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 scap. 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. Electromagnetic Coil
1. TMS Neurostimulator
1. Cooling System
1. Positioning System and Helmet
1. Cart

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the Brainsway Deep TMS System (with HADD-coil) for short-term smoking cessation were primarily based on the statistical significance and clinical meaningfulness of the 4-week Continuous Quit Rate (CQR), supported by secondary endpoints.

Acceptance Criteria	Reported Device Performance
Primary Endpoint: Statistically significant and clinically meaningful higher 4-week Continuous Quit Rate (CQR) in the DTMS arm compared to the sham arm.	Primary Endpoint: The 4-week CQR was statistically significantly higher (p-value = 0.0238) in the DTMS arm (17.1%) than in the sham arm (7.9%) for the ITT-Safety population (N=262) up to 4 months follow-up. This was considered clinically meaningful.
Secondary Endpoint: Statistically significant higher 4-week CQR in subjects with at least 4 weeks of diary records.	Secondary Endpoint: The 4-week CQR was statistically significantly higher (p-value = 0.0071) in the DTMS arm (27.3%) compared to the sham arm (11.3%) for subjects with at least 4 weeks of diary records.
Secondary Endpoint: Statistically significant lower number of cigarettes smoked per day (per diary entry) in the DTMS treatment arm compared to the sham arm.	Secondary Endpoint: The number of cigarettes smoked per day (per diary entry) was statistically significantly lower in the DTMS treatment arm compared to the sham arm (specific p-value not given for this point, but stated as statistically significant).
Secondary Endpoint: Statistically significant higher 4-week CQR up to the 6th week visit.	Secondary Endpoint: The 4-week CQR up to the 6th week visit was statistically significantly higher (p-value = 0.0022) in the DTMS arm (15.4%) than in the sham arm (4.3%).
Safety Profile: No individual adverse event types with a significant difference between study groups, except for expected application site discomfort and muscle twitching.	Safety Profile: No individual adverse event types showed a significant difference between groups, except for application site discomfort and muscle twitching. Heading reporting was not statistically significant. Application site discomfort (11.38% vs 2.16%, p=0.0043) and muscle twitching (5.69% vs 0%, p=0.0046) were higher in the DTMS group but were not considered to deter treatment.

Study Details Proving Acceptance Criteria

Sample size used for the test set and the data provenance:
- Test Set Sample Size: N=262 (ITT-Safety population), with 123 subjects in the DTMS arm and 139 subjects in the sham arm.
- Data Provenance: The study was a "prospective, double blind, randomized, sham controlled, multi-center trial." No specific countries of origin for the data are explicitly stated, but multi-center typically implies multiple sites, which could be in one or more countries. It is a prospective clinical trial.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the "ground truth" establishment by independent experts for the smoking cessation outcomes. The ground truth for effectiveness (smoking cessation) was determined by objective measures like Continuous Quit Rate (CQR) based on participant self-reporting and likely biochemical verification (though not explicitly stated for this 510(k) summary, it's common in smoking cessation trials). The study was clinically managed, but the role of external experts in adjudicating individual cases of "quit" status is not detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method for the test set outcomes (i.e., whether participants met the smoking cessation criteria). The outcomes appear to be derived from direct data collection (e.g., self-reported smoking diary, likely backed by CO-oximetry or similar biochemical tests, though not mentioned in this excerpt) rather than subjective expert interpretation requiring adjudication.
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 was not an MRMC comparative effectiveness study. This device is a treatment device (Transcranial Magnetic Stimulation), not an AI diagnostic or assistance tool that would involve human readers interpreting cases.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The Brainsway Deep TMS System is a medical device for treatment, not an algorithm, and it is designed for use by a human operator (clinician) to administer the therapy. Its performance is as a therapeutic device, not an AI or algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for device efficacy was outcomes data directly from the clinical trial, specifically the 4-week Continuous Quit Rate (CQR) for smoking cessation, along with other self-reported and indirect measures of smoking behavior (e.g., number of cigarettes per day).
The sample size for the training set:
- This question is not applicable. This is a medical device for treatment, not an AI or machine learning model that requires a "training set." The clinical trial data (N=262) served as the validation for its efficacy for the stated indication.
How the ground truth for the training set was established:
- This question is not applicable as there is no "training set" in the context of this traditional medical device validation.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

June 2, 2021

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

Re: K200957

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: QMD

Dear Ahava Stein:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 21, 2020. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Pamela Scott, OHT5: Office of Neurological and Physical Medicine Devices, 301-796-5433, PamelaD.Scott@fda.hhs.gov.

Sincerely,

Pamela D Diaitally signed by Scott -S

Pamela D. Scott -S ate: 2021.06.02 12:09:08

Pamela Scott 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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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

August 21, 2020

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

Re: K200957

Dear Ms. 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.

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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) 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-devices/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 (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Pamela D. Scott -S

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K200957

Device Name Brainsway Deep TMS System

Indications for Use (Describe)

The Brainsway Deep Transcranial Magnetic Stimulation System is indicated to be used as an aid in short-term smoking cessation for adults.

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 THE BRAINSWAY DTMS SYSTEM

510(k) Number K200957

Applicant Name:

Company Name:	Brainsway Ltd.
Address:	19 Hartom St. (Bynet Bldg) Har Hotzvim,Jerusalem, 9777518, Israel.
	Tel: +972 54 6420642
	Fax: +972-9-7668534
	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 Israel
	Tel: +972-9-7670002
	Fax: +972-9-7668534
	E-mail: ahava@asteinrac.com
Date Prepared:	July 14, 2020

Trade Name : Brainsway DTMS System Classification Name : CFR classification sections 882.5802; (Product code: QMD) Classification: Class II device.

Predicate Device:

The Brainsway DTMS System is substantially equivalent to the following predicate devices:

Predicate	Manufacturer	De Novo No.
Brainsway Ltd.	Brainsway Deep TMS System	DEN170078

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Device Description:

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

1. Electromagnetic Coil
1. TMS Neurostimulator
1. Cooling System
1. Positioning System and Helmet
1. Cart

Indications for Use

The Brainsway Deep Transcranial Magnetic Stimulation System is indicated to be used as an aid in short-term smoking cessation for adults.

Performance Standards:

The Brainsway DTMS System with the HADD-coil complies with the following recognized consensus standards:

· IEC 60601-1: 2005 (Third Edition, MOD) Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance and C1:2006 and C2:2007 and A1:2012 (or IEC60601-1:(R)2012)
· IEC 60601-1-2: Medical electrical equipment; Part 1-2: Collateral Standard: Electromagnetic compatibility - Requirements and tests, Edition 4.0 (2014).

All the requirements of these standards were met. No adaptations were made to any of the test methods recommended in the standard. There were no applied deviations from the standard. Test Certificates and reports for these tests are provided in Section 17.

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Non-Clinical (Bench) Performance Data:

Bench testing was conducted for the Brainsway DTMS System and presented in Section 18. The following magnetic and electrical field characteristics and testing were conducted as proposed in the FDA Guidance document for TMS systems, Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems:

Electric Field Output Waveform and Linearity Measurement .
. Electrical Field Spatial Distribution
Magnetic Field Strength Gradient .
Description of the Physical Characteristics of the HADD-Coil .
Side-by-Side Comparison .

Additional testing conducted with the Brainsway DTMS System included testing the life time of the device.

Pre-Clinical (Animal) Performance Data:

Not Applicable.

Clinical Performance Data:

The efficacy of the Brainsway DTMS System indicated as an aid to short-term smoking cessation has been demonstrated in a prospective, double blind, randomized, sham controlled, multi-center trial. Subjects were randomly assigned to either active DTMS or Sham treatment. TMS sessions were performed daily, five days a week, for 3 weeks (15 DTMS sessions) followed by 3 once-aweek DTMS treatments. Treatment was administered according to a predefined treatment protocol (10 Hz, 120% stimulation intensity of the measured MT, 3 sec pulse trams, 15 sec inter-train intervals, 60 trains, 1800 pulses per session). Demographic data and smoking history baseline characteristics for all the study patients in the ITT-Safety population (N=262) are presented in the tables below.

	DTMS	Sham
Age (years)	N	123	139

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		DTMS	Sham
Mean (SD)		45.0 (13.00)	44.8 (13.40)
Median [Range]		46.5 [21.5;67.8]	45.8 [22.9;67.4]
Gender	Male	51.2% (63/123)	52.5% (73/139)
	Female	48.8% (60/123)	47.5% (66/139)
Race	Caucasian	68.3% (84/123)	66.9% (93/139)
	Afro-American	25.2% (31/123)	25.9% (36/139)
	Hispanic	4.1% (5/123)	3.6% (5/139)
	Other	2.4% (3/123)	4.3% (6/139)

Smoking History

		DTMS	Sham
Age Started Smoking (years)	NMean (SD)Median [Range]	12316.9 (3.96)17.0 [8;40]	13917.4 (5.35)16.0 [8;41]
Total Years Smoking	NMean (SD)Median [Range]	12327.1 (13.05)27.0 [4;50]	13926.2 (13.73)25.0 [3;62]
No. of Cigarettes / Day	NMean (SD)Median [Range]	12318.3 (7.68)16.0 [10;60]	13918.2 (7.21)18.0 [10;50]
No. Tries to Stop	1	14.3% (17/119)	21.9% (30/137)
	2	10.9% (13/119)	16.1% (22/137)
	3	23.5% (28/119)	18.2% (25/137)
	4	11.8% (14/119)	9.5% (13/137)
	5	12.6% (15/119)	7.3% (10/137)
	>5	26.9% (32/119)	27.0% (37/137)
Previous Stopping Methods	Zyban	12.4% (15/121)	10.1% (14/138)
	Chantix	24.0% (29/121)	25.4% (35/138)
	Nicotine Patch	33.9% (41/121)	35.5% (49/138)
	Nicotine Gum	27.3% (33/121)	26.8% (37/138)
	Nicotine Lozenge	9.1% (11/121)	10.1% (14/138)
	Nicotine Oral Inhaler	5.8% (7/121)	4.3% (6/138)
	Cold Turkey	73.6% (89/121)	76.8% (106/138)
	CBT or therapy	3.3% (4/121)	2.9% (4/138)
	Hypnosis	10.7% (13/121)	5.8% (8/138)
	Other	21.5% (26/121)	18.1% (25/138)

The primary efficacy end-point, 4-week Continuous Quit Rate (CQR) was statistically significant ly higher (p-value=0.0238) in the DTMS arm (17.1%) than in the sham arm (7.9%) for the ITT-Safety population, (N=262), up to 4 months follow-up. Based on the primary efficacy analysis of the study, the Brainsway DTMS has a positive treatment outcome and has demonstrated a beneficial effect in short-term smoking cessation. The higher 4-week CQR in the active DTMS arm is clinically

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meaningful and statistically significant compared to the sham. Prognostic factors were assessed by adding the factors to the logistic model one at the time, except subject sex that is one of the covariates. The type III p-values were: 0.1816 for the subject sex, 0.9189 for the subject age, 0.6966 for the treatment question, 0.1238 for the age of smoking onset, and 0.7869 for the duration of smoking at baseline. None of the prognostic factors were found statistically significant. The primary efficacy endpoint of the study was substantiated by the secondary endpoints including the four-week CQR in subjects with at least 4 weeks of diary records in which the CQR was statistically significantly higher (p-value=0.0071) in the DTMS arm (27.3%) compared to the sham arm (11.3%)and the number of cigarettes smoked per day (per diary entry) was statistically significantly lower in the DTMS treatment arm compared to the sham arm. . In addition, the fourweek CQR up to the 6th week visit in which the CQR was statistically significantly higher (pvalue=0.0022) in DTMS arm (15.4%) than in the sham arm (4.3%).There were no individual adverse event types for which a significant difference between the study groups was found, except for application site discomfort and muscle twitching. Application site discomfort did not deter subjects from receiving the treatments.

The table below presents the most common adverse events reported in the clinical study in >5% or more of the patients who received the Brainsway DTMS Treatment or the sham (placebo) treatment. Safety information is provided from all patients who were treated in the clinical study.

	Deep TMS Treatment(N=123 Subject)		Sham Treatment(N-139 Subjects)
Anticipated Event	No of Subjects	Incidence	No of Subjects	Incidence	p-value
Headache	30	24.39%	25	17.99%	0.2259
Application Site Discomfort	14	11.38%	3	2.16%	0.0043
Back Pain	8	6.50%	3	2.16%	0.1211
Muscle Twitching	7	5.69%	0	0%	0.0046
Discomfort	7	5.69%	2	1.44%	0.0878

Adverse Events

The differences in any of the reported adverse events in patients who received the Brainsway DTMS Treatment compared to patients who received the sham treatment, that were statistically significant, were application site discomfort and Muscle Twitching. The most frequent AE was headache reported by 24% of the subjects who received the DTMS treatment and by 18% of the subjects who received the Sham treatment. Reporting of Headaches was not statistically significantly different

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between the treatment groups. The safety and efficacy results of the Multicenter DTMS clinical study presented above demonstrate the safety and effectiveness of the Brainsway DTMS System as an aid in short-term Smoking Cessation.

Substantial Equivalence:

The Brainsway DTMS System is substantially equivalent to the previously FDA-Cleared Brainsway Deep DTMS System (also manufactured by Brainsway Ltd., and the subject of De Novo (DEN170078). The De Novo Summary for the previous Brainsway Deep TMS Systems is provided in Appendix 12-1.

A comparison table is provided below comparing the intended use and basic technological characteristics of the subject Brainsway Deep TMS System to the intended use and basic technological characteristics of the previously cleared Brainsway Deep TMS System.

A Discussion of the Similarities and Differences between the subject Brainsway Deep TMS System and the previously cleared Brainsway Deep TMS System is found following the comparison table.

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COMPARISON TABLE:

TechnologicalCharacteristic	Subject DeviceDTMS System with the HADD-coil(BRAINSWAY LTD.)	Predicate DeviceDTMS System(BRAINSWAY LTD.)DEN170078
Indication forUse	The Brainsway Deep TranscranialMagnetic Stimulation System isindicated to be used as an aid in short-term smoking cessation for adults.	The Brainsway Deep TranscranialMagnetic Stimulation System isindicated for used as an adjunct for thetreatment of adult patients sufferingfrom Obsessive-Compulsive Disorder.
TargetPopulation	Adult subjects with smoking addiction	Adult subjects with Obsessive-Compulsive Disorder
Anatomical Sites	Head - stimulation to the prefrontalcortex and insula	Head - stimulation to the prefrontalcortex
EnvironmentUsed	Hospitals, Clinics	Hospitals, Clinics
Classification/Product Code	21 CFR 882.5802/QMD	21 CFR 882.5802/QCI
Energy Used /Delivered	Electromagnetic energy is delivered	Electromagnetic energy is delivered
Design:	The Brainsway DTMS System design isbased on applying transcranialmagnetic stimulation by means ofrepetitive pulse trains at apredetermined frequency.	The Brainsway DTMS System design isbased on applying transcranialmagnetic stimulation by means ofrepetitive pulse trains at apredetermined frequency.
Mechanism ofAction	The Brainsway DTMS System is anelectromechanical instrument thatproduces and delivers brief duration,rapidly alternating (pulsed) magneticfields to induce electrical currents inlocalized regions of the prefrontalcortex and insula. This is a non-invasive tool for the stimulation ofcortical neurons for the treatment ofadult patients with smoking addiction.	The Brainsway DTMS System is anelectromechanical instrument thatproduces and delivers brief duration,rapidly alternating (pulsed) magneticfields to induce electrical currents inlocalized regions of the prefrontalcortex. This is a non-invasive tool forthe stimulation of cortical neurons forthe treatment of adult patients withObsessive-Compulsive Disorder.
Area of brainto be	Prefrontal Cortex and insula	Prefrontal Cortex
stimulatedSystemComponents	The Brainsway DTMS System consistsof the following components:- Mobile Cart- HADD-Coil & Helmet Unit- Positioning Arm- Cooling System- Magstim TMS stimulator	The Brainsway DTMS System consistsof the following components:- Mobile Cart- HAC-Coil & Helmet Unit- Positioning Arm- Cooling System- Magstim TMS stimulator
TechnologicalCharacteristic	Subject DeviceDTMS System with the HADD-coil(BRAINSWAY LTD.)	Predicate DeviceDTMS System(BRAINSWAY LTD.)DEN170078
SystemAccessories	The Brainsway DTMS System consistsof the following accessories:-Head Cap-Head Positioning Straps- Earplugs	The Brainsway DTMS System consistsof the following accessories:-Head Cap-Head Positioning Straps- Earplugs
Features /OperationalProcedures	- Determination of Motor Threshold(MT)- Coil Positioning- Administration of Treatment	- Determination of Motor Threshold(MT)- Coil Positioning- Administration of Treatment
Dimensions	Cart Dimensions:680mm (L) x 625mm (W) (26.7"(L) x24.6"(W))	Cart Dimensions:680mm (L) x 625mm (W) (26.7"(L) x24.6"(W))
Weight	122.5 kg (270lbs)	122.5 kg (270lbs)
Performance	Short-term Smoking CessationTreatment Parameters:• Magnetic Field Intensity: 120% of thepatient's observed motor threshold• Frequency: 10 Hz• Train Duration: 3 seconds• Inter-train interval: 15 seconds• Number of trains : 60• Magnetic Pulses per Session: 1800• Treatment Session Duration: ~20 min• Sessions per week: 5 daily sessionsfor 3 weeks, followed by 1 session perweek for another 3 weeks	OCD Treatment Parameters:• Magnetic Field Intensity: 100% of thepatient's observed motor threshold• Frequency: 20 Hz• Train Duration: 2 seconds• Inter-train interval: 20 seconds• Number of trains: 50• Magnetic Pulses per Session: 2000• Treatment Session Duration: ~20 min• Sessions per week: 5• 5 daily sessions for 5 weeks, 4 dailysessions for 1 week
HumanFactors	The Brainsway DTMS System uses theMagstim TMS stimulator software forparameter configuration.Patient positioning and MTdetermination are done manually.	The Brainsway DTMS System uses theBrainsway TMS stimulator software forparameter configuration.Patient positioning and MTdetermination are done manually.
Standards Met	IEC 60601-1IEC 60601-1-2	IEC 60601-1IEC 60601-1-2
Materials	Personal Head Cap - Fabrifoammaterial	Personal Head Cap - Fabrifoammaterial
Biocompatibility	Materials are biocompatible	Materials are biocompatible
Compatibilitywith theEnvironment	The Brainsway DTMS System iscompliant with the IEC 60601-1-2(EMC Safety) standard.	The Brainsway DTMS System iscompliant with the IEC 60601-1-2(EMC Safety) standard.
Sterility	Not Applicable	Not Applicable
TechnologicalCharacteristic	Subject DeviceDTMS System with the HADD-coil(BRAINSWAY LTD.)	Predicate DeviceDTMS System(BRAINSWAY LTD.)DEN170078
Electrical Safety	Power Requirements:110-120 VAC / 60 Hz220-240 VAC / 50 HzThe Brainsway DTMS System iscompliant with the IEC 60601-1standard.	Power Requirements:110-120 VAC / 60 Hz220-240 VAC / 50 HzThe Brainsway DTMS System iscompliant with the IEC 60601-1standard.
MechanicalSafety	The Brainsway DTMS System iscompliant with IEC 60601-1 standard.	The Brainsway DTMS System iscompliant with IEC 60601-1 standard.
Chemical Safety	Not Applicable	Not Applicable
Thermal Safety	The Brainsway DTMS System iscompliant with IEC 60601-1 standard.	The Brainsway DTMS System iscompliant with IEC 60601-1 standard.
Radiation Safety	The Brainsway DTMS System iscompliant with IEC 60601-1-2 (EMCSafety) standard.	The Brainsway DTMS System iscompliant with IEC 60601-1-2 (EMCSafety) standard.

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DISCUSSION OF SIMILARITIES AND DIFFERENCES:

The new Brainsway DTMS System and the predicate Brainsway DTMS System (DEN170078) are both identified under the same device classification (21 CFR 882.5802) for transcranial magnetic stimulation systems. The new Brainsway DTMS System is indicated for use as an aid in short-term smoking cessation. Heavy smoking (>10 cigarettes/day for more than 1 year) is considered an addiction, which is a psychiatric disorder or condition. The predicate device, Brainsway DTMS System (DEN170078) is intended for use as an adjunct for the treatment of adult patients suffering from OCD. Both indications for use fall under the classification regulation, 21 CFR 882.5802, for a transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.

The design and mechanism of action of the Brainsway DTMS System is similar to the design and mechanism of action of the previously cleared Brainsway DTMS System (DEN170078). The components are exactly the same, including the use of the same Magstim stimulators and the incorporation of an electromagnetic coil. Both coils are designed for effective activation of desired brain areas. The operational procedure is similar in both DTMS Systems, although the treatment stimulation parameters are different and appropriate for the relevant treatment administered. The differences in the coils, treatment stimulation parameters and resulting electromagnetic fields produced by the coils and the stimulation of the brain areas do not raise new or different questions of safety and effectiveness. Furthermore, performance testing, including the coil electrical and magnetic field distribution testing, demonstrates that the coil has output characteristics that are as safe as the predicate coil and the clinical performance testing, including the clinical results from the multicenter, Smoking Cessation clinical study, demonstrates that the coil is as effective as the predicate device in treating the specific psychiatric disorder/condition for which it is indicated to treat.

Conclusions:

In summary, the subject Brainsway DTMS System is substantially equivalent to the previous DeNovo granted predicate Brainsway DTMS System (DEN170078).

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.