(161 days)
Not Found
No
The summary describes a hardware-based TMS system and its clinical trial results, with no mention of AI or ML components in the device description or performance studies.
Yes
The device is indicated for the treatment of depressive episodes in adult patients with Major Depressive Disorder, and its description details a non-invasive technique to apply magnetic pulses to the brain to activate neurons, which directly treats the disease.
No
The device is indicated for the "treatment of depressive episodes" and its description focuses on how it applies magnetic pulses to the brain for therapeutic effect, not for diagnosing a condition.
No
The device description explicitly lists multiple hardware components: Electromagnetic Coil, TMS Neurostimulator, Cooling System, Positioning Device, and a cart. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Brainsway Deep TMS System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of depressive episodes in adult patients with Major Depressive Disorder. IVD devices are used to diagnose or monitor a condition by examining 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. This is a physical intervention, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
The Brainsway Deep TMS System is a therapeutic device that uses transcranial magnetic stimulation to treat a medical condition.
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 (DTMS) System is intended for the treatment of depressive episodes in patients suffering from MDD. 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 electromagnetic radiation emitted is at a low frequency of the order of 1-10 kHz. The only interaction with the human body is caused by the briefly changing magnetic field, and its effect may be neuronal activation.
Many neurological and psychiatric disorders are associated with abnormal neuronal activity patterns in deep brain regions. These regions cannot be affected directly, but only indirectly, through secondary processes involving cortical structures, which are directly activated by TMS and then affect the deeper structures.
The Brainsway DTMS System's unique design enables to produce directed electromagnetic fields that can induce excitation or inhibition of neurons deep inside the brain non-invasively.
The Brainsway Deep TMS (DTMS) System is composed of the following main components:
- An Electromagnetic Coil (H1 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
Prefrontal Cortex
Indicated Patient Age Range
adult patients, 22 and 68
Intended User / Care Setting
Not Found
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 Performance Data:
The Brainsway Deep TMS System included testing of the magnetic field characteristics of the system, as required by the FDA Guidance document for TMS systems. Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems, as follows:
Output Waveform: The output waveform produced by the H-coil was measured in a human head phantom model. The probe was located in the head model in a position analogous to the left lateral prefrontal cortex, where the coil's induced field is maximal according to the electric field distribution mapping. The electric field pulse outputs and waveforms were measured at predefined stimulator outputs.
Electric Field Spatial Distribution: The field distribution produced by the H-coil was measured in a human head phantom model. The probe was moved in three directions inside the phantom model using a displacement system with 1 mm resolution, and the field distribution of the H1-coil was measured in the whole head model volume in 1cm resolution. Axial and coronal field maps were produced. The field maps were superimposed on anatomical T1-weighted MRI coronal slices, to show the induced field in each anatomical brain region.
Magnetic Field Strength Gradient: The magnetic field strength was also measured in a human head phantom model. The magnetic field strength at the H-coil surface and at certain points at various distances from the coil was measured. The probe was located in the head model at a distance of 0 and 2 cm from the coil edge, in a position analogous to the left lateral prefrontal cortex. where the coil's induced field is maximal according to the electric field distribution mapping. The stimulator was operated at 50% and at 100% output and the magnetic field output waveform was measured along three orthogonal axes: X- Anteriorposterior, Y- Lateral-medial, and Z- Superior-inferior. These results demonstrate the ability of the H-coil to stimulate deeper brain structures without overstimulation of superficial regions.
Cooling System Testing: The cooling system tests included measurement of the air flow, suction pressure, compression pressure and currents measured at different voltage levels. The temperature of the cooling system was measured over an extended period of time to test the life expectancy of the system. Life expectancy testing demonstrated that the cooling system thermostat temperature remains consistent during a continuous operation of >180 days.
Clinical Performance Data:
Study Type: prospective, double blind, randomized, controlled, multi-center trial.
Sample Size:
ITT analysis set: n=229 (108 DTMS and 121 Sham)
mITT analysis set: n=212 (101 DTMS and 111 Sham)
PP analysis set: n=181 (89 DTMS and 92 Sham). This was identified as the most appropriate analysis set.
Key Results:
The model estimated mean change from baseline in HDRS-21 scores in the Deep TMS group was -6.39 points across 5 weeks compared to only -3.28 points in the sham group in the PP analysis set. This difference of 3.11 points was statistically significant (p=0.0080).
The response rate was significantly better in the Deep TMS group (38.4% and 37.0%) compared to the sham group (21.4% and 22.8%) (p=0.0138 and p=0.0310) in the PP analysis set and the mITT analysis set, respectively.
The remission rate was significantly better in the Deep TMS group (32.6% and 30.4%) compared to the sham group (14.6% and 15.8%) (p=0.0051 and p=0.0158) in the PP analysis set and the mITT analysis set, respectively.
The efficacy of the Deep TMS Treatment was maintained at 16 weeks, based on a statistically significant change from baseline in HDRS-21 scores (p=0.0259) in the PP analysis set.
The efficacy of the Deep TMS Treatment was further maintained at 16 weeks based on a significantly better response rate in the Deep TMS group compared to the sham group (p=0.0086 and p=0.0276), in the PP analysis set and the mITT analysis set.
The efficacy of the Deep TMS Treatment, based on statistically significant differences in the CGI-S scores, was demonstrated at 5 weeks and also maintained at 16 weeks in the PP analysis set and the mITT analysis set.
The efficacy of the Deep TMS Treatment, based on statistically significant differences in the CGI-I, PGI and GAF scores, was demonstrated at 16 weeks in the PP analysis set and the mITT analysis set. These scores were also statistically significantly lower in the Deep TMS treatment group at 5 weeks in the PP analysis set.
The cognitive tests (MMSE, BSRT and AMI-SF) demonstrated that the Deep TMS treatment does not have a negative cognitive effect on MDD subjects.
Adverse Events: The adverse events reported with the Deep TMS System are typical to TMS treatments and were reported with similar or lower incidence rates compared to these events reported with other TMS devices. One serious adverse event (seizure) was reported and considered device related, with the caveat of alcohol withdrawal contributing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Model estimated mean change from baseline in HDRS-21 scores:
- Deep TMS group: -6.39 points
- Sham group: -3.28 points
- Difference: 3.11 points (p=0.0080)
Response rate:
- Deep TMS group: 38.4% (PP analysis), 37.0% (mITT analysis)
- Sham group: 21.4% (PP analysis), 22.8% (mITT analysis)
- p-value: 0.0138 (PP analysis), 0.0310 (mITT analysis)
Remission rate:
- Deep TMS group: 32.6% (PP analysis), 30.4% (mITT analysis)
- Sham group: 14.6% (PP analysis), 15.8% (mITT analysis)
- p-value: 0.0051 (PP analysis), 0.0158 (mITT analysis)
Adverse Event Incidence:
- Eye Pain: Deep TMS 1.9%, Sham 3.3% (p=0.6864)
- Dental Pain: Deep TMS 2.8%, Sham 1.7% (p=0.6687)
- Pain in Jaw: Deep TMS 10.2%, Sham 0.8% (p=0.0017)
- Application Site Discomfort: Deep TMS 19.4%, Sham 4.1% (p=0.0003)
- Application Site Pain: Deep TMS 25.0%, Sham 0.8% (p
§ 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
510(K) SUMMARY
BRAINSWAY DEEP TMS SYSTEM
510(k) Number K122288
Applicant Name:
| Company Name: | |
|---|---|
| Address: |
Brainsway Ltd. 19 Hartum St. (Bynet Bldg) Har Hotzvim, Jerusalem, ISRAEL 91451 Tel: +972-2-5813140 Fax: +972-2-5812517 E-mail: hila@Brainsway.com
Contact Person:
| Official Correspondent: | Ahava Stein |
|---|---|
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
| Address: | 20 Hata'as Str., Suite 102 |
| Kfar Saba 44425 | |
| Israel | |
| Tel: | +972-9-7670002 |
| Fax: | +972-9-7668534 |
| E-mail: | ahava@asteinrac.com |
| Date Prepared: | July 10, 2012 |
| Trade Name: | Repetitive Transcranial Magnetic Stimulator |
Classification Name: CFR Classification section 882.5805 (Product code OBP)
Classification: Class II Medical Device
Predicate Device:
The Brainsway Deep TMS System is substantially equivalent to the following predicate device:
| Manufacturer | Device | 510(k) No. | Product
Code |
|--------------|--------------------------------------------|------------|-----------------|
| Neuronetics | NEUROSTAR TMS SYSTEM | K061053 | OBP |
| Neuronetics | NEUROSTAR TMS THERAPY
SYSTEM, MODEL 1.1 | K083538 | OBP |
1
Device Description:
The Brainsway Deep TMS (DTMS) System is intended for the treatment of depressive episodes in patients suffering from MDD. 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 electromagnetic radiation emitted is at a low frequency of the order of 1-10 kHz. The only interaction with the human body is caused by the briefly changing magnetic field, and its effect may be neuronal activation.
Many neurological and psychiatric disorders are associated with abnormal neuronal activity patterns in deep brain regions. These regions cannot be affected directly, but only indirectly, through secondary processes involving cortical structures, which are directly activated by TMS and then affect the deeper structures.
The Brainsway DTMS System's unique design enables to produce directed electromagnetic fields that can induce excitation or inhibition of neurons deep inside the brain non-invasively.
The Brainsway Deep TMS (DTMS) System is composed of the following main components:
- An Electromagnetic Coil (H1 Coil) 1.
-
- A TMS Neurostimulator
-
- A Cooling System
- A Positioning Device 4.
-
- 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:
The Brainsway Deep TMS System has been tested and complies with the following voluntary recognized standards:
- Electrical & Mechanical Safety testing according to IEC 60601-1 .
- . Electromagnetic Compatibility testing according to IEC 60601-1-2
- ETSI EN 301 489-1 V1.8.1 Electromagnetic Compatibility and Radio Spectrum . Matters (ERM); Electromagnetic Compatibility (EMC) Standard for Radio Equipment and Services; Part 1: Common Technical Requirements (2008) Immunity
2
Non-Clinical Performance Data:
The non-clinical performance testing with the Brainsway Deep TMS System included testing of the magnetic field characteristics of the system, as required by the FDA Guidance document for TMS systems. Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems, as follows:
Output Waveform
The output waveform produced by the H-coil was measured in a human head phantom model. The probe was located in the head model in a position analogous to the left lateral prefrontal cortex, where the coil's induced field is maximal according to the electric field distribution mapping. The electric field pulse outputs and waveforms were measured at predefined stimulator outputs.
. Electric Field Spatial Distribution
The field distribution produced by the H-coil was measured in a human head phantom model. The probe was moved in three directions inside the phantom model using a displacement system with 1 mm resolution, and the field distribution of the H1-coil was measured in the whole head model volume in 1cm resolution. Axial and coronal field maps were produced. The field maps were superimposed on anatomical T1-weighted MRI coronal slices, to show the induced field in each anatomical brain region.
Magnetic Field Strength Gradient
The magnetic field strength was also measured in a human head phantom model. The magnetic field strength at the H-coil surface and at certain points at various distances from the coil was measured. The probe was located in the head model at a distance of 0 and 2 cm from the coil edge, in a position analogous to the left lateral prefrontal cortex. where the coil's induced field is maximal according to the electric field distribution mapping. The stimulator was operated at 50% and at 100% output and the magnetic field output waveform was measured along three orthogonal axes: X- Anteriorposterior, Y- Lateral-medial, and Z- Superior-inferior. These results demonstrate the ability of the H-coil to stimulate deeper brain structures without overstimulation of superficial regions.
Cooling System Testing
The cooling system tests included measurement of the air flow, suction pressure, compression pressure and currents measured at different voltage levels. The temperature of the cooling system was measured over an extended period of time to test the life expectancy of the system. Life expectancy testing demonstrated that the cooling system thermostat temperature remains consistent during a continuous operation of >180 days.
The performance tests, along with the clinical study validation demonstrate that the Brainsway DTMS System may be safely and effectively used for treatment of Major Depressive Disorder.
3
Clinical Performance Data:
The safety and effectiveness of the Brainsway Deep TMS System for treatment of Major Depressive Disorder was demonstrated in a prospective, double blind, randomized, controlled, multi-center trial. The study was conducted at 20 study sites in the United States (13 sites), Israel (4 sites), Germany (2 sites) and Canada (1 site), During the initial treatment phase. TMS sessions were performed daily for 4 weeks and during the maintenance phase, subjects were treated twice a week for another 12 weeks.
The study results were summarized for three patient analysis sets, the ITT analysis set (n=229, 108 DTMS and 121 Sham), the mITT analysis set (n=212, 101 DTMS and 111 Sham) and the PP analysis set (n=181, 89 DTMS and 92 Sham). The most appropriate analysis set for the purpose of assessing the effectiveness of the Brainsway Deep TMS System is the PP analysis set. The reason for this is that the ITT analysis set and the mITT analysis set include 31 subjects (12 DTMS and 19 Sham) who did not receive the adequate DTMS treatment regimen. Furthermore, the ITT analysis set also includes subjects who did not meet the inclusion/exclusion criteria for the study. The IFU contains clear instructions under the Warnings and Precautions section regarding the appropriate subjects who may be treated with the Brainsway Deep TMS System and clear instructions how to administer the treatment so that subjects will receive the appropriate stimulation intensity during the treatment. The efficacy results for the PP analysis set reflect the intended patient population and therefore are most relevant and presented below. The PP analysis set includes 181 subjects (89 DTMS and 92 Sham) between the ages of 22 and 68, diagnosed with Major Depressive Disorder, with an episode of less than 7 years. with an HDRS-21 score of greater than 20, did not receive benefit from 1 to 4 antidepressant treatments or were intolerant to at least 2 antidepressant treatments, and met the safety screening questionnaire for TMS. These subjects did not have MDD with psychotic features, another primary psychotic disorder or significant neurological disorder, were not at risk of seizure or suicide, did not fail to respond to previous ECT treatment and did not have any metal implants in or around the head or any other implants which could be affected by TMS.
The model estimated mean change from baseline in HDRS-21 scores in the Deep TMS group was -6.39 points across 5 weeks compared to only -3.28 points in the sham group in the PP analysis set. This difference of 3.11 points was statistically significant (p=0.0080). This change was found almost statistically significant in the mITT analysis i set (p=0.0578), but was not found statistically significant in the ITT analysis set. The response rate was significantly better in the Deep TMS group (38.4% and 37.0%) compared to the sham group (21.4% and 22.8%) (p=0.0138 and p=0.0310) in the PP analysis set and the mITT analysis set, respectively. The remission rate was significantly better in the Deep TMS group (32.6% and 30.4%) compared to the sham group (14.6% and 15.8%) (p=0.0051 and p=0.0158) in the PP analysis set and the mITT analysis set, respectively. The response and remission rates were not found statistically significant in the ITT analysis set.
The efficacy of the Deep TMS Treatment was maintained at 16 weeks, based on a statistically significant change from baseline in HDRS-21 scores (p=0.0259) in the PP analysis set. This was not shown in the mITT or ITT analysis sets. The efficacy of the Deep TMS Treatment was further maintained at 16 weeks based on a significantly better response rate in the Deep TMS group compared to the sham group (p=0.0086 and
4
p=0.0276), in the PP analysis set and the mITT analysis set. This was not shown in the ITT analysis set. The efficacy of the Deep TMS Treatment, based on statistically significant differences in the CGI-S scores, was demonstrated at 5 weeks and also maintained at 16 weeks in the PP analysis set and the mITT analysis set. The efficacy of the Deep TMS Treatment, based on statistically significant differences in the CGI-I, PGI and GAF scores, was demonstrated at 16 weeks in the PP analysis set and the mITT analysis set. These scores were also statistically significantly lower in the Deep TMS treatment group at 5 weeks in the PP analysis set. These scores were not found to be statistically significantly different in the ITT analysis set. No significant differences were found in the SF-36 scores, however all the SF-36 Quality of Life parameters were better in the Deep TMS group than in the sham group in all the analysis sets.
The results of the cognitive tests (MMSE, BSRT and AMI-SF) demonstrated that the Deep TMS treatment does not have a negative cognitive effect on MDD subjects in all the analysis sets.
The following table summarizes the main adverse events reported in the study for all the study subjects.
| | Deep TMS Treatment
(N=111 Subjects) | | Sham Treatment
(N-122 Subjects) | | |
|------------------------------------------|----------------------------------------|-----------|------------------------------------|-----------|---------|
| Anticipated Event | No of Subjects | Incidence | No of Subjects | Incidence | p-value |
| Eye Pain | 2 | 1.9% | 4 | 3.3% | 0.6864 |
| Dental Pain | 3 | 2.8% | 2 | 1.7% | 0.6687 |
| Pain in Jaw | 11 | 10.2% | 1 | 0.8% | 0.0017 |
| Application Site Discomfort | 21 | 19.4% | 5 | 4.1% | 0.0003 |
| Application Site Pain | 27 | 25.0% | 1 | 0.8% |