(265 days)
Not Found
No
The description focuses on the electromechanical nature of the device and the principles of magnetic stimulation, with no mention of AI or ML.
Yes
The device is indicated for the treatment of Major Depressive Disorder in adult patients, which is a therapeutic purpose.
No
The device is indicated for the "treatment of Major Depressive Disorder," not for diagnosing it.
No
The device description explicitly states it is a "computerized, electromechanical medical device" and lists several hardware components including a stimulator, trolley, coil, marking apparatus, patient head fixation, and isolation transformer. This indicates it is a system with significant hardware components, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The MagVita TMS Therapy System directly interacts with the patient's brain using magnetic fields to induce electrical currents. It is a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use is for the treatment of Major Depressive Disorder, not for diagnosing or analyzing biological samples related to the condition.
Therefore, the MagVita TMS Therapy System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MagVita TMS Therapy System w/ Theta Burst Stimulation is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Product codes (comma separated list FDA assigned to the subject device)
OBP
Device Description
The MagVita TMS Therapy System w/Theta Burst Stimulation Is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. The MagVita TMS Therapy System w/ Theta Burst Stimulation is indicated for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neural tissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current are generated with a circuit containing a capacitor connected to the stimulating coil. With the capacitor charged to a certain level, the conducting state will cause the discharging of the capacitor through the coil. A magnetic field is generated proportional to this current. The rapid change in the magnetic field induces a current in conducting materials e.g. the body tissue. If the current induced in the human body is of sufficient amplitude and duration, it will excite neurons. The standard-of-care FDA approved TMS protocol for treatment of MDD uses repetitive transcranial magnetic pulses applied at a frequency of 10 Hz. Such stimulation has been shown to be effective in modulating cortical excitability. The observed and documented increase in cortical excitability after high frequency (10 Hz rTMS) repetitive TMS (rTMS) has been shown to persist beyond the duration of the train of stimulation, and 10 Hz rTMS on the Left-Dorsolateral prefrontal cortex (L-DLPFC) has been shown to be effective and safe in the treatment of MDD. A newer form of the TMS, called intermittent Theta Burst Stimulation (iTBS), mimics the endogenous theta rhythms of the human brain, and has been shown to evoke equally potent excitatory effects. Intermittent TBS provides bursts of three individual stimuli at a rate of 50 Hz (i.e. 20 ms apart), repeated at 5 Hz (i.e. 200 ms between burst) mimicking the theta rhythm of the brain. Thus, the iTBS protocol is more demanding in terms of stimulator output. The clinical performance is based on the fact that the actual individual stimuli are of equal intensity, to ensure that a constant dose of stimuli is delivered during treatment.
MagVita TMS therapy system w/Theta Burst stimulation is applied to the human brain of the left dorsolateral prefrontal cortex (L-DLPFC) using iTBS.
The MagVita TMS Therapy System w/ Theta Burst Stimulation is an integrated system consisting of the following components:
- MagPro Stimulator and Trolley .
- MagPro family
- Trolley with holding arrangements
- Coil for MT determination and Depression treatment .
- Coil Cool-B70 with Coil Cooler Unit
- Marking apparatus for locating treatment area .
- Marking plate for Coil Cool-B70
- Pen for marking, Cap, Ruler
- Patient head fixation .
- Treatment Chair
- Vacuum Pump and Vacuum pillow
- Super Flexible Arm mounted on the trolley
- Isolation Transformer
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anatomical Site: cerebral cortex, Left-Dorsolateral prefrontal cortex (L-DLPFC)
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 effectiveness, safety and tolerability of iTBS have been demonstrated in a large randomized, multicenter trial. iTBS has similar effectiveness and side effect profile compared to standard-of-care 10 Hz rTMS. Based on performance testing, the MagVita TMS Therapy System w/Theta Burst Stimulation, is as safe and effective and performs as well as the predicate devices with enhanced ease of use and reduced treatment time to the benefit of both patient and operator.
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.
MagVita TMS Therapy System (K150641, K171481, K171967 and K172667)
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.
Not Found
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
§ 882.5805 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 shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 14, 2018
Tonica Elektronik A/S Sanne Jessen Medical Advisor Lucernemarken 15 Farum, 3520 Dk
Re: K173620
Trade/Device Name: Mag Vita TMS Therapy System w/Theta Burst Stimulation Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: July 10, 2018 Received: July 13, 2018
Dear Sanne Jessen:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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,
Carlos L. Pena -S
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) K173620
Device Name
MagVita TMS Therapy System w/Theta Burst Stimulation
Indications for Use (Describe)
The MagVita TMS Therapy System w/ Theta Burst Stimulation is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
MagVita TMS Therapy System w/Theta Burst Stimulation
510(k) Summary
Submitter's Information
| Name of 510(k) owner: | Tonica Elektronik A/S
Lucernemarken 15
DK-3520 Farum, Denmark | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Phone: | +45 4499 8444 | |
| Fax: | +45 4499 1544 | |
| Contact person: | Sanne Barsballe Jessen
Medical Advisor
Email: sj@magventure.com
Phone: +45 44390418
Other:
Jan Kjoeller
Email: jk@tonica.dk | |
| Preparation date: | August 10, 2018 | |
| Trade name: | MagVita TMS Therapy System w/ Theta Burst Stimulation | |
| Common name: | Transcranial Magnetic Stimulator | |
| Classification name: | Repetitive Transcranial Magnetic Stimulator for treatment of
Major Depressive Disorder [21 CFR 882.5805, Product Code
OBP] | |
| Classification: | Class II Medical Device | |
| Predicate Devices: | MagVita TMS Therapy System (K150641, K171481,
K171967 and K172667)
21 CFR 882.5805, Repetitive Transcranial Magnetic
Stimulation
Product code: OBP
Device Class: II | |
4
510(k)
MagVita TMS Therapy System w/Theta Burst Stimulation
Device description
The MagVita TMS Therapy System w/Theta Burst Stimulation is a computerized. electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. The MagVita TMS Therapy System w/ Theta Burst Stimulation is indicated for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neural tissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current are generated with a circuit containing a capacitor connected to the stimulating coil. With the capacitor charged to a certain level, the conducting state will cause the discharging of the capacitor through the coil. A magnetic field is generated proportional to this current. The rapid change in the magnetic field induces a current in conducting materials e.g. the body tissue. If the current induced in the human body is of sufficient amplitude and duration, it will excite neurons. The standard-of-care FDA approved TMS protocol for treatment of MDD uses repetitive transcranial magnetic pulses applied at a frequency of 10 Hz. Such stimulation has been shown to be effective in modulating cortical excitability. The observed and documented increase in cortical excitability after high frequency (10 Hz rTMS) repetitive TMS (rTMS) has been shown to persist beyond the duration of the train of stimulation, and 10 Hz rTMS on the Left-Dorsolateral prefrontal cortex (L-DLPFC) has been shown to be effective and safe in the treatment of MDD. A newer form of the TMS, called intermittent Theta Burst Stimulation (iTBS), mimics the endogenous theta rhythms of the human brain, and has been shown to evoke equally potent excitatory effects. Intermittent TBS provides bursts of three individual stimuli at a rate of 50 Hz (i.e. 20 ms apart), repeated at 5 Hz (i.e. 200 ms between burst) mimicking the theta rhythm of the brain. Thus, the iTBS protocol is more demanding in terms of stimulator output. The clinical performance is based on the fact that the actual individual stimuli are of equal intensity, to ensure that a constant dose of stimuli is delivered during treatment.
MagVita TMS therapy system w/Theta Burst stimulation is applied to the human brain of the left dorsolateral prefrontal cortex (L-DLPFC) using iTBS.
The MagVita TMS Therapy System w/ Theta Burst Stimulation is an integrated system consisting of the following components:
- MagPro Stimulator and Trolley .
- o MagPro family
- Trolley with holding arrangements o
- Coil for MT determination and Depression treatment .
- o Coil Cool-B70 with Coil Cooler Unit
- Marking apparatus for locating treatment area .
- Marking plate for Coil Cool-B70 o
- Pen for marking, Cap, Ruler o
- Patient head fixation .
- Treatment Chair o
- Vacuum Pump and Vacuum pillow o
- Super Flexible Arm mounted on the trolley o
5
- Isolation Transformer .
Intended Use/Indication for Use:
The MagVita TMS Therapy System w/Theta Burst Stimulation and the predicate device are indicated for:
Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Performance Standards:
The MagVita TMS Therapy System w/Theta Burst Stimulation has been tested and complies with the following standards
- ISO 13485:2012 .
- IEC60601-1 .
- . IEC60601-1-2
Non-Clinical performance data:
The non-clinical performance testing of the components of the Mag Vita TMS Therapy System w/ Theta Burst Stimulation has been tested as required according to the standards listed above.
To establish substantial equivalency for the new coil and the predicate devices we have performed a comparative testing of the magnetic field distribution for the Cool-B70 coil and the predicate devices, that determines that the magnetic spatial distribution is substantially equivalent.
The MagVita TMS Therapy System w/Theta Burst Stimulation consists of components that are identical to those of the predicate devices. The New Device is identical to the predicate devices in terms of biocompatibility, design elements, such as cable lengths, coil materials, size and coil windings as well as cooling media, isolation design and functionalities. All coils are subject to high-voltage tests and leakage current tests to ensure safety.
In addition, the MagVita TMS Therapy System w/Theta Burst Stimulation has been verification tested to ensure that the intensity of the individual stimuli in iTBS is equal and kept constant. The clinical performance is based on the fact that the actual individual stimuli are of equal intensity, to ensure that a constant dose of stimuli is delivered during treatment.
We have also tested the device according to IEC60601 3rd edition and verified that the device complies with the specified permissible sound pressure levels. The device also complies with the permissible thresholds for exposure defined by the Occupational Safety and Health Administration (OSHA).
These tests provide evidence that the MagVita TMS Therapy System w/Theta Burst Stimulation does not pose any risk for potential hearing reduction or loss in either patients or operators.
6
510(k) MagVita TMS Therapy System w/Theta Burst Stimulation
Clinical performance data:
The effectiveness, safety and tolerability of iTBS have been demonstrated in a large randomized, multicenter trial. iTBS has similar effectiveness and side effect profile compared to standard-of-care 10 Hz rTMS. Based on performance testing, the MagVita TMS Therapy System w/Theta Burst Stimulation, is as safe and effective and performs as well as the predicate devices with enhanced ease of use and reduced treatment time to the benefit of both patient and operator.
Substantial equivalence:
The MagVita TMS Therapy System w/Theta Burst Stimulation is substantially equivalent to the predicate device. Mag Vita TMS Therapy System. The Mag Vita TMS Therapy System w/Theta Burst Stimulation and the predicate device have identical indication for use, and the technological characteristics are very similar such that they can be considered equivalent. The clinical performance and effectiveness, as well as tolerability and side effect profile for the new device and the predicate devices are substantially equivalent.
Design of the MagVita TMS Therapy System w/Theta Burst Stimulation is identical to the predicate device MagVita TMS Therapy System as both systems apply Transcranial Magnetic Stimulation at an intensity of 1.2xMT (120% of MT) as repetitive pulse trains delivered as brief rapidly alternating magnetic fields to induce electrical currents over the prefrontal cortex.
Both the MagVita TMS Therapy System w/Theta Burst Stimulation and the predicate device MagVita TMS Therapy System consist on the same components, that is TMS stimulator with software, electromagnetic coil and an articulated arm for positioning of the treatment coil. The operational procedures including system setup, patient preparations, motor threshold determination and coil positioning are essentially the same. The two systems only differ in predefined treatment stimulation parameters.
| Area | New Device
MagVita TMS Therapy
System w/
Theta Burst Stimulation | Predicate Device
MagVita TMS Therapy
System
Tonica Elektronik A/S
(K150641, K171481, K171967 and
K172667) |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance | Waveforms: Biphasic.
Frequency: 0.1 -30 pulses
per second or 0.1 -100
pulses, depending on model
Preset range of % MT: 0% -
140% | Waveforms: Biphasic.
Frequency: 0.1 -30 pulses
per second or 0.1 -100
pulses, depending on model
Preset range of % MT: 0% -
140% |
Characteristics of the Device as Compared to Predicate Devices*
7
510(k)
| Area | New Device
MagVita TMS Therapy
System w/
Theta Burst Stimulation | Predicate Device
MagVita TMS Therapy
System
Tonica Elektronik A/S
(K150641, K171481, K171967 and
K172667) |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | iTBS treatment protocol:
Stimulation Intensity: 120%
MT
(MT=Motor Threshold
intensity)
Repetition rate:
50 Hz (5 pulses pr sec)
Train duration:
2 sec
Interval between Trains:
8 secs
Burst pulses: 3
Bursts : 200
Inter pulse interval:
20 msec | Standard treatment:
Stimulation Intensity: 120%
MT
(MT=Motor Threshold
intensity)
Repetition rate:
10 Hz
Train duration:
4 sec
Interval between pulses: 11-
26 sec |
| | Number of trains : 20
Numbers of pulses/session:
600
Total duration: 3 min and 9
sec | Number of trains: 75
Numbers of pulses/ session:
3000
Total duration: 19-37.5 min. |
| Area | New Device
MagVita TMS Therapy System w/
Theta Burst Stimulation | Predicate Device
MagVita TMS Therapy System
Tonica Elektronik A/S
(K150641, K171481, K171967 and K172667) |
| | Output Stimulation
Parameters:
Available Stimulation
Amplitude in Standard
Motor Threshold (SMT) units
Amplitude Range: 0 - 1.7 SMT
The clinical performance of TBS is dependent on the fact that the stimuli are of equal intensity. At the relevant TBS intensities required in the treatment setting, the individual intensity of the three stimuli is kept constant (i.e. at maximum a 1% drop referred to maximum machine output between the first stimuli and the third stimuli in a burst). | Output Stimulation
Parameters:
Available Stimulation
Amplitude in Standard
Motor Threshold (SMT) units
Amplitude Range: 0 - 1.7 SMT |
| Coil
Configuration | Figure-of-eight coil
Air core | Figure-of-eight coil
Air core |
| Cooling | Liquid cooling | Liquid cooling |
| Standards met | Company complies with ISO
13485:2012. | Company complies with ISO
13485:2012. |
| Electrical safety | Complies with IEC60601-1
and IEC60601-1-2. | Complies with IEC60601-1
and IEC60601-1-2. |
MagVita TMS Therapy System w/Theta Burst Stimulation
8
510(k)
MagVita TMS Therapy System w/Theta Burst Stimulation
*For a more comprehensive comparison of devices please refer to section 12 Substantial Equivalence Comparison and to section 20 Clinical Performance.
9
Conclusion:
The indication for use, the target population, the treatment procedure and the treatment position are all 100 % identical for the MagVita TMS Therapy System w/Theta Burst Stimulation and the predicate device MagVita TMS Therapy System.
The protocol parameters are not equivalent in terms of dosage, repetition rate, number of pulses in a train or the number of trains. Hence, the dosage is much smaller for the New Device, whereas the repetition rate in contrast is higher. The intensity is identical for the Mag Vita TMS Therapy System w/Theta Burst Stimulation and the predicate devices. However, the iTBS protocol is more demanding in terms of stimulator output, and the MagVita TMS Therapy System w/Theta Burst Stimulation delivers stimuli of equal intensity, thereby verifying that the dose is maintained throughout the course of treatment.
The performance and the clinical effectiveness are substantially equivalent to that of the predicate devices, and the iTBS protocol with MagVita TMS Therapy System w/Theta Burst Stimulation in addition offers advantages over the predicate devices in terms of treatment duration to the benefit of the patient as well as the operator.
The transducer design (figure-of-eight) is equivalent, the magnetic properties of the MagVita TMS Therapy System w/Theta Burst Stimulation and the predicate devices, as well as the realized magnetic properties are substantially equivalent for the coils (K172667). Additionally, the new device offers the advantage that the same coil can be used for MT determination and treatment to the benefit of the Operator.
The reliability of the positioning method used by the MagVita TMS Therapy System w/Theta Burst Stimulation is, based on the direct relationship of the underlying cortical brain anatomy to the patient's scalp, identical to the method used for the predicate device, MagVita TMS Therapy System and previously FDA cleared (K150641 and K171481).
The MagVita TMS Therapy System does not introduce any new safety considerations in comparison to the predicate devices based on clinical trial data.
All other identified differences between the two systems are minor and without any impact on safety or efficacy.
The above comparison demonstrates and supports the substantial equivalency of the MagVita TMS Therapy System w/Theta Burst Stimulation to the predicate device, MagVita TMS Therapy System.