(169 days)
Not Found
No
The summary describes a hardware-based system for transcranial magnetic stimulation and does not mention any software or algorithms that would suggest the use of AI or ML.
Yes
The device is indicated for the treatment of depressive episodes, which is a therapeutic purpose.
No
Explanation: The device is described as a treatment system for Major Depressive Disorder, not a tool for diagnosis. Its function is to activate brain structures for therapeutic purposes, as clearly stated in the "Intended Use / Indications for Use" and "Device Description" sections.
No
The device description explicitly lists multiple hardware components (Electromagnetic Coil, TMS Neurostimulator, Cooling System, Positioning Device, Cart) that are integral to the system's function. While software validation is mentioned, the device is clearly not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of depressive episodes in adult patients. IVDs are used for the diagnosis or monitoring of diseases or conditions using samples taken from the body (like blood, urine, or tissue).
- Device Description: The device description details a system that applies magnetic pulses to the brain for therapeutic purposes. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, using reagents, or providing diagnostic information based on biological markers.
The Brainsway Deep TMS System is a therapeutic device that directly interacts with the patient's body (non-invasive stimulation of the brain) for treatment, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
OBP
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:
-
- An Electromagnetic Coil
-
- A TMS Neurostimulator
-
- A Cooling System
-
- A Positioning Device
-
- A Cart
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
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Hospitals, Clinics
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 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
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.(b)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
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);
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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: +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: | 20 Hata'as Str., Suite 102 |
| Kfar Saba 4442520 Israel | |
| Tel: +972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-mail: ahava@asteinrac.com | |
| 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 |
4
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:
-
- An Electromagnetic Coil
-
- A TMS Neurostimulator
-
- A Cooling System
-
- A Positioning Device
-
- 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)
5
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
Characteristic | Modified Brainsway Deep TMS
System (K173540) | Brainsway Deep TMS System
(K122288) |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code,
Class | OBP
Class II | OBP
Class II |
| 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. | 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. |
| Target Population | Adult subjects with Major Depressive
Disorder | Adult subjects with Major Depressive
Disorder |
| Anatomical Sites | Head - stimulation to the prefrontal cortex | Head - stimulation to the prefrontal cortex |
| Environment Used | Hospitals, Clinics | Hospitals, Clinics |
| Energy Used /
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. |
| - 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. This is a
non-invasive tool for the stimulation of
cortical neurons for the treatment of adult
patients with Major Depressive Disorder
(MDD). | 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 Major Depressive Disorder
(MDD). |
| Technological
Characteristic | Modified Brainsway Deep TMS
System (K173540) | Brainsway Deep TMS System
(K122288) |
| - Components | The Brainsway DTMS System consists of
the following components:
- Mobile Cart
- Coil & Helmet Unit
- Positioning Arm
- Cooling System
- TMS stimulator & Software (Brainsway) | The Brainsway DTMS System consists of
the following components: - Mobile Cart
- Coil & Helmet Unit
- Positioning Arm
- Cooling System
- TMS stimulator & Software (Magstim) |
| - 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 |
| - Features | The Brainsway DTMS System consists of
the following features: - Determination of Motor Threshold (MT)
- Coil Positioning
- Administration of Treatment
- System Management, including patient
record keeping | The Brainsway DTMS System consists of
the following features: - Determination of Motor Threshold (MT)
- Coil Positioning
- Administration of Treatment |
| - 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)) |
| - Weight | 142 kg (313lbs) | 122.5 kg (270lbs) |
| Performance | MDD Treatment Parameters:
Magnetic Field Intensity: 120% of the
patient's observed motor threshold. - Frequency: 18 Hz.
- Train duration: 2 sec.
- Inter-train interval: 20 sec.
- Number of trains: 55
- Magnetic Pulses per Session: 1980
- Treatment Session Duration:
approximately 20.2 minutes - Sessions per Week: 5
- 5 daily sessions for 4 weeks
- Bi-weekly sessions for another 12 weeks
(optional maintenance treatments) | MDD Treatment Parameters:
Magnetic Field Intensity: 120% of the
patient's observed motor threshold. - Frequency: 18 Hz.
- Train duration: 2 sec.
- Inter-train interval: 20 sec.
- Number of trains: 55
- Magnetic Pulses per Session: 1980
- Treatment Session Duration:
approximately 20.2 minutes - Sessions per Week: 5
- 5 daily sessions for 4 weeks
- Bi-weekly sessions for another 12 weeks
(optional maintenance treatments) |
| 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. |
| Standards Met | IEC 60601-1
IEC 60601-1-2
IEC 62304 | IEC 60601-1
IEC 60601-1-2
IEC 62304 |
| Materials | Head Cap - biocompatible material | Head Cap - biocompatible material |
| Biocompatibility | Materials are biocompatible | Materials are biocompatible |
| Technological
Characteristic | Modified Brainsway Deep TMS System (K173540) | Brainsway Deep TMS System (K122288) |
| 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. |
| Sterility | Not Applicable | Not Applicable |
| Electrical Safety | 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:
110-120 VAC / 60 Hz
220-240 VAC / 50 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. |
| Chemical Safety | 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. |
| Radiation Safety | 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. |
7
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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.