MEGA-TMS

K192823 · Soterix Medical, Inc. · GWF · Aug 13, 2021 · Neurology

Device Facts

• Record ID: K192823
• Device Name: MEGA-TMS
• Applicant: Soterix Medical, Inc.
• Product Code: GWF · Neurology
• Decision Date: Aug 13, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

Stimulation of peripheral nerves for diagnostic purposes.

Device Story

MEGA-TMS is a magnetic stimulator for peripheral nerve conduction studies and evaluation of the peripheral nervous system. Device generates magnetic pulses via an air-core coil, inducing electrical currents in target tissue. Input consists of user-defined stimulation parameters; output is a magnetic field pulse. Device is intended for use by clinicians in diagnostic settings, typically paired with a separate, cleared EMG system (e.g., K102610) to record and evaluate the resulting nerve responses. Clinicians use the EMG output to assess nerve function. The device features a graphical user interface providing coil temperature, intensity, and system status indicators to assist the operator in managing stimulation delivery.

Clinical Evidence

Bench testing only. Evidence includes electrical and mechanical safety testing (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), software verification and validation, and risk management per ISO 14971. Performance testing included measurements and simulations of electric and magnetic field characteristics, including pulse shape, spatial distribution, strength gradient, linearity, and reliability.

Technological Characteristics

Air-core magnetic stimulator; 2.8 kV max voltage; 2.5 T peak magnetic field; pulse width 80-120 µsec. Features coil temperature/intensity GUI indicators. Compliant with IEC 60601-1 and IEC 60601-1-2. Standalone stimulator unit.

Indications for Use

Indicated for stimulation of peripheral nerves for diagnostic purposes. Contraindicated for patients or users with cardiac demand pacemakers, implanted electronic devices, cochlear implants, or pregnant women.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Predicate Devices

• Magstim 200² with Double 70mm Remote Coil (K060847)
• MagPro R30 incl. MagOption, X100, X100 incl. MagOption (K091940)

Reference Devices

• Focus EMG device (K102610)

Submission Summary (Full Text)

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August 13, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Soterix Medical, Inc. Abhishek Datta, Ph.D. Chief Technology Officer 237 West 35 Street, #1401 New York, New York 10001

Re: K192823

Trade/Device Name: MEGA-TMS Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF Dated: July 14, 2021 Received: July 14, 2021

Dear Dr. Abhishek Datta:

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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Xiaolin Zheng, Ph.D. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K192823

Device Name MEGA-TMS

Indications for Use (Describe) Stimulation of peripheral nerves for diagnostic purposes.

| 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

| Date Prepared: | August 26, 2019 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Information: | |
| Company Name: | Soterix Medical, Inc. |
| Company Address: | 237 W 35th Street<br>Suite 1401<br>New York, NY 10001 |
| Contact Person: | Abhishek Datta<br>Phone: [phone]<br>Fax: [phone] |
| Device Information: | |
| Trade Name: | MEGA-TMS |
| Common Name: | MEGA-TMS |
| Classification Name: | GWF - Evoked Response Electrical Stimulator (21 CFR 882.1870) |
| Device Class: | Class II |
| Predicate Devices: | Magstim 200² with Double 70mm Remote Coil (K060847)<br>Magstim Company US, LLC. (Primary Predicate)<br>Class II<br>MagPro R30 incl. MagOption, X100, X100 incl. MagOption (K091940)<br>Tonica Elektronik A/S (Secondary Predicate)<br>Class II |
| Device Description: | The MEGA-TMS is intended for stimulation of peripheral nerves for<br>diagnostic purposes. |

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The device introduces electrical stimulation to tissue through magnetic induction generated from the coil. The obtained responses of stimulated structures is recorded with an EMG system for further diagnostic evaluation. The MEGA-TMS device is intended to be paired with a Focus EMG device cleared under FDA 510(k): K102610. Magnetic stimulation is used for peripheral nerve conduction studies and to evaluate peripheral nervous system.

#### Indications for Use:

Stimulation of peripheral nerves for diagnostic purposes.

# Comparison of Technological Characteristics with the Predicate Devices:

At a high level, the subject and predicate devices (K060847 and K091940) are based on the following technological elements:

- . Introduction of electrical stimulation through tissue, through magnetic induction generated from coils
- Induced electrical current in nearby tissue causing nerve impulse ●
- . Stimulus intensity control, core material and coil positioning

The following technical differences exist between the subject device and predicate devices:

- Smaller pulse width
- . Change in maximum repetition rate
- Coil temperature/intensity indicators for stimulation graphical user interface ●
- Maximum voltage generated ●
- Peak magnetic field generated

| Parameter | MEGA-TMS<br>Proposed | Magstim 2002 with<br>Double 70mm Remote<br>Coil (Primary<br>Predicate) | MagPro R30 incl.<br>MagOption, X100,<br>X100 incl. MagOption<br>(Secondary Predicate) | Comparison |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K192823 | K060847 | K091940 | - |
| Parameter | MEGA-TMS<br>Proposed | Magstim 2002 with<br>Double 70mm Remote<br>Coil (Primary<br>Predicate) | MagPro R30 incl.<br>MagOption, X100,<br>X100 incl. MagOption<br>(Secondary Predicate) | Comparison |
| Device Name and<br>Model | MEGA-TMS | Magstim 2002 | MagPro X100, MagPro<br>X100 with<br>MagOption<br>MagPro R30 with<br>MagOption | - |
| Manufacturer | Neurosoft Ltd. | Magstim Company US,<br>Llc. | Tonica Elektronik A/S | - |
| Indications For<br>Use | Stimulation of<br>peripheral nerves<br>for diagnostic<br>purposes. | Stimulation of<br>peripheral nerves for<br>diagnostic purposes. | The magnetic<br>stimulators are intended<br>to be used for<br>stimulation of<br>peripheral nerves for<br>diagnostic purposes. | Identical |
| Contraindications<br>For Use | MEGA-TMS/Neuro-<br>MS and its<br>accessories should<br>not be used on or in<br>the vicinity of<br>patients or users with<br>cardiac demand<br>pacemakers,<br>implanted electronic<br>devices, cochlear<br>implants, pregnant<br>women. | Magstim 2002 and its<br>accessories should not be<br>used on or in the vicinity<br>of patients or users with<br>cardiac demand<br>pacemakers, implanted<br>defibrillators and/or<br>implanted<br>neurostimulators. | Do not use the<br>equipment on patients<br>with cardiac<br>pacemakers, cochlear<br>implants or other<br>implanted electronic<br>devices. Do not apply<br>the magnetic stimuli to<br>the head, neck or<br>abdomen of pregnant<br>women. | MEGA-TMS includes<br>additional contraindications to<br>the ones mentioned in the<br>Primary Predicate. MEGA-<br>TMS contraindications are<br>identical to the Secondary<br>Predicate. |
| Parameter | MEGA-TMS<br>Neurosoft, Ltd.<br>Proposed | Magstim 2002 with<br>Double 70mm Remote<br>Coil Magstim Company,<br>Lic. (Primary Predicate) | MagPro R30 incl.<br>MagOption, X100,<br>X100 incl. MagOption<br>(Secondary Predicate) | Comparison |
| Maximum<br>Voltage | 2.8 kV | 2.8 kV | 1.8 kV | MagPro has a smaller range<br>of maximum voltage. |
| Maximum<br>Repetition Rate | 30% - 0.7 sec /<br>1.42 Hz<br>50% - 1 sec / 1 Hz<br>100%- 3.3 sec /<br>0.3 Hz | 30% - 2 sec / 0.5 Hz<br>50% - 3 sec / 0.33 Hz<br>100%- 4 sec /0.25 Hz | 30% - 0.05 sec / 20 Hz<br>45% - 0.1 sec / 10 Hz<br>100%- 0.5 sec / 2 Hz | Differences in maximum<br>repetition rate |
| Pulse Width | 80+/-15 µsec<br>(monophasic)<br>120 +/- 15 µsec<br>(power) | 100 µsec (monophasic) | 70 µsec (monophasic)<br>100 µsec (power<br>monophasic) | MEGA-TMS has a slightly<br>lower pulse width in the<br>monophasic mode in<br>comparison to the primary<br>predicate. MEGA-TMS has a<br>slightly higher pulse width in<br>the monophasic mode in<br>comparison to the secondary<br>predicate. |
| Parameter | MEGA-TMS<br>Neurosoft, Ltd.<br>Proposed | Magstim 2002 with Double<br>70mm Remote Coil Magstim<br>Company, Llc. (Primary<br>Predicate) | MagPro R30 incl.<br>MagOption, X100,<br>X100 incl.<br>MagOption<br>(Secondary<br>Predicate) | Comparison |
| Stimulus Intensity | 0-100% Adjustable | 0-100% Adjustable | 0-100% Adjustable | Identical |
| Coil Positioning | Periphery other than<br>brain | Periphery other than brain | Periphery other than<br>brain | Identical |
| Core Material | Air Core | Air Core | Air Core | Identical |
| Peak Magnetic<br>Field | 2.5 T | 2.1 T | N/A | MEGA-TMS has a<br>slightly larger peak<br>magnetic field than |
| Certificates:<br>IEC 60601-1 | YES | YES | YES | Identical |
| Dimensions (in.)<br>[L x W x H] | 20.87" x 19.69" x<br>7.09" | 18.11" x 14.76" x 6.30" | MagPro: 210 x 530 x 400mm<br>MagOption: 130 x 530 x 400mm | MEGA-TMS has a<br>slightly larger<br>stimulator unit. |
| Parameter | MEGA-TMS<br>Neurosoft, Ltd.<br>Proposed | Magstim 2002 with<br>Double 70mm Remote<br>Coil Magstim<br>Company, Llc.<br>(Primary Predicate) | MagPro R30 incl.<br>MagOption, X100,<br>X100 incl.<br>MagOption<br>(Secondary<br>Predicate) | Comparison |
| Weight (lbs.,<br>oz.) [without<br>battery or<br>electrode<br>cables] | ~66 lbs | ~50 lbs | MagPro X100:<br>35kg / 77lbs<br>MagOption: 25kg<br>/ 55lbs | MEGA-TMS<br>has a slightly<br>larger stimulator<br>unit. |
| Menu<br>Display | Coil Temperature<br>and<br>Intensity Indicators:<br>Coil Type<br>Coil State<br>Armed/Disarmed<br>State<br>Power<br>Charging/Discharging<br>Status<br>High Voltage<br>Replace Coil | Coil Temperature and<br>Intensity Indicators:<br>Coil State<br>Armed/Disarmed State<br>Power<br>Status<br>Default Condition<br>Replace Coil | MagPro X100 has<br>1 display. All<br>parameter settings<br>can be shown on<br>the display.<br>· Intensity<br>· Repetition rate<br>· Pulses in train<br>· Number of trains<br>· Inter train interval<br>· Start delay<br>· Amplitude<br>· Realized di/dt<br>Status:<br>enable/disable<br>· Coil temperature<br>· Coil type<br>· Available stimuli<br>· Event log<br>information<br>and<br>date/time<br>· Treatment<br>sequence can be<br>stored and reused.<br>Event log and<br>Amplitude log<br>can be exported.<br>· Continuously<br>readout of di/dt<br>controlling the<br>stability of the<br>produced magnetic<br>stimulation | MEGA-TMS<br>has a slightly<br>more indicators<br>shown in the<br>menu display<br>compared to the<br>predicate device |

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#### Performance Testing:

The following performance data were provided in support of the substantial equivalence determination.

#### Safety and EMC

Electrical and mechanical safety and electromagnetic compatibility testing were conducted to demonstrate that the MEGA-TMS device is compliant with IEC 60601-1 (Edition 3.1) and IEC 60601-1-2 (Edition 4).

#### Design

Design verification demonstrated that the device functions as intended. Design validation was demonstrated using software validation testing and literature review. Validation testing confirmed that the device met end-user needs, intended use and evidence of device operation in actual use conditions.

#### Software

Following FDA's Guidance for Industry and Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," software verification and validation was conducted.

#### Risk Management

The potential risks of MEGA-TMS were identified and evaluated in compliance with ISO 14971. All risks were determined to be appropriately mitigated with risk control measures to acceptable residual levels.

# Electric and Magnetic Field Characteristics

For electric field, actual measurements were recorded and simulations performed. For magnetic field, pulse shape information, magnetic field spatial distribution, magnetic field strength gradient, linearity, and reliability information were collected. Bench top measurements of field strength were taken at coil surface and 20 mm above to determine spatial distribution of magnetic field.

#### Conclusion:

The non-clinical data demonstrates that the differences in technological characteristics between the subject device and predicate devices do not raise new or different questions of safety and effectiveness and is therefore comparable to the predicate devices that are currently marketed for the same intended use.