(95 days)
K182976 – SpringTMS
K161663 – sTMS mini
No
The summary describes a device that delivers a magnetic pulse for migraine treatment. There is no mention of AI, ML, or any data processing that would suggest the use of such technologies. The performance studies focus on the physical characteristics of the magnetic pulse and software validation related to device operation, not data-driven decision making or learning.
Yes
The device is indicated for the acute and prophylactic treatment of migraine headache, which is a therapeutic purpose.
No
The device is described as a therapy device for treating migraine headaches, not for diagnosing them. It delivers magnetic energy to induce an electrical current, which is a treatment mechanism.
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 that uses magnetic stimulation, not solely software.
No, the SAVI Dual™ Migraine Therapy device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SAVI Dual Function: The SAVI Dual device works by delivering a magnetic pulse to the head to treat migraine headaches. It does not analyze any biological samples from the patient.
The description clearly states that the device is a portable, hand-held device that delivers magnetic energy to the brain for therapeutic purposes. This falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
OKP
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.
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
adolescents (age 12 and older) and adults
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. 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
Non-Clinical Testing:
- Study Type: Performance Bench Testing
- Test Description: Magnetic Pulse Characteristics vs. Time
- Key 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.
- Test Description: Magnetic Pulse Field Map
- Key Results: No new issues of safety or efficacy have been raised. The Magnetic Pulse Field Maps for the subject device and the predicate device are substantially equivalent.
- Test Description: Location of 5 Gauss Line
- Key Results: No new issues of safety or efficacy have been raised. The location of the 5 Gauss line for the subject device and the predicate device are substantially equivalent.
- Study Type: Software Verification Validation Testing
- Test Description: SAVI Dual Software Testing
- Key Results: 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.
- Study Type: Electromagnetic Compatibility and Electrical Safety
- Test Description: Testing in accordance with the following standards: IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-11
- Key Results: The subject device met all acceptance criteria. No new issues of safety or efficacy have been raised. Therefore, the SAVI Dual is substantially equivalent to the predicate.
Key Metrics
Not Found
Predicate Device(s)
K182976 – SpringTMS
Reference Device(s)
K161663 – sTMS mini
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
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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)
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3
| Date Prepared: | 16-May-23 |
|---|---|
| eNeura® Inc | |
| 101 West Dickman St. | |
| Suite 900 | |
| Baltimore, MD 21230 | |
| Official Contact: | David Rosen - President and CEO |
| drosen@eneura.com | |
| 970-481-2492 | |
| 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 – SpringTMS |
| K161663 – sTMS mini |
Modification:
The subject device is similar to the predicate device except for:
- Hardware Modifications ●
- Software (firmware) updates
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.
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
| Feature | SAVI Dual™ Migraine
Therapy Device | SpringTMS®
Predicate Device | sTMS mini
Reference Device | Substantial
Equivalence
Rationale |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | eNeura, Inc. | eNeura, Inc. | eNeura, Inc. | -- |
| 510(k) Number | New Submission | K182976 | K161663 | -- |
| Indications for
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. | The eNeura Inc.
SpringTMS® is indicated
for the acute and
prophylactic treatment of
migraine headache in
adolescents (age 12 and
older) and adults. | The eNeura® sTMS mini
is indicated for the acute
treatment of pain
associated with migraine
headache with aura. | Indications for Use are
identical to the
predicate device. |
| 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 | 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) |
| 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. | 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. | Subject device allows
for a wireless
connection /
communication for
user to use the device
for the programmed
duration in addition to
the use of SIM chip.
No new issues of
safety or efficacy are
raised with this
change. |
| Display | LED indicators | LCD display | LED indicators | Subject device has the
same display as the
reference device. No
new issues of safety or
efficacy are raised
with this change. |
| Feature | SAVI Dual™ Migraine
Therapy Device | SpringTMS®
Predicate Device | sTMS mini
Reference Device | Substantial
Equivalence
Rationale |
| Magnetic Field | 0.9 Tesla Peak @ 180 µs
(total magnetic energy
140J) | 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 | 4 mA/cm2 induced at 1 cm | N/A (same) |
| Electrical Power | Internally powered with
rechargeable embedded
lithium ion battery pack.
Battery pack charger mains
input -100-240V AC,
50/60 Hz, output 12 V DC | Internally powered with
rechargeable embedded
lithium ion battery pack.
Battery pack charger mains
input -100-240V AC,
50/60 Hz, output 12 V DC | Internally powered with
rechargeable embedded
lithium ion battery pack.
Battery pack charger
mains input -100-240V
AC, 50/60 Hz, output 12
V DC | N/A (same) |
| Materials | Hand held portable
stimulator in
polycarbonate case
(integral coil) | Hand held portable
stimulator in
polycarbonate case
(integral coil) | Hand held portable
stimulator in
polycarbonate case
(integral coil) | N/A (same) |
| Environment of
Use | Home-use and where the
operator is | Home-use and where the
operator is | Home-use and where the
operator is | N/A (same) |
| Dimensions and
Weight | 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) | 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) | Subject device is
identical in size as the
reference device
(sTMS mini) No new
issues of safety or
efficacy are raised
with this change. |
| Compliance to
Standards | IEC 60601-1-2
IEC 60601-1
IEC 60601-1-11 | IEC 60601-1-2
IEC 60601-1
IEC 60601-1-11 | IEC 60601-1-2
IEC 60601-1
IEC 60601-1-11 | N/A (same) |
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 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 | ||
| subject device 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 | ||
| subject device and the predicate device are | ||
| substantially equivalent. | ||
| Software Verification | ||
| Validation Testing | SAVI Dual Software Testing | 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 and | ||
| Electrical Safety | Testing in accordance with | |
| the following standards: | ||
| • IEC 60601-1-1 | ||
| • IEC 60601-1-2 | ||
| • IEC 60601-1-11 | The subject device met all acceptance criteria. No | |
| new issues of safety or efficacy have been raised. | ||
| Therefore, the SAVI Dual is substantially | ||
| equivalent 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.