(127 days)
The Brainsway Deep Transcranial Magnetic Stimulation System is indicated to be used as an aid in short-term smoking cessation for adults.
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:
- Cart
a) TMS Neurostimulator
b) Cooling System
c) Positioning Device - Helmet
a) Aiming Apparatus (i.e., ruler/grid)
b) Electromagnetic Coil (H4-Coil)
c) Cap
Based on the provided text, the device in question is the Brainsway Deep TMS System, indicated as an aid in short-term smoking cessation for adults. The document outlines a 510(k) submission, classifying it as a Class II medical device.
Crucially, the provided document explicitly states under the "Clinical Performance Data" section: "Not Applicable." This indicates that no direct clinical efficacy or performance study of the device itself (i.e., algorithm only or human-in-the-loop performance with the device) was conducted or provided for this specific 510(k) submission for the Brainsway Deep TMS System for smoking cessation.
Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices by Brainsway Ltd., specifically:
- Main Predicate (K200957): Brainsway Deep TMS System for smoking cessation.
- Reference Predicate (K183303): Brainsway Deep TMS System for OCD (used to demonstrate equivalence of device modifications like the new stimulator).
The acceptance criteria and performance data provided are primarily non-clinical (bench) performance data showing that the modified Brainsway Deep TMS System performs similarly to already cleared versions. The "study that proves the device meets the acceptance criteria" in this context is the bench testing and compliance with recognized standards to demonstrate that the modifications made do not raise new safety or effectiveness concerns compared to the predicate devices.
Therefore, many of the requested details about acceptance criteria, test set sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets are not applicable or not provided in this specific 510(k) summary, as the clearance relies on substantial equivalence based on technical and performance similarities to existing cleared devices, rather than new clinical efficacy demonstrations.
Given this, I will answer the questions based on the information available in the document, highlighting what is and is not present.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission based on non-clinical performance and a pre-existing indication, the "acceptance criteria" are not framed as specific clinical performance metrics (e.g., sensitivity, specificity for a diagnostic device) but rather as successful demonstration of technical equivalence and safety.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Non-Clinical (Bench) Performance | |
| Output Waveform | Demonstrated "substantially equivalent" to the previously cleared Brainsway DTMS System (K200957) through performance testing. |
| Electrical Field Spatial Distribution | Demonstrated "substantially equivalent" to the previously cleared Brainsway DTMS System (K200957) through performance testing. |
| Magnetic Field Strength Gradient | Demonstrated "substantially equivalent" to the previously cleared Brainsway DTMS System (K200957) through performance testing. |
| Electrical Safety | Compliance with IEC 60601-1 standard. Results of tests demonstrated substantial equivalence. |
| Mechanical Safety | Compliance with IEC 60601-1 standard. Results of tests demonstrated substantial equivalence. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 standard. Results of tests demonstrated substantial equivalence. |
| Software Validation | Compliance with FDA guidelines for software validation and IEC 62304 standard requirements. The new stimulator software has been validated to ensure proper performance. |
| Biocompatibility | Materials are biocompatible. |
| Functional Equivalence | |
| Intended Use/Indications for Use | Same as the main predicate device (Brainsway Deep TMS System cleared in K200957) for aid in short-term smoking cessation for adults. |
| Mechanism of Action | Similar mechanism of action (electromechanical instrument producing pulsed magnetic fields to induce electrical currents in targeted brain regions for non-invasive stimulation of cortical neurons). |
| System Components | Basic components are similar to cleared predicate devices. Minor modifications (new Brainsway stimulator, minor cart/cooling system/coil wire/helmet changes) introduced, but already present in reference predicate (K183303). |
| Safety Features | Introduces similar safety features and complies with the same relevant consensus standards as predicate devices. Potential hazards from modifications were mitigated through performance testing. |
| Performance Parameters | Treatment parameters (Magnetic Field Intensity, Frequency, Train duration, Inter-train interval, Number of trains, Magnetic Pulses per Session, Tx Session Duration, Session frequency) are identical to the main predicate (K200957). |
| Environmental Parameters | Coil's Operating Temperature, Storage Temperature, Atmospheric Pressure Range, and Relative Humidity Range are within the same or comparable bounds as the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable / Not specified. The data provided focuses on non-clinical bench testing of the modified device's components and system performance against engineering and safety standards, rather than clinical performance on a patient test set.
- Data Provenance: The document does not specify the country of origin for the non-clinical bench test data. It is inherently prospective in the sense that new tests were performed on the modified device, but these are engineering tests, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. As indicated in point 2, there was no clinical test set requiring expert ground truth for patient outcomes or conditions. The "ground truth" for the non-clinical tests would be the established engineering and safety standards (e.g., IEC standards, FDA guidelines for software validation).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication was performed or reported in this 510(k) summary.
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 is a medical device for treatment (Transcranial Magnetic Stimulation), not an AI diagnostic/imaging device. Therefore, a MRMC study for AI assistance to human readers is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device (Brainsway Deep TMS System) is a physical medical device. It does not operate as a standalone algorithm in the way a diagnostic AI would. Its performance is evaluated through its physical output (magnetic pulses) and electrical/mechanical characteristics as detailed in the non-clinical tests, and its substantial equivalence to a predicate device. Clinical performance of the therapy using the device relies on the operator (human-in-the-loop) and the patient, but the performance evaluation here is for the device's technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For non-clinical performance: The "ground truth" is adherence to established engineering, electrical, mechanical, and software safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62304) and comparison to the output/characteristics of the legally marketed predicate devices.
- For the overall indication (smoking cessation): The acceptability of the indication itself and its efficacy as a therapy stems from the prior clearance of the predicate device (K200957), which would have established this efficacy through clinical trials (though not detailed in this particular 510(k) summary).
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns from data. The "training" in this context would be the design and development processes for the hardware and software, and testing against specifications.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" for an AI/ML algorithm in this context.
{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, PamelaD.Scott@fda.hhs.gov.
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 (1-800-638-2041 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.19 Hartom St. (Bynet Bldg)Har Hotzvim, Jerusalem, ISRAEL 9777518Tel: +972-2-5813140Fax: +972-2-5812517E-mail: ahava@asteinrac.com |
Contact Person:
| Official Correspondent: | Ahava Stein |
|---|---|
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
| Address: | 18 Hata'as Str., Suite 102Kfar Saba 4442520 IsraelTel: +972-9-7670002Fax: +972-9-7668534E-mail: ahava@asteinrac.com |
| 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:
-
- Cart
- a) TMS Neurostimulator
- b) Cooling System
- c) Positioning Device
-
- 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}------------------------------------------------
| TechnologicalCharacteristic | Modified Brainsway Deep TMSSystem | Brainsway Deep TMS SystemMain Predicate (K200957) | Brainsway Deep TMS SystemReference Predicate (K183303) |
|---|---|---|---|
| Classification/Product Code | 21 CFR 882.5802 | 21 CFR 882.5802 | 21 CFR 882.5802 |
| Product Code,Class | QMDClass II | QCIClass II | QCIClass II |
| Indications forUse | The Brainsway Deep TranscranialMagnetic Stimulation System isindicated to be used as an aid inshort-term smoking cessation foradults. | The Brainsway Deep TranscranialMagnetic Stimulation System isindicated to be used as an aid inshort-term smoking cessation foradults. | The Brainsway Deep TranscranialMagnetic Stimulation System isintended to be used as an adjunctfor the treatment of adult patientssuffering from Obsessive-Compulsive Disorder. |
| TargetPopulation | Adult subjects with smokingaddiction | Adult subjects with smokingaddiction | Adult subjects with ObsessiveCompulsive Disorder |
| Anatomical Sites | Head - stimulation to theprefrontal cortex and insula | Head - stimulation to theprefrontal cortex and insula | Head - stimulation to theprefrontal cortex |
| EnvironmentUsed | Hospitals, Clinics | Hospitals, Clinics | Hospitals, Clinics |
| Energy Used /Delivered | Electromagnetic Energy isdelivered | Electromagnetic Energy isdelivered | Electromagnetic Energy isdelivered |
| Design: | The Brainsway DTMS Systemdesign is based on applyingtranscranial magnetic stimulationby means of repetitive pulse trainsat a predetermined frequency. | The Brainsway DTMS Systemdesign is based on applyingtranscranial magnetic stimulationby means of repetitive pulse trainsat a predetermined frequency. | The Brainsway DTMS Systemdesign is based on applyingtranscranial magnetic stimulationby means of repetitive pulse trainsat a predetermined frequency. |
| - Mechanism ofAction | The Brainsway DTMS System isan electromechanical instrumentthat produces and delivers briefduration, rapidly alternating(pulsed) magnetic fields to induceelectrical currents in localizedregions of the prefrontal cortexand insula. This is a non-invasivetool for the stimulation of corticalneurons as an aid in short-termsmoking cessation | The Brainsway DTMS System isan electromechanical instrumentthat produces and delivers briefduration, rapidly alternating(pulsed) magnetic fields to induceelectrical currents in localizedregions of the prefrontal cortexand insula. This is a non-invasivetool for the stimulation of corticalneurons as an aid in short-termsmoking cessation | The Brainsway DTMS System isan electromechanical instrumentthat produces and delivers briefduration, rapidly alternating(pulsed) magnetic fields to induceelectrical currents in localizedregions of the prefrontal cortex.This is a non-invasive tool for thestimulation of cortical neurons forthe treatment of adult patients withObsessive Compulsive Disorder |
| TechnologicalCharacteristic | Modified Brainsway Deep TMSSystem | Brainsway Deep TMS SystemMain Predicate (K200957) | Brainsway Deep TMS SystemReference Predicate (K183303) |
| - SystemComponents | The Brainsway DTMS Systemconsists of the followingcomponents:- Mobile Cart- Cooling System- Positioning Arm- Brainsway TMS stimulator &SW- Helmet & Aiming Apparatus- H4/HADD-Coil | The Brainsway DTMS Systemconsists of the followingcomponents:- Mobile Cart- Cooling System- Positioning Arm- Magstim TMS stimulator- Helmet- H4/HADD-Coil | The Brainsway DTMS Systemconsists of the followingcomponents:- Mobile Cart- Cooling System- Positioning Arm- Brainsway TMS stimulator &SW- Helmet & Aiming Apparatus- H7/HAC-Coil |
| - SystemAccessories | The Brainsway DTMS Systemconsists of the followingaccessories:- Head Cap- Head Positioning Straps- Earplugs | The Brainsway DTMS Systemconsists of the followingaccessories:- Head Cap- Head Positioning Straps- Earplugs | The Brainsway DTMS Systemconsists of the followingaccessories:- Head Cap- Head Positioning Straps- Earplugs |
| - Features /OperationalProcedures | The Brainsway DTMS Systemconsists of the following features:- Determination of MotorThreshold- Coil Positioning- Administration of Treatment- System Management, includingpatient record keeping | The Brainsway DTMS Systemconsists of the following features:- Determination of MotorThreshold- Coil Positioning- Administration of Treatment | The Brainsway DTMS Systemconsists of the following features:- Determination of MotorThreshold- Coil Positioning- Administration of Treatment- System Management, includingpatient record keeping |
| - Dimensions | Cart Dimensions:680mm (L) x 688mm (W)(26.7"(L) x 27"(W)) | Cart Dimensions:680mm (L) x 625mm (W) (27"(L)x 25"(W)) | Cart Dimensions:680mm (L) x 688mm (W)(26.7"(L) x 27"(W)) |
| - Weight | 142 kg (313lbs) | 122.5 kg (270lbs) | 142 kg (313lbs) |
| Performance | Treatment Parameters:- Magnetic Field Intensity: 120%of the patient's observed motorthreshold.- Frequency: 10 Hz.- Train duration: 3 sec.- Inter-train interval: 15 sec.- Number of trains: 60- Magnetic Pulses per Session:1800- Tx Session Duration: ~20 min- 5 daily sessions for 3 weeks,followed by one weekly sessionfor another 3 weeks | Treatment Parameters:- Magnetic Field Intensity: 120%of the patient's observed motorthreshold.- Frequency: 10 Hz.- Train duration: 3 sec.- Inter-train interval: 15 sec.- Number of trains: 60- Magnetic Pulses per Session:1800- Tx Session Duration: ~20 min- 5 daily sessions for 3 weeks,followed by one weekly sessionfor another 3 weeks | Treatment Parameters:- Magnetic Field Intensity: 100%of the patient's observed motorthreshold.- Frequency: 20 Hz.- Train duration: 2 sec.- Inter-train interval: 20 sec.- Number of trains: 50- Magnetic Pulses per Session:2000- Tx Session Duration: ~18 min- 5 daily sessions for 5 weeks and4 daily sessions during the sixthweek |
| Technological | Modified Brainsway Deep TMS | Brainsway Deep TMS System | Brainsway Deep TMS System |
| Characteristic | System | Main Predicate (K200957) | Reference Predicate (K183303) |
| Coil's OperatingTemperature: | 10°C to 30°C | 15 °C to 30 °C | 10°C to 30°C |
| StorageTemperature | -20 °C to 60 °C | -20 °C to 60 °C | -20 °C to 60 °C |
| AtmosphericPressure Range | 500 hPa to 1060 hPa | 500 hPa to 1060 hPa | 500 hPa to 1060 hPa |
| RelativeHumidity Range | 10% to 80% Non-Condensing | 10% to 80% Non-Condensing | 10% to 80% Non-Condensing |
| Materials | Personal Head Cap - Fabrifoammaterial | Personal Head Cap - Fabrifoammaterial | Personal Head Cap - Fabrifoammaterial |
| Biocompatibility | Materials are biocompatible | Materials are biocompatible | Materials are biocompatible |
| Sterility | Not Applicable | Not Applicable | Not Applicable |
| Human Factors | The Brainsway DTMS Systemuses its own TMS stimulatorsoftware for parameterconfiguration.Patient positioning and MTdetermination are done manually. | The Brainsway DTMS Systemuses the Magstim TMS stimulatorsoftware for parameterconfiguration.Patient positioning and MTdetermination are done manually. | The Brainsway DTMS Systemuses its own TMS stimulatorsoftware for parameterconfiguration.Patient positioning and MTdetermination are done manually. |
| Standards Met | IEC 60601-1IEC 60601-1-2IEC 62304 | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2IEC 62304 |
| CompatibilityWith theEnvironmentand OtherDevices | 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. | The Brainsway DTMS System iscompliant with the IEC 60601-1-2(EMC Safety) standard. |
| Electrical Safety | Power Requirements:100-240 VAC50/60 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. | Power Requirements:100-240 VAC50/60 HzThe Brainsway DTMS System iscompliant with the IEC 60601-1standard. |
| MechanicalSafety | The Brainsway DTMS System iscompliant with the IEC 60601-1standard. | The Brainsway DTMS System iscompliant with the IEC 60601-1standard. | The Brainsway DTMS System iscompliant with the IEC 60601-1standard. |
| Chemical Safety | Not Applicable | Not Applicable | Not Applicable |
| Thermal Safety | The Brainsway DTMS System iscompliant with the IEC 60601-1standard. | The Brainsway DTMS System iscompliant with the IEC 60601-1standard. | The Brainsway DTMS System iscompliant with the IEC 60601-1standard. |
| 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.
§ 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.