(127 days)
No
The description focuses on the physical components and the mechanism of action of TMS, with no mention of AI or ML for treatment planning, targeting, or response prediction. The performance studies are bench tests and clinical data is not applicable, further suggesting the absence of AI/ML components that would typically require clinical validation.
Yes.
The device is indicated to be used as an aid in short-term smoking cessation for adults, which is a therapeutic purpose.
No
The device is described as a system for actively stimulating deep brain structures using transcranial magnetic stimulation (TMS) to aid in short-term smoking cessation. Its function is to induce an electric field and activate neurons, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including a cart, neurostimulator, cooling system, positioning device, helmet, aiming apparatus, electromagnetic coil, and cap. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Brainsway Deep TMS System is a therapeutic device that uses magnetic pulses applied to the head to stimulate brain structures. It does not analyze samples taken from the body.
- Intended Use: The intended use is "as an aid in short-term smoking cessation," which is a therapeutic application, not a diagnostic one.
- Device Description: The description details the physical components and how they deliver magnetic stimulation, not how they analyze biological samples.
Therefore, the Brainsway Deep TMS System falls under the category of a therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
QMD, QCI
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head - stimulation to the prefrontal cortex and insula
Indicated Patient Age Range
Adults
Intended User / Care Setting
Hospitals, Clinics
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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
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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)
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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 9777518 | |
| Tel: +972-2-5813140 | |
| Fax: +972-2-5812517 | |
| E-mail: ahava@asteinrac.com |
Contact Person:
| Official Correspondent: | Ahava Stein |
|---|---|
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
| Address: | 18 Hata'as Str., Suite 102 |
| Kfar Saba 4442520 Israel | |
| Tel: +972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-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
| Technological
Characteristic | Modified Brainsway Deep TMS
System | Brainsway Deep TMS System
Main Predicate (K200957) | Brainsway Deep TMS System
Reference Predicate (K183303) |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification/
Product Code | 21 CFR 882.5802 | 21 CFR 882.5802 | 21 CFR 882.5802 |
| Product Code,
Class | QMD
Class II | QCI
Class II | QCI
Class II |
| 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. | 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 Transcranial
Magnetic Stimulation System is
intended to be used as an adjunct
for the treatment of adult patients
suffering from Obsessive-
Compulsive Disorder. |
| Target
Population | Adult subjects with smoking
addiction | Adult subjects with smoking
addiction | Adult subjects with Obsessive
Compulsive Disorder |
| Anatomical Sites | Head - stimulation to the
prefrontal cortex and insula | Head - stimulation to the
prefrontal cortex and insula | Head - stimulation to the
prefrontal cortex |
| Environment
Used | Hospitals, Clinics | Hospitals, Clinics | Hospitals, Clinics |
| Energy Used /
Delivered | Electromagnetic Energy is
delivered | Electromagnetic Energy is
delivered | Electromagnetic Energy is
delivered |
| Design: | The Brainsway DTMS System
design is based on applying
transcranial magnetic stimulation
by means of repetitive pulse trains
at a predetermined frequency. | The Brainsway DTMS System
design is based on applying
transcranial magnetic stimulation
by means of repetitive pulse trains
at a predetermined frequency. | The Brainsway DTMS System
design is based on applying
transcranial magnetic stimulation
by means of repetitive pulse trains
at a predetermined frequency. |
| - Mechanism of
Action | The Brainsway DTMS System is
an electromechanical instrument
that produces and delivers brief
duration, rapidly alternating
(pulsed) magnetic fields to induce
electrical currents in localized
regions of the prefrontal cortex
and insula. This is a non-invasive
tool for the stimulation of cortical
neurons as an aid in short-term
smoking cessation | The Brainsway DTMS System is
an electromechanical instrument
that produces and delivers brief
duration, rapidly alternating
(pulsed) magnetic fields to induce
electrical currents in localized
regions of the prefrontal cortex
and insula. This is a non-invasive
tool for the stimulation of cortical
neurons as an aid in short-term
smoking cessation | The Brainsway DTMS System is
an electromechanical instrument
that produces and delivers brief
duration, rapidly alternating
(pulsed) magnetic fields to induce
electrical currents in localized
regions of the prefrontal cortex.
This is a non-invasive tool for the
stimulation of cortical neurons for
the treatment of adult patients with
Obsessive Compulsive Disorder |
| Technological
Characteristic | Modified Brainsway Deep TMS
System | Brainsway Deep TMS System
Main Predicate (K200957) | Brainsway Deep TMS System
Reference Predicate (K183303) |
| - System
Components | The Brainsway DTMS System
consists of the following
components:
- Mobile Cart
- Cooling System
- Positioning Arm
- Brainsway TMS stimulator &
SW - Helmet & Aiming Apparatus
- H4/HADD-Coil | The Brainsway DTMS System
consists of the following
components: - Mobile Cart
- Cooling System
- Positioning Arm
- Magstim TMS stimulator
- Helmet
- H4/HADD-Coil | The Brainsway DTMS System
consists of the following
components: - Mobile Cart
- Cooling System
- Positioning Arm
- Brainsway TMS stimulator &
SW - Helmet & Aiming Apparatus
- H7/HAC-Coil |
| - System
Accessories | The Brainsway DTMS System
consists of the following
accessories: - Head Cap
- Head Positioning Straps
- Earplugs | The Brainsway DTMS System
consists of the following
accessories: - Head Cap
- Head Positioning Straps
- Earplugs | The Brainsway DTMS System
consists of the following
accessories: - Head Cap
- Head Positioning Straps
- Earplugs |
| - Features /
Operational
Procedures | The Brainsway DTMS System
consists of the following features: - Determination of Motor
Threshold - Coil Positioning
- Administration of Treatment
- System Management, including
patient record keeping | The Brainsway DTMS System
consists of the following features: - Determination of Motor
Threshold - Coil Positioning
- Administration of Treatment | The Brainsway DTMS System
consists of the following features: - Determination of Motor
Threshold - Coil Positioning
- Administration of Treatment
- System Management, including
patient 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 motor
threshold. - 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 session
for another 3 weeks | Treatment Parameters: - Magnetic Field Intensity: 120%
of the patient's observed motor
threshold. - 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 session
for another 3 weeks | Treatment Parameters: - Magnetic Field Intensity: 100%
of the patient's observed motor
threshold. - 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 and
4 daily sessions during the sixth
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
Temperature: | 10°C to 30°C | 15 °C to 30 °C | 10°C to 30°C |
| Storage
Temperature | -20 °C to 60 °C | -20 °C to 60 °C | -20 °C to 60 °C |
| Atmospheric
Pressure Range | 500 hPa to 1060 hPa | 500 hPa to 1060 hPa | 500 hPa to 1060 hPa |
| Relative
Humidity Range | 10% to 80% Non-Condensing | 10% to 80% Non-Condensing | 10% to 80% Non-Condensing |
| Materials | Personal Head Cap - Fabrifoam
material | Personal Head Cap - Fabrifoam
material | Personal Head Cap - Fabrifoam
material |
| Biocompatibility | Materials are biocompatible | Materials are biocompatible | Materials are biocompatible |
| Sterility | Not Applicable | Not Applicable | Not Applicable |
| Human Factors | The Brainsway DTMS System
uses its own TMS stimulator
software for parameter
configuration.
Patient positioning and MT
determination are done manually. | The Brainsway DTMS System
uses the Magstim TMS stimulator
software for parameter
configuration.
Patient positioning and MT
determination are done manually. | The Brainsway DTMS System
uses its own TMS stimulator
software for parameter
configuration.
Patient positioning and MT
determination are done manually. |
| Standards Met | IEC 60601-1
IEC 60601-1-2
IEC 62304 | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2
IEC 62304 |
| Compatibility
With the
Environment
and Other
Devices | The Brainsway DTMS System is
compliant with the IEC 60601-1-2
(EMC Safety) standard. | The Brainsway DTMS System is
compliant with the IEC 60601-1-2
(EMC Safety) standard. | The Brainsway DTMS System is
compliant with the IEC 60601-1-2
(EMC Safety) standard. |
| Electrical Safety | Power Requirements:
100-240 VAC
50/60 Hz
The Brainsway DTMS System is
compliant with the IEC 60601-1
standard. | Power Requirements:
110-120 VAC / 60 Hz
220-240 VAC / 50 Hz
The Brainsway DTMS System is
compliant with the IEC 60601-1
standard. | Power Requirements:
100-240 VAC
50/60 Hz
The Brainsway DTMS System is
compliant with the IEC 60601-1
standard. |
| Mechanical
Safety | The Brainsway DTMS System is
compliant with the IEC 60601-1
standard. | The Brainsway DTMS System is
compliant with the IEC 60601-1
standard. | The Brainsway DTMS System is
compliant with the IEC 60601-1
standard. |
| Chemical Safety | Not Applicable | Not Applicable | Not Applicable |
| Thermal Safety | The Brainsway DTMS System is
compliant with the IEC 60601-1
standard. | The Brainsway DTMS System is
compliant with the IEC 60601-1
standard. | The Brainsway DTMS System is
compliant with the IEC 60601-1
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.