Neurosoft TMS (also CloudTMS)

K173441 · Teleemg, LLC · OBP · Dec 13, 2017 · Neurology

Device Facts

• Record ID: K173441
• Device Name: Neurosoft TMS (also CloudTMS)
• Applicant: Teleemg, LLC
• Product Code: OBP · Neurology
• Decision Date: Dec 13, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5805
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Neurosoft TMS system 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.

Device Story

Neurosoft TMS is a repetitive transcranial magnetic stimulation (rTMS) system; used for Major Depressive Disorder treatment. Device consists of main stimulator unit, cooling unit, power supply, figure-of-eight coils, coil holder, flexible positioning arm, and trolley. Principle of operation: high-voltage capacitor (1.8 kV) discharges through stimulation coil; generates pulsed magnetic fields (up to 10 kA) to induce electrical currents in prefrontal cortex neurons. Operated by clinicians in clinical settings. System setup involves motor threshold determination and coil positioning. Output is repetitive magnetic pulse trains at predetermined frequencies. Modification allows variable inter-train intervals (11-26 seconds), reducing session duration from 37.5 to 18.8 minutes. Device includes automated safety shut-off if coil temperature exceeds 41°C. Benefits patients by providing non-invasive stimulation therapy for treatment-resistant depression.

Clinical Evidence

Bench testing only. No clinical data presented. Safety and effectiveness established via non-clinical performance testing and comparison to predicate devices.

Technological Characteristics

Repetitive transcranial magnetic stimulation system. Components: stimulator, liquid-cooled/non-cooled figure-of-eight coils, flexible arm. Energy: high-voltage capacitor discharge (1.8 kV, 10 kA). Waveform: biphasic sinusoid. Connectivity: standalone or PC-controlled. Standards: DIN EN ISO 13485:2012, ISO 10993-1, ISO 14971, IEC 60601-1, IEC 60601-1-2. Software: treatment administration control.

Indications for Use

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.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Neurosoft TMS (K160309)
• MagVita TMS Therapy System (K171481)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 13, 2017

TeleEMG, LLC % Barry Ashar President Makromed, Inc. 88 Stiles Road Salem, New Hampshire 03079

Re: K173441

Trade/Device Name: Neurosoft TMS (also CloudTMS) Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: October 23, 2017 Received: November 6, 2017

Dear Barry Ashar:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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1000-1050.

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR

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.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

William J. Heetderks -S 2017.12.13 12:00:03 -05'00'

Carlos L. Peña. PhD, MS for 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) K173441

Device Name Neurosoft TMS

Indications for Use (Describe)

The Neurosoft TMS 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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# 510(k) Summary for the TeleEMG, LLC Neurosoft TMS

(per 21 CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm)

#### 1. SUBMITTER/510(K) HOLDER

TeleEMG. LLC 27 Arlington Rd., Building 2, Unit 1 Woburn, MA 01801, USA

Contact Person: Barry V. Ashar, Makromed, Inc. Telephone: [phone] Date Prepared: October 12, 2017

#### 2. DEVICE NAME

| Proprietary Name: | Neurosoft TMS |
|----------------------|-----------------------------------------------------|
| Regulation Name: | Repetitive transcranial magnetic stimulation system |
| Regulation Number: | 21 CFR §882.5805 |
| Classification Name: | Transcranial Magnetic Stimulator |
| Device Class: | Class II |
| Product Code: | OBP |

### 3. PREDICATE DEVICES

- TeleEMG LLC, Neurosoft TMS, K160309 ●
- o Tonica Electronik A/S, MagVita TMS Therapy System, K171481

### 4. 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: Repeitive Transcranial Magnetic Stimulation (rTMS) Systems.

### 5. DEVICE DESCRIPTION

The Neurosoft TMS is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of

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sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Maior Depressive Disorder.

The Neurosoft TMS principle of operation is based on the discharge of high voltage capacitor (1.8 kV) through stimulation coil; the pulsed magnetic field generated by the discharge current (up to 10 kA) penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons.

The Neurosoft TMS consists of the following main components:

- 0 Main unit of the magnetic stimulator
- Cooling unit ●
- Extra power supply unit ●
- Coils ●
- Cooled figure-of-eight coil FEC-02-100-C o
- Cooled figure-of-eight coil AFEC-02-100-C o
- Figure-of-eight coil FEC-02-100 (optional) о
- o Figure-of-eight coil AFEC-02-100 (optional)
- o K8 coil holder
- K3 flexible arm for coil positioning o
- Trolley with casters ●

### 6. INTENDED USE/INDICATION FOR USE

The Neurosoft TMS system 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.

### 7. STANDARDS

The Neurosoft TMS system has been tested and complies with the following standards:

- DIN EN ISO 13485: 2012 o
- o ISO 10993-1
- ISO 14971
- IEC 60601-1 ●
- IEC 60601-1-2 ●

# 7. NON-CLINICAL PERFORMANCE DATA

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The non-clinical performance testing of Neurosoft TMS has been tested as required, and cleared by the FDA earlier on K160309. These tests demonstrate that the Neurosoft TMS is safe and effective for use in treatment of Major Depressive Disorder.

## 8. SUBSTANTIAL EQUIVALENCE

The Neurosoft TMS is substantially equivalent to the predicate devices (our own Neurosoft TMS and MagVita TMS Therapy System). The Neurosoft TMS 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 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 design of the Neurosoft TMS is similar to that of our predecessor Neurosoft TMS and the MagVita TMS Therapy System, as all systems are based on applying transcranial magnetic stimulation by means of repetitive pulse trains at a predetermined frequency. All systems use the same mechanism of action, i.e., an electromechanical instrument that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the prefrontal cortex.

The basic software capabilities related to treatment administration in the Neurosoft TMS are the same as these in the predicate devices.

The Neurosoft TMS and the predicate devices have the same components consisting of TMS stimulator with software, electromagnetic coil and a flexible arm for positioning of the treatment coil. The basic operational procedures including system setup, patient preparations, motor threshold determination, coil positioning and treatment with predefined treatment stimulation parameters are essentially the same. A thorough comparison among the Neurosoft TMS and the predicate devices is shown in a tabular form below:

| Criteria | Neurosoft TMS | Neurosoft TMS<br>(K160309) | MagVita TMS Therapy<br>System<br>(K171481) |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Neurosoft TMS is<br>indicated for the treatment of<br>Major Depressive Disorder in<br>adult patients who have failed<br>to receive satisfactory<br>improvement from prior | The Neurosoft TMS is<br>indicated for the treatment of<br>Major Depressive Disorder<br>in adult patients who have<br>failed to receive satisfactory<br>improvement from prior | The MagVita TMS<br>Therapy System is<br>indicated for the<br>treatment of Major<br>Depressive Disorder in<br>adult patients who have |
| Criteria | Neurosoft TMS | Neurosoft TMS<br>(K160309) | MagVita TMS Therapy<br>System<br>(K171481) |
| | antidepressant medication in<br>the current episode. | antidepressant medication in<br>the current episode. | failed to receive<br>satisfactory improvement<br>from prior antidepressant<br>medication in the current<br>episode. |
| Recommended standard treatment | | | |
| Magnetic Field<br>Intensity | 120% of the MT | 120% of the MT | 120% of the MT |
| Frequency | 10 Hz | 10 Hz | 10 Hz |
| Train duration | 4 sec | 4 sec | 4 sec |
| Inter-train interval | 11-26 sec | 26 sec | 11-26 sec |
| Number of trains | 75 | 75 | 75 |
| Magnetic Pulses<br>per Session | 3000 | 3000 | 3000 |
| Treatment Session<br>Duration | 18.8 min-37.0 min | 37.0 min | 18.8 min-37.0 min. |
| Sessions/week | 5 | 5 | 5 |
| Treatment<br>Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | 5 daily sessions for 6<br>weeks |
| Area of brain to be<br>stimulated | Frontal Cortex | Frontal Cortex | Frontal Cortex |
| | | Coils | |
| Coils (including<br>optional<br>accessories) | FEC-02-100-C, AFEC-02-100-<br>C<br>FEC-02-100 (optional), AFEC-<br>02-100 (optional) | FEC-02-100-C, AFEC-02-<br>100-C<br>FEC-02-100 (optional),<br>AFEC-02-100 (optional) | C-B60<br>C-B65 |
| Configuration | Figure-of-eight coil | Figure-of-eight coil | Figure-of-eight coil |
| Core material | Air core | Air core | Air core |
| Cooling | FEC-02-100-C & AFEC-02-<br>100-C: Liquid cooling | FEC-02-100-C & AFEC-02-<br>100-C: Liquid cooling | C-B65: Liquid cooling |
| | FEC-02-100 & AFEC-02-100<br>(optional accessories): None | FEC-02-100 & AFEC-02-100<br>(optional accessories): None | C-B60: None |
| Coil parameters | FEC-02-100-C<br>Inner diameter - 47x50 mm¹<br>Outer diameter - 97x100 mm¹<br>Area = 184725 mm²<br>Average Inductance 10 µH<br>Flat spiral winding<br>N = 16 turns (2 layers x 2<br>wings) | FEC-02-100-C<br>Inner diameter - 47x50 mm¹<br>Outer diameter - 97x100<br>mm¹<br>Area = 184725 mm²<br>Average Inductance 10 µH<br>Flat spiral winding<br>N = 16 turns (2 layers x 2 | Coil Cool-B65<br>Inner diameter - 35 mm<br>Outer diameter - 75 mm<br>Winding height - 12 mm<br>N = 2x (2 x 5) |
| Criteria | Neurosoft TMS<br>(K160309) | Neurosoft TMS | MagVita TMS Therapy System<br>(K171481) |
| | AFEC-02-100-C<br>Inner diameter - 36x51 mm¹<br>Outer diameter - 84x106 mm¹<br>Area = 184725 mm²<br>Average Inductance 10 μH<br>Flat spiral winding<br>N = 16 turns (2 layers x 2 wings) | wings) | |
| | FEC-02-100<br>Inner diameter - 47x50 mm¹<br>Outer diameter - 97x100 mm¹<br>Area = 91560 mm²<br>Average Inductance 10 μH<br>Flat spiral winding<br>N = 16 turns (2 layers x 2 wings) | FEC-02-100<br>Inner diameter - 47x50 mm¹<br>Outer diameter - 97x100 mm¹<br>Area = 91560 mm²<br>Average Inductance 10 μH<br>Flat spiral winding<br>N = 16 turns (2 layers x 2 wings) | Coil C-B60<br>Inner diameter - 35 mm<br>Outer diameter - 75 mm<br>Winding height - 12 mm<br>N = 2x (2 x 5) |
| | AFEC-02-100<br>Inner diameter - 36x51 mm¹<br>Outer diameter - 84x106 mm¹<br>Area = 87200 mm²<br>Average Inductance 10 μH<br>Flat spiral winding<br>N = 16 turns (2 layers x 2 wings) | AFEC-02-100<br>Inner diameter - 36x51 mm¹<br>Outer diameter - 84x106 mm¹<br>Area = 87200 mm²<br>Average Inductance 10 μH<br>Flat spiral winding<br>N = 16 turns (2 layers x 2 wings) | |
| Amplitude in<br>Standard Motor<br>Threshold (SMT)<br>units | FEC-02-100-C 0 - 1.89<br>AFEC-02-100-C 0 - 2.38<br>FEC-02-100 0 - 1.92<br>AFEC-02-100 0 - 2.33 | FEC-02-100-C 0 - 1.89<br>AFEC-02-100-C 0 - 2.38<br>FEC-02-100 0 - 1.92<br>AFEC-02-100 0 - 2.33 | 0 - 1.7 |
| Waveform | Biphasic sinusoid | Biphasic sinusoid | Biphasic sinusoid |
| Active pulse width<br>(μs) | 280 | 280 | 290 |
| Max initial dB/dt<br>(kT/s) near the coil<br>surface | FEC-02-100-C 25<br>AFEC-02-100-C 38<br>FEC-02-100 25<br>AFEC-02-100 32 | FEC-02-100-C 25<br>AFEC-02-100-C 38<br>FEC-02-100 25<br>AFEC-02-100 32 | C-B65: 36<br>C-B60: 35 |
| The system will<br>automatically be<br>disabled when the | 41 °C (106 °F) | 41 °C (106 °F) | 41 °C (106 °F) |
| Criteria | Neurosoft TMS | Neurosoft TMS<br>(K160309) | MagVita TMS Therapy<br>System<br>(K171481) |
| coil temperature<br>exceeds: | | | |
| Frequency range<br>(Hz) | 0.1 - 30 (Stand-alone)<br>0.1 - 100 (with PC) | 0.1 - 30 (Stand-alone)<br>0.1 - 100 (with PC) | 0.1 - 30 or 0.1 - 100,<br>depending on model |
| Pulse train<br>duration range (s) | 0.5 - 100 | 0.5 - 100 | Rep Rate: 0.1 ...100Hz<br>Pulses in Train: 1,2,3,4<br>... 1000<br>Train duration = Pulses<br>in Train / Rep Rate |
| Inter-train interval<br>range (s) | 0 - 300 | 0 - 300 | 1 - 120 |
| Maximum trains<br>per session | 4800 = 2400 s [max session] /<br>(0.5 s [min train]+ 0 s [min<br>pause]) | 4800 = 2400 s [max session]<br>/ (0.5 s [min train]+ 0 s [min<br>pause]) | 500 |
| Maximum number<br>of pulses per<br>session | 72000(Stand-alone)=2400 s<br>[max session] *30 Hz<br>240000(with PC)=2400 s [max<br>session] *100 Hz | 72000(Stand-alone)=2400 s<br>[max session] *30 Hz<br>240000(with PC)=2400 s<br>[max session] *100 Hz | N/A |
| Standards | | | |
| Electrical<br>safety | Complies with<br>IEC 60601-1 and<br>IEC 60601-1-2 | Complies with<br>IEC 60601-1 and<br>IEC 60601-1-2 | Complies with<br>IEC 60601-1, IEC 60601-<br>1-1 and IEC 60601-1-2. |
| ISO Standards<br>met | Company complies with DIN<br>EN ISO 13485: 2012<br>ISO 10993-1: 2009<br>ISO 14971: 2007 | Company complies with DIN<br>EN ISO 13485: 2012<br>ISO 10993-1: 2009<br>ISO 14971: 2007 | Company complies with<br>ISO 13485:2012. |

# Table: Side-by-Side Comparison of the Proposed Device with Cited Predicate Devices

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1 see Fig. 1

Image /page/8/Figure/2 description: The image shows a diagram with several measurements labeled. The measurements are labeled as 'A', 'B', 'a', and 'b'. The diagram appears to be a schematic of some kind of mechanical component or part.

Fig.1 Coil for magnetic stimulator

### 9. CONCLUSION

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The Neurosoft TMS and the predicate devices have identical intended use /indication for use, target population, treatment position and all recommended standard treatment protocol parameters (intensity, frequency, number of pulses in a train, number of trains in a session, number of treatment sessions).

All coils compared in the above Table share the same transducer design (figure-of-eight). The tested magnetic properties of the Neurosoft TMS and the predicate devices are substantial equivalent for the coils.

The reliability of the positioning method used by the Neurosoft TMS 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 Neurosoft TMS 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 Neurosoft TMS 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.

Based on the information and supporting documentation provided in the premarket notification, the Neurosoft TMS is substantially equivalent to the cited predicate devices. Testing demonstrates that the Neurosoft TMS fulfills prospectively defined design and performance specifications.