(679 days)
Not Found
No
The summary describes a TMS system and its clinical performance data, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the "treatment of depressive episodes and for decreasing anxiety symptoms" in patients with Major Depressive Disorder (MDD). This explicit mention of "treatment" and "decreasing symptoms" directly points to a therapeutic purpose.
No
The device is indicated for treatment of depressive episodes and decreasing anxiety symptoms. It is a therapeutic device that delivers transcranial magnetic stimulation to achieve its intended effect. The key metrics provided are related to treatment outcomes (remission rates, response rates) rather than diagnostic performance metrics (e.g., sensitivity, specificity).
No
The device description explicitly lists multiple hardware components including a cart with a neurostimulator, cooling system, and positioning device, and a helmet with an aiming apparatus, electromagnetic coil, and cap. This indicates it is a hardware-based medical device with associated software for control and operation.
Based on the provided information, the BrainsWay Deep TMS™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The BrainsWay Deep TMS™ System is described as a non-invasive device that uses magnetic pulses applied to the scalp to induce electric fields in the brain. This is a therapeutic intervention, not a diagnostic test performed on a sample.
- Intended Use: The intended use is for the treatment of depressive episodes and decreasing anxiety symptoms in patients with Major Depressive Disorder. This is a therapeutic indication, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the BrainsWay Deep TMS™ System is a therapeutic medical 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 and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant 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 to 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 (H Coil)
c) Cap
The BrainsWay Deep TMS™ System is identical to the previously cleared BrainsWay Deep TMS™ Systems.
The purpose of this 510(k) submission is to enable modifications to the device labeling (Instructions for Use), based on clinical data from a randomized clinical study and from Real-World Data (RWD), to support the extension of the adult population to include adult subjects >22 and 22 and 60 years old) MDD participants randomized to active Deep TMS experienced significantly greater remission and response rates than the sham group.
Real-World Data (RWD):
- Data Source: Electronic health records from 1,198 patients from 20 sites over the US.
- Time Span: 2012 to 2022.
- ITT Patient Population Analysis: 152 subjects were included, meeting main study eligibility criteria, including subjects > 69 years of age with a primary diagnosis of MDD (PHQ-9 score ≥ 10 or HDRS-21 score >14).
- Mean Patient Age: 73.6 years (range 69-86).
- Key Results: RWD based on HDRS-21 scores or HDRS-21 and PHQ-9 scores for the elderly MDD patient population (> 69 years of age) showed remission and response rates comparable to and consistent with the Kaster 2018 Study, and as good as or better than rates in the MDD Multicenter Study. RWD CGI-S remission rates were comparable, and RWD CGI-S response rates and change from baseline in CGI-S scores were significantly greater/better than those in the MDD Multicenter Study.
Overall Safety:
Overall safety of the BrainsWay Deep TMS System in both the Kaster 2018 Study and the RWD demonstrated adverse effects that were similar and typical of TMS treatment. There were no reports of new or unanticipated adverse events.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Remission Rate: Kaster 2018 Study: 64.0% (Active), 18.5% (Sham)
- Response Rate: Kaster 2018 Study: 64.0% (Active), 22.2% (Sham)
- NNT for remission: 2.2 (elderly MDD patient population in Kaster 2018 Study vs. 6.85 in MDD Multicenter Study)
- NNT for response: 2.4 (elderly MDD patient population in Kaster 2018 Study vs. 7.05 in MDD Multicenter Study)
- Reduction in HDRS-21 scores (difference between active and sham): 5.35 points (Kaster 2018 Study).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
May 31, 2024
Brainsway Ltd. % Ahava Stein Regulatory Consultant A. Stein - Regulatory Affairs Consulting Ltd. 18 Hata`as Str., Suite 21 Kfar Saba, 4442520 Israel
Re: K222196
Trade/Device Name: Deep TMS System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive transcranial magnetic stimulation system Regulatory Class: Class II Product Code: OBP Dated: Mav 27, 2024 Received: May 28, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.
Doe W. Kumsa -S
for Pamela Scott, MS Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality
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Enclosure
3
Indications for Use
510(k) Number (if known) K222196
Device Name BrainsWay Deep TMS™ System
Indications for Use (Describe)
The BrainsWay Deep TMS™ System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant 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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FORM FDA 3881 (8/23)
5
510(K) SUMMARY
BRAINSWAY DEEP TMS™ SYSTEM
510(k) Number K222196
Applicant Name:
| Company Name: | Brains Way Ltd |
|---|---|
| Address: | Brains Way 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 21 |
| Kfar Saba 4442518 Israel | |
| Tel: + 972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-mail: ahava@asteinrac.com | |
| Date Prepared: | July 14, 2022 |
| Trade Name: | BrainsWay Deep TMS™ System |
| Common Name: | Transcranial Magnetic Stimulation System |
| Classification Name: | CFR Classification section 882.5805; (Product Code OBP) |
| Classification: | Class II Medical Device |
Predicate Device:
The subject device is a substantially equivalent to the BrainsWay Deep TMSTM Systems (Model 102 and 104) ("predicate device") cleared in 510(k) K210201.
| Device | Manufacturer | 510(k) No. |
|---|---|---|
| BrainsWay Deep TMSTM System | BrainsWay Ltd. | K210201 |
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Device Description:
The BrainsWay Deep TMS™ System enables direct non-invasive activation of deep brain structures. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative to 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 (H Coil)
- c) Cap
The BrainsWay Deep TMS™ System is identical to the previously cleared BrainsWay Deep TMS™ Systems.
The purpose of this 510(k) submission is to enable modifications to the device labeling (Instructions for Use), based on clinical data from a randomized clinical study and from Real-World Data (RWD), to support the extension of the adult population to include adult subjects >22 and 60 years old) MDD participants randomized to active Deep TMS experienced a remission rate and response rate that was significantly greater than that observed in the sham group, based on both versions of the HDRS scale. The change from baseline in HDRS-21 scores after 4 weeks of treatment was also statistically significantly better in the active Deep TMS treatment group than in the sham treatment group.
R WD from adult MDD patients (> 60 years old) was provided to further support the safety and effectiveness of the Deep TMS treatment in this patient population. The reliability, accuracy, and relevancy of the RWD was demonstrated.
The real-world data (RWD) was derived from electronic health records of 1,198 patients (>22 years old) from 20 sites over the US, who received BrainsWay treatment for MDD over a span of 10 years from 2012 to 2022. A total of 152 subjects were included in the ITT patient population analysis, who met the main study eligibility criteria and included subjects > 69 years of age and had a primary diagnosis of MDD, with moderate or greater depression, defined as a PHQ-9 score ≥ 10 or an HDRS-21 score >14. The mean patient age was 73.6 years (range 69-86), 65% were female, 66% from the southeast US region and 34% from other regions of the US, the vast majority (97%) were from suburban/suburban dense areas and approximately 50% were treated by providers with >10 years or 69 years of age), has shown remission and response rates that are comparable to and consistent with those reported in the Kaster 2018 Study. The RWD remission and response rate are as good as or better than the remission and response rates reported in the MDD Multicenter Study. The RWD change from baseline in HDRS-21 scores was similar to the Kaster 2018 Study for a similar elderly MDD patient population and better than the change from baseline HDRS-21 scores in the MDD Multicenter Study. The RWD CGI-S remission rate is comparable to the
9
MDD Multicenter Study CGI-S remission rate. The RWD CGI-S response rate is significantly greater than the CGI-S response rate in the MDD Multicenter Study. The change from baseline in CGI-S scores are significantly better than the MDD Multicenter Study CGI-S results.
There did not appear to be large differences when comparing the safety and efficacy of the RWD by U.S. geographical location of the sites or urban-rural regions or when comparing safety of the RWD by provider experience. When comparing the efficacy of the RWD by provider experience, a slightly higher remission rate was seen in subjects treated by providers with more experience, as may be expected. Furthermore, in the review of data it was noted that the response rate was much higher in the RWD population of older patients than in the younger age group. A literature review of RCTs using TMS for treating MDD subjects in the expanded age range was conducted, which yielded 17 relevant studies (see Table 3 below). This literature review included studies with a wide variety of elderly age ranges and indicated heterogeneity with response rates ranging from 30-74%. Another study , although not a RCT but a retrospective analysis of 378 MDD patients aged 18-80 treated with Brainsway Deep TMS device, found response and remission rates increased with age and were stronger in female patients.
| Ref | Study | Study type | N | Nactive | Age range | Scale | Response [%] | Remission [%] |
|---|---|---|---|---|---|---|---|---|
| 1 | Kaster 2018 | RCT | 52 | 25 | 60-80 | HDRS | 44% | 40% |
| 2 | Blumberger | |||||||
| 2022 | RCT | 172 | 87 bilateral, 85 | |||||
| TBS | >60 | MADRS | Bilateral: 32.9% | |||||
| TBS: 44.3% | Bilateral: 32.9% | |||||||
| TBS: 35.4% | ||||||||
| 3 | Trevizol 2019 | RCT | 43 | 20-bilateral, 11- | ||||
| unilateral HF | 60-85 | HDRS | Bilateral: 45% | |||||
| Unilateral: 0% | Bilateral: 40% | |||||||
| Unilateral: 0% | ||||||||
| 4 | Zhang 2023 | |||||||
| Meta-analysis | Meta-analysis | 637 | 338 | 60- | HDRS | 52.7% | 18% | |
| 5 | Jorge 2008 | RCT | 92 | Exp 1: 15 | ||||
| Exp 2: 33 | 50- | HDRS | Exp 1: 33.3% | |||||
| Exp 2: 39.4% | Exp 1: 13.3% | |||||||
| Exp 2: 27.3% | ||||||||
| 6 | Cristancho | |||||||
| 2023 | RCT | 17 | 8 | 60-85 | MADRS | 37.5% | NA | |
| 7 | Manes 2001 | RCT | 20 | 10 | >50 | HDRS | 30% | NA |
| 8 | Mosimann | |||||||
| 2004 | RCT | 24 | 15 | 40-90 | HDRS | 6.7% | NA | |
| 9 | Leblhuber | |||||||
| 2019 | RCT | 29 | 19 | Mean=72.4 | HAMD-7 | NA | NA | |
| 10 | Desbeaumes | |||||||
| Jodoin 2019 | Retrospective | ≥60: 19 | ||||||
| 60 | MADRS | ≥60: 33% |
- Kryatova MS, Seiner SJ, Brown JC, Siddiqi SH. Older age associated with better antidepressant response to H1-coll transcranial magnetic stimulation in female patients. J Affect Disord 2024:S0165-0327(24)00176-9. doi: 10.1016/j.jad.2024.01.160. Online ahead of print.
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Overall safety of the BrainsWay Deep TMS System in both the Kaster 2018 Study and the RWD demonstrated adverse effects that were similar and typical of TMS treatment. There were no reports of new or unanticipated adverse events.
The results of the Kaster 2018 Study and the RWD provide sufficient supportive data to expand the use of the BrainsWay Deep TMS System to adult MDD patients ≥69 years old.
Furthermore, effect sizes from the elderly MDD patient population from the Kaster 2018 Study and from the RWD demonstrate a clinically meaningful improvement in anxiety symptoms in MDD for the BrainsWay Deep TMS System, in the elderly (>69 years old) MDD patient population.
The current Indication for Use statement, including treatment of MDD and reducing anxiety symptoms in the overall adult MDD patient population (i.e., >22 years) is supported by the clinical data provided in this 510(k) submission.
Substantial Equivalence:
The subject BrainsWay Deep TMS™ Systems (Models 102 and 104) have the same intended use and indications for use as the predicate BrainsWay Deep TMS™M Systems cleared in 510(k) K210201. The subject devices and the cleared BrainsWay Deep TMS™ Systems are similar in terms of their intended prescription use only, suitable for adult population, indicated for the same anatomical sites, according to the same indications for use and to be used in the same hospital and/or clinic settings.
The subject BrainsWay Deep TMS™ Systems have the same mechanism of operation and use the same underlying technology as the predicate BrainsWay Deep TMS™ Systems. The performance characteristics, including the Output Waveform, Electrical and Magnetic Field Distribution are substantially equivalent to the previously cleared BrainsWay Deep TMS™ Systems. The subject devices, as the cleared devices, introduce similar safety features and comply with same relevant consensus standards, including electrical and mechanical safety, EMC (electromagnetic compatibility), and software validation.
The subject BrainsWay Deep TMS™ Systems are composed of the same device components as the previously cleared, predicate BrainsWay Deep TMS™ Systems (Model 102 and Model 104).
This 510(k) contains clinical data to support the safety and efficacy of the subject BrainsWay Deep TMS™ Systems for the treatment of MDD in the adult elderly population. The clinical data demonstrates that the BrainsWay Deep TMSTM Systems are substantially equivalence to the performance of the predicate BrainsWay Deep TMS™ Systems for the treatment of MDD. No new questions of safety and efficacy have arisen due to the treatment in this additional patient population.
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Conclusions:
Consequently, it can be concluded that the subject BrainsWay Deep TMS™ Systems (Models 102 and 104) are substantially equivalent to the predicate BrainsWay Deep TMS™ Systems (Models 102 and 104), cleared under 510(k) K210201 and therefore, the modified BrainsWay Deep TMS™ System can be legally marketed in the USA.