(343 days)
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No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on controlled thermal waveforms and their interaction with the vestibular system, with no mention of adaptive algorithms or learning capabilities.
Yes
The device is indicated for the prophylactic treatment of episodic migraine, which is a therapeutic purpose.
No
Explanation: The device is described as "indicated for the prophylactic treatment of episodic migraine," which signifies a therapeutic rather than a diagnostic purpose. It stimulates the vestibular system to treat, not to detect or diagnose.
No
The device description explicitly states it consists of hardware components: an over-the-ear Headset, a Control Unit with a resistive touchscreen display, and a power cord. It also mentions optional hardware accessories.
Based on the provided information, this 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 about a person's health.
- Device Function: The TNM Device directly interacts with the patient's body by stimulating the vestibular system using thermal waveforms. It does not analyze any biological samples.
- Intended Use: The intended use is for the prophylactic treatment of episodic migraine, which is a therapeutic application, not a diagnostic one based on analyzing samples.
Therefore, the TNM Device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The TNM Device is intended to stimulate the vestibular system using tightly controlled thermal waveforms. The TNM Device is indicated for the prophylactic treatment of episodic migraine in adolescent and adult patients 12 years or older.
Product codes (comma separated list FDA assigned to the subject device)
QAR
Device Description
The TNM Device is a non-invasive, home-use, DC-powered medical device that consists of an over-the-ear Headset with earpieces that protrude into the external ear canals, a Control Unit with resistive touchscreen display, and a power cord. Optional accessories include a wedge pillow to support reclining during each treatment in place of a firm pillow, a stylus pen that can be used in place of a fingertip to interact with the display and prism spectacles that may be worn to enable reading and other visual relaxation activities during treatment.
The TNM device uses a set of controlled thermal waveforms delivered to the anodized aluminum earpieces. The fluctuations interact with the patient's vestibular system, causing changes which can be used to treat migraine headaches.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Ear
Indicated Patient Age Range
adolescent and adult patients 12 years or older
Intended User / Care Setting
Home-use, prescription device.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Scion NeuroStim, LLC conducted a multi-center, triple-blinded, placebo-controlled, randomized pivotal study for adjunctive prophylactic treatment of episodic migraine headache. The study included patients age 18-65 years of age with 4-14 attacks per month, diagnosed with episodic migraine headache at least six months prior to enrollment. The migraine diagnosis was consistent with the International Classification of Headache Disorders-II (ICHD-II) guidelines. Subjects must have had at least three consecutive months of stable migraine headaches, no changes in medication usage for three months leading up to the study, and no new medications introduced during the study. If subjects were already taking a prophylactic migraine medication they were allowed to continue medication as long as it met the criteria above (no changes in 3 months leading up the study, and no changes during study). There were no serious adverse events observed during the clinical study.
The study compared an active treatment group to a placebo treatment group. The active treatment involved a standardized CVS time-varving waveform lasting approximately 19 minutes, administered twice daily with the two daily treatments separated by at least one hour. The waveform schedule for active treatment patients consisted of a warm sawtooth delivered to one ear and a cold sawtooth delivered to the other ear. The warm sawtooth fluctuated from body temperature to 42 °C, and the cold sawtooth fluctuated from body temperature to 17 °C. The two waveforms were delivered simultaneously, but with different oscillation frequencies. After each two-day period, the warm and cold waveforms were switched so that the opposite ears will be treated with the different thermal vestibular stimulation. The placebo treatment involved a standardized CVS time-varving waveform lasting approximately 4 minutes, administered twice daily with the two daily treatments separated by at least one hour. The waveform schedule for placebo treatment patients consisted of turning on the cooling fans and leaving the earpieces unpowered for a ~4-minute period. The earpiece tips were covered with EVA rubber to prevent cooling of the ear canal by the metallic earpieces.
Primary Efficacy Endpoint: For active-treatment subjects as a group: During the third Month of the Treatment Period, their average total number of Monthly Migraine Headache Days will be lower than their comparable averages derived from the Pre-Treatment Baseline Period.
Results for Primary Outcome (Excluding Subjects >15 Monthly Headaches):
- Active group (n=28) baseline migraine days: 7.4 ± 0.5, third month: 3.8 ± 0.5, Change: -3.6 ± 0.7 (95% CI: -5.0 to -2.3).
- Placebo group (n=18) baseline migraine days: 6.7 ± 0.7, third month: 5.8 ± 1.0, Change: -0.9 ± 0.7 (95% CI: -2.3 to 0.5).
- Difference between groups: 2.8 (Per protocol), -2.4 (Intention-to-treat).
- Comparison between groups, p-value: 0.0142 (Per protocol), 0.0246 (Intention-to-treat).
Secondary Efficacy Endpoints:
- The number of active-treatment subjects having a reduction of 50% or more in Migraine Headache Days during the third Month of the Treatment Period as compared with the Pre-Treatment Baseline Period will exceed the number of placebo-treatment patients having that response rate.
- For active-treatment subjects as a group: During the third Month of the Treatment Period, their average Total Monthly Headache Pain Scores will be lower than their comparable averages derived from the Pre-Treatment Baseline Period.
- For active-treatment subjects as a group: During the third Month of the Treatment Period, their average number of Treated Headaches will be lower than their comparable averages derived from the Pre-Treatment Baseline Period.
- For active-treatment subjects as a group: On average, in comparison with their Pre-Treatment Baseline Period, they will have at the end of the Treatment Period, improvement in scores associated with the Quality of Life and Cognition Assessment measures.
Results for Secondary Outcomes (Excluding Subjects >15 Monthly Headaches):
- Percentage of responders (>50% reduction in monthly migraine days): Active: 57.1% (per protocol), 52.9% (ITT). Placebo: 33.3% (per protocol and ITT). Comparison p-value: 0.1146 (per protocol), 0.1772 (ITT).
- % reduction (baseline vs. third month of treatment): Active: -46.1% ± 7.3% (per protocol), -40.8% ± 7.6% (ITT). Placebo: -13.5% ± 14.2% (per protocol and ITT). Comparison p-value: 0.0336 (per protocol), 0.0677 (ITT).
- Total monthly headache pain scores (change from baseline to third month): Active: -21.3 ± 4.1 (per protocol), -18.7 ± 3.8 (ITT). Placebo: -8.9 ± 3.3 (per protocol and ITT). Comparison p-value: 0.0382 (per protocol), 0.0966 (ITT).
- Acute anti-migraine prescription drug intake (change from run-in to third month): Active: -3.7 ± 0.7 (per protocol), -3.4 ± 0.6 (ITT). Placebo: -1.4 ± 0.8 (per protocol), -1.3 ± 0.8 (ITT). Comparison p-value: 0.0195 (per protocol), 0.0464 (ITT).
Safety Endpoint: The principal safety endpoint for the Study is to verify the absence of material dizziness, with the associated risk of falls, as a consequence of using the active-treatment device. The Berg Balance test was used to assess any changes in balance performance as a result of device usage. Transient nausea and minor dizziness were experienced by some patients, as is sometimes reported in the diagnostic CVS literature. No serious adverse events were observed.
The results showed improvement in migraine headache days and in migraine headache pain in the active treatment group.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics described in "Summary of Performance Studies" section above include:
- Change in migraine days
- Percentage of responders (reduction of 50% or more in Migraine Headache Days)
- Percent reduction in monthly migraines
- Change in Total Monthly Headache Pain Scores
- Change in acute anti-migraine prescription drug intake
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.
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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.
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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).
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§ 882.5893 Thermal vestibular stimulator for headache.
(a)
Identification. The thermal vestibular stimulator for headache is a prescription device used to stimulate the vestibular system by applying thermal waveforms through earpieces placed in a patient's ear canal for the treatment of headache.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Performance testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety.
(3) The technical parameters of the device, including waveform outputs and temperature limits, must be identified.
(4) Cleaning validation of earpieces must be conducted.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include the following:
(i) Information on how the device operates and the typical sensations experienced during treatment;
(ii) A detailed summary of the device's technical parameters; and
(iii) Instructions for maintenance and cleaning of the device.
0
DE NOVO CLASSIFICATION REQUEST FOR ThermoNeuroModulation (TNM) Device
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Thermal vestibular stimulator for headache. A thermal vestibular stimulator for headache is a prescription device used to stimulate the vestibular system by applying thermal waveforms through earpieces placed in a patient's ear canal for the treatment of headache.
NEW REGULATION NUMBER: 21 CFR 882.5893
CLASSIFICATION: II
PRODUCT CODE: QAR
BACKGROUND
DEVICE NAME: ThermoNeuroModulation Device
SUBMISSION NUMBER: DEN170023
DATE OF DE NOVO: April 18, 2017
Scion NeuroStim, LLC CONTACT: 3105 Cone Manor Lane Raleigh, NC 27613
INDICATIONS FOR USE
The TNM Device is intended to stimulate the vestibular system using tightly controlled thermal waveforms. The TNM Device is indicated for the prophylactic treatment of episodic migraine in adolescent and adult patients 12 years or older.
LIMITATIONS
For prescription use only.
The safety and effectiveness of this device has not been demonstrated in the following patient populations:
- history of cardiovascular disease;
- active and unstable mood or anxiety disorders; ● patients with active ear infections of a perforated tympanic membrane (eardrum).
1
The TNM device should not be used by pregnant women.
The long-term effects of using the TNM device are unknown.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The TNM Device is a non-invasive, home-use, DC-powered medical device that consists of an over-the-ear Headset with earpieces that protrude into the external ear canals, a Control Unit with resistive touchscreen display, and a power cord. Optional accessories include a wedge pillow to support reclining during each treatment in place of a firm pillow, a stylus pen that can be used in place of a fingertip to interact with the display and prism spectacles that may be worn to enable reading and other visual relaxation activities during treatment.
Image /page/1/Picture/5 description: The image shows a ThermoNeuroModulation (TNM) device and its components. The device includes a handheld unit with a screen, a pair of headphones, and a power adapter. The components are arranged on a white surface, with the handheld unit in the center and the headphones and power adapter on either side. The cables connecting the components are visible and create a slightly cluttered appearance.
Figure 1: ThermoNeuroModulation Device Components
2
The TNM device uses a set of controlled thermal waveforms delivered to the anodized aluminum earpieces. The graph below indicates the thermal fluctuation delivered to the ear pieces on each side (left and right) of the headset. The fluctuations interact with the patient's vestibular system, causing changes which can be used to treat migraine headaches.
Image /page/2/Figure/1 description: The image shows a graph titled "Figure 2: Thermal Waveforms of TNM Device". The graph plots temperature in degrees Celsius on the y-axis against time in minutes on the x-axis, ranging from 0 to 20 minutes. There are four lines plotted: "L target", "L actual", "R target", and "R actual", showing the target and actual temperatures for the left and right sides of the device. The "L actual" and "L target" lines oscillate between approximately 17 and 40 degrees Celsius, while the "R actual" and "R target" lines oscillate between approximately 37 and 43 degrees Celsius.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The TNM device is considered a limited duration (≤ 24 hrs) intact skin contacting device. The FDA guidance document entitled "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" recommends cytotoxicity, sensitization, and irritation or intracutaneous reactivity tests for intact skin contacting devices with limited duration (15 Monthly Headaches
Table 5: Secondary Outcomes Excluding Subjects >15 Monthly Headaches
| Per protocol | Intention-to-treat** | ||||
|---|---|---|---|---|---|
| Active | Placebo | Active | Placebo | ||
| n | 28 | 18 | 34 | 18 | |
| Percentage of responders (reduction in monthly migraine days from baseline to third treatment month) | |||||
| Responders (>50% reduction) | 16 (57.1%) | 6 (33.3%) | 18 (52.9%) | 6 (33.3%) | |
| Comparison between the 2 groups. p | 0.1146 | 0.1772 | |||
| % reduction (baseline vs. third month of | |||||
| treatment) | -46.1% ± | ||||
| 7.3% | -13.5% ± | ||||
| 14.2% | -40.8% ± | ||||
| 7.6% | -13.5% ± | ||||
| 14.2% | |||||
| Comparison between the 2 groups, p | 0.0336 * | 0.0677 | |||
| Total monthly headache pain scores (baseline compared to third month of treatment) | |||||
| Total pain baseline month | 45.8 ± 3.7 | 35.7 ± 4.1 | 44.4 ± 3.3 | 35.7 ± 4.1 | |
| Total pain third month | 24.5 ± 2.9 | 26.7 ± 3.5 | 25.6 ± 2.7 | 26.7 ± 3.5 | |
| Change from baseline to third month | -21.3 ± 4.1 | -8.9 ± 3.3 | -18.7 ± 3.8 | -8.9 ± 3.3 | |
| 95% confidence interval | -29.7 to -12.9 | -15.9 to -1.9 | -29.0 to -6.0 | -15.9 to -1.9 | |
| Comparison between the 2 groups. p | 0.0382 * | 0.0966 | |||
| Acute anti-migraine prescription drug intake (baseline compared to third month of treatment) | |||||
| n (subjects that took antimigraine prescription | 24 | 16 | 29 | 16 |
10
| drugs) | ||||
|---|---|---|---|---|
| Acute anti-migraine drugs intake (baseline) | 7.3 ± 0.9 | 5.5 ± 1.6 | 7.3 ± 0.7 | 5.5 ± 1.6 |
| Acute anti-migraine drug intake third month | 3.6 ± 0.6 | 4.1 ± 1.5 | 3.9 ± 0.6 | 4.1 ± 1.5 |
| Change from run-in to third month | -3.7 ± 0.7 | -1.4 ± 0.8 | -3.4 ± 0.6 | -1.3 ± 0.8 |
| 95% confidence interval | -5.1 to -2.4 | -3.0 to -0.2 | -5.1 to -2.4 | -5.1 to -2.4 |
| p | 0.0195 * | 0.0464 * | ||
| * p |