SAVI Dual (TM) Migraine Therapy

K230358 · Eneura, Inc. · OKP · May 16, 2023 · Neurology

Device Facts

• Record ID: K230358
• Device Name: SAVI Dual (TM) Migraine Therapy
• Applicant: Eneura, Inc.
• Product Code: OKP · Neurology
• Decision Date: May 16, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5808
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SAVI Dual™ Migraine Therapy device is indicated for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults.

Device Story

Portable, hand-held transcranial magnetic stimulator (sTMS) for migraine treatment. Device delivers brief 0.9 Tesla magnetic pulse to occipital cortex to induce electrical current; stops or lessens migraine effects. Used in home or office settings; self-administered by patient under physician prescription. Device operation requires authorization via inserted SIM chip or wireless cellular connection for a programmed duration corresponding to prescribed months of use. Output is magnetic stimulation; healthcare provider uses device to manage migraine frequency/severity. Benefits include non-invasive, patient-controlled therapy.

Clinical Evidence

Bench testing only. Performance testing verified magnetic pulse characteristics (0.9 Tesla @ 180 µs), field maps, and 5 Gauss line location against predicate. Software verification/validation confirmed delivery of equivalent magnetic pulses. Electrical safety and EMC testing performed per IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11.

Technological Characteristics

Polycarbonate case; integral coil. Energy source: rechargeable lithium-ion battery (100-240V AC input). Output: 0.9 Tesla peak magnetic field @ 180 µs. Connectivity: SIM chip or wireless cellular. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11. Dimensions: 22.4 x 13 x 6.9 cm; 1.4 kg.

Indications for Use

Indicated for acute and prophylactic treatment of migraine headache in adolescents (age 12+) and adults.

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 (K182976)

Reference Devices

• sTMS mini (K161663)

Submission Summary (Full Text)

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May 16, 2023

eNeura, Inc. % Larry Getlin Regulatory Consultant eNeura, Inc 2690 Pheasant Road Orono, Minnesota 55331

Re: K230358

Trade/Device Name: SAVI Dual (TM) Migraine Therapy Regulation Number: 21 CFR 882.5808 Regulation Name: Transcranial Magnetic Stimulator For Headache Regulatory Class: Class II Product Code: OKP Dated: February 10, 2023 Received: February 10, 2023

Dear Larry 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. 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.

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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 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.

# Jitendra V. Virani -S

CDR Jitendra Virani Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine 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)

## K230358

Device Name

## SAVI Dual™ Migraine Therapy

Indications for Use (Describe)

The SAVI Dual™ Migraine Therapy device is indicated for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults.

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

XX Prescription Use (Part 21 CFR 801 Subpart D)

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| Date Prepared: | 16-May-23 |
|-------------------------------------------------------------------------|----------------------------------------------------------------------|
| eNeura® Inc<br>101 West Dickman St.<br>Suite 900<br>Baltimore, MD 21230 | |
| Official Contact: | David Rosen - President and CEO<br>[e-mail]<br>970-481-2492 |
| Submission Correspondent: | Larry W. Getlin |
| Proprietary or Trade Name: | SAVI Dual Migraine Therapy |
| Regulation Code: | 21 CFR§882.5808 |
| Regulation Name(s): | Transcranial Magnetic Stimulator for Headache |
| Device Class: | Class II |
| Product Code: | OKP |
| Predicate Device:<br>Reference Device: | K182976 – SpringTMS<br>K161663 – sTMS mini |

## Modification:

The subject device is similar to the predicate device except for:

- Hardware Modifications ●
- Software (firmware) updates

## Device Description:

The SAVI Dual Migraine Therapy device 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 SAVI Dual is indicated for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults. 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. To use the device, the user must either insert a SIM chip to use the device for a programmed duration or the user may connect wirelessly via a cellular connection for the programmed duration. The programmed duration corresponds to the prescribed months of use.

## Indications for Use:

The SAVI Dual™ Migraine Therapy is indicated for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults.

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| Feature | SAVI Dual™ Migraine<br>Therapy Device | SpringTMS®<br>Predicate Device | sTMS mini<br>Reference Device | Substantial<br>Equivalence<br>Rationale |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | eNeura, Inc. | eNeura, Inc. | eNeura, Inc. | -- |
| 510(k) Number | New Submission | K182976 | K161663 | -- |
| Indications for<br>Use | The SAVI Dual™<br>Migraine Therapy device<br>is indicated for the acute<br>and prophylactic treatment<br>of migraine headache in<br>adolescents (age 12 and<br>older) and adults. | The eNeura Inc.<br>SpringTMS® is indicated<br>for the acute and<br>prophylactic treatment of<br>migraine headache in<br>adolescents (age 12 and<br>older) and adults. | The eNeura® sTMS mini<br>is indicated for the acute<br>treatment of pain<br>associated with migraine<br>headache with aura. | Indications for Use are<br>identical to the<br>predicate device. |
| Operating<br>Principle | Induces electrical current in region near coil Transcranial Evoked response Stimulation on the occipital cortex | Induces electrical current in region near coil Transcranial Evoked response Stimulation on the occipital cortex | Induces electrical current in region near coil Transcranial Evoked response Stimulation on the occipital cortex | N/A (same) |
| Design | Time varying magnetic field Non-invasive | Time varying magnetic field Non-invasive | Time varying magnetic field Non-invasive | N/A (same) |
| Use<br>Authorization | With the SAVI Dual™<br>Migraine Therapy device,<br>the user may connect<br>either with the SIM chip<br>just as the predicate or the<br>user may connect<br>wirelessly via a cellular<br>connection for the<br>programmed duration. The<br>programmed duration<br>corresponds to the<br>prescribed months of use.<br>The device remains under<br>physician prescription. | The user must insert a SIM<br>chip to use the device for a<br>programmed duration.<br>The 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<br>device 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. | Subject device allows<br>for a wireless<br>connection /<br>communication for<br>user to use the device<br>for the programmed<br>duration in addition to<br>the use of SIM chip.<br>No new issues of<br>safety or efficacy are<br>raised with this<br>change. |
| Display | LED indicators | LCD display | LED indicators | Subject device has the<br>same display as the<br>reference device. No<br>new issues of safety or<br>efficacy are raised<br>with this change. |
| Feature | SAVI Dual™ Migraine<br>Therapy Device | SpringTMS®<br>Predicate Device | sTMS mini<br>Reference Device | Substantial<br>Equivalence<br>Rationale |
| Magnetic 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) | 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 | 4 mA/cm2 induced at 1 cm | N/A (same) |
| Electrical Power | Internally powered with<br>rechargeable embedded<br>lithium ion battery pack.<br>Battery pack charger mains<br>input -100-240V AC,<br>50/60 Hz, output 12 V DC | Internally powered with<br>rechargeable embedded<br>lithium ion battery pack.<br>Battery pack charger mains<br>input -100-240V AC,<br>50/60 Hz, output 12 V DC | Internally powered with<br>rechargeable embedded<br>lithium ion battery pack.<br>Battery pack charger<br>mains input -100-240V<br>AC, 50/60 Hz, output 12<br>V DC | N/A (same) |
| 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) | Hand held portable<br>stimulator in<br>polycarbonate case<br>(integral coil) | N/A (same) |
| Environment of<br>Use | Home-use and where the<br>operator is | Home-use and where the<br>operator is | Home-use and where the<br>operator is | N/A (same) |
| Dimensions and<br>Weight | 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) | 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) | Subject device is<br>identical in size as the<br>reference device<br>(sTMS mini) No new<br>issues of safety or<br>efficacy are raised<br>with this change. |
| Compliance to<br>Standards | IEC 60601-1-2<br>IEC 60601-1<br>IEC 60601-1-11 | IEC 60601-1-2<br>IEC 60601-1<br>IEC 60601-1-11 | IEC 60601-1-2<br>IEC 60601-1<br>IEC 60601-1-11 | N/A (same) |

## Table 5.1 – Comparison – Subject vs. Predicate and Reference Devices

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## Substantial Equivalence Discussion

## Intended Use/ Indications for Use

The indications for use are identical to those which were cleared for the predicate device, SpringTMS, under K182976.

## Patient Population

The patient population is identical to that cleared for the predicate device, SpringTMS, under K182976.

## Design and Technology

The SAVI Dual™ Migraine Therapy device, like the predicate device, 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 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.

To use the subject device, the user must either insert a SIM chip to use the device for a programmed duration or the user may connect wirelessly via a cellular connection for the programmed duration. The programmed duration corresponds to the prescribed months of use. The predicate device use authorization by the patient is done by inserting only a SIM chip into the device. Addition of the wireless cellular connection for subject device does not raise any new issues of safety or efficacy.

Thus, the design and technological characteristics of the SAVI Dual are substantially equivalent to the predicate device, SpringTMS (K182976).

## Principles of Operation

The principle of operation remains unchanged to the predicate including that each device:

- Induces electrical current in region near coil
- Transcranial
- . Evoked response
- Stimulation on the occipital cortex ●

## Use Authorization:

With the SAVI Dual™ Migraine Therapy device, the user may connect either with the SIM chip just as the predicate or the user may connect wirelessly via a cellular connection for the programmed duration. The programmed duration corresponds to the prescribed months of use. The device remains under physician prescription only. Though the predicate device use authorization only allowed for use by the patient inserting a SIM chip into the device, this technology modification does not raise any new issues of safety or efficacy.

## Environment of Use

The environment of use is identical to that cleared for the predicate device, SpringTMS under K 182976.

## Non-Clinical Testing

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All necessary performance testing was conducted on the proposed SAVI Dual to support a determination of substantial equivalence to the predicate device. The testing performed is provided in the section below:

| Testing Type | Test Description | Results Supporting Substantial Equivalence |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Bench<br>Testing | Magnetic Pulse<br>Characteristics vs. Time | Both devices have the same specification for<br>magnetic pulse shape and both devices tested<br>within specification. No new issues of safety or<br>efficacy have been raised. The measured rate of<br>change of the magnetic field is substantially<br>equivalent. |
| | Magnetic Pulse Field Map | No new issues of safety or efficacy have been<br>raised. The Magnetic Pulse Field Maps for the<br>subject device and the predicate device are<br>substantially equivalent. |
| | Location of 5 Gauss Line | No new issues of safety or efficacy have been<br>raised. The location of the 5 Gauss line for the<br>subject device and the predicate device are<br>substantially equivalent. |
| Software Verification<br>Validation Testing | SAVI Dual Software Testing | The SAVI Dual software was tested against<br>requirements of the Software Requirements<br>Specification (SRS) and no new issues of safety<br>or efficacy have been raised. The software<br>requirements specify device operations that result<br>in the delivery of a magnetic pulse that is<br>substantially equivalent to the magnetic pulse of<br>the 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<br>• IEC 60601-1-11 | The subject device met all acceptance criteria. No<br>new issues of safety or efficacy have been raised.<br>Therefore, the SAVI Dual is substantially<br>equivalent to the predicate. |

| Table 5.2 Non-Clinical Performance Testing and Substantial Equivalence Support | | |
|--------------------------------------------------------------------------------|--|--|
|--------------------------------------------------------------------------------|--|--|

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

## Substantial Equivalence Conclusion

The SAVI Dual is considered by eNeura to be substantially equivalent to the predicate device. Any differences do not present different questions of safety or effectiveness than the predicate device.