(109 days)
No
The description focuses on the electromechanical and magnetic stimulation principles of the device, with no mention of AI or ML technologies for treatment planning, delivery, or analysis.
Yes
The device is indicated for the "treatment of Major Depressive Disorder," which explicitly signifies a therapeutic purpose.
No
This device is indicated for the "treatment" of Major Depressive Disorder, not for diagnosis. It produces magnetic fields to induce electrical currents for therapeutic purposes.
No
The device description explicitly lists multiple hardware components including a stimulator, coils, a trolley, a treatment chair, and a vacuum pump, indicating it is a hardware-based system with potentially integrated software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of Major Depressive Disorder in adult patients. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description clearly states that it produces and delivers magnetic fields to induce electrical currents in the brain for therapeutic purposes (stimulating neurons). It does not mention analyzing biological samples (blood, urine, tissue, etc.) which is characteristic of IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
The device is a therapeutic medical device that uses transcranial magnetic stimulation (TMS) to treat a medical condition.
N/A
Intended Use / Indications for Use
The MagVita TMS Therapy - w/MagPro R20 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
OBP
Device Description
The MagVita TMS Therapy w/MagPro R20 is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents directed at regions of the cerebral cortex.
The MagVita TMS Therapy w/MagPro R20 is an integrated system consisting of the following components:
- MagPro Stimulator and Trolley
- MagPro R20
- Trolley with holding arrangements
- Coils for MT determination and Depression Treatment
- Coil MCF-B65
- Marking apparatus for locating treatment area
- Marking plate for Coil MCF-B65
- 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
left dorsolateral prefrontal cortex (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)
Non-Clinical performance data: The non-clinical performance testing of the components of the Mag Vita TMS Therapy w/MagPro R20 has been tested as required, and cleared by the FDA earlier in: K160280: MagPro R20 K150641: Chair, flexible arm, vacuum pump and pillow, isolation transformer, marking accessories and caps K071821: Coil MCF-B65.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MagVita TMS Therapy System (K150641)
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a family of three people.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 1, 2017
Tonica Elektronik A/S Lise Terkelsen Regulatory Affairs / Ouality Assurance Specialist Lucernemarken 15 Farum, DK-3520 DK
Re: K170114
Trade/Device Name: Magvita TMS Therapy - W/MagPro R20 Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: March 31, 2017 Received: April 3, 2017
Dear Lise Terkelsen:
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. 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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
William J.
Heetderks -S
Digitally signed by William J. Heetderks -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=0010149848,
cn=William J. Heetderks -S
Date: 2017.05.01 13:08:06 -04'00'
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) K170114
Device Name
MagVita TMS Therapy System with MagPro R20
Indications for Use (Describe)
The MagVita TMS Therapy - w/MagPro R20 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)
| ☐ Exported and/or Identified in CITES Article 2, Section 2(a) |
|---|
| ☐ Live, To a country outside the U.S. |
X | 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
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: | Lise Terkelsen
Email: lise.terkelsen@tonica.dk |
| Preparation date: | January 9, 2017 |
| Trade name: | MagVita TMS Therapy w/MagPro R20 |
| 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 Device: | MagVita TMS Therapy System (K150641)
21 CFR 882.5805, Repetitive Transcranial Magnetic
Stimulation
Product code: OBP
Device Class: II |
| Special Controls: | The 510k submission addressed the special controls required
by regulation and specified in the FDA guidance document
titled "Class II Special Controls Guidance
Document: Repetitive Transcranial Magnetic Stimulation
(rTMS) Systems |
4
Device description
The MagVita TMS Therapy w/MagPro R20 is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents directed at regions of the cerebral cortex. The MagVita TMS Therapy w/MagPro R20 is 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.
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.
In the MagVita TMS therapy w/MagPro R20 TMS pulses are applied repetitively at a frequency of 10Hz. Such stimulation has been shown to be as effective as the predicate device in modulating cortical excitability. The observed and documented increase in cortical excitability after high frequency (10Hz) repetitive transcranial magnetic stimulation has been shown to persist beyond the duration of the train of stimulation. Repetitive Magnetic stimulation with the Mag Vita TMS therapy w/MagPro R20 is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC).
The MagVita TMS Therapy w/MagPro R20 is an integrated system consisting of the following components:
- . MagPro Stimulator and Trolley
- MagPro R20 o
- Trolley with holding arrangements o
- Coils for MT determination and Depression Treatment .
- o Coil MCF-B65
- Marking apparatus for locating treatment area
- Marking plate for Coil MCF-B65 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
- . Isolation Transformer
Intended Use/Indication for Use:
5
Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Standards:
The MagVita TMS Therapy w/MagPro R20 has been tested and complies with the following standards
- ISO13485:2012 •
- IEC60601-1 .
- IEC60601-1-2 .
Non-Clinical performance data:
The non-clinical performance testing of the components of the Mag Vita TMS Therapy w/MagPro R20 has been tested as required, and cleared by the FDA earlier in: K160280: MagPro R20 K150641: Chair, flexible arm, vacuum pump and pillow, isolation transformer, marking accessories and caps K071821: Coil MCF-B65.
Substantial equivalence:
The MagVita TMS Therapy w/MagPro R20 is substantially equivalent to the predicate device (MagVita TMS Therapy System). The MagVita TMS Therapy w/MagPro R20 and the predicate device have identical intended use /indication for use, and the technological characteristics are very similar such that they in our view can be considered equivalent.
The MagVita TMS Therapy w/MagPro R20 and the predicate device are both 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.
Design of the MagVita TMS Therapy w/MagPro R20 is similar to the predicate device as both systems apply Transcranial Magnetic Stimulation as repetitive pulse trains at 10Hz delivered as brief rapidly alternating magnetic fields to induce electrical currents over the prefrontal cortex. Also the magnetic field/pulses for both devices are identical. Both the MagVita TMS Therapy w/MagPro R20 and the predicate device have the same components consisting of 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, coil positioning and treatment with predefined treatment stimulation parameters are essentially the same.
6
| Area | MagVita TMS Therapy
w/MagPro R20 | MagVita TMS Therapy System
(K150641) |
|---------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Performance | Waveforms: Biphasic
Frequency: 0.1 -20 pulses per
second. | Waveforms: Biphasic.
Frequency: 0.1 -30 pulses per
second or 0.1 -100 pulses per
second, depending on model |
| | Preset range of % MT: 50%-140% | Preset range of % MT: 0% -140% |
| | Recommended standard treatment:
Stimulation Intensity: 120% MT
(MT=Motor Threshold intensity) | Recommended standard treatment:
Stimulation Intensity: 120% MT
(MT=Motor Threshold intensity) |
| | Repetition rate: 10 Hz | Repetition rate: 10 Hz |
| | Train duration: 4 sec | Train duration: 4 sec |
| | Interval between pulses: 26 sec | Interval between pulses: 26 sec |
| | Numbers of pulses/session: 3000 | Numbers of pulses/ session: 3000 |
| | Output Stimulation Parameters:
Available Stimulation Amplitude
in Standard Motor Threshold
(SMT) units | Output Stimulation Parameters:
Available Stimulation Amplitude
in Standard Motor Threshold
(SMT) units |
| | Amplitude Range: 0 - 1.2 SMT | Amplitude Range: 0 - 1.7 SMT |
| | Pulse width:
290 μs (±5%), Biphasic sinusoid
waveform. | Pulse width:
290 μs (±5%), Biphasic sinusoid
waveform. |
| | Frequency Range:
0.1-20 pps (±2%) | Frequency Range:
0.1-30 pps (±2%) or 0.1-100 pps,
depending on model |
| Coil | Figure-of-eight coil
Air core | Figure-of-eight coil
Air core |
| Configuration | | |
| Cooling | Liquid cooling | Forced liquid cooling |
| Standards | Company complies with ISO
13485:2012 | Company complies with ISO
13485:2012. |
| met | | |
| Electrical | Complies with IEC60601-1 and
IEC60601-1-2 | Complies with IEC60601-1,
IEC60601-1-1 and IEC60601-1-2 |
| safety | | |
Characteristics of the Device as Compared to Predicate Device*
*For a more comprehensive comparison of devices please refer to section 12 Substantial Equivalence Comparison
7
Conclusion:
The above summary of the comparison, demonstrates and supports the substantial equivalency of the MagVita TMS Therapy w/MagPro R20 to the MagVita TMS Therapy System.
The indication for use, the target population, the dosage, the treatment procedure, the treatment position and all relevant protocol parameters (intensity, repetition rate, number of pulses in a train, numbers of trains, number of treatment sessions) are identical for the MagVita TMS Therapy w/MagPro R20 and the predicate device MagVita TMS Therapy System.
The transducer design (figure-of-eight) are equivalent and the realized magnetic properties of the coils used in the MagVita TMS Therapy w/MagPro R20 and the predicate system are substantial equivalent for the two coils.
The reliability of the positioning method used by the MagVita TMS Therapy w/MagPro R20 is, based on the direct relationship of the underlying cortical brain anatomy to the patient's scalp, as is the method used in the predicate device. The method for identifying the correct treatment position in the MagVita TMS Therapy w/MagPro R20 is as effective as the method employed by the predicate device, as they are identical.
The MagVita TMS Therapy w/MagPro R20 does not introduce any new safety considerations in comparison to the predicate device.
All other identified differences between the two systems are minor and without any known impact on safety or efficacy.