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 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
1. Helmet
- a) Aiming Apparatus (i.e., ruler/grid)
- b) Electromagnetic Coil (H1-Coil)
- c) Cap

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BrainsWay Deep TMS System with iTBS Protocol, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are established through demonstrating non-inferiority of the new iTBS protocol compared to an already FDA-cleared High Frequency (HF) protocol for the same device. The primary endpoint for non-inferiority was the change in HDRS-21 score.

Acceptance Criteria (Study Hypothesis - Null Hypothesis)	Reported Device Performance (Summary of Results)
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. (Non-inferiority margin: 3 points)	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.
Secondary Endpoints (No specific numerical acceptance criteria mentioned, but demonstrate similar performance)	HDRS-21 Response Rate at 5 weeks, HDRS-21 Remission Rate at 5 weeks, Change in CGI-S from baseline to 6 weeks, CGI-S Response Rate at 6 weeks, CGI-S Remission Rate at 6 weeks. (The document states "the change from baseline was similar between the two treatment groups at 5 weeks," implying similar performance on these secondary endpoints as well.)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: 146 subjects
- 66 subjects received iTBS stimulation protocol.
- 80 subjects received HF stimulation protocol.
Data Provenance: Not explicitly stated as retrospective or prospective, nor country of origin. However, given it's a clinical study for FDA clearance, it's highly likely to be a prospective multi-center study, though the specific locations are not provided in this summary. The mention of "multicenter MDD study" for age eligibility criteria might hint at a multi-site study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This particular study does not involve establishing ground truth through expert review of specific data like images. Instead, the "ground truth" for the effectiveness of the treatment is based on patient-reported outcomes and clinician-administered scales (HDRS-21, CGI-S), which inherently involve expert clinicians in their administration and interpretation during the study.

4. Adjudication Method

Not applicable in the typical sense of radiological or pathological adjudication. The primary and secondary endpoints are based on standardized clinical assessment scales (HDRS-21, CGI-S) administered by qualified clinical personnel as part of the study protocol.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This study is a clinical trial comparing two different stimulation protocols (iTBS vs. HF) on human patients for Major Depressive Disorder (MDD), not a reader study involving interpretation of cases by multiple human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is a medical device for treatment, not an AI/algorithm for diagnosis or analysis where standalone performance would typically be evaluated. The "performance" being assessed is the clinical effectiveness of the device (iTBS protocol) in treating MDD. Therefore, a standalone algorithm-only performance study is not applicable.

7. The Type of Ground Truth Used

The ground truth used for determining the effectiveness of the device in this clinical study is:

Clinical Outcomes Data: Specifically, changes in patient depression levels as measured by established clinical rating scales (HDRS-21 and CGI-S scores) from baseline to follow-up, along with derived response and remission rates.

8. The Sample Size for the Training Set

Not applicable. This document describes a clinical study to evaluate the effectiveness of a medical device's protocol, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned or implied for a machine learning algorithm. The "training" for this device refers to the clinical application of the stimulation protocol in the context of treating patients.

Summary

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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

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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Indications for Use

510(k) Number (if known) K203735

Device Name Brainsway Deep TMS System

Indications for Use (Describe)

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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510(K) SUMMARY

BRAINSWAY DEEP TMS SYSTEM

510(k) Number K203745

Applicant Name:

Company Name:	BrainsWay Ltd
Address:	BrainsWay Ltd.19 Hartom St. (Bynet Bldg)Har Hotzvim, Jerusalem, ISRAEL 9777518Tel: +972-2-5813140Fax: +972-2-5812517E-mail: ahava@asteinrac.com

Contact Person:

Official Correspondent:	Ahava Stein
Company Name:	A. Stein – Regulatory Affairs Consulting Ltd.
Address:	18 Hata'as Str., Suite 102Kfar Saba 4442520 IsraelTel: +972-9-7670002Fax: +972-9-7668534E-mail: ahava@asteinrac.com
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/ ThetaBurst Stimulation	Tonica Elektronik A/S	K173620
Secondary	BrainsWay Deep TMS System	BrainsWay Ltd.	K122288

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

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Device Description:

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

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

Intended Use/Indication for Use:

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 .

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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-inferiority of the iTBS stimulation protocol with the BrainsWayDeep TMS (H1-Coil) System compared to the FDA-clearedHigh Frequency (HF) stimulation protocol using the sameBrainsWay Deep TMS (H1-Coil) System, for the treatment ofMDD.
Study duration	5 weeks
Number of subjects	66 subjects received iTBS stimulation protocol and 80 subjectsreceived HF stimulation protocol.
Primary Endpoint	The primary efficacy endpoint was the change from baseline to5 weeks visit (after 20 treatment sessions) in the patientsdepression 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.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

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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.

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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)

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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.

Regulation Number and Section

§ 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.

TechnologicalCharacteristic	BrainsWay Deep TMSSystem (Models 102 & 104)with the Theta Burststimulation protocol	BrainsWay Deep TMSSystem (Models 102 & 104)(K122288 and K173540)(Secondary Predicates)	MagVita TMS TherapySystem w/ Theta BurstStimulation (Tonica ElektronikA/S) (K173620) (Main Predicate)
Product Code,Class	OBPClass II	OBPClass II	OBPClass II
Indications for Use	The BrainsWay Deep TMSSystem is indicated for thetreatment of depressive episodesin adult patients suffering fromMajor Depressive Disorder whofailed to achieve satisfactoryimprovement from previous anti-depressant medication treatmentin the current episode.	The BrainsWay Deep TMSSystem is indicated for thetreatment of depressive episodesin adult patients suffering fromMajor Depressive Disorder whofailed to achieve satisfactoryimprovement from previous anti-depressant medication treatmentin the current episode.	The MagVita TMS TherapySystem w/ Theta Burst Stimulationis indicated for the treatment ofMajor Depressive Disorder in adultpatients who have failed to receivesatisfactory improvement fromprior antidepressant medication inthe current episode.
Target Population	Adult subjects with MajorDepressive Disorder	Adult subjects with MajorDepressive Disorder	Adult subjects with MajorDepressive Disorder
Anatomical Sites	Head – stimulation to theprefrontal cortex	Head – stimulation to theprefrontal cortex	Head – stimulation to the prefrontalcortex
Environment Used	Hospitals, Clinics	Hospitals, Clinics	Hospitals, Clinics
Energy Used /Delivered	Electromagnetic Energy isdelivered	Electromagnetic Energy isdelivered	Electromagnetic Energy isdelivered
Design:	The BrainsWay Deep TMSSystem design is based onapplying transcranial magneticstimulation by means of repetitivepulse trains at a predeterminedfrequency	The BrainsWay Deep TMSSystem design is based onapplying transcranial magneticstimulation by means of repetitivepulse trains at a predeterminedfrequency	The MagVita System design isbased on applying transcranialmagnetic stimulation by means ofrepetitive pulse trains at apredetermined frequency.
TechnologicalCharacteristic	BrainsWay Deep TMSSystem (Models 102 & 104)with the Theta Burststimulation protocol	BrainsWay Deep TMSSystem (Models 102 & 104)(K122288 and K173540)(Secondary Predicates)	MagVita TMS TherapySystem w/ Theta BurstStimulation (Tonica ElektronikA/S) (K173620) (Main Predicate)
- Mechanism ofAction	The BrainsWay Deep TMSSystem is an electromechanicalinstrument that produces anddelivers brief duration, rapidlyalternating (pulsed) magneticfields to induce electrical currentsin localized regions of theprefrontal cortex. This is a non-invasive tool for the stimulationof cortical neurons for thetreatment of adult patients withMajor Depressive Disorder(MDD).	The BrainsWay Deep TMSSystem is an electromechanicalinstrument that produces anddelivers brief duration, rapidlyalternating (pulsed) magneticfields to induce electrical currentsin localized regions of theprefrontal cortex. This is a non-invasive tool for the stimulationof cortical neurons for thetreatment of adult patients withMajor Depressive Disorder(MDD).	The MagVita System is anelectromechanical instrument thatproduces and delivers briefduration, rapidly alternating(pulsed) magnetic fields to induceelectrical currents in localizedregions of the prefrontal cortex.This is a non-invasive tool for thestimulation of cortical neurons forthe treatment of adult patients withMajor Depressive Disorder(MDD).
- Components	The BrainsWay Deep TMS Systemconsists of the followingcomponents:- Mobile Cart- Coil & Helmet Unit- Positioning Arm- Cooling System- TMS stimulator & Software(BrainsWay stimulator in Model 104& Magstim stimulator in Model 102)	The BrainsWay Deep TMS Systemconsists of the followingcomponents:- Mobile Cart- Coil & Helmet Unit- Positioning Arm- Cooling System- TMS stimulator & Software(BrainsWay stimulator in Model 104& Magstim stimulator in Model 102)	The MagVita System consists of thefollowing components:- Trolley- Coil- Arm mounted on the trolley- Coil Cooler Unit- MagPro Stimulator
TechnologicalCharacteristic	BrainsWay Deep TMSSystem (Models 102 & 104)with the Theta Burststimulation protocol	BrainsWay Deep TMSSystem (Models 102 & 104)(K122288 and K173540)(Secondary Predicates)	MagVita TMS TherapySystem w/ Theta BurstStimulation (Tonica ElektronikA/S) (K173620) (Main Predicate)
- Accessories	The BrainsWay Deep TMS Systemconsists of the followingaccessories:- Head Cap- Head Positioning Straps- Earplugs	The BrainsWay Deep TMS Systemconsists of the followingaccessories:- Head Cap- Head Positioning Straps- Earplugs	The MagVita System consists of thefollowing accessories:- Head Cap- Holding arrangements- Marking plate, pen and ruler- Patient head fixation with treatmentChair- Vacuum Pump and Vacuum pillow
Performance	Treatment Parameters:- Magnetic Field Intensity: 120% ofthe patient's observed motorthreshold.- Repetition rate: 50 Hz- Train duration: 2 sec- Inter-train interval: 8 sec- Burst pulses: 3- Bursts : 200- Number of trains: 20- Magnetic Pulses per Session: 600- Treatment Session Duration:approximately 3 minutes- Sessions per Week: 5- 5 daily sessions for 4 weeks- Bi-weekly sessions for another 12weeks (optional maintenancetreatments)	Treatment Parameters:- Magnetic Field Intensity: 120% ofthe patient's observed motorthreshold.- Frequency: 18 Hz- Train duration: 2 sec- Inter-train interval: 20 sec- Burst pulses: NA- Bursts : NA- Number of trains: 55- Magnetic Pulses per Session: 1980- Treatment Session Duration:approximately 20.2 minutes- Sessions per Week: 5- 5 daily sessions for 4 weeks- Bi-weekly sessions for another 12weeks (optional maintenancetreatments)	Treatment Parameters:- Magnetic Field Intensity: 120% ofthe patient's observed motorthreshold.- Repetition rate: 50 Hz- Train duration: 2 sec- Inter-train interval: 8 sec- Burst pulses: 3- Bursts : 200- Number of trains: 20- Magnetic Pulses per Session: 600- Treatment Session Duration:approximately 3 minutes- Sessions per Week: 5- 5 daily sessions for 6 weeks
	Waveform: Biphasic	Waveform: Biphasic	Waveform: Biphasic
	Output Stimulation Parameters:Available Stimulation Amplitude inStandard Motor Threshold (SMT)units Amplitude Range: 0.6-1.4 SMT	Output Stimulation Parameters:Available Stimulation Amplitude inStandard Motor Threshold (SMT)units Amplitude Range: 0.6-1.4 SMT	Output Stimulation Parameters:Available Stimulation Amplitude inStandard Motor Threshold (SMT)units Amplitude Range: 0 - 1.7 SMT
TechnologicalCharacteristic	BrainsWay Deep TMSSystem (Models 102 & 104)with the Theta Burststimulation protocol	BrainsWay Deep TMSSystem (Models 102 & 104)(K122288 and K173540)(Secondary Predicates)	MagVita TMS TherapySystem w/ Theta BurstStimulation (Tonica ElektronikA/S) (K173620) (Main Predicate)
CoilConfiguration	Deep TMS coilAir core	Deep TMS coilAir core	Figure-of-eight coilAir core
Cooling	Air cooling	Air cooling	Liquid cooling
Standards Met	Company complies with ISO13485:2016	Company complies with ISO13485:2016	Company complies with ISO13485:2012
Electrical & EMCSafety	IEC 60601-1IEC 60601-1-2IEC 62304	IEC 60601-1IEC 60601-1-2IEC 62304	IEC 60601-1IEC 60601-1-2