Brainsway Deep (DTMS) System

K173540 · Brainsway , Ltd. · OBP · May 3, 2018 · Neurology

Device Facts

• Record ID: K173540
• Device Name: Brainsway Deep (DTMS) System
• Applicant: Brainsway , Ltd.
• Product Code: OBP · Neurology
• Decision Date: May 3, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5805
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

Brainsway Deep TMS System provides non-invasive stimulation of deep brain structures; utilizes electromagnetic coil to deliver brief, high-current magnetic pulses to scalp; induces electric fields in prefrontal cortex to depolarize neurons. System comprises electromagnetic coil, neurostimulator, cooling system, positioning arm, and mobile cart. Used in hospitals/clinics by trained operators. Clinician determines treatment settings (e.g., 120% of motor threshold) and manages patient records via integrated software. Treatment involves repetitive pulse trains to modulate neuronal activity; intended to alleviate symptoms of treatment-resistant MDD. Benefits include non-invasive therapeutic intervention for patients failing medication.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including output waveform, electrical field spatial distribution, magnetic field strength gradient testing, and software validation.

Technological Characteristics

Electromagnetic stimulation system; components include mobile cart, coil/helmet, positioning arm, cooling system, and stimulator. Complies with IEC 60601-1 (electrical/mechanical/thermal safety), IEC 60601-1-2 (EMC), and IEC 62304 (software lifecycle). Biocompatible materials used in head cap. Operates at 110-120 VAC/60Hz or 220-240 VAC/50Hz. Software-controlled parameter configuration.

Indications for Use

Indicated for adult patients with Major Depressive Disorder (MDD) who have failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Brainsway Deep TMS System (K122288)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |

#### Contact Person:

| Official Correspondent: | Ahava Stein |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Company Name: | A. Stein – Regulatory Affairs Consulting Ltd. |
| Address: | 20 Hata'as Str., Suite 102<br>Kfar Saba 4442520 Israel<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| 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 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

# Intended Use/Indication for Use:

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 ..

# 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:

| Technological<br>Characteristic | Modified Brainsway Deep TMS<br>System (K173540) | Brainsway Deep TMS System<br>(K122288) |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code,<br>Class | OBP<br>Class II | OBP<br>Class II |
| Indications for Use | The Brainsway Deep TMS System is<br>indicated for the treatment of depressive<br>episodes in adult patients suffering from<br>Major Depressive Disorder who failed<br>to achieve satisfactory improvement from<br>previous anti-depressant medication<br>treatment in the current episode. | The Brainsway Deep TMS System is<br>indicated for the treatment of depressive<br>episodes in adult patients suffering from<br>Major Depressive Disorder who failed<br>to achieve satisfactory improvement from<br>previous anti-depressant medication<br>treatment in the current episode. |
| Target Population | Adult subjects with Major Depressive<br>Disorder | Adult subjects with Major Depressive<br>Disorder |
| Anatomical Sites | Head - stimulation to the prefrontal cortex | Head - stimulation to the prefrontal cortex |
| Environment Used | Hospitals, Clinics | Hospitals, Clinics |
| Energy Used /<br>Delivered | Electromagnetic Energy is delivered | Electromagnetic Energy is delivered |
| Design: | The Brainsway DTMS System design is<br>based on applying transcranial magnetic<br>stimulation by means of repetitive pulse<br>trains at a predetermined frequency. | The Brainsway DTMS System design is<br>based on applying transcranial magnetic<br>stimulation by means of repetitive pulse<br>trains at a predetermined frequency. |
| - Mechanism of<br>Action | The Brainsway DTMS System is an<br>electromechanical instrument that produces<br>and delivers brief duration, rapidly<br>alternating (pulsed) magnetic fields to<br>induce electrical currents in localized<br>regions of the prefrontal cortex. This is a<br>non-invasive tool for the stimulation of<br>cortical neurons for the treatment of adult<br>patients with Major Depressive Disorder<br>(MDD). | The Brainsway DTMS System is an<br>electromechanical instrument that produces<br>and delivers brief duration, rapidly<br>alternating (pulsed) magnetic fields to<br>induce electrical currents in localized<br>regions of the prefrontal cortex. This is a<br>non-invasive tool for the stimulation of<br>cortical neurons for the treatment of adult<br>patients with Major Depressive Disorder<br>(MDD). |
| Technological<br>Characteristic | Modified Brainsway Deep TMS<br>System (K173540) | Brainsway Deep TMS System<br>(K122288) |
| - Components | The Brainsway DTMS System consists of<br>the following components:<br>- Mobile Cart<br>- Coil & Helmet Unit<br>- Positioning Arm<br>- Cooling System<br>- TMS stimulator & Software (Brainsway) | The Brainsway DTMS System consists of<br>the following components:<br>- Mobile Cart<br>- Coil & Helmet Unit<br>- Positioning Arm<br>- Cooling System<br>- TMS stimulator & Software (Magstim) |
| - Accessories | The Brainsway DTMS System consists of<br>the following accessories:<br>- Head Cap<br>- Head Positioning Straps<br>- Earplugs | The Brainsway DTMS System consists of<br>the following accessories:<br>- Head Cap<br>- Head Positioning Straps<br>- Earplugs |
| - Features | The Brainsway DTMS System consists of<br>the following features:<br>- Determination of Motor Threshold (MT)<br>- Coil Positioning<br>- Administration of Treatment<br>- System Management, including patient<br>record keeping | The Brainsway DTMS System consists of<br>the following features:<br>- Determination of Motor Threshold (MT)<br>- Coil Positioning<br>- Administration of Treatment |
| - Dimensions | Cart Dimensions:<br>680mm (L) x 688mm (W) (26.7"(L) x<br>27"(W)) | Cart Dimensions:<br>680mm (L) x 625mm (W) (27"(L) x<br>25"(W)) |
| - Weight | 142 kg (313lbs) | 122.5 kg (270lbs) |
| Performance | MDD Treatment Parameters:<br>Magnetic Field Intensity: 120% of the<br>patient's observed motor threshold.<br>- Frequency: 18 Hz.<br>- Train duration: 2 sec.<br>- Inter-train interval: 20 sec.<br>- Number of trains: 55<br>- Magnetic Pulses per Session: 1980<br>- Treatment Session Duration:<br>approximately 20.2 minutes<br>- Sessions per Week: 5<br>- 5 daily sessions for 4 weeks<br>- Bi-weekly sessions for another 12 weeks<br>(optional maintenance treatments) | MDD Treatment Parameters:<br>Magnetic Field Intensity: 120% of the<br>patient's observed motor threshold.<br>- Frequency: 18 Hz.<br>- Train duration: 2 sec.<br>- Inter-train interval: 20 sec.<br>- Number of trains: 55<br>- Magnetic Pulses per Session: 1980<br>- Treatment Session Duration:<br>approximately 20.2 minutes<br>- Sessions per Week: 5<br>- 5 daily sessions for 4 weeks<br>- Bi-weekly sessions for another 12 weeks<br>(optional maintenance treatments) |
| Human Factors | The Brainsway DTMS System uses its own<br>TMS stimulator software for parameter<br>configuration.<br>Patient positioning and MT determination<br>are done manually. | The Brainsway DTMS System uses the<br>Magstim TMS stimulator software for<br>parameter configuration.<br>Patient positioning and MT determination<br>are done manually. |
| Standards Met | IEC 60601-1<br>IEC 60601-1-2<br>IEC 62304 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 62304 |
| Materials | Head Cap - biocompatible material | Head Cap - biocompatible material |
| Biocompatibility | Materials are biocompatible | Materials are biocompatible |
| Technological<br>Characteristic | Modified Brainsway Deep TMS System (K173540) | Brainsway Deep TMS System (K122288) |
| Compatibility With<br>the Environment<br>and Other Devices | The Brainsway DTMS System is compliant<br>with the IEC 60601-1-2 (EMC Safety)<br>standard. | The Brainsway DTMS System is compliant<br>with the IEC 60601-1-2 (EMC Safety)<br>standard. |
| Sterility | Not Applicable | Not Applicable |
| Electrical Safety | Power Requirements:<br>110-120 VAC / 60 Hz<br>220-240 VAC / 50 Hz<br>The Brainsway DTMS System is compliant<br>with the IEC 60601-1 standard. | Power Requirements:<br>110-120 VAC / 60 Hz<br>220-240 VAC / 50 Hz<br>The Brainsway DTMS System is compliant<br>with the IEC 60601-1 standard. |
| Mechanical Safety | The Brainsway DTMS System is compliant<br>with the IEC 60601-1 standard. | The Brainsway DTMS System is compliant<br>with the IEC 60601-1 standard. |
| Chemical Safety | Not Applicable | Not Applicable |
| Thermal Safety | The Brainsway DTMS System is compliant<br>with the IEC 60601-1 standard. | The Brainsway DTMS System is compliant<br>with the IEC 60601-1 standard. |
| Radiation Safety | The Brainsway DTMS System is compliant<br>with the IEC 60601-1-2 (EMC Safety)<br>standard. | The Brainsway DTMS System is compliant<br>with the IEC 60601-1-2 (EMC Safety)<br>standard. |

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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.