K Number

Device Name

Manufacturer

eNeura, Inc.

Date Cleared

2023-05-16

(95 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

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 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.

AI/ML Overview

The provided text describes the regulatory clearance for the SAVI Dual™ Migraine Therapy device and establishes its substantial equivalence to a predicate device (SpringTMS) and a reference device (sTMS mini). The focus is on non-clinical performance testing rather than clinical study results comparing device performance against specific disease metrics.

Therefore, the acceptance criteria and study information will be presented based on the available non-clinical testing data provided in the document.

Description of Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The SAVI Dual™ Migraine Therapy device underwent non-clinical performance testing to demonstrate its substantial equivalence to the predicate device, SpringTMS (K182976), and a reference device, sTMS mini (K161663). The acceptance criteria were primarily focused on ensuring that the SAVI Dual maintained similar performance characteristics to the predicate device regarding its magnetic pulse output and safety standards, despite hardware and software modifications.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Magnetic Pulse Characteristics vs. Time	The SAVI Dual device was expected to have the same magnetic pulse specification as the predicate device (SpringTMS) and perform within that specification. The measured rate of change of the magnetic field should be substantially equivalent to the predicate.	Both SAVI Dual and the predicate device have the same specification for magnetic pulse shape, and both devices tested within specification. The measured rate of change of the magnetic field is substantially equivalent. No new issues of safety or efficacy have been raised.
Magnetic Pulse Field Map	The Magnetic Pulse Field Map for the SAVI Dual was expected to be substantially equivalent to that of the predicate device.	The Magnetic Pulse Field Maps for the subject device and the predicate device are substantially equivalent. No new issues of safety or efficacy have been raised.
Location of 5 Gauss Line	The location of the 5 Gauss line for the SAVI Dual was expected to be substantially equivalent to that of the predicate device.	The location of the 5 Gauss line for the subject device and the predicate device are substantially equivalent. No new issues of safety or efficacy have been raised.
Software Verification & Validation	The SAVI Dual software was expected to be tested against requirements of the Software Requirements Specification (SRS) and ensure device operations result in a magnetic pulse substantially equivalent to the predicate device. The testing should raise no new safety or efficacy issues.	The SAVI Dual software was tested against requirements of the Software Requirements Specification (SRS), and no new issues of safety or efficacy have been raised. The software requirements specify device operations that result in the delivery of a magnetic pulse that is substantially equivalent to the magnetic pulse of the predicate device.
Electromagnetic Compatibility & Electrical Safety	The SAVI Dual device was expected to meet all acceptance criteria in accordance with the following standards: IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-1-11. The testing should raise no new safety or efficacy issues.	The subject device met all acceptance criteria for Electromagnetic Compatibility and Electrical Safety testing in accordance with IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-1-11. No new issues of safety or efficacy have been raised. Therefore, the SAVI Dual is substantially equivalent to the predicate.

2. Sample size used for the test set and the data provenance

The document details non-clinical performance testing rather than testing on human subjects or clinical data sets for efficacy. Therefore, there is no stated sample size for a "test set" in the context of patient data. The "test set" in this context refers to the individual SAVI Dual™ devices or components that underwent the various non-clinical engineering and safety tests (e.g., magnetic pulse characteristics, software performance, EMC/electrical safety). The provenance of this data is from eNeura, Inc.'s internal testing facilities. The testing described is prospective, as it was performed on the proposed SAVI Dual device to support its regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable in the context of the provided document. The "ground truth" for non-clinical performance testing is established by engineering specifications, international consensus standards (e.g., IEC 60601 series), and direct comparison to the predicate device's measured performance. It does not involve human expert adjudication in the way clinical diagnostic studies do. The experts involved would be the engineers and technicians performing the tests and comparing the results to established physical and regulatory requirements.

4. Adjudication method for the test set

Not applicable. As described above, the "test set" refers to physical device characteristics and engineering performance, not interpretative medical decisions requiring adjudication by experts. Results are compared against specific quantitative thresholds and established standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The SAVI Dual™ Migraine Therapy device is a hardware device (transcranial magnetic stimulator), not an AI-powered diagnostic or interpretive tool. The provided document does not describe any MRMC studies or AI assistance in the context of its use.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The SAVI Dual is a therapeutic device that stimulates the brain. Its performance is evaluated based on its physical output (magnetic field characteristics) and safety, not as a standalone algorithm delivering a diagnosis or prediction without human interaction. While it has software/firmware, its "performance" in this context is its ability to produce the intended physical magnetic pulse, which was tested.

7. The type of ground truth used

The "ground truth" for the non-clinical performance testing (magnetic pulse characteristics, software function, electrical safety) was based on:

Established engineering specifications and design requirements for the device.
Measured performance of the legally marketed predicate device (SpringTMS) for comparative equivalence in magnetic field characteristics.
International consensus standards for medical device safety and electromagnetic compatibility (IEC 60601 series).

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data. Its development involved engineering design and testing, not machine learning.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

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.

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)

Page 1 of 1

B PSC Publishing Services (301) 443-6740

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

{3}------------------------------------------------

Date Prepared:	16-May-23
eNeura® Inc101 West Dickman St.Suite 900Baltimore, MD 21230
Official Contact:	David Rosen - President and CEOdrosen@eneura.com970-481-2492
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:Reference Device:	K182976 – SpringTMSK161663 – sTMS mini

Modification:

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

Hardware Modifications ●
Software (firmware) updates

Device Description:

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.

{4}------------------------------------------------

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

{5}------------------------------------------------

{6}------------------------------------------------

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

{7}------------------------------------------------

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 BenchTesting	Magnetic PulseCharacteristics vs. Time	Both devices have the same specification formagnetic pulse shape and both devices testedwithin specification. No new issues of safety orefficacy have been raised. The measured rate ofchange of the magnetic field is substantiallyequivalent.
	Magnetic Pulse Field Map	No new issues of safety or efficacy have beenraised. The Magnetic Pulse Field Maps for thesubject device and the predicate device aresubstantially equivalent.
	Location of 5 Gauss Line	No new issues of safety or efficacy have beenraised. The location of the 5 Gauss line for thesubject device and the predicate device aresubstantially equivalent.
Software VerificationValidation Testing	SAVI Dual Software Testing	The SAVI Dual software was tested againstrequirements of the Software RequirementsSpecification (SRS) and no new issues of safetyor efficacy have been raised. The softwarerequirements specify device operations that resultin the delivery of a magnetic pulse that issubstantially equivalent to the magnetic pulse ofthe predicate device.
ElectromagneticCompatibility andElectrical Safety	Testing in accordance withthe following standards:• IEC 60601-1-1• IEC 60601-1-2• IEC 60601-1-11	The subject device met all acceptance criteria. Nonew issues of safety or efficacy have been raised.Therefore, the SAVI Dual is substantiallyequivalent 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.

Regulation Number and Section

§ 882.5808 Transcranial magnetic stimulator for headache.

(a)
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.(b)
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.

Feature	SAVI Dual™ MigraineTherapy Device	SpringTMS®Predicate Device	sTMS miniReference Device	SubstantialEquivalenceRationale
Manufacturer	eNeura, Inc.	eNeura, Inc.	eNeura, Inc.	--
510(k) Number	New Submission	K182976	K161663	--
Indications forUse	The SAVI Dual™Migraine Therapy deviceis indicated for the acuteand prophylactic treatmentof migraine headache inadolescents (age 12 andolder) and adults.	The eNeura Inc.SpringTMS® is indicatedfor the acute andprophylactic treatment ofmigraine headache inadolescents (age 12 andolder) and adults.	The eNeura® sTMS miniis indicated for the acutetreatment of painassociated with migraineheadache with aura.	Indications for Use areidentical to thepredicate device.
OperatingPrinciple	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)
UseAuthorization	With the SAVI Dual™Migraine Therapy device,the user may connecteither with the SIM chipjust as the predicate or theuser may connectwirelessly via a cellularconnection for theprogrammed duration. Theprogrammed durationcorresponds to theprescribed months of use.The device remains underphysician prescription.	The user must insert a SIMchip to use the device for aprogrammed duration.The programmed durationcorresponds to theprescribed months of use.The SIM chip is onlyavailable under physicianprescription.	The user must insert aSIM chip to use thedevice for a programmedduration. Theprogrammed durationcorresponds to theprescribed months of use.The SIM chip is onlyavailable under physicianprescription.	Subject device allowsfor a wirelessconnection /communication foruser to use the devicefor the programmedduration in addition tothe use of SIM chip.No new issues ofsafety or efficacy areraised with thischange.
Display	LED indicators	LCD display	LED indicators	Subject device has thesame display as thereference device. Nonew issues of safety orefficacy are raisedwith this change.
Feature	SAVI Dual™ MigraineTherapy Device	SpringTMS®Predicate Device	sTMS miniReference Device	SubstantialEquivalenceRationale
Magnetic Field	0.9 Tesla Peak @ 180 µs(total magnetic energy140J)	0.9 Tesla Peak @ 180 µs(total magnetic energy140J)	0.9 Tesla Peak @ 180 µs(total magnetic energy140J)	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 withrechargeable embeddedlithium ion battery pack.Battery pack charger mainsinput -100-240V AC,50/60 Hz, output 12 V DC	Internally powered withrechargeable embeddedlithium ion battery pack.Battery pack charger mainsinput -100-240V AC,50/60 Hz, output 12 V DC	Internally powered withrechargeable embeddedlithium ion battery pack.Battery pack chargermains input -100-240VAC, 50/60 Hz, output 12V DC	N/A (same)
Materials	Hand held portablestimulator inpolycarbonate case(integral coil)	Hand held portablestimulator inpolycarbonate case(integral coil)	Hand held portablestimulator inpolycarbonate case(integral coil)	N/A (same)
Environment ofUse	Home-use and where theoperator is	Home-use and where theoperator is	Home-use and where theoperator is	N/A (same)
Dimensions andWeight	8.8 in. (22.4 cm) long5.1 in. (13 cm) wide2.7 in. (6.9 cm) deep3.2 lb. (1.4 kg)	9 in. (23 cm) long5 in. (13 cm) wide3 in. (8 cm) deep3.8 lb. (1.7 kg)	8.8 in. (22.4 cm) long5.1 in. (13 cm) wide2.7 in. (6.9 cm) deep3.2 lb. (1.4 kg)	Subject device isidentical in size as thereference device(sTMS mini) No newissues of safety orefficacy are raisedwith this change.
Compliance toStandards	IEC 60601-1-2IEC 60601-1IEC 60601-1-11	IEC 60601-1-2IEC 60601-1IEC 60601-1-11	IEC 60601-1-2IEC 60601-1IEC 60601-1-11	N/A (same)