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.

AI/ML Overview

This document describes the 510(k) premarket notification for the eNeura® sTMS Mini, a transcranial magnetic stimulator for headache. The submission focuses on demonstrating substantial equivalence to a predicate device, SpringTMS® (K140094).

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative manner for clinical efficacy. Instead, it focuses on demonstrating technological equivalence to a predicate device through non-clinical performance testing. The "results supporting substantial equivalence" serve as the de facto "reported device performance" against the implicitly accepted "criteria" of being equivalent to the predicate.

Testing Type	Test Description	Acceptance Criteria (Implicit)	Reported Device Performance
Performance Bench Testing: Magnetic Pulse Characteristics	Magnetic Pulse Characteristics vs. Time	Same specification for magnetic pulse shape as predicate; within specification.	Both devices have the same specification for magnetic pulse shape and both devices 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.
Performance Bench Testing: Magnetic Pulse Field Map	Magnetic Pulse Field Map	Substantially equivalent to predicate.	No new issues of safety or efficacy have been raised. The Magnetic Pulse Field Maps for the sTMS mini and the predicate device are substantially equivalent.
Performance Bench Testing: Location of 5 Gauss Line	Location of 5 Gauss Line	Substantially equivalent to predicate.	No new issues of safety or efficacy have been raised. The location of the 5 Gauss line for the sTMS mini and the predicate device are substantially equivalent.
Software Verification Validation Testing	sTMS mini Software Testing	Meet requirements of Software Requirements Specification (SRS); no new safety/efficacy issues.	The sTMS mini software was tested against requirements of the Software Requirements Specification (SRS) and no new issues of safety or efficacy have been raised. The sTMS mini 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 and Electrical Safety	Testing in accordance with IEC 60601-1-1 & -1-2	Meet all acceptance criteria of IEC 60601-1-1 and IEC 60601-1-2.	The sTMS mini and the predicate device met all acceptance criteria. No new issues of safety or efficacy have been raised. Therefore, the sTMS mini is substantially equivalent to the predicate.

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

The document describes non-clinical performance testing (bench testing) and software verification/validation. It does not mention any clinical studies, test sets involving human subjects, or data provenance (country of origin, retrospective/prospective). The assessment is based on physical and software characteristics compared to the predicate device.

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

Since no clinical test set with human subjects is described, there is no mention of experts establishing ground truth. The "ground truth" for the non-clinical tests is based on established engineering specifications, safety standards (e.g., IEC 60601 series), and the characteristics of the predicate device.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set is described.

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

No, an MRMC comparative effectiveness study was not done or mentioned in this document. This submission focuses on technological equivalence, not clinical efficacy or comparative effectiveness with human readers.

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

This device is a physical medical device (Transcranial Magnetic Stimulator) and not an algorithm or AI system in the typical sense that would have "standalone performance" evaluated as an algorithm. Its performance is evaluated through physical and software testing.

7. The Type of Ground Truth Used:

For the non-clinical performance testing, the "ground truth" is based on:

Engineering specifications for magnetic pulse characteristics (e.g., 0.9 Tesla Peak @ 180 µs, 4 mA/cm² induced at 1 cm).
International standards for safety and electromagnetic compatibility (IEC 60601-1-1, IEC 60601-1-2).
Software requirements specifications (SRS).
Characteristics of the legally marketed predicate device (SpringTMS®), which serves as the benchmark for "substantial equivalence."

8. The Sample Size for the Training Set:

Not applicable. This document does not describe the development or testing of an AI algorithm or model that would require a "training set." The device is a hardware product with associated software.

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

Not applicable, as no training set for an AI algorithm is mentioned.

Summary

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

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.

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

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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use

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)
	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)

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 required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)	Page 1 of 1
----------------------	-------------

PSC Publishing Services (301) 443-6740 EF

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

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: 408-245-6400 FAX: 408-245-6424

Contact Person:

Larry W. Getlin Regulatory Consultant for eNeura® Inc 2690 Pheasant Road Orono, MN 55331 U.S.A. E-mail: lwgetlin@gmail.com Phone: 612-850-8144

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)

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

DEVICE DESCRIPTION [807.92(a)(4)]

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)Number	K140094	TBD	--
OperatingPrinciple	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

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

510(k) SUMMARY (CONT.)

Feature	SpringTMS®	sTMS mini	Substantial Equivalence Rationale
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.	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.	N/A (same)
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 1 cm	N/A (same)
ElectricalPower	Internally powered withrechargeable removablelithium ion battery pack.Battery pack chargermains input --100-240V AC, 50/60 Hz,output 12 V DC	Internally powered withrechargeable non-removable lithium ionbattery pack. Battery packcharger mains input --100-240V AC, 50/60 Hz,output 12 V DC	The sTMS mini and predicatedevice utilize the same batteries,same voltage and power and bothmeet all criteria for establishingelectrical 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)	8.8 in. (22.4 cm) long5.1 in. (13 cm) wide2.7 in. (6.9 cm) deep3.2 lb. (1.4 kg)	The reduced size of the sTMS miniraises no new issues of safety orefficacy.

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.

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

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 SubstantialEquivalence
Performance BenchTesting	Magnetic PulseCharacteristics vs. Time	Both devices have the samespecification for magnetic pulse shapeand both devices tested withinspecification. No new issues of safetyor efficacy have been raised. Themeasured rate of change of themagnetic field is substantiallyequivalent.
	Magnetic Pulse Field Map	No new issues of safety or efficacyhave been raised. The Magnetic PulseField Maps for the sTMS mini and thepredicate device are substantiallyequivalent.
	Location of 5 Gauss Line	No new issues of safety or efficacyhave been raised. The location of the 5Gauss line for the sTMS mini and thepredicate device are substantiallyequivalent.
Software VerificationValidation Testing	sTMS mini Software Testing	The sTMS mini software was testedagainst requirements of the SoftwareRequirements Specification (SRS) andno new issues of safety or efficacyhave been raised. The sTMS minisoftware requirements specify deviceoperations that result in the delivery ofa magnetic pulse that is substantiallyequivalent to the magnetic pulse of thepredicate device.
ElectromagneticCompatibility andElectrical Safety	Testing in accordance withthe following standards:● IEC 60601-1-1● IEC 60601-1-2	The sTMS mini and the predicatedevice met all acceptance criteria. Nonew issues of safety or efficacy havebeen raised. Therefore, the sTMS miniis substantially equivalent to thepredicate.

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

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

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.

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.