SPRINGTMS TOTAL MIGRAINE SYSTEM

K140094 · Eneura Therapeutics, LLC · OKP · May 21, 2014 · Neurology

Device Facts

• Record ID: K140094
• Device Name: SPRINGTMS TOTAL MIGRAINE SYSTEM
• Applicant: Eneura Therapeutics, LLC
• Product Code: OKP · Neurology
• Decision Date: May 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5808
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The eNeura Therapeutics SpringTMS® is indicated for the acute treatment of pain associated with migraine headache with aura.

Device Story

SpringTMS is a portable, hand-held transcranial magnetic stimulator (sTMS) for acute migraine treatment. Device delivers brief single pulse of magnetic energy (0.9 Tesla) to occipital cortex to induce electrical current, aiming to stop or lessen migraine effects. Intended for patient self-administration in home or office settings via physician prescription. Device features a SIM chip-based authorization system to control treatment duration; LCD display communicates status. Powered by internal rechargeable lithium-ion battery. Output affects clinical decision-making by providing non-invasive, drug-free acute pain relief for migraineurs.

Clinical Evidence

Bench testing only. Performance testing included magnetic pulse characteristics, magnetic field mapping, 5 Gauss line location, software verification/validation, and electromagnetic compatibility/electrical safety (IEC 60601-1, IEC 60601-1-2). Results demonstrated substantial equivalence to the predicate device.

Technological Characteristics

Hand-held portable stimulator; polycarbonate case with integral coil. Operating principle: time-varying magnetic field (0.9 Tesla peak @ 180 μs) inducing electrical current in occipital cortex. Power: internal rechargeable lithium-ion battery. Connectivity: SIM chip for use authorization. Software: verification/validation per SRS. Standards: IEC 60601-1:2005, IEC 60601-1-2:2007.

Indications for Use

Indicated for acute treatment of pain associated with migraine headache with aura in patients prescribed the device.

Regulatory Classification

Identification

A transcranial magnetic stimulator device for headache is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electrical currents for the treatment of headache.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety. (2) Appropriate verification, validation, and hazard analysis must be performed on the device software and firmware. (3) The elements of the device that contact the patient must be assessed to be biocompatible. (4) Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. This includes full characterization of the magnetic pulse output and resulting magnetic field map. This also includes characterization of the sound level of the device during use. (5) Clinical testing must demonstrate that the device is safe and effective for treating headache in the indicated patient population. (6) The physician and patient labeling must include the following: (i) A summary of the clinical performance testing, including any adverse events and complications. (ii) The intended use population in terms of the types of headaches appropriate for use with the device. (iii) Information on how to report adverse events and device malfunctions. (iv) A diagram or picture depicting the proper placement of the device on the user.

1. Appropriate analysis/testing must demonstrate electromagnetic compatibility (EMC), electrical safety, and thermal safety. 2. Appropriate verification, validation, and hazard analysis must be performed on the device software and firmware. 3. The elements of the device that contact the patient must be assessed to be biocompatible. 4. Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. This includes full characterization of the magnetic pulse output and resulting magnetic field map. This also includes characterization of the sound level of the device during use. 5. Clinical testing must demonstrate that the device is safe and effective for treating headache in the indicated patient population. 6. The physician and patient labeling must include the following: a. A summary of the clinical performance testing, including any adverse events and complications. b. The intended use population in terms of the types of headaches appropriate for use with the device. c. Information on how to report adverse events and device malfunctions. d. A diagram or picture depicting the proper placement of the device on the user.

Predicate Devices

• eNeura Therapeutics® Cerena™ Transcranial Magnetic Stimulator (K130556)

Submission Summary (Full Text)

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## 510(k) Notification K140094

#### GENERAL INFORMATION

#### Applicant:

eNeura Therapeutics, LLC 240 North Wolfe Road Sunnyvale, CA 94085 U.S.A. Phone: [phone] FAX: [phone]

#### Contact Person:

Larry Getlin Regulatory Consultant for eNeura Therapeutics, LLC 2690 Pheasant Road Orono, MN 55331 U.S.A. Phone: [phone]

## DEVICINFORMATION

Trade Name: SpringTMS®

#### Generic/Common Name:

Transcranial magnetic stimulator for the treatment of migraine headache 21 CFR§882.5808

# Classification:

Class II

#### Product Code: OKP

#### PREDICATE DEVICE(S)

eNeura Therapeutics® Cerena™ Transcranial Magnetic Stimulator (K130556)

#### INTENDED USE

The eNeura Therapeutics SpringTMS® is indicated for the acute treatment of pain associated with migraine headache with aura.

## PRODUCT DESCRIPTION

The SpringTMS® is a portable, hand-held device that delivers a brief single pulse of magnetic energy at 0.9 Tesla to the back of the head to induce an electrical current in a

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portion of the brain called the occipital cortex to stop or lessen the effects of migraine headaches. Since a single pulse of magnetic stimulation is emitted, this method of stimulation is called single pulse transcranial magnetic stimulation or sTMS. The SpringTMS is indicated for the acute treatment of pain associated with migraine headache with aura. The device is designed for patient use where treatments are selfadministered and can be delivered in a variety of settings including the home or office. The device is intended for prescription use only.

## TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the SpringTMS are substantially equivalent to the predicate device. Table 1 lists the technological characteristics of the SpringTMS and the predicate device and provides the rationale to support a determination of substantial equivalence. Any differences in the technological characteristics of the device do not affect the safety and effectiveness of the device.

| Feature | SpringTMS® | Cerena™ Transcranial<br>Magnetic Stimulator | Substantial Equivalence Rationale |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Number | K140094 | K130556 | New 510(k) submission |
| Operating<br>Principle | Induces electrical<br>current in region near<br>coil<br>Transcranial<br>Evoked response<br>Stimulation on the<br>occipital cortex | Induces electrical<br>current in region<br>near coil<br>Transcranial<br>Evoked response<br>Stimulation on the<br>occipital cortex | N/A (same) |
| Design | Time varying<br>magnetic field<br>Non-invasive | Time varying<br>magnetic field<br>Non-invasive | N/A (same) |
| Use<br>Authorization | The user must insert a<br>SIM chip to use the device<br>for a programmed<br>duration. The<br>programmed duration<br>corresponds to the<br>prescribed months of use.<br>The SIM chip is only<br>available under physician<br>prescription. | None | The addition of this Use<br>Authorization feature does not<br>affect the operating principle or<br>performance of the device and no<br>additional risks or hazards have<br>been identified related to this<br>change. |
| Display | LCD display | LED indicators | In both devices, the display serves<br>to communicate device status to the<br>patient and no additional risks or<br>hazards have been identified related<br>to this change. |
| Magnetic<br>Field | 0.9 Tesla Peak @ 180 μs<br>(total magnetic energy<br>140J) | 0.9 Tesla Peak @ 180 μs<br>(total magnetic energy<br>140J) | N/A (same) |
| Current | 4 mA/cm² induced at 1 cm | 4 mA/cm² induced at 1<br>cm | N/A (same) |

## Table 1: Summary of Technological Characteristics

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| Electrical<br>Power | Internally powered with<br>rechargeable lithium ion<br>battery pack. Battery pack<br>charger mains input --<br>100-240V AC, 47/63 Hz,<br>output 12 V DC | Externally powered by<br>AC/DC power adapter.<br>Mains input --<br>100-240V AC, 50/60 Hz,<br>output 12 V DC | The SpringTMS and predicate<br>device utilize the same voltage and<br>power and both meet all criteria for<br>establishing electrical safety. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | Hand held portable<br>stimulator in<br>polycarbonate case<br>(integral coil) | Hand held portable<br>stimulator in<br>polycarbonate case<br>(integral coil) | N/A (same) |
| Where used | Home-use and where the<br>operator is | Home-use and where the<br>operator is | N/A (same) |
| Dimensions<br>and Weight | 9 in. (23 cm) long<br>5 in. (13 cm) wide<br>3 in. (8 cm) deep<br>3.8 lb. (1.7 kg) | 13 in. (33 cm) long<br>5 in. (13 cm) wide<br>5 in. (13 cm) deep<br>3.4 lb. (1.54 kg) | The form factor changes raise no<br>new issues of safety or efficacy. |

## SUBSTANTIAL EQUIVALENCE

The indications for use for the predicate device is identical to the proposed indications for use for the SpringTMS. The differences in the technological characteristics (Replacement of LED indicators with LCD screen, addition of the Use Authorization Feature, power supply type change and minor dimensional changes) do not raise any new issues of safety or effectiveness. Thus, the SpringTMS is substantially equivalent to the predicate device.

## TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary performance testing was conducted on the SpringTMS to support a determination of substantial equivalence to the predicate device. Table 2 lists the non-clinical performance testing conducted and the results supporting substantial equivalence.

| Testing Type | Test Description | Results Supporting Substantial Equivalence |
|---------------------------|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Bench Testing | Magnetic Pulse Characteristics vs. Time | Both devices have the same specification for magnetic pulse shape and both tested within specification. No new issues of safety or efficacy have been raised. The measured rate of change of the magnetic field is substantially equivalent. |
| | Magnetic Pulse Field Map | No new issues of safety or efficacy have been raised. The Magnetic Pulse Field Maps for the SpringTMS and the predicate device are substantially equivalent. |
| | Location of 5 Gauss Line | No new issues of safety or efficacy have been raised. The location of the 5 Gauss line for the SpringTMS and the predicate are substantially equivalent. |

## Table 2: Non-Clinical Performance Testing and Substantial Equivalence Support

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| Software Verification<br>Validation Testing | SpringTMS Software Testing | SpringTMS Software met all<br>requirements of the SRS. No new<br>issues of safety or efficacy have been<br>raised. All safety and performance<br>specifications for the SpringTMS SRS<br>are substantially equivalent to those in<br>the SRS for the predicate. |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electromagnetic<br>Compatibility and<br>Electrical Safety | Testing in accordance with<br>the following standards:<br>• IEC 60601-1:2005<br>• IEC 60601-1-2:2007 | The SpringTMS and the predicate<br>device met all acceptance criteria. No<br>new issues of safety or efficacy have<br>been raised. Therefore the SpringTMS<br>is substantially equivalent to the<br>predicate. |

The collective results of performance testing demonstrate that the materials chosen, the manufacturing processes, and design of the SpringTMS meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the SpringTMS does not raise new questions of safety or effectiveness when compared to the predicate device.

## CONCLUSION

The SpringTMS is substantially equivalent to the predicate device. The indications for use is identical to that of the predicate device, and the product performance testing has demonstrated that the SpringTMS is as safe, as effective and performs in the same manner as the predicate device in terms of intended use, safety and technological characteristics, and patient populations. The differences include the device external design such as size and weight, display type, power supply type, and the authorization system for the device use; however, those changes do not raise any new safety or efficacy concerns. The information contained in this 510(k) premarket notification demonstrates the substantial equivalence of the SpringTMS to the predicate device.

#### SUMMARY

The SpringTMS is substantially equivalent to the predicate device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WORE-COON Silver Spring, MD 20993-0002

May 21, 2014

eNeura Therapeutics, LLC c/o Larry Getlin 2690 Pheasant Road Orono, MN 55331

Re: K140094

Trade/Device Name: Spring TMS® Regulation Number: 21 CFR §882.5808 Regulation Name: Transcranial magnetic stimulator for the treatment of migraine headache Regulatory Class: Class II Product Code: OKP Dated: April 18, 2014 Received: April 21, 2014

Dear Mr. Getlin:

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 cnactment 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 docs 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 (sec 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

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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); 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Carlos L. Pena -S

Carlos L. Peña, Ph.D., M.S. 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) K140094

Device Name eNeura Therapeutics Spring TMS

The eNeura Therapeutics® Spring TMS® is indicated for the acute treatment of pain associated with migraine headache with aura.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Carlos L. Pena -S

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