(68 days)
The eNeura® sTMS mini is indicated for the acute treatment of pain associated with migraine headache with aura.
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.
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.
§ 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.