sTMS mini

K161663 · Eneura, Inc. · OKP · Aug 23, 2016 · Neurology

Device Facts

• Record ID: K161663
• Device Name: sTMS mini
• Applicant: Eneura, Inc.
• Product Code: OKP · Neurology
• Decision Date: Aug 23, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5808
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Portable, hand-held transcranial magnetic stimulator; delivers single pulse of magnetic energy (0.9 Tesla) to occipital cortex; induces electrical current to stop/lessen migraine headache effects. Used in home or office settings; self-administered by patient per physician prescription. Device requires insertion of SIM chip to enable operation for prescribed duration. Output is magnetic pulse; status communicated via LED indicators. Benefits patient by providing non-invasive acute migraine pain relief.

Clinical Evidence

Bench testing only. Testing included magnetic pulse characteristics, field mapping, 5 Gauss line location, software verification/validation, and electrical safety/EMC (IEC 60601-1-1, IEC 60601-1-2). Results demonstrate performance equivalent to predicate.

Technological Characteristics

Polycarbonate case; integral coil; internally powered by rechargeable lithium-ion battery. Delivers 0.9 Tesla peak magnetic field at 180 µs; 4 mA/cm² induced current at 1 cm. Operates via SIM chip-controlled prescription duration. Standards: IEC 60601-1-1, IEC 60601-1-2.

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

• SpringTMS® (K140094)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 23, 2016

Eneura Inc % Mr. Larry Getlin Regulatory Consultant for Eneura Inc Larry W. Getlin 2690 Pheasant Road Orono, Minnesota 55331

Re: K161663

Trade/Device Name: sTMS Mini Regulation Number: 21 CFR 882.5808 Regulation Name: Transcranial magnetic stimulator for headache Regulatory Class: Class II Product Code: OKP Dated: July 22, 2016 Received: July 25, 2016

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 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

William J.
Heetderks -A

Digitally signed by William J. Heetderks -A
DN: c=US, o=U.S. Government, ou=HHS, ou=NI
ou=People,
0.9.2342.19200300.100.1.1=0010149848,
cn=William J. Heetderks -A

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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |
| <b>Indications for Use</b> |

| Form Approved: OMB No. 0910-0120 |
|-----------------------------------|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |

| 510(k) Number (if known) | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Device Name | eNeura® sTMS Mini |
| Indications for Use (Describe) | The eNeura® sTMS mini is indicated for the acute treatment of pain associated with migraine headache with aura. |

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| | <label><input checked="checked" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| | <label><input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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#### 510(k) Summary (Cont.)

#### 510(k) Notification *K383885+

#### GENERAL INFORMATION [807.92(a)(1)]

#### Applicant:

eNeura® Inc 715 North Pastoria Avenue Sunnyvale, CA 94085 U.S.A. Phone: [phone] FAX: [phone]

#### Contact Person:

Larry W. Getlin Regulatory Consultant for eNeura® Inc 2690 Pheasant Road Orono, MN 55331 U.S.A. E-mail: [e-mail] Phone: [phone]

Date Prepared: June 15, 2016

#### DEVICE INFORMATION [807.92(a)(2)]

Classification: Class II

### Product Code: OKP

Trade Name: sTMS mini

Generic/Common Name per 21 CFR§882.5808: Transcranial magnetic stimulator for headache

### PREDICATE DEVICE(S) [807.92(a)(3)]

SpringTMS® (K140094)

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## DEVICE DESCRIPTION [807.92(a)(4)]

The sTMS mini 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 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 sTMS mini is indicated for the acute treatment of pain associated with migraine headache with aura. The device is designed for patient use where treatments are self-administered and can be delivered in a variety of settings including the home or office. The device is intended for prescription use only.

### INDICATIONS FOR USE [807.92(a)(5)]

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

### TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the sTMS mini are substantially equivalent to the predicate device, SpringTMS (K140094). Table 1 lists the technological characteristics of the sTMS mini and the predicate device and provides the rationale to support a determination of substantial equivalence. Any differences between the devices do not raise any new issues of safety or efficacy.

| Feature | SpringTMS® | sTMS mini | Substantial Equivalence Rationale |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| 510(k)<br>Number | K140094 | TBD | -- |
| Operating<br>Principle | Induces electrical current in region near coil Transcranial Evoked response Stimulation on the occipital cortex Single Pulse TMS (sTMS) | Induces electrical current in region near coil Transcranial Evoked response Stimulation on the occipital cortex Single Pulse TMS (sTMS) | N/A (same) |
| Design | Time varying magnetic field Non-invasive | Time varying magnetic field Non-invasive | N/A (same) |

#### Table 1: Summary of Technological Characteristics

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## 510(k) SUMMARY (CONT.)

| Feature | SpringTMS® | sTMS mini | Substantial Equivalence Rationale |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. | N/A (same) |
| 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 cm | N/A (same) |
| Electrical<br>Power | Internally powered with<br>rechargeable removable<br>lithium ion battery pack.<br>Battery pack charger<br>mains input --<br>100-240V AC, 50/60 Hz,<br>output 12 V DC | Internally powered with<br>rechargeable non-<br>removable lithium ion<br>battery pack. Battery pack<br>charger mains input --<br>100-240V AC, 50/60 Hz,<br>output 12 V DC | The sTMS mini and predicate<br>device utilize the same batteries,<br>same voltage and power and both<br>meet all criteria for establishing<br>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) | 8.8 in. (22.4 cm) long<br>5.1 in. (13 cm) wide<br>2.7 in. (6.9 cm) deep<br>3.2 lb. (1.4 kg) | The reduced size of the sTMS mini<br>raises no new issues of safety or<br>efficacy. |

### Table 1: Summary of Technological Characteristics (cont.)

## SUBSTANTIAL EQUIVALENCE

The sTMS mini is substantially equivalent to the predicate device with regard to intended use or the indications for use and the fundamental scientific technology. Furthermore, the predicate SpringTMS and the proposed sTMS mini deliver the same energy in the same manner to the same area of the brain. Any differences between the two devices do not raise any new issues of safety or efficacy. Thus, the proposed sTMS mini is considered to be substantially equivalent to the predicate device.

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## PERFORMANCE DATA [807.92(b)]

All necessary performance testing was conducted on the proposed sTMS mini to support a determination of substantial equivalence to the predicate device.

## TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary performance testing was conducted on the sTMS mini 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<br>Equivalence |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Bench<br>Testing | Magnetic Pulse<br>Characteristics vs. Time | Both devices have the same<br>specification for magnetic pulse shape<br>and both devices tested within<br>specification. No new issues of safety<br>or efficacy have been raised. The<br>measured rate of change of the<br>magnetic field is substantially<br>equivalent. |
| | Magnetic Pulse Field Map | No new issues of safety or efficacy<br>have been raised. The Magnetic Pulse<br>Field Maps for the sTMS mini and the<br>predicate device are substantially<br>equivalent. |
| | Location of 5 Gauss Line | No new issues of safety or efficacy<br>have been raised. The location of the 5<br>Gauss line for the sTMS mini and the<br>predicate device are substantially<br>equivalent. |
| Software Verification<br>Validation Testing | sTMS mini Software Testing | The sTMS mini software was tested<br>against requirements of the Software<br>Requirements Specification (SRS) and<br>no new issues of safety or efficacy<br>have been raised. The sTMS mini<br>software requirements specify device<br>operations that result in the delivery of<br>a magnetic pulse that is substantially<br>equivalent to the magnetic pulse of the<br>predicate device. |
| Electromagnetic<br>Compatibility and<br>Electrical Safety | Testing in accordance with<br>the following standards:<br>● IEC 60601-1-1<br>● IEC 60601-1-2 | The sTMS mini and the predicate<br>device met all acceptance criteria. No<br>new issues of safety or efficacy have<br>been raised. Therefore, the sTMS mini<br>is substantially equivalent to the<br>predicate. |

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

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## 510(k) SUMMARY (CONT.)

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

## CONCLUSIONS [807.92(b)(3)]

The sTMS mini is considered by eNeura to be substantially equivalent to the predicate device.