(127 days)
Not Found
No
The summary describes a device that delivers a magnetic pulse for migraine treatment. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The performance studies focus on physical characteristics, software validation, and electrical safety, not algorithmic performance.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for the acute treatment of pain associated with migraine headache with aura," which signifies a therapeutic purpose.
No
The device is described as treating pain associated with migraine headaches, not diagnosing them.
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 bench testing for magnetic pulse characteristics and electromagnetic compatibility, further confirming it is not software-only.
Based on the provided information, the eNeura Therapeutics® Spring TMS® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Spring TMS® device directly interacts with the human body by delivering a magnetic pulse to the head. It is a therapeutic device used for the acute treatment of pain associated with migraine headache with aura.
The description clearly indicates a therapeutic device applied externally to the patient, not a device used to analyze biological samples.
N/A
Intended Use / Indications for Use
The eNeura Therapeutics SpringTMS® is indicated for the acute treatment of pain associated with migraine headache with aura.
Product codes (comma separated list FDA assigned to the subject device)
OKP
Device 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 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.
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 selfadministered and can be delivered in a variety of settings including the home or office. The device is intended for 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)
Study Type: Performance Bench Testing
Sample Size: Not Found
Key Results: 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.
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.
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.
Study Type: Software Verification Validation Testing
Sample Size: Not Found
Key Results: 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.
Study Type: Electromagnetic Compatibility and Electrical Safety
Sample Size: Not Found
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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™ Transcranial
Magnetic Stimulator | Substantial Equivalence Rationale |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | K140094 | K130556 | New 510(k) submission |
| Operating
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 | N/A (same) |
| Design | Time varying
magnetic field
Non-invasive | Time varying
magnetic field
Non-invasive | N/A (same) |
| 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. | None | The addition of this Use
Authorization feature does not
affect the operating principle or
performance of the device and no
additional risks or hazards have
been identified related to this
change. |
| 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) |
Table 1: Summary of Technological Characteristics
2
| Electrical
Power | Internally powered with
rechargeable lithium ion
battery pack. Battery pack
charger mains input --
100-240V AC, 47/63 Hz,
output 12 V DC | Externally powered by
AC/DC power adapter.
Mains input --
100-240V AC, 50/60 Hz,
output 12 V DC | The SpringTMS and predicate
device utilize the 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) | 13 in. (33 cm) long
5 in. (13 cm) wide
5 in. (13 cm) deep
3.4 lb. (1.54 kg) | The form factor changes raise no
new 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
3
| Software Verification
Validation Testing | SpringTMS Software Testing | 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 and
Electrical Safety | Testing in accordance with
the following standards:
• IEC 60601-1:2005
• IEC 60601-1-2:2007 | 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. |
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.
4
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
5
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
6
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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