The Brainsway Deep Transcranial Magnetic Stimulation System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder.

Device Description

The proposed device is a modification to the Brainsway Deep TMS System that was cleared under DEN170078. Brainsway has implemented minor changes to the helmet configuration, improved the user interface, modified the measurement method, and made other minor component changes. None of these changes alter the technical specifications for the device, which maintains the same voltage and current, same frequencies, and same electrical mains compatibility. The same technological features have previously been cleared by FDA for use in major depressive disorder in K173540.

Consistent with the predicate and reference device, the proposed 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.

AI/ML Overview

The provided text describes modifications to the Brainsway Deep TMS System and asserts its substantial equivalence to a previously cleared predicate device. It does not provide detailed acceptance criteria or results of a clinical study to prove the device meets specific performance criteria. Instead, it focuses on demonstrating that the modifications do not introduce new questions of safety or effectiveness compared to the predicate device.

Therefore, many of the requested details about acceptance criteria, clinical study methodology, and ground truth establishment cannot be found in the provided document. The document primarily confirms that the modified device functions as intended and meets the same acceptance criteria as the predicate and reference devices, based on software verification, electrical safety, EMC, and bench performance testing.

Here's an analysis based on the provided text, highlighting what is available and what is not:

Acceptance Criteria and Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets and corresponding reported device performance for a clinical study proving efficacy or diagnostic accuracy. Instead, it states:

"In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate and reference device."

This implies that the acceptance criteria are generally related to the proper functioning of the device, electrical safety, electromagnetic compatibility, and bench performance, rather than clinical efficacy metrics. For an efficacy study demonstrating treatment outcomes for OCD, such details would typically be found in a separate clinical study report.

The "Indications for Use" section states: "The Brainsway Deep Transcranial Magnetic Stimulation System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder." This is the clinical claim, but the document doesn't present a study proving the device meets this claim with performance metrics. It relies on the substantial equivalence to the predicate device, which presumably had clinical data supporting its efficacy for this indication.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (from text)
Software Verification & Validation	"the subject device functions as intended"
Electrical Safety (IEC 60601-1)	"meets all the same acceptance criteria as the predicate and reference device"
EMC (IEC 60601-1-2)	"meets all the same acceptance criteria as the predicate and reference device"
Bench Performance Testing	"the subject device functions as intended and meets all the same acceptance criteria as the predicate and reference device"
Clinical Efficacy for OCD Treatment (Implied from Indications for Use)	The document does not present a new clinical study to establish this for the modified device, but rather relies on substantial equivalence to the predicate, which previously established this.

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

Not provided in the document. The document describes "software verification and validation," "electrical safety," "EMC," and "bench performance testing." These are engineering and performance validation tests, not typically clinical studies with "test sets" of patient data in the sense of a machine learning model.
If a prior clinical study for the predicate device existed for OCD treatment, that information is not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not provided. Since this document describes engineering and bench testing, rather than a clinical trial or an AI/diagnostic device study requiring expert ground truth establishment for a patient dataset, this information is not relevant to the described testing.

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

Not applicable / Not provided. See explanation for #3.

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

No. This document describes a medical device (Transcranial Magnetic Stimulation System) for treatment, not an AI-assisted diagnostic or imaging device used by "human readers." Therefore, an MRMC study is not relevant to the described device.

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

Stand-alone performance was indirectly evaluated through bench testing and compliance. The device itself is a "human-in-the-loop" device as it delivers treatment under medical supervision. The "standalone" performance here refers to the device's technical specifications and electrical/mechanical performance, which was assessed through the described tests (software, electrical safety, EMC, bench performance). The document states: "In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate and reference device." This implies standalone technical performance testing.

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

For the technical and safety testing described (software, electrical safety, EMC, bench performance):
- Ground Truth: Engineering specifications, regulatory standards (e.g., IEC 60601-1, IEC 60601-1-2), and comparison to the performance of the predicate and reference devices. The "ground truth" is that the device should operate within specified technical parameters and safety limits.
For the clinical efficacy of the device for OCD treatment (which is its intended use):
- The document implies that the predicate device (DEN170078) already established clinical efficacy for OCD. This specific document for K183303 relies on "substantial equivalence" and does not describe a new clinical trial for efficacy. If such a trial existed for the predicate, the ground truth would likely have been clinical outcome measures for OCD (e.g., Yale-Brown Obsessive Compulsive Scale (YBOCS) scores or similar psychiatric outcome scales).

8. The sample size for the training set

Not applicable / Not provided. The Brainsway Deep TMS System is a Transcranial Magnetic Stimulation device, not an AI/machine learning algorithm that requires a "training set" of data in the common sense. Its "training" is its engineering design and manufacturing.

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

Not applicable / Not provided. As explained in #8, there is no "training set" in the context of an AI model for this device.

Summary

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March 8, 2019

Brainsway Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market St., 23rd Floor Philadelphia, Pennsylvania 19103

Re: K183303

Trade/Device Name: Brainsway Deep TMS System Regulation Number: 21 CFR 882.5802 Regulation Name: Transcranial Magnetic Stimulation System For Neurological And Psychiatric Disorders And Conditions Regulatory Class: Class II Product Code: QCI Dated: February 5, 2019 Received: February 5, 2019

Dear Janice Hogan:

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 Actinclude 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

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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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.

Digitally signed by Pamela D. Pamela D. Scott -S Date: 2019.03.08 Scott -S 22:30:01 -05'00'

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) K183303

Device Name Brainsway Deep TMS System

Indications for Use (Describe)

The Brainsway Deep Transcranial Magnetic Stimulation System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder.

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 K183303

Brainsway Deep TMS System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Moria Ankri Brainsway Ltd 19 Hartom St. (Bynet Bldg) Har Hotzvim, Jerusalem, ISRAEL 9777518 Tel: +972-2-5813140 Fax: +972-2-5812517 E-mail: moria@brainsway.com

February 7, 2019

Device Name

Brainsway Deep TMS System

Classification Names

Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions

Classification

21 CFR 882.5802, Class II, Product Code QCI

Predicate Devices

Brainsway Deep TMS System (DEN170078) (predicate) Brainsway Deep TMS System (K173540) (reference device)

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Indications for Use

The Brainsway Deep Transcranial Magnetic Stimulation System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder.

Device Description

Comparison of Technological Characteristics

Parameter	Subject Device(K183303)	Predicate Device(DEN170078)	Reference Device(K173540)	Comparison
Indications forUse	The BrainswayDeep TranscranialMagneticStimulation Systemis intended to beused as an adjunctfor the treatment ofadult patientssuffering fromObsessive-CompulsiveDisorder.	The BrainswayDeep TranscranialMagneticStimulationSystem is intendedto be used as anadjunct for thetreatment of adultpatients sufferingfrom Obsessive-CompulsiveDisorder.	The BrainswayDeep TMS isindicated for thetreatment ofdepressiveepisodes in adultpatients sufferingfrom MajorDepressiveDisorder whofailed to achievesatisfactoryimprovement fromprevious anti-depressantmedicationtreatment in thecurrent episode.	SAME asPredicate
Classification/Product Code	21 CFR882.5802/QCI	21 CFR882.5802/QCI	21 CFR882.5805/OBP	SAME asPredicate
Parameter	Subject Device(K183303)	Predicate Device(DEN170078)	Reference Device(K173540)	Comparison
TreatmentParameters	OCD TreatmentParameters:• Magnetic FieldIntensity: 100% ofthe patient'sobserved motorthreshold• Frequency: 20Hz• Train Duration:2 seconds• Inter-traininterval: 20seconds• Number oftrains: 50• Magnetic Pulsesper Session: 2000• TreatmentSession Duration:Approximately 18.3minutes• Sessions perweek: 5• 5 daily sessionsfor 5 weeks, 4 dailysessions for 1 week	OCD TreatmentParameters:• Magnetic FieldIntensity: 100% ofthe patient'sobserved motorthreshold• Frequency: 20Hz• Train Duration:2 seconds• Inter-traininterval: 20seconds• Number oftrains: 50• MagneticPulses perSession: 2000• TreatmentSession Duration:Approximately18.3 minutes• Sessions perweek: 5• 5 dailysessions for 5weeks, 4 dailysessions for 1week	MDD TreatmentParameters:• Magnetic FieldIntensity: 120% ofthe patient'sobserved motorthreshold.• Frequency: 18Hz• Train Duration:2 seconds• Inter-traininterval: 20 sec• Number oftrains: 55• MagneticPulses perSession: 1980• TreatmentSession Duration:Approximately20.2 minutes• Sessions perweek: 5• 5 dailysessions for 4weeks• Bi-weeklysessions foranother 12 weeks(optionalmaintenancetreatments)	SAME asPredicate
Area of brainto bestimulated	Prefrontal Cortex	Prefrontal Cortex	Prefrontal Cortex	SAME asandPredicateandReferenceDevice
Configuration	Biphasic	Biphasic	Biphasic	SAME asPredicateandReferenceDevice
Core material	Air	Air	Air	SAME asPredicateandReference
Parameter	Subject Device(K183303)	Predicate Device(DEN170078)	Reference Device(K173540)	Comparison
Peak ElectricCurrent	6000 A	5000-6000 A	6000 A	Similar toPredicateand SAMEasReferenceDevice
MaximalOperatingVoltage	1.7 kV	1.7 kV	1.7 kV	SAME asPredicateandReferenceDevice
Amplitude inStandardMotorThreshold(SMT) units	0.6-1.4	0.6-1.4	0.6-1.4	SAME asPredicateandReferenceDevice
Pulse width(usec)	324	324	369	SAME asPredicate
Frequencyrange (Hz)	0.1-50	1-50	0.1-50	SAME asReferenceDevice
Pulse trainduration range(sec)	1-20	1-20	1-20	SAME asPredicateandReferenceDevice
Inter-traininterval range(sec)	10-60	10-60	10-60	SAME asandReferenceDevice
Maximumtrains persession	~140	~140	~140	SAME asPredicateandReferenceDevice
Maximum # ofpulses persession(cumulativeexposure)	5000	5000	~5000	SAME asPredicateandReferenceDevice
Parameter	Subject Device(K183303)	Predicate Device(DEN170078)	Reference Device(K173540)	Comparison
Physical unitof amplitudesetting (e.g.,coil current,peakmagnetic field)at coil & itsrelation toSMT unit:Electric fieldat 1.5cm fromcoil(equivalent to1.0 SMT [V/m])	100	100	100	SAME asPredicateandReferenceDevice
CartDimensions	680 mm (L) x688mm (W)	680 mm (L) x625mm (W)	680 mm (L) x688mm (W)	Device
MaximumSystem Height	2050 mm	2050 mm	2050 mm	SAME asPredicateandReferenceDevice
Voltage	100-240 VAC	110-120 VAC	100-240 VAC	SAME asReferenceDevice
Frequency	50/60 Hz	50/60 Hz	50/60 Hz	SAME asPredicateandReferenceDevice
Coil'sOperatingTemperature:	10°C to 30°C	15 °C to 30 °C	10°C to 31°C	SAME asReferenceDevice
StorageTemperature	-20 °C to 60 °C	-20 °C to 60 °C	-20 °C to 60 °C	SAME asPredicateandReferenceDevice
AtmosphericPressureRange	500 hPa to 1060hPa	500 hPa to 1060hPa	500 hPa to 1060hPa	SAME asPredicateandReferenceDevice
Parameter	Subject Device(K183303)	Predicate Device(DEN170078)	Reference Device(K173540)	Comparison
RelativeHumidityRange	10% to 80% Non-Condensing	10% to 80% Non-Condensing	10% to 80% Non-Condensing	SAME asPredicateandReference

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Both the subject and predicate device have an almost identical movable cart that is used to place the TMS neurostimulator and the cooling system. In both the subject and predicate device, the positioning device is connected to the cart. Although the subject device has a slightly larger cart as compared to the predicate device, this difference does not raise new questions of safety and effectiveness.

Further, both the subject and predicate device consist of a TMS neurostimulator that delivers electrical stimulation to the brain, enabling a controlled output, frequency, pulse duration and indication of coil temperature. Although the predicate device uses commercially available TMS neurostimulators and the subject device uses the Brainsway Stimulator, this difference does not raise new of different questions of safety and effectiveness as demonstrated through performance testing. Further, the identical Brainsway Stimulator was cleared in the reference device, further establishing substantial equivalence.

The subject device has a substantially similar cooling system as compared to the predicate device. The Cooling System continues to consist of an external unit and an air hose streaming the cooled air into the helmet. The air flow cools the coils during pulse trains and maintains them at ambient temperature (less than 30°C). The only difference between the cooling system cleared in the predicate device as compared to the subject device is that the proposed cooling system has a better and stronger compressor, which leads to improved performance as demonstrated in the repeated cooling system development tests. This identical cooling system has been cleared in the reference device further demonstrating substantial equivalence.

Further, the positioning device of the subject and the predicate device continues to feature an adjustable arm that enables the rotation of the helmet around three orthogonal rotation axes (XYZ axes). The positioning device continues to enable accurate and comfortable displacement and positioning of the coil over the patient's head.

The helmet used in both the subject and predicate device are nearly identical. The frontal contour of the helmet has changed slightly from straight to concave configuration. In addition, a transparent plastic guide through which a grid can be observed has been added. The guide shows a red vertical line and a black horizontal line with end markings for positioning. This difference does not raise new or different questions of safety and effectiveness.

The H-Coil of both the subject and predicate device are nearly identical. Although the diameter and cross section of the copper wire of the H-Coil is slightly larger in the subject device as compared to the predicate device, this difference does not raise new of different questions of safety and effectiveness, as demonstrated through performance testing.

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Although the predicate used two flexible rulers (medial & lateral) that were attached along the midline of the Cap to assist in proper helmet positioning whereas the subject device uses a grid, this difference introduces no new questions of safety and effectiveness as demonstrated through completed performance testing.

Performance Data

The following tests were performed to validate the modifications to the device:

. Software verification and validation;
Electrical safety in accordance with IEC 60601-1 and EMC in accordance with IEC ● 60601-1-2;
Bench performance testing.

In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate and reference device.

Substantial Equivalence

The modified Brainsway Deep TMS System has the same intended use and indications, principles of operation, and similar technological characteristics as the previously cleared predicate device. The minor differences in the technical characteristics of the updated device do not raise any new or different questions of safety or effectiveness. Performance data demonstrates that the modified device is safe and effective for its intended use. Thus, the modified Brainsway Deep TMS System is substantially equivalent.

Regulation Number and Section

§ 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.

(a)
Identification. A transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is a prescription, non-implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety.
(2) Software verification, validation, and hazard analysis must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Magnetic pulse output testing;
(ii) Magnetic and electrical field testing;
(iii) Testing of the safety features built into the device; and
(iv) Testing of the sound levels patients are exposed to during device use.
(5) The physician and patient labeling must include the following:
(i) The risks and benefits associated with use of the device;
(ii) Detailed instructions to prevent seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and
(iii) A description of the ear protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating.