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 FDA cleared Brainsway Deep TMS System is composed of the following main components: 1. An Electromagnetic Coil 2. A TMS Neurostimulator 3. A Cooling System 4. A Positioning Device 5. A Cart

AI/ML Overview

This document is a 510(k) premarket notification for the Brainsway Deep TMS System. It focuses on demonstrating substantial equivalence to a previously cleared device (K122288), also from Brainsway Ltd., rather than presenting a de novo study with explicit acceptance criteria for a novel device performance claim. Therefore, the information requested in the prompt, which is typically found in clinical studies establishing the efficacy and safety of a new device, is largely not applicable or not provided in the context of this 510(k) submission.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria for diagnostic/AI performance, nor does it report specific device performance metrics in that context. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence for modifications to an existing device.

From the text, the performance aspects evaluated are primarily related to safety and technical specifications:

Output Waveform
Electrical Field Spatial Distribution
Magnetic Field Strength Gradient Testing
Software validation testing (compliance with FDA guidelines and IEC 62304)
Compliance with electrical and mechanical safety, electromagnetic compatibility, and software validation standards (IEC 60601-1, IEC 60601-1-2, IEC 62304).

The reported performance is that these characteristics are substantially equivalent to the predicate device and that the device complies with the mentioned standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not applicable as this submission is for modifications to an existing device, and the testing described is non-clinical (bench testing) and software validation. No new clinical test set (i.e. patients for diagnostic performance evaluation) was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. There was no clinical test set requiring expert-established ground truth for performance evaluation of a new diagnostic claim. The "ground truth" here is the established safety and performance of the predicate device and relevant international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. No clinical test set requiring adjudication was used.

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

A MRMC comparative effectiveness study was not done. The device is not an AI-assisted diagnostic tool but a therapeutic device (Repetitive Transcranial Magnetic Stimulation System).

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

This information is not applicable. The device is a therapeutic system, not an algorithm for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this 510(k) submission, the "ground truth" for the device's technical performance and safety is its conformance with recognized international standards (IEC 60601-1, IEC 60601-1-2, IEC 62304) and demonstration of substantial equivalence to a previously cleared predicate device in terms of:

Output Waveform
Electrical Field Spatial Distribution
Magnetic Field Strength Gradient
Software validation

Safety and effectiveness are established by showing that modifications do not introduce new hazards and that the device operates within established parameters, which are deemed safe and effective based on the predicate device's clearance.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device requiring a training set in the conventional sense. The "training" for the device's development and validation would refer to engineering design, testing iterations, and software development, not a data-driven machine learning training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as point 8.

Summary

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May 3, 2018 Brainsway Ltd. % Ahava Stein A. Stein-Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba 4442520 Israel

Re: K173540

Trade/Device Name: Brainsway Deep TMS System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: March 29, 2018 Received: April 2, 2018

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

William J. Heetderks -S 2018.05.03 20:54:06 -04'00'

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) TBD

Device Name Brainsway Deep TMS System

Indications for Use (Describe)

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

X 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 K173540

Applicant Name:

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

Contact Person:

Official Correspondent:	Ahava Stein
Company Name:	A. Stein – Regulatory Affairs Consulting Ltd.
Address:	20 Hata'as Str., Suite 102Kfar Saba 4442520 IsraelTel: +972-9-7670002Fax: +972-9-7668534E-mail: ahava@asteinrac.com
Date Prepared:	November 11, 2017
Trade Name:	Brainsway Deep TMS System
Classification Name:	CFR Classification section 882.5805; (Product Code OBP)
Classification:	Class II Medical Device

Predicate Device:

Brainsway Deep TMS System is substantially equivalent to the previously cleared, Brainsway Deep TMS System, also manufactured by Brainsway Ltd.

Device	Manufacturer	510(k) No.
Brainsway Deep TMS System	Brainsway Ltd.	K122288

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Device Description:

The FDA cleared Brainsway Deep TMS System is composed of the following main components:

1. An Electromagnetic Coil
1. A TMS Neurostimulator
1. A Cooling System
1. A Positioning Device
1. A Cart

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 . safety 1: collateral standard: safety requirements for medical electrical systems (2005 +A12012)
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 3 2007)
. IEC 62304 Medical Devices Software Software life-cycle processes (2006 + A1:2015)

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Non-Clinical (Bench) Performance Data:

Tests were conducted on the modified Brainsway Deep TMS System. The tests were performed in a similar manner as to the tests performed with the cleared predicate device and 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 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 Brainsway Deep TMS System is substantially equivalent to the predicate device.

Animal Performance Data / Histology Data:

Not Applicable

Clinical Performance Data:

Not Applicable

Substantial Equivalence:

The modified device has the same intended use and indications for use as the cleared Brainsway Deep TMS System. Both the modified device and the cleared Brainsway Deep TMS System 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.

The basic components of modified Brainsway DTMS System are still similar to the cleared, predicate device 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 substantially equivalent to the previously cleared Brainsway DTMS System, as demonstrated in the performance testing.

Using the modified or the cleared Brainsway devices, the user can determine the treatment settings, record patient data, etc. The modified device, as the cleared device, introduces similar safety features and complies with same relevant consensus standards, including software validation. That is, the new stimulator software has been validated to ensure its proper performance.

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All device modifications were tested under the design control activities, including inhouse bench testing of the coil and cooling system, software validation in compliance with international standards and FDA guidelines, as well as testing for compliance with relevant consensus standards for electrical and mechanical safety, electromagnetic compatibility and software validation. All potential hazards were mitigated in the performance testing conducted as part of the design control activities. All performance activities show that the modifications made to the cleared device do not pose any new safety and effectiveness concerns. Furthermore, the labeling material was revised to support the above-mentioned modifications.

A comparison of the modified device and the predicate device is presented in the following table:

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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 therefore, the modified Brainsway Deep TMS System 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	Modified Brainsway Deep TMSSystem (K173540)	Brainsway Deep TMS System(K122288)
Product Code,Class	OBPClass II	OBPClass II
Indications for Use	The Brainsway Deep TMS System isindicated for the treatment of depressiveepisodes in adult patients suffering fromMajor Depressive Disorder who failedto achieve satisfactory improvement fromprevious anti-depressant medicationtreatment in the current episode.	The Brainsway Deep TMS System isindicated for the treatment of depressiveepisodes in adult patients suffering fromMajor Depressive Disorder who failedto achieve satisfactory improvement fromprevious anti-depressant medicationtreatment in the current episode.
Target Population	Adult subjects with Major DepressiveDisorder	Adult subjects with Major DepressiveDisorder
Anatomical Sites	Head - stimulation to the prefrontal cortex	Head - stimulation to the prefrontal cortex
Environment Used	Hospitals, Clinics	Hospitals, Clinics
Energy Used /Delivered	Electromagnetic Energy is delivered	Electromagnetic Energy is delivered
Design:	The Brainsway DTMS System design isbased on applying transcranial magneticstimulation by means of repetitive pulsetrains at a predetermined frequency.	The Brainsway DTMS System design isbased on applying transcranial magneticstimulation by means of repetitive pulsetrains at a predetermined frequency.
- Mechanism ofAction	The Brainsway DTMS System is anelectromechanical instrument that producesand delivers brief duration, rapidlyalternating (pulsed) magnetic fields toinduce electrical currents in localizedregions of the prefrontal cortex. This is anon-invasive tool for the stimulation ofcortical neurons for the treatment of adultpatients with Major Depressive Disorder(MDD).	The Brainsway DTMS System is anelectromechanical instrument that producesand delivers brief duration, rapidlyalternating (pulsed) magnetic fields toinduce electrical currents in localizedregions of the prefrontal cortex. This is anon-invasive tool for the stimulation ofcortical neurons for the treatment of adultpatients with Major Depressive Disorder(MDD).
TechnologicalCharacteristic	Modified Brainsway Deep TMSSystem (K173540)	Brainsway Deep TMS System(K122288)
- Components	The Brainsway DTMS System consists ofthe following components:- Mobile Cart- Coil & Helmet Unit- Positioning Arm- Cooling System- TMS stimulator & Software (Brainsway)	The Brainsway DTMS System consists ofthe following components:- Mobile Cart- Coil & Helmet Unit- Positioning Arm- Cooling System- TMS stimulator & Software (Magstim)
- Accessories	The Brainsway DTMS System consists ofthe following accessories:- Head Cap- Head Positioning Straps- Earplugs	The Brainsway DTMS System consists ofthe following accessories:- Head Cap- Head Positioning Straps- Earplugs
- Features	The Brainsway DTMS System consists ofthe following features:- Determination of Motor Threshold (MT)- Coil Positioning- Administration of Treatment- System Management, including patientrecord keeping	The Brainsway DTMS System consists ofthe following features:- Determination of Motor Threshold (MT)- Coil Positioning- Administration of Treatment
- Dimensions	Cart Dimensions:680mm (L) x 688mm (W) (26.7"(L) x27"(W))	Cart Dimensions:680mm (L) x 625mm (W) (27"(L) x25"(W))
- Weight	142 kg (313lbs)	122.5 kg (270lbs)
Performance	MDD Treatment Parameters:Magnetic Field Intensity: 120% of thepatient's observed motor threshold.- Frequency: 18 Hz.- Train duration: 2 sec.- Inter-train interval: 20 sec.- 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 12 weeks(optional maintenance treatments)	MDD Treatment Parameters:Magnetic Field Intensity: 120% of thepatient's observed motor threshold.- Frequency: 18 Hz.- Train duration: 2 sec.- Inter-train interval: 20 sec.- 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 12 weeks(optional maintenance treatments)
Human Factors	The Brainsway DTMS System uses its ownTMS stimulator software for parameterconfiguration.Patient positioning and MT determinationare done manually.	The Brainsway DTMS System uses theMagstim TMS stimulator software forparameter configuration.Patient positioning and MT determinationare done manually.
Standards Met	IEC 60601-1IEC 60601-1-2IEC 62304	IEC 60601-1IEC 60601-1-2IEC 62304
Materials	Head Cap - biocompatible material	Head Cap - biocompatible material
Biocompatibility	Materials are biocompatible	Materials are biocompatible
TechnologicalCharacteristic	Modified Brainsway Deep TMS System (K173540)	Brainsway Deep TMS System (K122288)
Compatibility Withthe Environmentand Other Devices	The Brainsway DTMS System is compliantwith the IEC 60601-1-2 (EMC Safety)standard.	The Brainsway DTMS System is compliantwith the IEC 60601-1-2 (EMC Safety)standard.
Sterility	Not Applicable	Not Applicable
Electrical Safety	Power Requirements:110-120 VAC / 60 Hz220-240 VAC / 50 HzThe Brainsway DTMS System is compliantwith the IEC 60601-1 standard.	Power Requirements:110-120 VAC / 60 Hz220-240 VAC / 50 HzThe Brainsway DTMS System is compliantwith the IEC 60601-1 standard.
Mechanical Safety	The Brainsway DTMS System is compliantwith the IEC 60601-1 standard.	The Brainsway DTMS System is compliantwith the IEC 60601-1 standard.
Chemical Safety	Not Applicable	Not Applicable
Thermal Safety	The Brainsway DTMS System is compliantwith the IEC 60601-1 standard.	The Brainsway DTMS System is compliantwith the IEC 60601-1 standard.
Radiation Safety	The Brainsway DTMS System is compliantwith the IEC 60601-1-2 (EMC Safety)standard.	The Brainsway DTMS System is compliantwith the IEC 60601-1-2 (EMC Safety)standard.