(101 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware modifications and established TMS technology.
Yes
The device is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder, which directly indicates its therapeutic purpose.
No
The device is described as a treatment adjunct for Obsessive-Compulsive Disorder, and its function involves activating brain structures through magnetic pulses, which is a therapeutic action, not a diagnostic one.
No
The device description explicitly mentions hardware components like a helmet configuration, electromagnetic coil, and electrical mains compatibility, and the performance studies include electrical safety and bench performance testing, indicating it is a hardware device with software modifications.
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 Obsessive-Compulsive Disorder. IVDs are used for the diagnosis or monitoring of diseases or conditions using samples taken from the human body (like blood, urine, tissue).
- Device Description: The device description clearly explains that it's a system that applies magnetic pulses to the brain to induce electrical fields and activate neurons. This is a therapeutic 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 testing.
The device is a therapeutic device that uses transcranial magnetic stimulation (TMS) to treat a neurological condition.
N/A
Intended Use / Indications for Use
The Brainsway Deep Transcranial Magnetic Stimulation System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder.
Product codes (comma separated list FDA assigned to the subject device)
QCI
Device Description
The proposed device is a modification to the Brainsway Deep TMS System that was cleared under DEN170078. Brainsway has implemented minor changes to the helmet configuration, improved the user interface, modified the measurement method, and made other minor component changes. None of these changes alter the technical specifications for the device, which maintains the same voltage and current, same frequencies, and same electrical mains compatibility. The same technological features have previously been cleared by FDA for use in major depressive disorder in K173540.
Consistent with the predicate and reference device, the proposed Brainsway Deep TMS System enables direct non-invasive activation of deep brain structures. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold, and is directed in an appropriate orientation relative the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure.
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
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)
The following tests were performed to validate the modifications to the device:
- . Software verification and validation;
- Electrical safety in accordance with IEC 60601-1 and EMC in accordance with IEC ● 60601-1-2;
- Bench performance testing.
In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate and reference device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
(a)
Identification. A transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is a prescription, non-implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety.
(2) Software verification, validation, and hazard analysis must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Magnetic pulse output testing;
(ii) Magnetic and electrical field testing;
(iii) Testing of the safety features built into the device; and
(iv) Testing of the sound levels patients are exposed to during device use.
(5) The physician and patient labeling must include the following:
(i) The risks and benefits associated with use of the device;
(ii) Detailed instructions to prevent seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and
(iii) A description of the ear protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating.
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.
March 8, 2019
Brainsway Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market St., 23rd Floor Philadelphia, Pennsylvania 19103
Re: K183303
Trade/Device Name: Brainsway Deep TMS System Regulation Number: 21 CFR 882.5802 Regulation Name: Transcranial Magnetic Stimulation System For Neurological And Psychiatric Disorders And Conditions Regulatory Class: Class II Product Code: QCI Dated: February 5, 2019 Received: February 5, 2019
Dear Janice Hogan:
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 Actinclude 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Pamela D. Pamela D. Scott -S Date: 2019.03.08 Scott -S 22:30:01 -05'00'
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183303
Device Name Brainsway Deep TMS System
Indications for Use (Describe)
The Brainsway Deep Transcranial Magnetic Stimulation System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY K183303
Brainsway Deep TMS System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Moria Ankri Brainsway Ltd 19 Hartom St. (Bynet Bldg) Har Hotzvim, Jerusalem, ISRAEL 9777518 Tel: +972-2-5813140 Fax: +972-2-5812517 E-mail: moria@brainsway.com
February 7, 2019
Device Name
Brainsway Deep TMS System
Classification Names
Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions
Classification
21 CFR 882.5802, Class II, Product Code QCI
Predicate Devices
Brainsway Deep TMS System (DEN170078) (predicate) Brainsway Deep TMS System (K173540) (reference device)
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Indications for Use
The Brainsway Deep Transcranial Magnetic Stimulation System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder.
Device Description
The proposed device is a modification to the Brainsway Deep TMS System that was cleared under DEN170078. Brainsway has implemented minor changes to the helmet configuration, improved the user interface, modified the measurement method, and made other minor component changes. None of these changes alter the technical specifications for the device, which maintains the same voltage and current, same frequencies, and same electrical mains compatibility. The same technological features have previously been cleared by FDA for use in major depressive disorder in K173540.
Consistent with the predicate and reference device, the proposed Brainsway Deep TMS System enables direct non-invasive activation of deep brain structures. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold, and is directed in an appropriate orientation relative the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure.
Comparison of Technological Characteristics
| Parameter | Subject Device
(K183303) | Predicate Device
(DEN170078) | Reference Device
(K173540) | Comparison |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Indications for
Use | The Brainsway
Deep Transcranial
Magnetic
Stimulation System
is intended to be
used as an adjunct
for the treatment of
adult patients
suffering from
Obsessive-
Compulsive
Disorder. | The Brainsway
Deep Transcranial
Magnetic
Stimulation
System is intended
to be used as an
adjunct for the
treatment of adult
patients suffering
from Obsessive-
Compulsive
Disorder. | The Brainsway
Deep TMS 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. | SAME as
Predicate |
| Classification/
Product Code | 21 CFR
882.5802/QCI | 21 CFR
882.5802/QCI | 21 CFR
882.5805/OBP | SAME as
Predicate |
| Parameter | Subject Device
(K183303) | Predicate Device
(DEN170078) | Reference Device
(K173540) | Comparison |
| Treatment
Parameters | OCD Treatment
Parameters:
• Magnetic Field
Intensity: 100% of
the patient's
observed motor
threshold
• Frequency: 20
Hz
• Train Duration:
2 seconds
• Inter-train
interval: 20
seconds
• Number of
trains: 50
• Magnetic Pulses
per Session: 2000
• Treatment
Session Duration:
Approximately 18.3
minutes
• Sessions per
week: 5
• 5 daily sessions
for 5 weeks, 4 daily
sessions for 1 week | OCD Treatment
Parameters:
• Magnetic Field
Intensity: 100% of
the patient's
observed motor
threshold
• Frequency: 20
Hz
• Train Duration:
2 seconds
• Inter-train
interval: 20
seconds
• Number of
trains: 50
• Magnetic
Pulses per
Session: 2000
• Treatment
Session Duration:
Approximately
18.3 minutes
• Sessions per
week: 5
• 5 daily
sessions for 5
weeks, 4 daily
sessions for 1
week | MDD Treatment
Parameters:
• Magnetic Field
Intensity: 120% of
the patient's
observed motor
threshold.
• Frequency: 18
Hz
• Train Duration:
2 seconds
• Inter-train
interval: 20 sec
• Number of
trains: 55
• Magnetic
Pulses per
Session: 1980
• Treatment
Session Duration:
Approximately
20.2 minutes
• Sessions per
week: 5
• 5 daily
sessions for 4
weeks
• Bi-weekly
sessions for
another 12 weeks
(optional
maintenance
treatments) | SAME as
Predicate |
| Area of brain
to be
stimulated | Prefrontal Cortex | Prefrontal Cortex | Prefrontal Cortex | SAME as
and
Predicate
and
Reference
Device |
| Configuration | Biphasic | Biphasic | Biphasic | SAME as
Predicate
and
Reference
Device |
| Core material | Air | Air | Air | SAME as
Predicate
and
Reference |
| Parameter | Subject Device
(K183303) | Predicate Device
(DEN170078) | Reference Device
(K173540) | Comparison |
| Peak Electric
Current | 6000 A | 5000-6000 A | 6000 A | Similar to
Predicate
and SAME
as
Reference
Device |
| Maximal
Operating
Voltage | 1.7 kV | 1.7 kV | 1.7 kV | SAME as
Predicate
and
Reference
Device |
| Amplitude in
Standard
Motor
Threshold
(SMT) units | 0.6-1.4 | 0.6-1.4 | 0.6-1.4 | SAME as
Predicate
and
Reference
Device |
| Pulse width
(usec) | 324 | 324 | 369 | SAME as
Predicate |
| Frequency
range (Hz) | 0.1-50 | 1-50 | 0.1-50 | SAME as
Reference
Device |
| Pulse train
duration range
(sec) | 1-20 | 1-20 | 1-20 | SAME as
Predicate
and
Reference
Device |
| Inter-train
interval range
(sec) | 10-60 | 10-60 | 10-60 | SAME as
and
Reference
Device |
| Maximum
trains per
session | ~140 | ~140 | ~140 | SAME as
Predicate
and
Reference
Device |
| Maximum # of
pulses per
session
(cumulative
exposure) | 5000 | 5000 | ~5000 | SAME as
Predicate
and
Reference
Device |
| Parameter | Subject Device
(K183303) | Predicate Device
(DEN170078) | Reference Device
(K173540) | Comparison |
| Physical unit
of amplitude
setting (e.g.,
coil current,
peak
magnetic field)
at coil & its
relation to
SMT unit:
Electric field
at 1.5cm from
coil
(equivalent to
1.0 SMT [V/m]) | 100 | 100 | 100 | SAME as
Predicate
and
Reference
Device |
| Cart
Dimensions | 680 mm (L) x
688mm (W) | 680 mm (L) x
625mm (W) | 680 mm (L) x
688mm (W) | Device |
| Maximum
System Height | 2050 mm | 2050 mm | 2050 mm | SAME as
Predicate
and
Reference
Device |
| Voltage | 100-240 VAC | 110-120 VAC | 100-240 VAC | SAME as
Reference
Device |
| Frequency | 50/60 Hz | 50/60 Hz | 50/60 Hz | SAME as
Predicate
and
Reference
Device |
| Coil's
Operating
Temperature: | 10°C to 30°C | 15 °C to 30 °C | 10°C to 31°C | SAME as
Reference
Device |
| Storage
Temperature | -20 °C to 60 °C | -20 °C to 60 °C | -20 °C to 60 °C | SAME as
Predicate
and
Reference
Device |
| Atmospheric
Pressure
Range | 500 hPa to 1060
hPa | 500 hPa to 1060
hPa | 500 hPa to 1060
hPa | SAME as
Predicate
and
Reference
Device |
| Parameter | Subject Device
(K183303) | Predicate Device
(DEN170078) | Reference Device
(K173540) | Comparison |
| Relative
Humidity
Range | 10% to 80% Non-
Condensing | 10% to 80% Non-
Condensing | 10% to 80% Non-
Condensing | SAME as
Predicate
and
Reference |
5
6
7
8
Both the subject and predicate device have an almost identical movable cart that is used to place the TMS neurostimulator and the cooling system. In both the subject and predicate device, the positioning device is connected to the cart. Although the subject device has a slightly larger cart as compared to the predicate device, this difference does not raise new questions of safety and effectiveness.
Further, both the subject and predicate device consist of a TMS neurostimulator that delivers electrical stimulation to the brain, enabling a controlled output, frequency, pulse duration and indication of coil temperature. Although the predicate device uses commercially available TMS neurostimulators and the subject device uses the Brainsway Stimulator, this difference does not raise new of different questions of safety and effectiveness as demonstrated through performance testing. Further, the identical Brainsway Stimulator was cleared in the reference device, further establishing substantial equivalence.
The subject device has a substantially similar cooling system as compared to the predicate device. The Cooling System continues to consist of an external unit and an air hose streaming the cooled air into the helmet. The air flow cools the coils during pulse trains and maintains them at ambient temperature (less than 30°C). The only difference between the cooling system cleared in the predicate device as compared to the subject device is that the proposed cooling system has a better and stronger compressor, which leads to improved performance as demonstrated in the repeated cooling system development tests. This identical cooling system has been cleared in the reference device further demonstrating substantial equivalence.
Further, the positioning device of the subject and the predicate device continues to feature an adjustable arm that enables the rotation of the helmet around three orthogonal rotation axes (XYZ axes). The positioning device continues to enable accurate and comfortable displacement and positioning of the coil over the patient's head.
The helmet used in both the subject and predicate device are nearly identical. The frontal contour of the helmet has changed slightly from straight to concave configuration. In addition, a transparent plastic guide through which a grid can be observed has been added. The guide shows a red vertical line and a black horizontal line with end markings for positioning. This difference does not raise new or different questions of safety and effectiveness.
The H-Coil of both the subject and predicate device are nearly identical. Although the diameter and cross section of the copper wire of the H-Coil is slightly larger in the subject device as compared to the predicate device, this difference does not raise new of different questions of safety and effectiveness, as demonstrated through performance testing.
9
Although the predicate used two flexible rulers (medial & lateral) that were attached along the midline of the Cap to assist in proper helmet positioning whereas the subject device uses a grid, this difference introduces no new questions of safety and effectiveness as demonstrated through completed performance testing.
Performance Data
The following tests were performed to validate the modifications to the device:
- . Software verification and validation;
- Electrical safety in accordance with IEC 60601-1 and EMC in accordance with IEC ● 60601-1-2;
- Bench performance testing.
In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate and reference device.
Substantial Equivalence
The modified Brainsway Deep TMS System has the same intended use and indications, principles of operation, and similar technological characteristics as the previously cleared predicate device. The minor differences in the technical characteristics of the updated device do not raise any new or different questions of safety or effectiveness. Performance data demonstrates that the modified device is safe and effective for its intended use. Thus, the modified Brainsway Deep TMS System is substantially equivalent.