Brainsway Deep (DTMS) System

K203616 · Brainsway , Ltd. · QMD · Apr 16, 2021 · Neurology

Device Facts

• Record ID: K203616
• Device Name: Brainsway Deep (DTMS) System
• Applicant: Brainsway , Ltd.
• Product Code: QMD · Neurology
• Decision Date: Apr 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5802
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Non-invasive neuromodulation system; applies brief magnetic pulses to brain via electromagnetic coil (H4-Coil) placed on scalp. Induces electric fields in prefrontal cortex and insula to depolarize neurons. Used in hospitals/clinics by trained operators. System includes mobile cart, neurostimulator, cooling system, positioning arm, and helmet. Operator configures treatment parameters (frequency, intensity, pulse trains) via software; performs manual motor threshold determination and coil positioning. Output is repetitive magnetic pulse trains. Benefits include non-invasive aid for smoking cessation.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including output waveform analysis, electrical field spatial distribution, magnetic field strength gradient testing, and electrical/mechanical safety and EMC testing per IEC 60601-1 and IEC 60601-1-2. Software validation performed per IEC 62304.

Technological Characteristics

Electromagnetic stimulation system; 100-240 VAC power. Components: mobile cart, cooling system, positioning arm, Brainsway TMS stimulator, H4-Coil, helmet. Materials: Fabrifoam head cap. Biocompatible. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993-5/10, ISO 14971. Software-controlled parameter configuration.

Indications for Use

Indicated for short-term smoking cessation in adults.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is subject to the following special controls:

*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.

Predicate Devices

• Brainsway Deep TMS System (K200957)

Reference Devices

• Brainsway Deep TMS System (K183303)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 2, 2021

Brainsway Ltd. % Ahava Stein Regulatory Consultant A. Stein Regulatory Affairs Consulting Ltd. 18 Hataas St., Suite 102 Kfar Saba, 4442520 Israel

Re: K203616

Trade/Device Name: Brainsway Deep (DTMS) 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 April 16, 2021. 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, [e-mail].

Sincerely,

Image /page/0/Picture/9 description: The image shows the name "Pamela D. Scott -S" in a bold, sans-serif font. To the right of the name is the text "Digitally signed by Pamela D. Scott -S" followed by the date "Date: 2021.06.02 12:07:38-04'00'". The text suggests that the document has been digitally signed by the person named.

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

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

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.

April 16, 2021

Brainsway Ltd. % Ahava Stein Regulatory Consultant A. Stein Regulatory Affairs Consulting Ltd. 18 Hataas St., Suite 102 Kfar Saba, 4442520 Israel

Re: K203616

Trade/Device Name: Brainsway Deep (DTMS) 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: March 24, 2021 Received: March 29, 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.

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

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-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 [phone] or 301-796-7100).

Sincerely,

Image /page/2/Picture/5 description: The image shows the name "Pamela D. Scott -S" in large font on the left side of the image. On the right side of the image, it says "Digitally signed by Pamela D. Scott -S" and "Date: 2021.04.16 19:44:43 -04'00'". The text on the right side of the image is in a smaller font than the text on the left side of the image.

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

Enclosure

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

# Indications for Use

510(k) Number (if known) K203616

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) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# 510(K) SUMMARY

# BRAINSWAY DEEP TMS SYSTEM

#### 510(k) Number K203616

# Applicant Name:

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

## Contact Person:

| Official Correspondent: | Ahava Stein |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
| Address: | 18 Hata'as Str., Suite 102<br>Kfar Saba 4442520 Israel<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | February 21, 2021 |
| Trade Name: | Brainsway Deep TMS System |
| Classification Name: | CFR Classification section 882.5802; (Product Code QMD) |
| Classification: | Class II Medical Device |

# Predicate Device:

The subject device is a modification of the Brainsway Deep TMS System ("predicate device") that was cleared in 510(k) document no. K200957. Similar modifications have been made to the Brainsway Deep TMS System cleared in K183303 ("reference device").

| Predicate | Device | Manufacturer | 510(k) No. |
|-----------|---------------------------|----------------|------------|
| Main | Brainsway Deep TMS System | Brainsway Ltd. | K200957 |
| Reference | Brainsway Deep TMS System | Brainsway Ltd. | K183303 |

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

# Device Description:

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

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

- 1. Cart
- a) TMS Neurostimulator
- b) Cooling System
- c) Positioning Device
- 2. Helmet
- a) Aiming Apparatus (i.e., ruler/grid)
- b) Electromagnetic Coil (H4-Coil)
- c) Cap

# Intended Use/Indication 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:

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

- IEC 60601-1 Medical Electrical Equipment Part 1: General requirements for o 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-cvcle processes (2006 + A1:2015) .
- ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for . irritation and delayed-type hypersensitivity
- ISO 14971 Medical devices Application of risk management to medical devices .

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

#### 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 devices 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 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 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 subject device is substantially equivalent to the Brainsway Deep TMS System intended for use as an aid for short-term Smoking Cessation, also manufactured by Brainsway Ltd., and cleared in 510(k) No. K200957 (main predicate device). The subject device is also substantially equivalent to the Brainsway Deep TMS System for the treatment of OCD, cleared in 510(k) K183303 (reference predicate device), regarding the device modifications, including the new Brainsway stimulator component and minor modifications to the device cart, cooling system, coil wire and helmet.

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 Systems.

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

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

| Technological<br>Characteristic | Modified Brainsway Deep TMS<br>System | Brainsway Deep TMS System<br>Main Predicate (K200957) | Brainsway Deep TMS System<br>Reference Predicate (K183303) |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification/<br>Product Code | 21 CFR 882.5802 | 21 CFR 882.5802 | 21 CFR 882.5802 |
| Product Code,<br>Class | QMD<br>Class II | QCI<br>Class II | QCI<br>Class II |
| Indications for<br>Use | The Brainsway Deep Transcranial<br>Magnetic Stimulation System is<br>indicated to be used as an aid in<br>short-term smoking cessation for<br>adults. | The Brainsway Deep Transcranial<br>Magnetic Stimulation System is<br>indicated to be used as an aid in<br>short-term smoking cessation for<br>adults. | The Brainsway Deep Transcranial<br>Magnetic Stimulation System is<br>intended to be used as an adjunct<br>for the treatment of adult patients<br>suffering from Obsessive-<br>Compulsive Disorder. |
| Target<br>Population | Adult subjects with smoking<br>addiction | Adult subjects with smoking<br>addiction | Adult subjects with Obsessive<br>Compulsive Disorder |
| Anatomical Sites | Head - stimulation to the<br>prefrontal cortex and insula | Head - stimulation to the<br>prefrontal cortex and insula | Head - stimulation to the<br>prefrontal cortex |
| Environment<br>Used | Hospitals, Clinics | Hospitals, Clinics | Hospitals, Clinics |
| Energy Used /<br>Delivered | Electromagnetic Energy is<br>delivered | Electromagnetic Energy is<br>delivered | Electromagnetic Energy is<br>delivered |
| Design: | The Brainsway DTMS System<br>design is based on applying<br>transcranial magnetic stimulation<br>by means of repetitive pulse trains<br>at a predetermined frequency. | The Brainsway DTMS System<br>design is based on applying<br>transcranial magnetic stimulation<br>by means of repetitive pulse trains<br>at a predetermined frequency. | The Brainsway DTMS System<br>design is based on applying<br>transcranial magnetic stimulation<br>by means of repetitive pulse trains<br>at a predetermined frequency. |
| - Mechanism of<br>Action | The Brainsway DTMS System is<br>an electromechanical instrument<br>that produces and delivers brief<br>duration, rapidly alternating<br>(pulsed) magnetic fields to induce<br>electrical currents in localized<br>regions of the prefrontal cortex<br>and insula. This is a non-invasive<br>tool for the stimulation of cortical<br>neurons as an aid in short-term<br>smoking cessation | The Brainsway DTMS System is<br>an electromechanical instrument<br>that produces and delivers brief<br>duration, rapidly alternating<br>(pulsed) magnetic fields to induce<br>electrical currents in localized<br>regions of the prefrontal cortex<br>and insula. This is a non-invasive<br>tool for the stimulation of cortical<br>neurons as an aid in short-term<br>smoking cessation | The Brainsway DTMS System is<br>an electromechanical instrument<br>that produces and delivers brief<br>duration, rapidly alternating<br>(pulsed) magnetic fields to induce<br>electrical currents in localized<br>regions of the prefrontal cortex.<br>This is a non-invasive tool for the<br>stimulation of cortical neurons for<br>the treatment of adult patients with<br>Obsessive Compulsive Disorder |
| Technological<br>Characteristic | Modified Brainsway Deep TMS<br>System | Brainsway Deep TMS System<br>Main Predicate (K200957) | Brainsway Deep TMS System<br>Reference Predicate (K183303) |
| - System<br>Components | The Brainsway DTMS System<br>consists of the following<br>components:<br>- Mobile Cart<br>- Cooling System<br>- Positioning Arm<br>- Brainsway TMS stimulator &<br>SW<br>- Helmet & Aiming Apparatus<br>- H4/HADD-Coil | The Brainsway DTMS System<br>consists of the following<br>components:<br>- Mobile Cart<br>- Cooling System<br>- Positioning Arm<br>- Magstim TMS stimulator<br>- Helmet<br>- H4/HADD-Coil | The Brainsway DTMS System<br>consists of the following<br>components:<br>- Mobile Cart<br>- Cooling System<br>- Positioning Arm<br>- Brainsway TMS stimulator &<br>SW<br>- Helmet & Aiming Apparatus<br>- H7/HAC-Coil |
| - System<br>Accessories | The Brainsway DTMS System<br>consists of the following<br>accessories:<br>- Head Cap<br>- Head Positioning Straps<br>- Earplugs | The Brainsway DTMS System<br>consists of the following<br>accessories:<br>- Head Cap<br>- Head Positioning Straps<br>- Earplugs | The Brainsway DTMS System<br>consists of the following<br>accessories:<br>- Head Cap<br>- Head Positioning Straps<br>- Earplugs |
| - Features /<br>Operational<br>Procedures | The Brainsway DTMS System<br>consists of the following features:<br>- Determination of Motor<br>Threshold<br>- Coil Positioning<br>- Administration of Treatment<br>- System Management, including<br>patient record keeping | The Brainsway DTMS System<br>consists of the following features:<br>- Determination of Motor<br>Threshold<br>- Coil Positioning<br>- Administration of Treatment | The Brainsway DTMS System<br>consists of the following features:<br>- Determination of Motor<br>Threshold<br>- Coil Positioning<br>- Administration of Treatment<br>- System Management, including<br>patient record keeping |
| - Dimensions | Cart Dimensions:<br>680mm (L) x 688mm (W)<br>(26.7"(L) x 27"(W)) | Cart Dimensions:<br>680mm (L) x 625mm (W) (27"(L)<br>x 25"(W)) | Cart Dimensions:<br>680mm (L) x 688mm (W)<br>(26.7"(L) x 27"(W)) |
| - Weight | 142 kg (313lbs) | 122.5 kg (270lbs) | 142 kg (313lbs) |
| Performance | Treatment Parameters:<br>- Magnetic Field Intensity: 120%<br>of the patient's observed motor<br>threshold.<br>- Frequency: 10 Hz.<br>- Train duration: 3 sec.<br>- Inter-train interval: 15 sec.<br>- Number of trains: 60<br>- Magnetic Pulses per Session:<br>1800<br>- Tx Session Duration: ~20 min<br>- 5 daily sessions for 3 weeks,<br>followed by one weekly session<br>for another 3 weeks | Treatment Parameters:<br>- Magnetic Field Intensity: 120%<br>of the patient's observed motor<br>threshold.<br>- Frequency: 10 Hz.<br>- Train duration: 3 sec.<br>- Inter-train interval: 15 sec.<br>- Number of trains: 60<br>- Magnetic Pulses per Session:<br>1800<br>- Tx Session Duration: ~20 min<br>- 5 daily sessions for 3 weeks,<br>followed by one weekly session<br>for another 3 weeks | Treatment Parameters:<br>- Magnetic Field Intensity: 100%<br>of the patient's observed motor<br>threshold.<br>- Frequency: 20 Hz.<br>- Train duration: 2 sec.<br>- Inter-train interval: 20 sec.<br>- Number of trains: 50<br>- Magnetic Pulses per Session:<br>2000<br>- Tx Session Duration: ~18 min<br>- 5 daily sessions for 5 weeks and<br>4 daily sessions during the sixth<br>week |
| Technological | Modified Brainsway Deep TMS | Brainsway Deep TMS System | Brainsway Deep TMS System |
| Characteristic | System | Main Predicate (K200957) | Reference Predicate (K183303) |
| Coil's Operating<br>Temperature: | 10°C to 30°C | 15 °C to 30 °C | 10°C to 30°C |
| Storage<br>Temperature | -20 °C to 60 °C | -20 °C to 60 °C | -20 °C to 60 °C |
| Atmospheric<br>Pressure Range | 500 hPa to 1060 hPa | 500 hPa to 1060 hPa | 500 hPa to 1060 hPa |
| Relative<br>Humidity Range | 10% to 80% Non-Condensing | 10% to 80% Non-Condensing | 10% to 80% Non-Condensing |
| Materials | Personal Head Cap - Fabrifoam<br>material | Personal Head Cap - Fabrifoam<br>material | Personal Head Cap - Fabrifoam<br>material |
| Biocompatibility | Materials are biocompatible | Materials are biocompatible | Materials are biocompatible |
| Sterility | Not Applicable | Not Applicable | Not Applicable |
| Human Factors | The Brainsway DTMS System<br>uses its own TMS stimulator<br>software for parameter<br>configuration.<br>Patient positioning and MT<br>determination are done manually. | The Brainsway DTMS System<br>uses the Magstim TMS stimulator<br>software for parameter<br>configuration.<br>Patient positioning and MT<br>determination are done manually. | The Brainsway DTMS System<br>uses its own TMS stimulator<br>software for parameter<br>configuration.<br>Patient positioning and MT<br>determination are done manually. |
| Standards Met | IEC 60601-1<br>IEC 60601-1-2<br>IEC 62304 | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 62304 |
| Compatibility<br>With the<br>Environment<br>and Other<br>Devices | The Brainsway DTMS System is<br>compliant with the IEC 60601-1-2<br>(EMC Safety) standard. | The Brainsway DTMS System is<br>compliant with the IEC 60601-1-2<br>(EMC Safety) standard. | The Brainsway DTMS System is<br>compliant with the IEC 60601-1-2<br>(EMC Safety) standard. |
| Electrical Safety | Power Requirements:<br>100-240 VAC<br>50/60 Hz<br>The Brainsway DTMS System is<br>compliant with the IEC 60601-1<br>standard. | Power Requirements:<br>110-120 VAC / 60 Hz<br>220-240 VAC / 50 Hz<br>The Brainsway DTMS System is<br>compliant with the IEC 60601-1<br>standard. | Power Requirements:<br>100-240 VAC<br>50/60 Hz<br>The Brainsway DTMS System is<br>compliant with the IEC 60601-1<br>standard. |
| Mechanical<br>Safety | The Brainsway DTMS System is<br>compliant with the IEC 60601-1<br>standard. | The Brainsway DTMS System is<br>compliant with the IEC 60601-1<br>standard. | The Brainsway DTMS System is<br>compliant with the IEC 60601-1<br>standard. |
| Chemical Safety | Not Applicable | Not Applicable | Not Applicable |
| Thermal Safety | The Brainsway DTMS System is<br>compliant with the IEC 60601-1<br>standard. | The Brainsway DTMS System is<br>compliant with the IEC 60601-1<br>standard. | The Brainsway DTMS System is<br>compliant with the IEC 60601-1<br>standard. |
| Radiation Safety | | | |

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

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

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

The modified device has the same intended use and indications for use as the Brainsway Deep TMS System cleared in 510(k) K200957. 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 (K200957), as demonstrated in the performance testing.

The modified Brainsway DTMS System incorporates the new Brainsway stimulator and minor modifications to the device cart, cooling system, coil wire and helmet. Using the new Brainsway stimulator, 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. The new stimulator and the minor modifications to the device cart, cooling system and helmet were already introduced in the reference predicate, the Brainsway DTMS System intended for treatment of OCD and cleared in 510(k) K183303.

All device modifications were tested under the design control activities, including inhouse bench testing of the coil, 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 device do not pose any new safety and effectiveness concerns. Furthermore, the labeling material was revised to support the above-mentioned device modifications.

### Conclusions:

Consequently, it can be concluded that the modified Brainsway Deep TMS System is substantially equivalent to the main predicate Brainsway Deep TMS System, cleared under 510(k) K200957 and the reference predicate Brainsway TMS System, cleared under 510(k) K183303. Therefore, the modified Brainsway Deep TMS System can be legally marketed in the USA.