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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the SpringTMS device. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Cerena™ Transcranial Magnetic Stimulator).

However, it does not contain acceptance criteria related to clinical performance (e.g., diagnostic accuracy, treatment efficacy percentages) for the device itself. Instead, the "acceptance criteria" discussed are primarily related to engineering, safety, and performance bench testing to demonstrate substantial equivalence to a previously approved device.

Therefore, the requested information components related to clinical studies, ground truth, expert adjudication, sample sizes for test/training sets, and MRMC studies are largely not present in the provided text.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Testing Type	Acceptance Criteria (Implied)	Reported Device Performance
Performance Bench Testing
Magnetic Pulse Characteristics vs. Time	Within specification for magnetic pulse shape (identical to predicate)	"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	Substantially equivalent to predicate device's field map, raising no new safety/efficacy issues.	"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	Substantially equivalent to predicate device's location of the 5 Gauss line, raising no new safety/efficacy issues.	"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."
Software Verification Validation Testing	Meeting all requirements of the Software Requirements Specification (SRS), with safety/performance specifications substantially equivalent to predicate's SRS.	"SpringTMS Software met all requirements of the SRS. No new issues of safety or efficacy have been raised. All safety and performance specifications for the SpringTMS SRS are substantially equivalent to those in the SRS for the predicate."
Electromagnetic Compatibility & Electrical Safety	Meeting acceptance criteria of specified standards (IEC 60601-1:2005, IEC 60601-1-2:2007), raising no new safety/efficacy issues.	"The SpringTMS and the predicate device met all acceptance criteria. No new issues of safety or efficacy have been raised. Therefore the SpringTMS is substantially equivalent to the predicate."
Clinical Performance (e.g., treatment efficacy)	Not specified in this document. The document states the device has the "identical" indication for use as the predicate, meaning its clinical effectiveness is assumed to be equivalent based on the predicate's prior approval.	No new clinical performance data is presented in this document to establish efficacy percentages or outcomes for the SpringTMS. It relies on the substantial equivalence to the predicate device, which was presumably justified by its own clinical data at the time of its approval (K130556).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable as the testing described is primarily bench testing and software verification, not clinical performance testing on a patient sample. No "test set" of patient data is mentioned.
Data Provenance: Not applicable. The testing is internal engineering and software verification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. No clinical "ground truth" or expert adjudication for performance criteria is described.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not conducted or described in this document. The submission focuses on substantial equivalence to a predicate device based on technological characteristics and bench testing, not on comparative clinical efficacy against human readers or other treatments.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Standalone Performance: Not applicable. This is a medical device (Transcranial Magnetic Stimulator), not an AI algorithm. Its "performance" refers to its physical output (magnetic pulses) and safety characteristics, not an algorithmic assessment of data.

7. The Type of Ground Truth Used

Type of Ground Truth: For the technical and safety testing (magnetic pulse characteristics, software requirements, electrical safety), the "ground truth" involved adherence to established engineering specifications and international standards (e.g., IEC 60601-1, IEC 60601-1-2) or demonstrating equivalence to the predicate device's measured characteristics.
There is no clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient response) discussed for the SpringTMS itself in this document, as the submission relies on the predicate's known efficacy.

8. The Sample Size for the Training Set

Sample Size: Not applicable. This refers to training data for an algorithm. The SpringTMS is a hardware device for treatment, not an AI/algorithm that is "trained."

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable for the same reasons as #8.

Summary

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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: 408-245-6500 FAX: 408-245-6424

Contact Person:

Larry Getlin Regulatory Consultant for eNeura Therapeutics, LLC 2690 Pheasant Road Orono, MN 55331 U.S.A. Phone: 612-850-8144

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™ TranscranialMagnetic Stimulator	Substantial Equivalence Rationale
510(k)Number	K140094	K130556	New 510(k) submission
OperatingPrinciple	Induces electricalcurrent in region nearcoilTranscranialEvoked responseStimulation on theoccipital cortex	Induces electricalcurrent in regionnear coilTranscranialEvoked responseStimulation on theoccipital cortex	N/A (same)
Design	Time varyingmagnetic fieldNon-invasive	Time varyingmagnetic fieldNon-invasive	N/A (same)
UseAuthorization	The user must insert aSIM chip to use the devicefor a programmedduration. Theprogrammed durationcorresponds to theprescribed months of use.The SIM chip is onlyavailable under physicianprescription.	None	The addition of this UseAuthorization feature does notaffect the operating principle orperformance of the device and noadditional risks or hazards havebeen identified related to thischange.
Display	LCD display	LED indicators	In both devices, the display servesto communicate device status to thepatient and no additional risks orhazards have been identified relatedto this change.
MagneticField	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 1cm	N/A (same)

Table 1: Summary of Technological Characteristics

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ElectricalPower	Internally powered withrechargeable lithium ionbattery pack. Battery packcharger mains input --100-240V AC, 47/63 Hz,output 12 V DC	Externally powered byAC/DC power adapter.Mains input --100-240V AC, 50/60 Hz,output 12 V DC	The SpringTMS and predicatedevice utilize the same voltage andpower and both meet all criteria forestablishing electrical safety.
Materials	Hand held portablestimulator inpolycarbonate case(integral coil)	Hand held portablestimulator inpolycarbonate case(integral coil)	N/A (same)
Where used	Home-use and where theoperator is	Home-use and where theoperator is	N/A (same)
Dimensionsand Weight	9 in. (23 cm) long5 in. (13 cm) wide3 in. (8 cm) deep3.8 lb. (1.7 kg)	13 in. (33 cm) long5 in. (13 cm) wide5 in. (13 cm) deep3.4 lb. (1.54 kg)	The form factor changes raise nonew 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 VerificationValidation Testing	SpringTMS Software Testing	SpringTMS Software met allrequirements of the SRS. No newissues of safety or efficacy have beenraised. All safety and performancespecifications for the SpringTMS SRSare substantially equivalent to those inthe SRS for the predicate.
ElectromagneticCompatibility andElectrical Safety	Testing in accordance withthe following standards:• IEC 60601-1:2005• IEC 60601-1-2:2007	The SpringTMS and the predicatedevice met all acceptance criteria. Nonew issues of safety or efficacy havebeen raised. Therefore the SpringTMSis substantially equivalent to thepredicate.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

Carlos L. Pena -S

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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.