(95 days)
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 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.
The provided text describes the regulatory clearance for the SAVI Dual™ Migraine Therapy device and establishes its substantial equivalence to a predicate device (SpringTMS) and a reference device (sTMS mini). The focus is on non-clinical performance testing rather than clinical study results comparing device performance against specific disease metrics.
Therefore, the acceptance criteria and study information will be presented based on the available non-clinical testing data provided in the document.
Description of Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
The SAVI Dual™ Migraine Therapy device underwent non-clinical performance testing to demonstrate its substantial equivalence to the predicate device, SpringTMS (K182976), and a reference device, sTMS mini (K161663). The acceptance criteria were primarily focused on ensuring that the SAVI Dual maintained similar performance characteristics to the predicate device regarding its magnetic pulse output and safety standards, despite hardware and software modifications.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Magnetic Pulse Characteristics vs. Time | The SAVI Dual device was expected to have the same magnetic pulse specification as the predicate device (SpringTMS) and perform within that specification. The measured rate of change of the magnetic field should be substantially equivalent to the predicate. | Both SAVI Dual and the predicate device have the same specification for magnetic pulse shape, and both devices tested within specification. The measured rate of change of the magnetic field is substantially equivalent. No new issues of safety or efficacy have been raised. |
| Magnetic Pulse Field Map | The Magnetic Pulse Field Map for the SAVI Dual was expected to be substantially equivalent to that of the predicate device. | The Magnetic Pulse Field Maps for the subject device and the predicate device are substantially equivalent. No new issues of safety or efficacy have been raised. |
| Location of 5 Gauss Line | The location of the 5 Gauss line for the SAVI Dual was expected to be substantially equivalent to that of the predicate device. | The location of the 5 Gauss line for the subject device and the predicate device are substantially equivalent. No new issues of safety or efficacy have been raised. |
| Software Verification & Validation | The SAVI Dual software was expected to be tested against requirements of the Software Requirements Specification (SRS) and ensure device operations result in a magnetic pulse substantially equivalent to the predicate device. The testing should raise no new safety or efficacy issues. | 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 & Electrical Safety | The SAVI Dual device was expected to meet all acceptance criteria in accordance with the following standards: IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-1-11. The testing should raise no new safety or efficacy issues. | The subject device met all acceptance criteria for Electromagnetic Compatibility and Electrical Safety testing in accordance with IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-1-11. No new issues of safety or efficacy have been raised. Therefore, the SAVI Dual is substantially equivalent to the predicate. |
2. Sample size used for the test set and the data provenance
The document details non-clinical performance testing rather than testing on human subjects or clinical data sets for efficacy. Therefore, there is no stated sample size for a "test set" in the context of patient data. The "test set" in this context refers to the individual SAVI Dual™ devices or components that underwent the various non-clinical engineering and safety tests (e.g., magnetic pulse characteristics, software performance, EMC/electrical safety). The provenance of this data is from eNeura, Inc.'s internal testing facilities. The testing described is prospective, as it was performed on the proposed SAVI Dual device to support its regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of the provided document. The "ground truth" for non-clinical performance testing is established by engineering specifications, international consensus standards (e.g., IEC 60601 series), and direct comparison to the predicate device's measured performance. It does not involve human expert adjudication in the way clinical diagnostic studies do. The experts involved would be the engineers and technicians performing the tests and comparing the results to established physical and regulatory requirements.
4. Adjudication method for the test set
Not applicable. As described above, the "test set" refers to physical device characteristics and engineering performance, not interpretative medical decisions requiring adjudication by experts. Results are compared against specific quantitative thresholds and established standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The SAVI Dual™ Migraine Therapy device is a hardware device (transcranial magnetic stimulator), not an AI-powered diagnostic or interpretive tool. The provided document does not describe any MRMC studies or AI assistance in the context of its use.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The SAVI Dual is a therapeutic device that stimulates the brain. Its performance is evaluated based on its physical output (magnetic field characteristics) and safety, not as a standalone algorithm delivering a diagnosis or prediction without human interaction. While it has software/firmware, its "performance" in this context is its ability to produce the intended physical magnetic pulse, which was tested.
7. The type of ground truth used
The "ground truth" for the non-clinical performance testing (magnetic pulse characteristics, software function, electrical safety) was based on:
- Established engineering specifications and design requirements for the device.
- Measured performance of the legally marketed predicate device (SpringTMS) for comparative equivalence in magnetic field characteristics.
- International consensus standards for medical device safety and electromagnetic compatibility (IEC 60601 series).
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data. Its development involved engineering design and testing, not machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
§ 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.