(158 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on the physical components and mechanism of action of TMS.
Yes
The device is indicated for the "treatment of depressive episodes and for decreasing anxiety symptoms" in patients with Major Depressive Disorder (MDD), which clearly indicates a therapeutic purpose.
No
The device is indicated for treatment of depressive episodes and decreasing anxiety symptoms, not for diagnosis.
No
The device description explicitly lists hardware components such as a Cart (TMS Neurostimulator, Cooling System, Positioning Device) and a Helmet (Aiming Apparatus, Electromagnetic Coil, Cap). This indicates it is a hardware-based medical device with associated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of depressive episodes and anxiety symptoms in patients with Major Depressive Disorder. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description details a system that applies magnetic pulses to the brain to induce electrical fields and activate neurons. This is a physical intervention, not a test performed on biological samples in vitro.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions in vitro.
The device is clearly a therapeutic device used for direct intervention on the patient's brain.
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 (H7 Coil)
c) Cap
The BrainsWay TMS neurostimulator is connected to the electromagnetic H7 Coil, which in turn is connected to the patient's head. The helmet aiming apparatus is used to position the BrainsWay H7 Coil at the correct position on the patient's head. The cooling system maintains the electromagnetic coil at ambient temperature. The stimulator generates a changing electric current within the coil, which induces the magnetic field. The magnetic field causes a second inductance of inverted electric charge specifically in the prefrontal cortex. Deep TMS stimulation in the area of the prefrontal cortex has been shown to be therapeutically beneficial for the following indication for use.
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 / Adult subjects
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)
Study Type: Clinical Performance Data - Multicenter H7 vs H1 Study (A Prospective Multicenter Double Blind Randomized Controlled Trial to Compare the Efficacy of the H7 Coil to H1 Coil Deep Transcranial Magnetic Stimulation (Deep TMS) in Subjects with Major Depression Disorder (MDD)), Protocol No. CTP-0002-00.
Sample Size: 169 (total subjects across both H7 and H1 coil groups)
Key Results: The primary effectiveness endpoint was the change from baseline in HDRS-21 scores to the 6-week visit. In both study groups, there was a statistically significant reduction in HDRS-21 scores. The repeated measure model showed that the difference between the slopes of at 6 weeks was found non-statistically significant (p=0.8). The upper limit of the one-sided 95% CI's was 1.9, i.e., lower than 3, which is the non-inferiority limit, therefore the study is deemed successful. The response rates and the remission rates at the week 6 visit were not found statistically significantly different between the H7 and H1 Coil treatment groups. It was concluded that the BrainsWay Deep TMS™ treatment with the H7 Coil is as effective as treatment with the H1 Coil. There was no statistically significant difference in the incidence of any of the adverse events reported between the treatment groups, indicating that the safety of the BrainsWay Deep TMS™ device with the H7 Coil is similar to the safety with the H1 Coil.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Primary effectiveness endpoint: change from baseline in HDRS-21 scores to the 6-week visit.
HDRS-21 baseline: Mean (SD) 24.0 (3.48), Median [Range] 24.0 [19;36] (N=169)
HARS baseline: Mean (SD) 19.5 (6.21), Median [Range] 19.0 [6;43] (N=168)
Difference in Change from Baseline in HDRS-21 at 6 weeks (H7 vs H1): Estimate 0.229, Standard Error 1.020, p-value 0.8231, 95% CI [-1.789;2.246], Upper limit of one-sided 95% CI 1.918.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 26, 2022
BrainsWay Ltd. % Ahava Stein Regulatory Consultant A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 21 Kfar Saba, 4442518 Israel
Re: K220819
Trade/Device Name: BrainsWay Deep TMS System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: March 16, 2022 Received: March 21, 2022
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 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
1
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,
for Pamela Scott 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
Enclosure
2
Indications for Use
510(k) Number (if known) K220819
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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236
3
510(K) SUMMARY
BRAINSWAY DEEP TMS™ SYSTEM
510(k) Number K220819
Applicant Name:
| Company Name: | BrainsWay Ltd
BrainsWay Ltd. |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 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: | March 16, 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 substantially equivalent to the BrainsWay Deep TMS™ Systems (Model 102 and 104) ("predicate device") cleared in 510(k) K210201 and to the reference predicate devices, the BrainsWay Deep TMS™ Systems, DEN170078 and K183303.
| Predicate | Device | Manufacturer | 510(k) No. |
|---|---|---|---|
| Main | BrainsWay Deep TMS™ System | BrainsWay Ltd. | K210201 |
| Reference | BrainsWay Deep TMS™ System | BrainsWay Ltd. | K183303 |
| Reference | BrainsWay Deep TMS™ System | BrainsWay Ltd. | DEN170078 |
4
Device Description:
The BrainsWay Deep TMS™ System enables direct non-invasive activation of deep brain structures. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative 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 (H7 Coil)
- c) Cap
The BrainsWay TMS neurostimulator is connected to the electromagnetic H7 Coil, which in turn is connected to the patient's head. The helmet aiming apparatus is used to position the BrainsWay H7 Coil at the correct position on the patient's head. The cooling system maintains the electromagnetic coil at ambient temperature. The stimulator generates a changing electric current within the coil, which induces the magnetic field. The magnetic field causes a second inductance of inverted electric charge specifically in the prefrontal cortex. Deep TMS stimulation in the area of the prefrontal cortex has been shown to be therapeutically beneficial for the following indication for use.
Intended Use/Indication 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.
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)
5
- 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 . cytotoxicity (1999)
- 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 TMSTM System is substantially equivalent to the predicate device.
Animal Performance Data / Histology Data:
Not Applicable
Clinical Performance Data:
The safety and effectiveness and substantial equivalence of the BrainsWay Deep TMS™ device for the treatment of MDD and Anxiety symptoms in MDD was demonstrated in the Multicenter H7 vs H1 Study (A Prospective Multicenter Double Blind Randomized Controlled Trial to Compare the Efficacy of the H7 Coil to H1 Coil Deep Transcranial Magnetic Stimulation (Deep TMS) in Subjects with Major Depression Disorder (MDD)), Protocol No. CTP-0002-00. The purpose of the study was to compare the safety and effectiveness of the BrainsWay Deep TMS™ H7 Coil compared to the H1 Coil for the treatment of Major Depressive Disorder (MDD).
Baseline demographic and main effectiveness information is provided in Tables 1 and 2 below.
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| Baseline Characteristics | % (n/N) | |
|---|---|---|
| Sex | Male | 39.1% (66/169) |
| Female | 60.9% (103/169) | |
| Marital | ||
| Status | Married | 43.2% (73/169) |
| Single | 36.1% (61/169) | |
| Divorced | 17.8% (30/169) | |
| Widower | 3.0% (5/169) | |
| Race | Caucasian | 80.5% (136/169) |
| Afro-American | 6.5% (11/169) | |
| Hispanic | 7.7% (13/169) | |
| Other | 5.9% (10/169) | |
| Education | Less than 9 years of education | 1.2% (2/169) |
| 9 to 12 years of education | 18.9% (32/169) | |
| Over 12 years of education | 78.1% (132/169) | |
| Unknown | 1.8% (3/169) | |
| Age (years) | N | 169 |
| Mean (SD) | 45.4 (11.67) | |
| Median [Range] | 46.6 [22.1;68.9] |
Table 1: Demographic Characteristics
Table 2 - Key Baseline Effectiveness Assessments
| Safety and Effectiveness Scales | ||
|---|---|---|
| N | ||
| HDRS-21 | 169 | |
| Mean (SD) | 24.0 (3.48) | |
| Median [Range] | 24.0 [19;36] | |
| N | ||
| HARS | 168 | |
| Mean (SD) | 19.5 (6.21) | |
| Median [Range] | 19.0 [6;43] |
The primary effectiveness endpoint was the change from baseline in HDRS-21 scores to the 6-week visit. In both study groups there was a statistically significant reduction in HDRS-21 scores. The repeated measure model showed that the difference between the slopes of at 6 weeks was found non-statistically significant (p=0.8). The upper limit of the one-sided 95% CI's was 1.9, i.e., lower than 3, which is the non-inferiority limit, therefore the study is deemed successful. The response rates and the remission rates at the week 6 visit were not found statistically significantly different between the H7 and H1 Coil treatment groups.
7
| Table 3: Difference in Change from Baseline in HDRS-21 at 6 Week Visit (Repeated | ||||||
|---|---|---|---|---|---|---|
| Measures Model) | ||||||
| Estimate | Standard | |||||
| Error | p-value | 95% CI | Upper limit of one- | |||
| sided 95% CI | ||||||
| Difference in Change from Baseline | ||||||
| in HDRS-21 at 6 weeks (H7 vs H1) | 0.229 | 1.020 | 0.8231 | [-1.789;2.246] | 1.918 |
According to these results, it may be concluded that the BrainsWay Deep TMS™ treatment with the H7 Coil is as effective as treatment with the H1 Coil.
There was also no statistically significant difference in the incidence of any of the adverse events reported between the treatment groups. Therefore, we can conclude that the safety of the BrainsWay Deep TMS™ device with the H7 Coil is similar to the safety with the H1 Coil.
Substantial Equivalence:
The subject BrainsWay Deep TMS™ devices (Models 102 and 104) with the H7 Coil are substantially equivalent to the previously cleared BrainsWay Deep TMS 110 devices (also manufactured by BrainsWay Ltd., and the subject of 510(k) K210201 (Models 102 and 104). A comparison table is provided below comparing the intended use and basic technological characteristics of the subject BrainsWay Deep TMSTM device with the H7 Coil to the intended use and basic technological characteristics of the previously cleared BrainsWay Deep TMS™ devices. A Discussion of the Similarities and Differences between the subject BrainsWay Deep TMS™1 devices with the H7 Coil and the previously cleared BrainsWay Deep TMSTM devices is found following the comparison table.
| predicate BrainsWay Deep TMS™ Systems (with the H1 Coil) | ||
|---|---|---|
| Technological | ||
| Characteristic | BrainsWay Deep TMS™ Systems | |
| (Models 102 & 104 with the H7 Coil) | BrainsWay Deep TMS™ Systems | |
| (Models 102 & 104 with H1 Coil) | ||
| (K210201) | ||
| Product Code, Class | OBP | |
| Class II | OBP | |
| Class II | ||
| Indications for Use | The BrainsWay Deep TMS™ System is | |
| indicated for the treatment of depressive | ||
| episodes 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 | 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 | ||
| Technological | ||
| Characteristic | BrainsWay Deep TMS TM Systems | |
| (Models 102 & 104 with the H7 Coil) | BrainsWay Deep TMS TM Systems | |
| (Models 102 & 104 with H1 Coil) | ||
| (K210201) | ||
| Target Population | Adult subjects with Major Depressive | |
| Disorder | Adult subjects with Major Depressive | |
| Disorder | ||
| Anatomical Sites | Head – stimulation to the prefrontal cortex | Head – stimulation to the prefrontal cortex |
| Environment Used | Hospitals, Clinics | Hospitals, Clinics |
| Energy Used / | ||
| Delivered | Electromagnetic Energy is delivered | Electromagnetic Energy is delivered |
| Design: | The BrainsWay Deep TMSTM System design | |
| is based on applying transcranial magnetic | ||
| stimulation by means of repetitive pulse | ||
| trains at a predetermined frequency. | The BrainsWay Deep TMSTM System design | |
| is based on applying transcranial magnetic | ||
| stimulation by means of repetitive pulse | ||
| trains at a predetermined frequency. | ||
| - Mechanism of Action | The BrainsWay Deep TMSTM System is an | |
| electromechanical instrument that produces | ||
| and delivers brief duration, rapidly | ||
| alternating (pulsed) magnetic fields to | ||
| induce electrical currents in localized | ||
| regions of the prefrontal cortex. This is a | ||
| non-invasive tool for the stimulation of | ||
| cortical neurons for the treatment of adult | ||
| patients with Major Depressive Disorder | ||
| (MDD). | The BrainsWay Deep TMSTM System is an | |
| electromechanical instrument that produces | ||
| and delivers brief duration, rapidly | ||
| alternating (pulsed) magnetic fields to | ||
| induce electrical currents in localized | ||
| regions of the prefrontal cortex. This is a | ||
| non-invasive tool for the stimulation of | ||
| cortical neurons for the treatment of adult | ||
| patients with Major Depressive Disorder | ||
| (MDD). | ||
| - Components | The BrainsWay Deep TMSTM System | |
| consists of the following components: |
- Mobile Cart
- Coil & Helmet Unit
- Positioning Arm
- Cooling System
- TMS stimulator & Software (BrainsWay
stimulator in Model 104 & Magstim
stimulator in Model 102) | The BrainsWay Deep TMSTM System
consists of the following components: - Mobile Cart
- Coil & Helmet Unit
- Positioning Arm
- Cooling System
- TMS stimulator & Software (Brainsway
stimulator in Model 104 & Magstim
stimulator in Model 102) |
| - Accessories | The BrainsWay Deep TMSTM System
consists of the following accessories: - Head Cap
- Head Positioning Straps
- Earplugs | The BrainsWay Deep TMSTM System
consists of the following accessories: - Head Cap
- Head Positioning Straps
- Earplugs |
| - Features | The BrainsWay Deep TMSTM System
consists of the following features: - Determination of Motor Threshold (MT)
- Coil Positioning
- Administration of Treatment
- System Management, including patient
record keeping (Model 104) | The BrainsWay Deep TMSTM System
consists of the following features: - Determination of Motor Threshold (MT)
- Coil Positioning
- Administration of Treatment
- System Management, including patient
record keeping (Model 104) |
| - Dimensions | Cart Dimensions:
Model 102: 680x625mm / 27x25")
Model 104: 680x688mm / 26.7x27" | Cart Dimensions:
Model 102: 680x625mm / 27x25")
Model 104: 680x688mm / 26.7x27" |
| - Weight | Model 102: 122.5 kg (270lbs)
Model 104: 142 kg (313lbs) | Model 102: 122.5 kg (270lbs)
Model 104: 142 kg (313lbs) |
| Technological
Characteristic | BrainsWay Deep TMS™ Systems
(Models 102 & 104 with the H7 Coil) | BrainsWay Deep TMS™ Systems
(Models 102 & 104 with H1 Coil)
(K210201) |
| Performance | Treatment Parameters: - Magnetic Field Intensity: 120% of the
patient's observed hand motor threshold. - Repetition rate: 18 Hz
- Train duration: 2 sec
- Inter-train interval: 20 sec
- Number of trains: 55
- Magnetic Pulses per Session: 1980
- Treatment Session Duration: ~ 20 min
- Sessions per Week: 5
- 5 daily sessions for 4 weeks
- Bi-weekly sessions for another 12 weeks
(optional maintenance treatments) | Treatment Parameters: - Magnetic Field Intensity: 120% of the
patient's observed hand motor threshold. - Repetition rate: 18 Hz
- Train duration: 2 sec
- Inter-train interval: 20 sec
- Number of trains: 55
- Magnetic Pulses per Session: 1980
- Treatment Session Duration: ~ 20 min
- Sessions per Week: 5
- 5 daily sessions for 4 weeks
- Bi-weekly sessions for another 12 weeks
(optional maintenance treatments) |
| Human Factors | The BrainsWay Deep TMS™ System uses a
TMS neurostimulator software for parameter
configuration.
Patient positioning and MT determination
are done manually. | The BrainsWay Deep TMS™ System uses a
TMS neurostimulator software for parameter
configuration.
Patient positioning and MT determination
are done manually. |
| Standards Met | IEC 60601-1
IEC 60601-1-2
IEC 62304 | IEC 60601-1
IEC 60601-1-2
IEC 62304 |
| Materials | Personal Head Cap | Personal Head Cap |
| Biocompatibility | Materials are biocompatible | Materials are biocompatible |
| Compatibility With
the Environment and
Other Devices | The BrainsWay Deep TMS™ System are
compliant with the IEC 60601-1-2 standard. | The BrainsWay Deep TMS™ System are
compliant with the IEC 60601-1-2 standard. |
| Sterility | Not Applicable | Not Applicable |
| Electrical Safety | Power Requirements:
110-120 VAC / 60 Hz
220-240 VAC / 50 Hz
The BrainsWay Deep TMS™ System are
compliant with the IEC 60601-1 standard. | Power Requirements:
110-120 VAC / 60 Hz
220-240 VAC / 50 Hz
The BrainsWay Deep TMS™ System are
compliant with the IEC 60601-1 standard. |
| Mechanical Safety | The BrainsWay Deep TMS™ System are
compliant with the IEC 60601-1 standard. | The BrainsWay Deep TMS™ System are
compliant with the IEC 60601-1 standard. |
| Chemical Safety | Not Applicable | Not Applicable |
| Thermal Safety | The BrainsWay Deep TMS™ System are
compliant with the IEC 60601-1 standard. | The BrainsWay Deep TMS™ System are
compliant with the IEC 60601-1 standard. |
| Radiation Safety | The BrainsWay Deep TMS™ System are
compliant with the IEC 60601-1-2 standard. | The BrainsWay Deep TMS™ System are
compliant with the IEC 60601-1-2 standard. |
Table 4: Comparison of the BrainsWay Deep TMS™ Systems (with the H7 Coil) to the predicate BrainsWay Deep TMS™ Systems (with the H1 Coil)
8
9
10
DISCUSSION OF SIMILARITIES AND DIFFERENCES:
The subject BrainsWay Deep TMS™ devices (Models 102 and 104) have the same intended use and indications for use as the predicate BrainsWay Deep TMS™ devices cleared in 510(k) K210201. The subject devices and the cleared BrainsWay Deep TMS™ devices 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™ devices have the same mechanism of operation and use the same underlying technology as the predicate BrainsWay Deep TMS™ devices. The performance characteristics, including the Output Waveform, Electrical and Magnetic Field Distribution are substantially equivalent to the previously cleared BrainsWay Deep TMS™ devices. The subject devices, as the cleared devices, introduce similar safety features and comply with same relevant consensus standards, including electrical and mechanical safety, Electromagnetic Ddisturbances, and software validation.
The subject BrainsWay Deep TMS™ devices are composed of the same device components as the previously cleared, predicate BrainsWay Deep TMS™ devices (Model 102 and Model 104), with the exception of the coil. The subject BrainsWay Deep TMS™ devices use the H7 Coil and the predicate BrainsWay Deep TMS™ devices use the H1 Coil.
This 510(k) contains clinical data to support the safety and effectiveness of the subject BrainsWay Deep TMS™ devices with the H7 Coil for the treatment of MDD. Furthermore, the clinical data demonstrates that the BrainsWay Deep TMS™ devices with the H7 Coil are substantially equivalent in performance to the predicate BrainsWay Deep TMSTM devices with the H1 Coil for the treatment of MDD. No new questions of safety and effectiveness have arisen due to the use of the new H7 Coil.
Conclusions:
Consequently, it can be concluded that the subject BrainsWay Deep TMS™ devices (Models 102 and 104) with the H7 Coil are substantially equivalent to the predicate BrainsWay Deep TMS™ devices (Models 102 and 104) with the H1 Coil, cleared under 510(k) K210201 and therefore, the modified BrainsWay Deep TMS™ System can also be legally marketed in the USA.