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.

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

AI/ML Overview

The provided text is a 510(k) summary for the BrainsWay Deep TMS™ System, seeking to enable modifications to the device labeling based on clinical data. It is important to note that this document does not describe an AI medical device that has acceptance criteria based on diagnostic performance metrics (e.g., sensitivity, specificity, AUC) and a study proving those criteria were met via a test set adjudicated by experts. Instead, this document details a study for a therapeutic device (Transcranial Magnetic Stimulation System) and focuses on clinical outcomes (remission and response rates for Major Depressive Disorder (MDD)).

Therefore, I cannot fulfill all parts of your request as it pertains to an AI medical device's performance study. However, I can extract the relevant information about the clinical studies conducted for the BrainsWay Deep TMS™ System's expanded indication for use.

Here's an analysis based on the provided text, adapted to the context of a therapeutic device rather than a diagnostic AI:

Acceptance Criteria and Study for BrainsWay Deep TMS™ System

This 510(k) submission primarily focuses on expanding the indicated adult population for the BrainsWay Deep TMS™ System to include adult subjects >22 and <86 years of age suffering from MDD, who failed to achieve satisfactory improvement from previous antidepressant medication treatment. The "acceptance criteria" here are not diagnostic performance metrics, but rather clinical efficacy outcomes that demonstrate safety and effectiveness in the expanded patient population, comparable or superior to previously cleared indications and/or standard of care.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a therapeutic device, the "acceptance criteria" are implied to be clinically meaningful improvements in depression symptoms (remission and response rates) and safety comparable to previous findings. The document measures performance against its own previous studies (MDD Multicenter Study) and sham treatment.

Acceptance Criterion (Implicit)	Reported Device Performance (Kaster 2018 Study - Active Deep TMS)	Reported Device Performance (Kaster 2018 Study - Sham Deep TMS)	Comparison to Prior Data (MDD Multicenter Study - Deep TMS)
Remission Rate (HDRS-21 after 4 Weeks)	64.0% (16/25) [42.5%; 82.0%]	18.5% (5/27) [6.3%; 38.1%]	Higher (vs. 30.4%)
Response Rate (HDRS-21 after 4 Weeks)	64.0% (16/25) [42.5%; 82.0%]	22.2% (6/27) [8.6%; 42.3%]	Higher (vs. 37.0%)
NNT for Remission (Implied clinical benefit)	2.2	Not applicable	Better (vs. 6.85)
NNT for Response (Implied clinical benefit)	2.4	Not applicable	Better (vs. 7.05)
Change from baseline in HDRS-21 scores (Diff between active and sham)	5.35 points (statistically significant, p=0.0025)	Not directly applicable (this is a differential)	Higher (vs. 2.23 points)
Safety Profile	Adverse effects similar and typical of TMS treatment; no new or unanticipated adverse events.	Adverse effects similar and typical of TMS treatment; no new or unanticipated adverse events.	Comparable
CGI-S Remission Rate (RWD)	Comparable to MDD Multicenter Study CGI-S remission rate	Not applicable	Comparable
CGI-S Response Rate (RWD)	Significantly greater than MDD Multicenter Study CGI-S response rate	Not applicable	Significantly greater
Change from baseline in CGI-S scores (RWD)	Significantly better than MDD Multicenter Study CGI-S results	Not applicable	Significantly better

2. Sample Sizes and Data Provenance for Test Set (Clinical Studies)

Kaster 2018 Study (Double-blind, Randomized, Sham-controlled Trial):
- Total Sample Size: 52 participants
- Active Deep TMS Treatment Group: 25 participants
- Sham Deep TMS Treatment Group: 27 participants
- Provenance: Not explicitly stated, but the study is referenced as "Kaster 2018 Study", implying a published clinical trial. The context of a 510(k) submission generally implies prospective clinical trial data.
- Population: Elderly MDD patient population (> 60 years old).
Real-World Data (RWD):
- Total Patient Records: 1,198 patients
- Source: Electronic health records from 20 sites over the US.
- Time Span: 2012 to 2022 (10 years).
- ITT Patient Population Analysis (met eligibility criteria): 152 subjects
- Population: Elderly MDD patients (>69 years old: mean age 73.6, range 69-86).
- Provenance: Retrospective, from the US.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This is a clinical efficacy study for a therapeutic device, not an AI diagnostic device. Therefore, the concept of "ground truth" established by experts for a test set (e.g., radiological reads) as would be the case for an AI diagnostic device, does not apply here.
Clinical outcomes (HDRS-21, CGI-S, PHQ-9 scores) are typically rated by trained clinicians (e.g., psychiatrists, psychologists). The document does not specify the number or qualifications of clinicians involved in assessing these scores for the Kaster 2018 Study or the RWD. It mentions that approximately 50% of RWD patients were treated by providers with >10 years or <10 years of experience, which relates to treatment providers, not necessarily independent assessors for ground truth.

4. Adjudication Method for the Test Set:

Again, for a therapeutic device efficacy study measuring clinical scales, "adjudication" in the sense of reconciling reviewer disagreements on diagnostic labels is not directly applicable.
The Kaster 2018 Study was a double-blind, randomized, sham-controlled trial, which is a strong methodology for assessing treatment efficacy, inherently minimizing bias in outcome assessment. Blinding (neither patient nor assessor knows treatment assignment) often serves a similar purpose to prevent bias as adjudication attempts to for diagnostic interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size of human improvement with vs. without AI assistance:

No, an MRMC study was not done. This document is for a therapeutic device. MRMC studies are typically performed for diagnostic AI tools to evaluate their impact on human reader performance.
The study does compare the device's effect to a sham treatment and to previously documented performance (MDD Multicenter Study), showing improvement with the active device. However, this is not a human-AI collaboration study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The BrainsWay Deep TMS™ System is a medical device, a transcranial magnetic stimulation system, that directly delivers therapy, not a diagnostic algorithm. Therefore, there is no "standalone" algorithm performance to evaluate. Its "performance" is its clinical efficacy when administered.

7. The Type of Ground Truth Used:

The "ground truth" for efficacy was established through clinical outcome measures based on standardized psychiatric rating scales.
- Remission: HDRS-21 (Hamilton Depression Rating Scale 21-item), PHQ-9 (Patient Health Questionnaire-9).
- Response: HDRS-21, PHQ-9, CGI-S (Clinical Global Impression – Severity).
These are based on the assessment of clinical symptoms and patient status by trained clinicians, not pathology, imaging, or direct outcomes data in the sense of a definitive diagnostic gold standard.

8. The Sample Size for the Training Set:

Not applicable. This device is a hardware therapeutic system, not an AI algorithm that undergoes a training phase with a dataset. The results presented are from clinical trials and real-world data specifically used to support the expanded indications for use, not to "train" the device.

9. How the Ground Truth for the Training Set was Established:

Not applicable, for the same reasons as #8. There is no training set or corresponding ground truth for this type of device.

Summary

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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"

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(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

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Indications for Use

510(k) Number (if known) K222196

Device Name BrainsWay Deep TMS™ System

Indications for Use (Describe)

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)

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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 9777518Tel: +972-2-5813140Fax: +972-2-5812517E-mail: ahava@asteinrac.com

Contact Person:

Official Correspondent:	Ahava Stein
Company Name:	A. Stein – Regulatory Affairs Consulting Ltd.
Address:	18 Hata'as Str., Suite 21Kfar 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 is composed of the following main components:

1. Cart
- a) TMS Neurostimulator
- b) Cooling System
- c) Positioning Device
1. 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 <86 years of age, suffering from MDD.

Intended Use/Indication for Use:

Performance Standards:

The 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)

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IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General requirements for ● basic safety and essential performance - Collateral standard: Electromagnetic Disturbances - 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 cvtotoxicity (199)
ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for . irritation and delayed-type hypersensitivity (2002)
. ISO 14971 Medical devices - Application of risk management to medical devices (2nd Ed. 2007, (R) 2016)

Non-Clinical (Bench) Performance Data:

Tests were conducted on the BrainsWay Deep TMS™ System. The tests were performed 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. The results of the performance tests demonstrated that the BrainsWay Deep TMS™ System is substantially equivalent to the predicate device.

Animal Performance Data / Histologv Data:

Not Applicable

Clinical Performance Data:

Data from a double-blind, randomized, sham-controlled trial (Kaster 2018 Study) and from RWD provide valid scientific evidence that is relevant, reliable, and accurate to support the safety and effectiveness of the expanded patient population.

In the Kaster 2018 Study, Deep TMS was associated with a meaningful remission rate (64%) (Table 1), which is higher than that reported for the Deep TMS group in the MDD Multicenter Study (30.4%) submitted in support of the cleared 510(k) K122288 for the BrainsWay Deep TMSTM System. The reported NNT for remission (2.2) in the elderly MDD patient population was better than that reported in the MDD Multicenter Study (6.85) for the overall adult MDD patient population.

Furthermore, Deep TMS was associated with a meaningful response rate (64.0%) (Table 2), which is also higher than that reported for the Deep TMS group in the MDD Multicenter Study (37.0%) submitted in support of the cleared 510(k) K122288 for the BrainsWay Deep TMSTM System. Similarly, the reported NNT for response (2.4) in the elderly MDD patient population was better than that reported in the MDD Multicenter Study (7.05) for the overall adult MDD patient population.

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		Active Deep TMS Treatment		Sham Deep TMS Treatment
		% (n/N)	Two-sided 95% CI	% (n/N)	Two-sided 95% CI
ITT	After 4 Weeks of Treatment	64.0% (16/25)	[42.5%; 82.0%]	18.5% (5/27)	[6.3%; 38.1%]

Table 1: Remission Rate hased on HDRS-21 (ITT)

Table 2: Response Rate based on HDRS-21 (ITT)

		Active Deep TMS Treatment		Sham Deep TMS Treatment
		% (n/N)	Two-sided 95% CI	% (n/N)	Two-sided 95% CI
ITT	After 4 Weeksof Treatment	64.0% (16/25)	[42.5%; 82.0]	22.2% (6/27)	[8.6%; 42.3%]

The difference between the active and sham Deep TMS treatment groups, in the change from baseline in HDRS-21 scores at 4 weeks of treatment (i.e., after 20 treatment sessions) was 5.35 points. This difference was found to be statistically significantly different (p=0.0025). Here too, the difference between the treatment groups for the elderly MDD patient population is higher than the difference between the treatment groups in the general MDD patient population, as reported in the MDD Multicenter Study as 2.23 points.

The elderly (> 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 < 10 years of experience.

The RWD based on only HDRS-21 scores or HDRS-21 and PHQ-9 scores, obtained for the elderly MDD patient population (> 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

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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	Blumberger2022	RCT	172	87 bilateral, 85TBS	>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 2023Meta-analysis	Meta-analysis	637	338	60-	HDRS	52.7%	18%
5	Jorge 2008	RCT	92	Exp 1: 15Exp 2: 33	50-	HDRS	Exp 1: 33.3%Exp 2: 39.4%	Exp 1: 13.3%Exp 2: 27.3%
6	Cristancho2023	RCT	17	8	60-85	MADRS	37.5%	NA
7	Manes 2001	RCT	20	10	>50	HDRS	30%	NA
8	Mosimann2004	RCT	24	15	40-90	HDRS	6.7%	NA
9	Leblhuber2019	RCT	29	19	Mean=72.4	HAMD-7	NA	NA
10	DesbeaumesJodoin 2019	Retrospective	≥60: 19<60: 54	19	60-89	MADRS	≥60: 73.7%<60: 35.2%	≥60: 63.2%<60: 33.3%
11	Milev 2009	Open study	49	49	58-89	HDRS	18.4%	8.2%
12	Almheiri2023	Retrospective	≥60: 78<60: 427	78	>60	MADRS	≥60: 33%<60: 30%	≥60: 36%<60: 36%
13	Fabre 2004	Open study	11	11	56-77	HDRS	45.5%	NA
14	Conelea 2017	Retrospective	≥60: 75<60: 156	75	60-84	IDS-SRPHQ-9	IDS-SR:≥60: 45.3%<60: 44.9%PHQ-9:≥60: 58.7%<60: 55.4%	IDS-SR:≥60: 26.7%<60: 25%PHQ-9:≥60: 33.3%<60: 25.6%
15	Quinn 2023	Open study	25	25	50-79	IDS-C-30	52%	20%
16	Cristancho2020	Open study	13	13	61-73	MADRS	33.3%	33.3%
17	Vidya 2023	RCT	31	16	50-79	HDRS	50%	56.3%

Table 3- Results of a formal literature search of rTMS in late-life depression

+ 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.

Regulation Number and Section

§ 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.