(28 days)
The Mag Vita TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to recieve satisfactory improvement from prior antidepressant medication in the current episode
The MagVita TMS Therapy System 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 Mag Vita TMS Therapy System 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 system TMS pulses are applied repetitively at a frequency of 10Hz. Such stimulation has been shown to be effective 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 MagVita TMS therapy system is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC).
The provided document is a 510(k) summary for the MagVita TMS Therapy System (K171481). This document asserts substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study designed for that purpose. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly in terms of clinical efficacy against numerical thresholds, is not present in this document.
The document focuses on demonstrating that the modified MagVita TMS Therapy System (K171481) is as safe and effective as previously cleared predicate devices (MagVita TMS Therapy System, K150641, and Neurostar TMS Therapy System, K160703). The primary modification is a reduction in inter-train interval, leading to shorter treatment times.
Here's a breakdown of the information that can be extracted or inferred based on the provided text, and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of explicit acceptance criteria with numerical thresholds for clinical performance (e.g., specific rates of symptom reduction or remission). Instead, it states that the device is "safe and effective," and that "all other identified differences between the three systems are minor and without impact on safety or efficacy."
The table provided in the document compares various technical specifications and operational parameters of the subject device to its predicates. These comparisons serve as the "performance" data to argue for substantial equivalence, rather than direct measurements against pre-defined clinical acceptance criteria.
| Criteria | MagVita TMS Therapy System (K171481) | Predicate: MagVita TMS Therapy System (K150641) | Predicate: NeuroStar TMS Therapy System (K160703) |
|---|---|---|---|
| Performance (Treatment Parameters) | |||
| Waveforms | Biphasic | Biphasic | Biphasic |
| Frequency | 0.1 - 30 pulses/second or 0.1 - 100 pulses/second (depending on model) | 0.1 - 30 pulses/second or 0.1 - 100 pulses/second (depending on model) | 0.1 - 30 pulses/second |
| Stimulation Intensity (Recommended Standard) | 120% MT | 120% MT | 120% MT |
| Repetition Rate (Recommended Standard) | 10 Hz | 10 Hz | 10 Hz |
| Train Duration (Recommended Standard) | 4 sec | 4 sec | 4 sec |
| Inter-train Interval (Recommended Standard) | 11-26 sec | 26 sec | 11-26 sec |
| Pulses/Session (Recommended Standard) | 3000 | 3000 | 3000 |
| Treatment Duration (Recommended Standard) | 18.8 min | 37 min | 18.8 min |
| Amplitude in SMT units | 0 - 1.7 | 0 - 1.7 | 0.22 - 1.6 |
| Pulse width | 290 μs, Biphasic sinusoid waveform | 290 μs, Biphasic sinusoid waveform | 185 μs (±10%), Biphasic sinusoid waveform |
| Frequency Range (Coil specific?) | 0.1-30 pps or 0.1-100 pps (depending on model) | 0.1-30 pps or 0.1-100 pps (depending on model) | 0.1-30 pps |
| Technical Characteristics | |||
| Coil Configuration | Figure-of-eight coil, Air core | Figure-of-eight coil, Air core | Figure-of-eight coil, Ferromagnetic core |
| Cooling | Liquid cooling | Liquid cooling | Ferrofluidic cooling |
| Standards met | ISO 13485:2012, IEC60601-1 3rd edition, IEC60601-1-1, IEC60601-1-2 | ISO 13485:2012, IEC60601-1 3rd edition, IEC60601-1-1, IEC60601-1-2 | ISO 13485:2003, IEC60601-1, IEC60601-1-2 |
| Electrical safety | Complies with IEC60601-1 3rd edition, and IEC60601-1-2 | Complies with IEC60601-1 3rd edition, and IEC60601-1-2 | Complies with IEC60601-1 and IEC60601-1-2 |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided as the submission is a 510(k) for substantial equivalence, not a clinical trial report with a test set of patient data for efficacy evaluation. The "test set" in this context refers to the device's adherence to the technical specifications of its predicates. Non-clinical performance data for components was "tested as required" and cleared in previous 510(k) submissions (K091940 and K150641), but no details on sample sizes or data provenance are given for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable/not provided. The "ground truth" in this submission relates to the technical specifications and operational parameters, which are established through engineering design, testing, and regulatory standards, not expert clinical consensus on patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are typically used in clinical studies when establishing ground truth from multiple expert interpretations of medical data. This document focuses on technical equivalence.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/not provided. An MRMC study is relevant for diagnostic devices often involving human interpretation of images or other data with and without AI assistance. This device is a therapeutic system (rTMS) for Major Depressive Disorder, not a diagnostic imaging device. It does not involve "human readers" in the sense of interpreting outputs that an AI could also interpret.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This device is a physical therapeutic system and does not function as an "algorithm only" device without human involvement. It requires a trained clinician for setup, motor threshold determination, coil positioning, and ongoing patient monitoring.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is based on:
- Compliance with established medical device standards (e.g., ISO 13485:2012, IEC60601-1, IEC60601-1-1, IEC60601-1-2).
- Demonstration of technical and operational equivalence to predicate devices cleared by the FDA, which were previously determined to be safe and effective based on their own clinical evidence (or substantial equivalence to even earlier devices).
- The premise that minor modifications (like adjusted inter-train interval for shorter treatment time) do not introduce new safety concerns or alter efficacy, meaning the "ground truth" of safety and efficacy established for the predicates applies.
8. The sample size for the training set
This information is not applicable/not provided. No "training set" of patient data is mentioned or implied, as this is a traditional medical device submission for a physical therapy system, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 16, 2017
Tonica Elektronik A/S Lise Terkelsen QA/RA Manager Lucernemarken 15 Farum, 3520 Dk
Re: K171481
Trade/Device Name: MagVita TMS Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive transcranial magnetic stimulation system Regulatory Class: Class II Product Code: OBP Dated: May 17, 2017 Received: May 19, 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
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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 2017.06.16 12:07:00 -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
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Indications for Use
510(k) Number (if known) K171481
Device Name MagVita TMS Therapy System
Indications for Use (Describe)
The Mag Vita TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to recieve 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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510(k) Summary
Submitter's Information
| Name of 510(k) owner: | Tonica Elektronik A/SLucernemarken 15DK-3520 Farum, Denmark | ||
|---|---|---|---|
| Phone: | +45 4499 8444 | ||
| Fax: | +45 4499 1544 | ||
| Contact person: | Lise TerkelsenEmail: lise.terkelsen@tonica.dk | ||
| Preparation date: | May 15, 2017 | ||
| Trade name: | MagVita TMS Therapy System | ||
| Common name: | Transcranial Magnetic Stimulator | ||
| Classification name: | Repetitive Transcranial Magnetic Stimulator for treatment ofMajor Depressive Disorder [21 CFR 882.5805, Product CodeOBP] | ||
| Classification: | Class II Medical Device | ||
| Predicate Devices: | Neurostar TMS Therapy System, K160703MagVita TMS Therapy System, K150641 | ||
| Special Controls: | The 510k submission addressed the special controls requiredby regulation and specified in the FDA guidance documenttitled "Class II Special Controls GuidanceDocument: Repetitive Transcranial Magnetic Stimulation(rTMS) Systems |
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Device description
The MagVita TMS Therapy System 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 Mag Vita TMS Therapy System 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 system TMS pulses are applied repetitively at a frequency of 10Hz. Such stimulation has been shown to be effective 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 MagVita TMS therapy system is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC).
- MagPro Stimulator and Trolley .
- MagPro family o
- Trolley with holding arrangements o
- Coil for MT determination .
- Coil C-B60 o
- Marking apparatus for locating treatment area .
- Marking plate for Coil C-B60 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
- Coil for Depression Treatment .
- Coil Cool-B65 with Coil Cooler unit o
- Isolation Transformer •
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Intended Use/Indication for Use:
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 System has been tested and complies with the following standards
- ISO 13485:2012 .
- IEC60601-1 •
- IEC60601-1-1 .
- IEC60601-1-2 .
Non-Clinical performance data:
The non-clinical performance testing of the components of the Mag Vita TMS Therapy System has been tested as required, and cleared by the FDA earlier on K091940 and K150641.
These tests demonstrate that the Mag Vita TMS Therapy System is safe and effective for use in treatment of Major Depressive Disorder.
Substantial equivalence:
The MagVita TMS Therapy System is substantially equivalent to the predicate devices (our own MagVita TMS Therapy System and Neurostar TMS). The MagVita TMS Therapy System and the predicate devices have identical intended use /indication for use, and technological characteristics. The principles of operation, the output stimulation parameters and the materials are equivalent to the predicates. The modification to the device allows a range of inter-train intervals from 11 to 26 seconds, rather than the fixed 26 second duration, which will allow a reduction in treatment time from 37.5 minutes to a minimum of 18.8 minutes.
The MagVita TMS Therapy System and the predicate devices are all 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 System 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.
Both the MagVita TMS Therapy System and the predicate devices 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
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positioning and treatment with predefined treatment stimulation parameters are essentially the same.
| Criteria | MagVita TMS TherapySystem | MagVita TMS TherapySystem (K150641) | NeuroStar TMS TherapySystem (K160703) | |
|---|---|---|---|---|
| Performance | Waveforms: Biphasic.Frequency: 0.1 -30 pulses persecond or 0.1 -100 pulses,depending on model | Waveforms: Biphasic.Frequency: 0.1 -30 pulses persecond or 0.1 -100 pulses,depending on model | Waveforms: BiphasicFrequency: 0.1 -30 pulses persecond. | |
| Recommended standardtreatment:Stimulation Intensity: 120% MTRepetition rate:10 HzTrain duration: 4 secInter-train interval: 11-26 secPulses/session: 3000Treatment duration: 18.8 min. | Recommended standardtreatment:Stimulation Intensity: 120% MTRepetition rate: 10 HzTrain duration: 4 secInter-train interval: 26 secPulses/session: 3000Treatment duration: 37 min. | Recommended standardtreatment:Stimulation Intensity: 120% MTRepetition rate: 10 HzTrain duration: 4 secInter-train interval: 11-26 secPulses/session: 3000Treatment duration: 18.8 min. | ||
| Output Stimulation Parameters:Amplitude in Standard MotorThreshold (SMT) units :0 - 1.7 | Output Stimulation Parameters:Amplitude in Standard MotorThreshold (SMT) units:0 - 1.7 | Output Stimulation Parameters:Amplitude in Standard MotorThreshold (SMT) units:0.22 - 1.6 | ||
| Pulse width:290 μs, Biphasic sinusoidwaveform. | Pulse width:290 μs, Biphasic sinusoidwaveform. | Pulse width:185 μs (±10%), Biphasicsinusoid waveform.. | ||
| Frequency Range:0.1-30 pps or 0.1-100 pps,depending on model | Frequency Range:0.1-30 pps or 0.1-100 pps,depending on model | Frequency Range:0.1-30 pps | ||
| CoilConfiguration | Figure-of-eight coilAir core | Figure-of-eight coilAir core | Figure-of-eight coilFerromagnetic core | |
| Cooling | Liquid cooling | Liquid cooling | Ferrofluidic cooling | |
| Standards met | Company complies with ISO13485:2012. | Company complies with ISO13485:2012 | Company complies with ISO13485:2003 | |
| Electrical safety | Complies with IEC60601-1 3rdedition, and IEC60601-1-2. | Complies with IEC60601-1 3rdedition, and IEC60601-1-2. | Complies with IEC60601-1 andIEC60601-1-2. |
Characteristics of the Device as Compared to Predicate Devices
Conclusion:
The above comparison, demonstrates and supports the substantial equivalency of the MagVita TMS Therapy System to our own MagVita TMS Therapy System and the NeuroStar 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 System and the predicate devices.
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The transducer design (figure-of-eight) are equivalent and the realized magnetic properties of the MagVita TMS Therapy System and the predicate devices are substantial equivalent.
The reliability of the positioning method used by the MagVita TMS Therapy System 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 devices. The method for identifying the correct treatment position in the Mag Vita TMS Therapy System is at least as effective as the method employed by the predicate devices.
On the basis of the only modification of the treatment parameter, the MagVita TMS Therapy System does not introduce any new safety considerations in comparison to the predicate devices
All other identified differences between the three systems are minor and without impact on safety or efficacy.
§ 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.