(322 days)
Not Found
No
The summary describes a hardware-based system for transcranial magnetic stimulation and does not mention any software components or algorithms that would suggest the use of AI or ML.
Yes
The device is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder, indicating a therapeutic purpose.
No
The device is described as a system intended for the treatment of Obsessive-Compulsive Disorder, not for diagnosing it. It focuses on activating brain structures to produce therapeutic effects rather than gathering information for diagnosis.
No
The device description explicitly lists multiple hardware components (Electromagnetic Coil, TMS Neurostimulator, Cooling System, Positioning Device, Personal Head Cap) that are integral to the system's function.
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 by directly stimulating brain structures. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- 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 treatment method.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to directly treat a condition through physical stimulation.
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
OCI
Device Description
The Brainsway DTMS System enables direct non-invasive activation of brain structures. 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 DTMS System is composed of the following five main components:
- Electromagnetic Coil (HAC-Coil) ●
- . TMS Neurostimulator
- Cooling System ●
- Positioning Device
- Personal Head Cap ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cerebral cortex, brain structures, head, prefrontal cortex, tibialis motor cortex.
Indicated Patient Age Range
Adult patients, aged 22-68.
Intended User / Care Setting
Prescription use only.
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
Description: The study was a randomized, double blinded, multi-site, sham-controlled clinical trial. Subjects were outpatients, aged 22-68, with a DSM-IV diagnosis of OCD and a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of >20. They were maintained on SSRI medications and/or psychotherapeutic behavioral intervention therapy at stable dosages. Subjects were excluded for other primary Axis I diagnoses, severe Personality Disorder (excluding Obsessive Compulsive Personality Disorder), significant neurological injury, increased seizure risk, prior rTMS, significant hearing loss, substance abuse, pregnancy, intracranial implants or metal objects, present suicide risk, or history of suicide attempt in the last 3 years.
Sample Size: A total of 100 OCD subjects were enrolled. The Intent-to-treat (ITT) analysis set included 99 randomized patients (48 DTMS, 51 Sham). The modified intent-to-treat (mITT) analysis set included 94 subjects (47 DTMS, 47 Sham). The Per-Protocol (PP) analysis set included 93 subjects (46 DTMS, 47 Sham).
Data Source: 11 study sites in the United States (9 sites), Israel (1 site) and Canada (1 site).
Annotation Protocol:
- Primary outcome measure: Compare the change in YBOCS scores from baseline to the 6 week (post-randomization) visit, between the two treatment groups.
- Secondary outcome measures:
- Compare the change from baseline to the 6 week visit in the Sheehan Disability Scale (SDS) score and Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I) scores, between the treatment groups.
- Response rate comparison at the 6 week visit, where response is defined as a reduction of at least 30% in YBOCS score from baseline, between the treatment groups.
- Partial Response rate comparison at the 6 week visit, where response is defined as a reduction of at least 20% in YBOCS score from baseline, between the treatment groups.
- Compare the change from baseline to the 10-week visit in the YBOCS score between the treatment groups.
- Compare the change from baseline to the 10 week visit in the Sheehan Disability Scale (SDS) score and Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I) scores, between the treatment groups.
- Remission rates comparison at the 6-week visit, where remission is defined as YBOCS score
§ 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
DE NOVO CLASSIFICATION REQUEST FOR BRAINSWAY DEEP TRANSCRANIAL MAGNETIC STIMULATION SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions. 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 the 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.
NEW REGULATION NUMBER: 21 CFR 882.5802
CLASSIFICATION: Class II
PRODUCT CODE: OCI
BACKGROUND
DEVICE NAME: Brainsway Deep Transcranial Magnetic Stimulation System
SUBMISSION NUMBER: DEN170078
DATE OF DE NOVO: September 29, 2017
- Brainsway Ltd. CONTACT: Bynet Building, P.O.B. 45169 19 Hartum Street Har Hotzvim, Jerusalem, 9777518 Israel
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.
LIMITATIONS
For prescription use only.
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Patients already on Obsessive-Compulsive Disorder (OCD) treatments (psychotropic medications and/or psychotherapy) should be maintained at their current dosages during the Deep Transcranial Magnetic Stimulation (DTMS) treatment.
The Brainsway DTMS System is contraindicated in patients with the following conditions:
- . Metallic Objects in or near the Head - rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 30 cm of the treatment coil. Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes. Failure to follow this restriction could result in serious injury or death.
- . Implanted Stimulator Devices in or near the Head - rTMS devices are contraindicated for use in patients who have active or inactive implants (including device leads), deep brain stimulators, cochlear implants, and vagus nerve stimulators. Contraindicated use could result in serious injury or death.
During treatment with the device, the patient must use earplugs with a rating of at least 30 dB of noise reduction. Verify proper use of earplugs. Ask users to immediately report any loosening or detachment of an earplug. and stop rTMS if a user reports, or if a treater observes, that an earplug has loosened or has fallen out.
The Brainsway DTMS system should be used with caution in patients who have a history of seizures, or a potential for alteration in seizure threshold. Stimulation parameters outside of those studied in the clinical study and recommended for use in the Instructions for Use have not been tested for safety during brain stimulation, particularly for seizure induction.
Long-term effects of exposure to rTMS are unknown.
The safety and effectiveness of the Brainsway DTMS System has not been established in the following patient populations or clinical conditions:
- . Age less than 22 and greater than 68;
- . Severe Personality Disorder (excluding Obsessive Compulsive Personality Disorder) or severe borderline personality disorder;
- . Suicide plan or recent suicide attempt;
- Neurological disorders including a history of seizures, cerebrovascular disease, . primary or secondary tumors in CNS, cerebral aneurysm, dementia, or movement disorders;
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- History of increased intracranial pressure or head trauma; .
- Cardiac pacemakers, implantable cardioverter defibrillators, ocular implants, deep . brain stimulators, vagus nerve stimulators, implanted medication pumps, intracardiac lines, or significant cardiac disease;
- . History of substance abuse in the past six months prior to treatment;
- Prescribed high doses of antidepressant or psychotropic medications, which are . known to lower the seizure threshold or patients on Clomipramine; or
- . Pregnant or nursing.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
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DEVICE DESCRIPTION
The Brainsway DTMS System enables direct non-invasive activation of brain structures. 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 DTMS System is composed of the following five main components:
- Electromagnetic Coil (HAC-Coil) ●
- . TMS Neurostimulator
- Cooling System ●
- Positioning Device
- Personal Head Cap ●
The Brainsway DTMS System is illustrated in Figure 1. Except for a different Electromagnetic Coil and updated cooling system, the components of this new DTMS system are identical to the Brainsway DTMS System currently marketed in the United States to treat Major Depressive Disorder (K122288).
Image /page/3/Picture/9 description: The image shows a medical device with several components. A positioning device is connected to a helmet comprising the H-coil. The device also includes a stimulator, a cooling system, and an ITD Medical Cart. The device appears to be a medical device used for brain stimulation.
Figure 1: Illustration of the Brainsway DTMS System
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A description of each component is provided below:
- HAC-Coil: The HAC-Coil is made of insulated copper wires. The total length is about ● 500 cm, winded into 16 windings and connected in series. The coil is flexible in order to fit the variability in human skull shape. The electromagnetic coil is contained in a helmet. which is connected by an adaptor to a positioning device. The coil is connected to the neurostimulator cable and a connector. This connector can be connected to the Magstim Rapid, Rapid2 or Super Rapid2 neurostimulator. In addition, a temperature sensor is included with an appropriate cable.
- TMS Neurostimulator: The Magstim Rapid, Rapid2 or Super Rapid2 neurostimulators are ● used to deliver the electrical stimulus to the HAC-Coil. These commercial TMS neurostimulators provide a controlled output, frequency, pulse duration, and indication of coil temperature. The Magstim software provided with the neurostimulators allows the user direct control over power level, frequency, train duration, and the interval between trains.
- Cooling System: The Cooling System is designed to maintain ambient temperature in the ● coils during repetitive and prolonged operation. The cooling system consists of an external unit and an air hose streaming the cooled air into the helmet. The air flow cools the coils while repetitive electrical stimuli are pulsed through the HAC-Coil.
- . Positioning Device: The positioning system includes a helmet that comprises the Electromagnetic Coils (one for each side of the head), an adjustable arm connected to the helmet and a device enabling rotation of the helmet around three orthogonal rotation axes. The positioning device enables accurate and comfortable displacement and positioning of the coil over the patient's head.
- Personal Head Cap: A personal cap is provided for each patient. The cap is made of ● (b) (4) A flexible ruler is attached along the cap midline, with the 0 mark positioned at the patient's nasion. The cap is used for accurate positioning of the coil on the patient's head during each treatment session, by moving the coil from the area above the motor cortex to the treatment location at the prefrontal cortex. In addition, the cap guarantees hygienic treatment conditions.
Procedural Information
The detailed procedures are described in the Instructions for Use. The following is a brief summary.
The Brainsway Deep TMS device is intended to safely deliver high-frequency (20Hz) repetitive transcranial magnetic pulses (2 second trains) to induce electric field of sufficient magnitude, i.e., 100% of resting Motor Threshold of the foot, for the treatment of OCD, using a flexible coil conforming to the shape of the head.
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Before starting each treatment. subjects are instructed to insert earplugs to lessen any possible adverse effect on hearing. Prior to treatment, the treatment administrator must determine the position of the tibialis motor cortex and the subject's individual motor threshold. The minimal stimulator power output required for activation of the tibialis is determined. After finding the position on the patient's head, which requires the minimal stimulator output for reaching the motor threshold for activation of the tibialis, the treatment administrator moves the HAC-coil to the marked treatment location and secures it to the patient's head. The treatment administrator then programs the treatment parameters as defined in the Instructions Manual for safe and effective OCD treatment. The power output for the DTMS treatment is determined relative to the individual motor threshold found for the patient.
The magnetic field characteristics as well as other specifications of the Brainsway DTMS System are summarized in Table 1 below.
| DTMS System | Specifications |
|---|---|
| Output Stimulation Parameters: | |
| Amplitude in Standard Motor Threshold (SMT) units | |
| Pulse width (usec) | |
| Frequency range (Hz) | |
| Pulse train duration range (sec) | |
| Inter-train interval range (sec) | |
| Maximum trains per session | |
| Maximum # of pulses per session (cumulative exposure) | 0.6-1.4 |
| 324 | |
| 0.02-30 | |
| 1-20 | |
| 10-60 | |
| ~140 | |
| 5000 | |
| 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 |
| Magnetic Field: | |
| Peak magnetic field strength at coil edge [T] | |
| Peak magnetic field strength at 2 cm from coil [T] | |
| Maximal dB/dt at coil edge (Gauss/usec) | |
| Maximum dB/dt at 2 cm from coil (Gauss/usec) | |
| dB/dt ratio | (b) (4) |
| Temperature on coil surface at maximum output | 34° C |
Table 1: Specifications for the Brainsway TMS System
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
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The personal head cap is the only patient contacting material and it is intended for limited duration contact (20 to be enrolled in the study. Subjects were maintained on SSRI medications (with or without additional antidepressant or psychotropic augmentation for treatment of OCD), at a stable therapeutic dosage for at least 2 months prior to study entry and/or subjects were maintained on psychotherapeutic behavioral intervention therapy. Symptoms stability was required during the 2-3 weeks of screening. Instability was defined as a change of ±30% in the patient's total YBOCS score between the screening assessment and baseline assessment.
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Subjects were excluded from the study if they suffered from any other Axis I diagnosis as the primary diagnosis or if they were diagnosed with severe Personality Disorder (excluding Obsessive Compulsive Personality Disorder). Additional exclusion criteria included any significant neurological injury, disorder or insult; increased risk of seizure for any reason, including familial or personal history of epilepsy; prior treatment with rTMS (because they could not be blinded); history of significant hearing loss; history of substance abuse; pregnancy; presence of intracranial implants or any other metal object within or near the head excluding the mouth that cannot be safely removed. Additionally, subjects were excluded if they were assessed with a present risk of suicide or if they had a history of suicide attempt in the last 3 years (because of risk the patient might be assigned to sham).
The study consisted of three phases:
- . Screening phase (approximately 2-3 weeks, with no treatment);
- 6-week treatment period (daily treatment with DTMS or sham); and
- . 10-week follow-up visit (4 weeks after the last treatment)
At the Baseline visit subjects were randomly assigned to either active DTMS treatment or Sham treatment (1:1 ratio). Subjects were stratified by center. During the treatment phase, TMS sessions were performed daily in a 5-day sequence. Subjects were discontinued from the study at any point if they had elevated risk for suicide as assessed by the investigator; if they missed more than 3 treatments; or if the investigator concluded that for safety reasons (e.g. an adverse event) it was in the best interest of the subject to stop treatment.
Prior to initiation of each treatment, OCD symptoms were provoked for each subject in an individual manner for up to 5 minutes to activate the relevant brain circuits. The symptom provocation had to induce a stress level between 4-7 on a visual analog scale (VAS) in order to proceed with DTMS treatment.
Each DTMS treatment (for active and sham groups) was conducted as follows: Before starting each treatment, the subject was instructed to insert earplugs to lessen any possible adverse effect on hearing. The patient's motor threshold (MT) was measured at the beginning of each week by delivering single stimulations over the leg area of the motor cortex. The anterior cingulate gyrus was chosen as the treatment location which was determined by locating the coil 4 cm anterior to the leg MT location using the ruler on the head cap. The treatment location was recorded in the operator case report forms. Subjects should have received treatment at a power output of 100% of the measured MT. The treatment group received DTMS at 20 Hz and 100% stimulation intensity of the measured MT. Each DTMS repetition included 2 second pulse trains and 20 second inter-train intervals. Subjects received 50 trains in each treatment session, for a total of 2000 pulses per session. Each session lasted about 30 minutes of which the DTMS session lasted approximately 20 minutes. The control group received sham (placebo) treatment with identical parameters. Subjects were told that facial and hand twitching may occur due to either sham or active treatment.
During the treatment session, the operator swiped the subject's treatment card reader in the DTMS System. The card reader activated either active or sham treatment mode according
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to the treatment group to which the subject had been randomized. The study personnel did not have any knowledge of whether the active mode or sham mode was activated by the subject's treatment card. Thus, all study personnel, including the operator, the independent rater and study subjects were blinded to the treatment administered. The study subjects were asked whether they believed they had received active or sham stimulation after the first treatment session. Patients were asked not to meet or discuss the study treatment with other subjects before, during and after assessment or treatments in order to maintain study blinding.
The primary outcome measure was the following:
-
. Compare the change in YBOCS scores from baseline to the 6 week (post-randomization) visit, between the two treatment groups.
The secondary outcome measures were the following: -
. Compare the change from baseline to the 6 week visit in the Sheehan Disability Scale (SDS) score and Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I) scores, between the treatment groups.
-
Response rate comparison at the 6 week visit, where response is defined as a reduction of . at least 30% in YBOCS score from baseline, between the treatment groups.
-
Partial Response rate comparison at the 6 week visit, where response is defined as a . reduction of at least 20% in YBOCS score from baseline, between the treatment groups.
-
. Compare the change from baseline to the 10-week visit in the YBOCS score between the treatment groups.
-
. Compare the change from baseline to the 10 week visit in the Sheehan Disability Scale (SDS) score and Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I) scores, between the treatment groups.
-
Remission rates comparison at the 6-week visit, where remission is defined as YBOCS . score t | 95% CI |
|----------------------------------|-------------|-------------------|---------|-----------------|
| Adjusted means of the changes | DTMS -6.044 | 1.049 | t | 95% CI |
|----------------------------------|------|----------|----------------|---------|-----------------|
| Adjusted means of the changes | DTMS | -5.967 | 1.106 |