(68 days)
Not Found
No
The summary describes a device that delivers a magnetic pulse and focuses on the physical characteristics of the pulse and software verification for device operation, with no mention of AI or ML.
Yes
The device is marketed for the acute treatment of pain associated with migraine headache with aura, which indicates a therapeutic purpose.
No
The device is indicated for the acute treatment of pain associated with migraine headache with aura, not for diagnosing it.
No
The device description explicitly states it is a "portable, hand-held device that delivers a brief single pulse of magnetic energy," indicating it is a hardware device. The performance studies also include hardware-related testing like "Magnetic Pulse Characteristics" and "Electromagnetic Compatibility and Electrical Safety."
Based on the provided information, the eNeura® sTMS mini is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the sTMS mini is a portable, hand-held device that delivers magnetic energy to the back of the head to treat migraine headaches. It interacts directly with the patient's body (transcranial magnetic stimulation) and does not involve the analysis of biological specimens.
Therefore, the eNeura® sTMS mini falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The eNeura® sTMS mini is indicated for the acute treatment of pain associated with migraine headache with aura.
Product codes
OKP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
occipital cortex
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient use where treatments are self-administered and can be delivered in a variety of settings including the home or office.
prescription use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Bench Testing: Magnetic Pulse Characteristics vs. Time, Magnetic Pulse Field Map, Location of 5 Gauss Line.
Results: 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. 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. 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.
Results: 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 the following standards: IEC 60601-1-1, IEC 60601-1-2.
Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.
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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)]
The sTMS mini is a portable, hand-held device that delivers a brief single pulse of magnetic energy at 0.9 Tesla to the back of the head to induce an electrical current in a portion of the brain, called the occipital cortex, to stop or lessen the effects of migraine headaches. Since a single pulse of magnetic stimulation is emitted, this method of stimulation is called single pulse transcranial magnetic stimulation or sTMS. The sTMS mini is indicated for the acute treatment of pain associated with migraine headache with aura. The device is designed for patient use where treatments are self-administered and can be delivered in a variety of settings including the home or office. The device is intended for prescription use only.
INDICATIONS FOR USE [807.92(a)(5)]
The eNeura® sTMS mini is indicated for the acute treatment of pain associated with migraine headache with aura.
TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the sTMS mini are substantially equivalent to the predicate device, SpringTMS (K140094). Table 1 lists the technological characteristics of the sTMS mini and the predicate device and provides the rationale to support a determination of substantial equivalence. Any differences between the devices do not raise any new issues of safety or efficacy.
| Feature | SpringTMS® | sTMS mini | Substantial Equivalence Rationale |
|---|---|---|---|
| 510(k) | |||
| Number | K140094 | TBD | -- |
| Operating | |||
| Principle | Induces electrical current in region near coil Transcranial Evoked response Stimulation on the occipital cortex Single Pulse TMS (sTMS) | Induces electrical current in region near coil Transcranial Evoked response Stimulation on the occipital cortex Single Pulse TMS (sTMS) | N/A (same) |
| Design | Time varying magnetic field Non-invasive | Time varying magnetic field Non-invasive | N/A (same) |
Table 1: Summary of Technological Characteristics
5
510(k) SUMMARY (CONT.)
| Feature | SpringTMS® | sTMS mini | Substantial Equivalence Rationale |
|---|---|---|---|
| Use | |||
| Authorization | The user must insert a | ||
| SIM chip to use the device | |||
| for a programmed | |||
| duration. The | |||
| programmed duration | |||
| corresponds to the | |||
| prescribed months of use. | |||
| The SIM chip is only | |||
| available under physician | |||
| prescription. | The user must insert a | ||
| SIM chip to use the device | |||
| for a programmed | |||
| duration. The | |||
| programmed duration | |||
| corresponds to the | |||
| prescribed months of use. | |||
| The SIM chip is only | |||
| available under physician | |||
| prescription. | N/A (same) | ||
| Display | LCD display | LED indicators | In both devices, the display serves |
| to communicate device status to the | |||
| patient and no additional risks or | |||
| hazards have been identified related | |||
| to this change. | |||
| Magnetic | |||
| Field | 0.9 Tesla Peak @ 180 µs | ||
| (total magnetic energy | |||
| 140J) | 0.9 Tesla Peak @ 180 µs | ||
| (total magnetic energy | |||
| 140J) | N/A (same) | ||
| Current | 4 mA/cm² induced at 1 cm | 4 mA/cm² induced at 1 cm | N/A (same) |
| Electrical | |||
| Power | Internally powered with | ||
| rechargeable removable | |||
| lithium ion battery pack. | |||
| Battery pack charger | |||
| mains input -- | |||
| 100-240V AC, 50/60 Hz, | |||
| output 12 V DC | Internally powered with | ||
| rechargeable non- | |||
| removable lithium ion | |||
| battery pack. Battery pack | |||
| charger mains input -- | |||
| 100-240V AC, 50/60 Hz, | |||
| output 12 V DC | The sTMS mini and predicate | ||
| device utilize the same batteries, | |||
| same voltage and power and both | |||
| meet all criteria for establishing | |||
| electrical safety. | |||
| Materials | Hand held portable | ||
| stimulator in | |||
| polycarbonate case | |||
| (integral coil) | Hand held portable | ||
| stimulator in | |||
| polycarbonate case | |||
| (integral coil) | N/A (same) | ||
| Where Used | Home-use and where the | ||
| operator is | Home-use and where the | ||
| operator is | N/A (same) | ||
| Dimensions | |||
| and Weight | 9 in. (23 cm) long | ||
| 5 in. (13 cm) wide | |||
| 3 in. (8 cm) deep | |||
| 3.8 lb. (1.7 kg) | 8.8 in. (22.4 cm) long | ||
| 5.1 in. (13 cm) wide | |||
| 2.7 in. (6.9 cm) deep | |||
| 3.2 lb. (1.4 kg) | The reduced size of the sTMS mini | ||
| raises no new issues of safety or | |||
| efficacy. |
Table 1: Summary of Technological Characteristics (cont.)
SUBSTANTIAL EQUIVALENCE
The sTMS mini is substantially equivalent to the predicate device with regard to intended use or the indications for use and the fundamental scientific technology. Furthermore, the predicate SpringTMS and the proposed sTMS mini deliver the same energy in the same manner to the same area of the brain. Any differences between the two devices do not raise any new issues of safety or efficacy. Thus, the proposed sTMS mini is considered to be substantially equivalent to the predicate device.
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 Substantial
Equivalence |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Bench
Testing | Magnetic Pulse
Characteristics vs. Time | 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. |
| | Magnetic Pulse Field Map | 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. |
| | Location of 5 Gauss Line | 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 | 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
the following standards:
● IEC 60601-1-1
● 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. |
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.