(123 days)
No
The summary describes a hardware-based transcranial magnetic stimulation system and does not mention any AI or ML components or capabilities.
Yes
The device 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.
No
This device is used for treatment, specifically for depressive episodes in patients with Major Depressive Disorder, and not for diagnosis.
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 indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The BrainsWay Deep TMS System is described as a non-invasive device that applies magnetic pulses to the brain to treat depression. It directly interacts with the patient's body.
- Intended Use: The intended use is for the treatment of depressive episodes, not for analyzing biological samples.
- Lack of Sample Analysis: There is no mention of collecting or analyzing any biological samples from the patient.
Therefore, the BrainsWay Deep TMS System is a therapeutic device, not an in vitro diagnostic device.
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 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 (H1-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
Indicated Patient Age Range
Adult patients / ≥ 18 years of age (or 22-68 years of age in the multicenter MDD study)
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)
The safety and effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (TMS) device for the intended use of Major Depressive Disorder (MDD) using the intermittent theta-burst (iTBS) stimulation protocol was demonstrated in a non-inferiority analysis, comparing the iTBS treatment with the FDA cleared BrainsWay Deep TMS device to the High Frequency (HF) protocol using the same device.
Study Objective: The objective of the current study was to evaluate the non-inferiority of the iTBS stimulation protocol with the BrainsWay Deep TMS (H1-Coil) System compared to the FDA-cleared High Frequency (HF) stimulation protocol using the same BrainsWay Deep TMS (H1-Coil) System, for the treatment of MDD.
Study duration: 5 weeks
Number of subjects: 66 subjects received iTBS stimulation protocol and 80 subjects received HF stimulation protocol.
Primary Endpoint: The primary efficacy endpoint was the change from baseline to 5 weeks visit (after 20 treatment sessions) in the patients depression level as measured by the HDRS-21 score
Secondary Endpoints: HDRS-21 Response Rate at 5 weeks, where response is defined as a >=50% reduction in HDRS-21 score from baseline HDRS-21 Remission Rate at 5 weeks, where remission is defined as HDRS-21 score = 18 years of age (or 22-68 years of age in the multicenter MDD study) Diagnosis of Major Depression Disorder
Study Hypothesis: Null Hypothesis: The mean change in HDRS-21 score from baseline at 5 weeks in the iTBS Deep TMS group is inferior to the mean change in HDRS-21 score from baseline at 5 weeks in the HF Deep TMS group, by more than 3 points. Alternative Hypothesis: The mean change in HDRS-21 score from baseline at 5 weeks in the iTBS Deep TMS group is inferior to the mean change in HDRS-21 score from baseline at 5 weeks in the HF Deep TMS group, by less than 3 points, i.e. is non-inferior.
Summary of Results: The non-inferiority analysis of the change from baseline between the two treatment groups was assessed. Since the upper limit of the confidence interval was less than the non-inferiority margin of 3 points, the null hypothesis of inferiority was rejected, indicating non-inferiority between the iTBS Deep TMS and HF Deep TMS treatments, when adjusted for baseline HDRS-21 scores. In summary, the change from baseline was similar between the two treatment groups at 5 weeks, which demonstrated the non-inferiority of the iTBS Deep TMS treatment
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
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April 23, 2021
Brainsway Ltd. % Ahava Stein Regulatory Consultant A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 Israel
Re: K203735
Trade/Device Name: Brainsway Deep TMS System (with iTBS Protocol) Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: January 19, 2021 Received: January 25, 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.
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
1
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,
Pamela Scott, M.S. 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
2
Indications for Use
510(k) Number (if known) K203735
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY
BRAINSWAY DEEP TMS SYSTEM
510(k) Number K203745
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: | January 14, 2021 |
| Trade Name: | BrainsWay Deep TMS System (with iTBS Protocol) |
Classification Name: CFR Classification section 882.5805; (Product Code OBP)
Classification: Class II Medical Device
Predicate Device:
The subject device is a modification of the BrainsWay Deep TMS System ("reference" predicate device) that was cleared in 510(k) K122288 and the BrainsWay Deep TMS System cleared in 510(k) K173540 ("reference" predicate device). The inclusion of the iTBS stimulation protocol is substantially equivalent to the MagVita TMS Therapy System w/ Theta Burst Stimulation (Tonica Elektronik A/S, cleared in 510(k) K173620 ("main" predicate device).
| Predicate | Device | Manufacturer | 510(k) |
|---|---|---|---|
| Main | MagVita TMS Therapy System w/ Theta | ||
| Burst Stimulation | Tonica Elektronik A/S | K173620 | |
| Secondary | BrainsWay Deep TMS System | BrainsWay Ltd. | K122288 |
4
| Secondary | BrainsWay Deep TMS System | BrainsWay Ltd. | K173540 |
|---|---|---|---|
| ----------- | --------------------------- | ---------------- | --------- |
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 (H1-Coil)
- c) Cap
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 . 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-cycle processes (2006 + A1:2015) .
- ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro ● cvtotoxicitv
- . ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and delaved-type hypersensitivity
- ISO 14971 Medical devices Application of risk management to medical devices .
6
Non-Clinical (Bench) Performance Data:
The clinical performance of iTBS is dependent on the stimuli being delivered at an equal intensity, to ensure that a constant dose of stimuli is delivered during treatment. The Theta Burst Stimulation verification testing demonstrated that the intensity of the individual stimuli in iTBS stimulation protocol is equal and maintained constant throughout the delivery of the entire treatment.
Tests were conducted on the cleared BrainsWay Deep TMS Systems for the iTBS stimulation protocol 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 Brains Way Deep TMS System is substantially equivalent to the predicate device.
Animal Performance Data / Histology Data:
Not Applicable
Clinical Performance Data:
The safety and effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (TMS) device for the intended use of Major Depressive Disorder (MDD) using the intermittent theta-burst (iTBS) stimulation protocol was demonstrated in a non-inferiority analysis, comparing the iTBS treatment with the FDA cleared BrainsWay Deep TMS device to the High Frequency (HF) protocol using the same device. Following is a summary of the study.
| Study Objective | The objective of the current study was to evaluate the non-
inferiority of the iTBS stimulation protocol with the BrainsWay
Deep TMS (H1-Coil) System compared to the FDA-cleared
High Frequency (HF) stimulation protocol using the same
BrainsWay Deep TMS (H1-Coil) System, for the treatment of
MDD. |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Study duration | 5 weeks |
| Number of subjects | 66 subjects received iTBS stimulation protocol and 80 subjects
received HF stimulation protocol. |
| Primary Endpoint | The primary efficacy endpoint was the change from baseline to
5 weeks visit (after 20 treatment sessions) in the patients
depression level as measured by the HDRS-21 score |
| Secondary Endpoints | HDRS-21 Response Rate at 5 weeks, where response is defined as a ≥50% reduction in HDRS-21 score from baseline HDRS-21 Remission Rate at 5 weeks, where remission is defined as HDRS-21 score