depressive Disorder who failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"></span> | <span style="font-size: 10pt;"></span> |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 10pt;"></span> 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."

{3}------------------------------------------------

#### 510(K) SUMMARY

# BRAINSWAY DEEP TMS SYSTEM

### 510(k) Number K203745

#### Applicant Name:

| Company Name: | BrainsWay Ltd |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | BrainsWay Ltd.<br>19 Hartom St. (Bynet Bldg)<br>Har Hotzvim, Jerusalem, ISRAEL 9777518<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |

#### Contact Person:

| Official Correspondent: | Ahava Stein |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Company Name: | A. Stein – Regulatory Affairs Consulting Ltd. |
| Address: | 18 Hata'as Str., Suite 102<br>Kfar Saba 4442520 Israel<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | January 14, 2021 |
| Trade Name: | BrainsWay Deep TMS System (with iTBS Protocol) |

Classification Name: CFR Classification section 882.5805; (Product Code OBP)

Classification: Class II Medical Device

#### Predicate Device:

The subject device is a modification of the BrainsWay Deep TMS System ("reference" predicate device) that was cleared in 510(k) K122288 and the BrainsWay Deep TMS System cleared in 510(k) K173540 ("reference" predicate device). The inclusion of the iTBS stimulation protocol is substantially equivalent to the MagVita TMS Therapy System w/ Theta Burst Stimulation (Tonica Elektronik A/S, cleared in 510(k) K173620 ("main" predicate device).

| Predicate | Device | Manufacturer | 510(k) |
|-----------|----------------------------------------------------------|-----------------------|---------|
| Main | MagVita TMS Therapy System w/ Theta<br>Burst Stimulation | Tonica Elektronik A/S | K173620 |
| Secondary | BrainsWay Deep TMS System | BrainsWay Ltd. | K122288 |

{4}------------------------------------------------

| Secondary | BrainsWay Deep TMS System | BrainsWay Ltd. | K173540 |
|-----------|---------------------------|----------------|---------|
|-----------|---------------------------|----------------|---------|

{5}------------------------------------------------

### Device Description:

The BrainsWay Deep TMS System enables direct non-invasive activation of deep brain structures. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold, and is directed in an appropriate orientation relative the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure.

The BrainsWay Deep TMS System is composed of the following main components:

- 1. Cart
- a) TMS Neurostimulator
- b) Cooling System
- c) Positioning Device
- 2. Helmet
- a) Aiming Apparatus (i.e., ruler/grid)
- b) Electromagnetic Coil (H1-Coil)
- c) Cap

# Intended Use/Indication for Use:

The BrainsWay Deep TMS System is indicated for the treatment of depressive episodes in adult patients suffering from Major Depressive Disorder who failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode.

# Performance Standards:

BrainsWay Deep TMS System complies with the following FDA recognized consensus standards:

- EC 60601-1 Medical Electrical Equipment Part 1: General requirements for . basic safety and essential performance (Ed 3.1, 2005 + CORR.1:2006 + CORR.2:2007 + A1:2012 AND 2006 + AC:2010 + A1:2013)
- IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and test (Ed 4 2014)
- IEC 62304 Medical Devices Software life-cycle processes (2006 + A1:2015) .
- ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro ● cvtotoxicitv
- . ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and delaved-type hypersensitivity
- ISO 14971 Medical devices Application of risk management to medical devices .

{6}------------------------------------------------

### Non-Clinical (Bench) Performance Data:

The clinical performance of iTBS is dependent on the stimuli being delivered at an equal intensity, to ensure that a constant dose of stimuli is delivered during treatment. The Theta Burst Stimulation verification testing demonstrated that the intensity of the individual stimuli in iTBS stimulation protocol is equal and maintained constant throughout the delivery of the entire treatment.

Tests were conducted on the cleared BrainsWay Deep TMS Systems for the iTBS stimulation protocol according to the FDA Guidance Document Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems. These tests included Output Waveform, Electrical Field Spatial Distribution and Magnetic Field Strength Gradient Testing. Additional performance testing included electrical and mechanical safety testing, electromagnetic compatibility testing and software validation testing in compliance with FDA guidelines for software validation and IEC 62304 standard requirements. The results of the performance tests demonstrated that the Brains Way Deep TMS System is substantially equivalent to the predicate device.

# Animal Performance Data / Histology Data:

Not Applicable

# Clinical Performance Data:

The safety and effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (TMS) device for the intended use of Major Depressive Disorder (MDD) using the intermittent theta-burst (iTBS) stimulation protocol was demonstrated in a non-inferiority analysis, comparing the iTBS treatment with the FDA cleared BrainsWay Deep TMS device to the High Frequency (HF) protocol using the same device. Following is a summary of the study.

| Study Objective | The objective of the current study was to evaluate the non-<br>inferiority of the iTBS stimulation protocol with the BrainsWay<br>Deep TMS (H1-Coil) System compared to the FDA-cleared<br>High Frequency (HF) stimulation protocol using the same<br>BrainsWay Deep TMS (H1-Coil) System, for the treatment of<br>MDD. |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Study duration | 5 weeks |
| Number of subjects | 66 subjects received iTBS stimulation protocol and 80 subjects<br>received HF stimulation protocol. |
| Primary Endpoint | The primary efficacy endpoint was the change from baseline to<br>5 weeks visit (after 20 treatment sessions) in the patients<br>depression level as measured by the HDRS-21 score |
| Secondary Endpoints | HDRS-21 Response Rate at 5 weeks, where response is defined as a ≥50% reduction in HDRS-21 score from baseline HDRS-21 Remission Rate at 5 weeks, where remission is defined as HDRS-21 score < 10 Change in CGI-S from baseline to 6 weeks CGI-S Response Rate at 6 weeks, where response is defined as 2 point reduction in CGI-S score from baseline CGI-S Remission Rate at 6 weeks, where remission is defined as CGI-S score ≤ 2 |
| Intervention | iTBS stimulation protocol compared to High Frequency (HF) stimulation protocol (both stimulation protocols were delivered using the FDA cleared BrainsWay Deep TMS device). |
| Eligibility criteria | Outpatients Men and women ≥ 18 years of age (or 22-68 years of age in the multicenter MDD study) Diagnosis of Major Depression Disorder |
| Study Hypothesis | Null Hypothesis: The mean change in HDRS-21 score from baseline at 5 weeks in the iTBS Deep TMS group is inferior to the mean change in HDRS-21 score from baseline at 5 weeks in the HF Deep TMS group, by more than 3 points.<br>Alternative Hypothesis: The mean change in HDRS-21 score from baseline at 5 weeks in the iTBS Deep TMS group is inferior to the mean change in HDRS-21 score from baseline at 5 weeks in the HF Deep TMS group, by less than 3 points, i.e. is non-inferior. |
| Summary of Results | The non-inferiority analysis of the change from baseline between the two treatment groups was assessed. Since the upper limit of the confidence interval was less than the non-inferiority margin of 3 points, the null hypothesis of inferiority was rejected, indicating non-inferiority between the iTBS Deep TMS and HF Deep TMS treatments, when adjusted for baseline HDRS-21 scores. In summary, the change from baseline was similar between the two treatment groups at 5 weeks, which demonstrated the non-inferiority of the iTBS Deep TMS treatment |

{7}------------------------------------------------

Based on clinical results, the BrainsWay Deep TMS device with iTBS is as safe and effective as the predicate devices and enables a reduced treatment time for the benefit of both patient and operator.

### Substantial Equivalence:

The following table describes the similarities and differences between the new BrainsWay Deep TMS System and the predicate devices.

{8}------------------------------------------------

# TABLE 1: COMPARISON OF THE MODIFIED BRAINSWAY DEEP TMS SYSTEM TO THE CLEARED BRAINSWAY DEEP TMS SYSTEMS (K122288 & K173540) AND THE MAGVITA TMS THERAPY SYSTEM W/ THETA BURST STIMULATION (TONICA ELEKTRONIK A/S (K173620)

| Technological<br>Characteristic | BrainsWay Deep TMS<br>System (Models 102 & 104)<br>with the Theta Burst<br>stimulation protocol | BrainsWay Deep TMS<br>System (Models 102 & 104)<br>(K122288 and K173540)<br>(Secondary Predicates) | MagVita TMS Therapy<br>System w/ Theta Burst<br>Stimulation (Tonica Elektronik<br>A/S) (K173620) (Main Predicate) |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code,<br>Class | OBP<br>Class II | OBP<br>Class II | OBP<br>Class II |
| Indications for Use | The BrainsWay Deep TMS<br>System is indicated for the<br>treatment of depressive episodes<br>in adult patients suffering from<br>Major Depressive Disorder who<br>failed to achieve satisfactory<br>improvement from previous anti-<br>depressant medication treatment<br>in the current episode. | The BrainsWay Deep TMS<br>System is indicated for the<br>treatment of depressive episodes<br>in adult patients suffering from<br>Major Depressive Disorder who<br>failed to achieve satisfactory<br>improvement from previous anti-<br>depressant medication treatment<br>in the current episode. | The MagVita TMS Therapy<br>System w/ Theta Burst Stimulation<br>is indicated for the treatment of<br>Major Depressive Disorder in adult<br>patients who have failed to receive<br>satisfactory improvement from<br>prior antidepressant medication in<br>the current episode. |
| Target Population | Adult subjects with Major<br>Depressive Disorder | Adult subjects with Major<br>Depressive Disorder | Adult subjects with Major<br>Depressive Disorder |
| Anatomical Sites | Head – stimulation to the<br>prefrontal cortex | Head – stimulation to the<br>prefrontal cortex | Head – stimulation to the prefrontal<br>cortex |
| Environment Used | Hospitals, Clinics | Hospitals, Clinics | Hospitals, Clinics |
| Energy Used /<br>Delivered | Electromagnetic Energy is<br>delivered | Electromagnetic Energy is<br>delivered | Electromagnetic Energy is<br>delivered |
| Design: | The BrainsWay Deep TMS<br>System design is based on<br>applying transcranial magnetic<br>stimulation by means of repetitive<br>pulse trains at a predetermined<br>frequency | The BrainsWay Deep TMS<br>System design is based on<br>applying transcranial magnetic<br>stimulation by means of repetitive<br>pulse trains at a predetermined<br>frequency | The MagVita System design is<br>based on applying transcranial<br>magnetic stimulation by means of<br>repetitive pulse trains at a<br>predetermined frequency. |
| Technological<br>Characteristic | BrainsWay Deep TMS<br>System (Models 102 & 104)<br>with the Theta Burst<br>stimulation protocol | BrainsWay Deep TMS<br>System (Models 102 & 104)<br>(K122288 and K173540)<br>(Secondary Predicates) | MagVita TMS Therapy<br>System w/ Theta Burst<br>Stimulation (Tonica Elektronik<br>A/S) (K173620) (Main Predicate) |
| - Mechanism of<br>Action | The BrainsWay Deep TMS<br>System is an electromechanical<br>instrument that produces and<br>delivers brief duration, rapidly<br>alternating (pulsed) magnetic<br>fields to induce electrical currents<br>in localized regions of the<br>prefrontal cortex. This is a non-<br>invasive tool for the stimulation<br>of cortical neurons for the<br>treatment of adult patients with<br>Major Depressive Disorder<br>(MDD). | The BrainsWay Deep TMS<br>System is an electromechanical<br>instrument that produces and<br>delivers brief duration, rapidly<br>alternating (pulsed) magnetic<br>fields to induce electrical currents<br>in localized regions of the<br>prefrontal cortex. This is a non-<br>invasive tool for the stimulation<br>of cortical neurons for the<br>treatment of adult patients with<br>Major Depressive Disorder<br>(MDD). | The MagVita System is an<br>electromechanical instrument that<br>produces and delivers brief<br>duration, rapidly alternating<br>(pulsed) magnetic fields to induce<br>electrical currents in localized<br>regions of the prefrontal cortex.<br>This is a non-invasive tool for the<br>stimulation of cortical neurons for<br>the treatment of adult patients with<br>Major Depressive Disorder<br>(MDD). |
| - Components | The BrainsWay Deep TMS System<br>consists of the following<br>components:<br>- Mobile Cart<br>- Coil & Helmet Unit<br>- Positioning Arm<br>- Cooling System<br>- TMS stimulator & Software<br>(BrainsWay stimulator in Model 104<br>& Magstim stimulator in Model 102) | The BrainsWay Deep TMS System<br>consists of the following<br>components:<br>- Mobile Cart<br>- Coil & Helmet Unit<br>- Positioning Arm<br>- Cooling System<br>- TMS stimulator & Software<br>(BrainsWay stimulator in Model 104<br>& Magstim stimulator in Model 102) | The MagVita System consists of the<br>following components:<br>- Trolley<br>- Coil<br>- Arm mounted on the trolley<br>- Coil Cooler Unit<br>- MagPro Stimulator |
| Technological<br>Characteristic | BrainsWay Deep TMS<br>System (Models 102 & 104)<br>with the Theta Burst<br>stimulation protocol | BrainsWay Deep TMS<br>System (Models 102 & 104)<br>(K122288 and K173540)<br>(Secondary Predicates) | MagVita TMS Therapy<br>System w/ Theta Burst<br>Stimulation (Tonica Elektronik<br>A/S) (K173620) (Main Predicate) |
| - Accessories | The BrainsWay Deep TMS System<br>consists of the following<br>accessories:<br>- Head Cap<br>- Head Positioning Straps<br>- Earplugs | The BrainsWay Deep TMS System<br>consists of the following<br>accessories:<br>- Head Cap<br>- Head Positioning Straps<br>- Earplugs | The MagVita System consists of the<br>following accessories:<br>- Head Cap<br>- Holding arrangements<br>- Marking plate, pen and ruler<br>- Patient head fixation with treatment<br>Chair<br>- Vacuum Pump and Vacuum pillow |
| Performance | Treatment Parameters:<br>- Magnetic Field Intensity: 120% of<br>the patient's observed motor<br>threshold.<br>- Repetition rate: 50 Hz<br>- Train duration: 2 sec<br>- Inter-train interval: 8 sec<br>- Burst pulses: 3<br>- Bursts : 200<br>- Number of trains: 20<br>- Magnetic Pulses per Session: 600<br>- Treatment Session Duration:<br>approximately 3 minutes<br>- Sessions per Week: 5<br>- 5 daily sessions for 4 weeks<br>- Bi-weekly sessions for another 12<br>weeks (optional maintenance<br>treatments) | Treatment Parameters:<br>- Magnetic Field Intensity: 120% of<br>the patient's observed motor<br>threshold.<br>- Frequency: 18 Hz<br>- Train duration: 2 sec<br>- Inter-train interval: 20 sec<br>- Burst pulses: NA<br>- Bursts : NA<br>- Number of trains: 55<br>- Magnetic Pulses per Session: 1980<br>- Treatment Session Duration:<br>approximately 20.2 minutes<br>- Sessions per Week: 5<br>- 5 daily sessions for 4 weeks<br>- Bi-weekly sessions for another 12<br>weeks (optional maintenance<br>treatments) | Treatment Parameters:<br>- Magnetic Field Intensity: 120% of<br>the patient's observed motor<br>threshold.<br>- Repetition rate: 50 Hz<br>- Train duration: 2 sec<br>- Inter-train interval: 8 sec<br>- Burst pulses: 3<br>- Bursts : 200<br>- Number of trains: 20<br>- Magnetic Pulses per Session: 600<br>- Treatment Session Duration:<br>approximately 3 minutes<br>- Sessions per Week: 5<br>- 5 daily sessions for 6 weeks |
| | Waveform: Biphasic | Waveform: Biphasic | Waveform: Biphasic |
| | Output Stimulation Parameters:<br>Available Stimulation Amplitude in<br>Standard Motor Threshold (SMT)<br>units Amplitude Range: 0.6-1.4 SMT | Output Stimulation Parameters:<br>Available Stimulation Amplitude in<br>Standard Motor Threshold (SMT)<br>units Amplitude Range: 0.6-1.4 SMT | Output Stimulation Parameters:<br>Available Stimulation Amplitude in<br>Standard Motor Threshold (SMT)<br>units Amplitude Range: 0 - 1.7 SMT |
| Technological<br>Characteristic | BrainsWay Deep TMS<br>System (Models 102 & 104)<br>with the Theta Burst<br>stimulation protocol | BrainsWay Deep TMS<br>System (Models 102 & 104)<br>(K122288 and K173540)<br>(Secondary Predicates) | MagVita TMS Therapy<br>System w/ Theta Burst<br>Stimulation (Tonica Elektronik<br>A/S) (K173620) (Main Predicate) |
| Coil<br>Configuration | Deep TMS coil<br>Air core | Deep TMS coil<br>Air core | Figure-of-eight coil<br>Air core |
| Cooling | Air cooling | Air cooling | Liquid cooling |
| Standards Met | Company complies with ISO<br>13485:2016 | Company complies with ISO<br>13485:2016 | Company complies with ISO<br>13485:2012 |
| Electrical & EMC<br>Safety | IEC 60601-1<br>IEC 60601-1-2<br>IEC 62304 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 62304 | IEC 60601-1<br>IEC 60601-1-2 |

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

{12}------------------------------------------------

The modified device has the same intended use as the BrainsWay Deep TMS Systems cleared in 510(k) K122288 and K173540. The subject device includes a Theta Burst stimulation protocol for the same intended use. The inclusion of the iTBS stimulation protocol is substantially equivalent to the Mag Vita TMS Therapy System w/ Theta Burst Stimulation (Tonica Elektronik A/S, cleared in 510(k) K173620).

Both the modified device and the cleared BrainsWay Deep TMS Systems are similar in terms of their intended prescription use only, suitable for adult population, indicated for anatomical sites according to indications for use and to be used in hospital or clinic settings.

All components of the subject BrainsWay Deep TMS System are identical to the previously cleared, predicate devices and have the same mechanism of operation and use the same underlying technology. The performance characteristics, including the Output Waveform, Electrical Field Spatial Distribution and Magnetic Field Strength Gradient are the same as the previously cleared BrainsWay Deep TMS Systems (K122288 and K173540). The additional non-clinical and clinical performance tests demonstrated substantial equivalence of the subject BrainsWay Deep TMS device to the predicate devices for the iTBS stimulation protocol.

#### Conclusions:

Consequently, it can be concluded that the modified BrainsWay Deep TMS System is substantially equivalent to the predicate BrainsWay Deep TMS System, cleared under 510(k) K122288 and the BrainsWay Deep TMS System, cleared under 510(k) K173540. The inclusion of the iTBS stimulation protocol is substantially equivalent to the MagVita TMS Therapy System w/ Theta Burst Stimulation (Tonica Elektronik A/S, cleared in 510(k) K173620). Therefore, the modified BrainsWay Deep TMS Systems can be legally marketed in the USA.