MeRT System
Device Facts
| Record ID | K260402 |
|---|---|
| Device Name | MeRT System |
| Applicant | Wave Neuroscience |
| Product Code | SIG · Neurology |
| Decision Date | Jun 3, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5802 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The MeRT System is intended to be used as a TMS system for neurological and psychiatric disorders and conditions.
Device Story
MeRT System (Magnetic EEG/ECG Resonance Therapy) uses MRT-005 software to analyze resting-state eyes-closed EEG/ECG data; derives personalized stimulation frequency (8-13 Hz) for TMS treatment. System components include MeRT software, TMS stimulator, motor threshold coil, and treatment coil. Used in clinical environments by healthcare providers. Software computes treatment parameters; transmits to compatible TMS device for delivery. TMS device applies electromagnetic pulses to dorsomedial prefrontal cortex. Personalized frequency aims to engage frequency-dependent neuromodulatory mechanisms to normalize brain function and reduce PTSD symptom severity. Benefits include non-pharmacological treatment option with favorable safety profile.
Clinical Evidence
Prospective, double-blind, randomized, sham-controlled pivotal trial (n=158; 77 active, 81 sham). Adults (≥18) with PTSD (CAPS-5 diagnosis, PCL-5 ≥30). Primary endpoint: PCL-5 improvement (p < 0.046). Secondary endpoint: CAPS-5 (p < 0.0006). Active group showed 27-point PCL-5 improvement vs. sham. Effect sizes: -0.32 (PCL-5) and -0.51 (CAPS-5). Remission rate at follow-up: 68.2% (active). No serious adverse events reported.
Technological Characteristics
Components: MeRT software (AWS cloud-hosted), TMS stimulator, figure-of-eight coil (dual windings, air core, 2x75mm). Energy: Electromagnetic, biphasic pulse, 290μs width. Cooling: Forced liquid, max 43°C. Connectivity: Cloud-based software interface to TMS hardware. Software: MRT-005 algorithm for personalized frequency derivation (8-13 Hz). Power: 110Vac, 20A.
Indications for Use
Indicated for use as an adjunct for the treatment of adult patients suffering from Post Traumatic Stress Disorder (PTSD).
Regulatory Classification
Identification
A transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is a prescription, non-implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808.
Special Controls
In combination with the general controls of the FD&C Act, the transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety. (2) Software verification, validation, and hazard analysis must be performed. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Magnetic pulse output testing; (ii) Magnetic and electrical field testing; (iii) Testing of the safety features built into the device; and (iv) Testing of the sound levels patients are exposed to during device use. (5) The physician and patient labeling must include the following: (i) The risks and benefits associated with use of the device; (ii) Detailed instructions to prevent seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and (iii) A description of the ear protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating.
Predicate Devices
- MagVenture TMS Therapy System (K251119)
Submission Summary (Full Text)
{0}
**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 3, 2026
Wave Neuroscience
Leslie Prichep, PhD
Chief Scientist
1601 Dove St.
Suite 205
Newport Beach, California 92660
Re: K260402
Trade/Device Name: MeRT System
Regulation Number: 21 CFR 882.5802
Regulation Name: Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions
Regulatory Class: Class II
Product Code: SIG
Dated: February 5, 2026
Received: February 6, 2026
Dear Dr. Prichep:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K260402 - Leslie Prichep, PhD
Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
{2}
K260402 - Leslie Prichep, PhD
Page 3
Sincerely,
ROBERT KANG -S
for Pamela Scott
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
{3}
# Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260402 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| MeRT System | | |
| Please provide your Indications for Use below. | | ? |
| The MeRT System is intended to be used as an adjunct for the treatment of adult patients suffering from Post Traumatic Stress Disorder (PTSD). | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
{4}
## 510(k) Summary
This summary of 510(k) safety and effectiveness is submitted in accordance with the requirements of 21 CFR §807.92.
**Sponsor:** Wave Neuroscience
1601 Dove St STE 205
Newport Beach, CA 92660**Contact:** Leslie S. Prichep, PhD, Chief Scientific Officer**Date Prepared:** **June 2, 2026***Trade Name:** MeRT System
**Common Name:** Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions**Classification:** II
**Regulation:** 21 CFR 882.5802
**Product Code:** SIG**Predicate Device:** K251119 MagVenture TMS Therapy System
### Description of Device:
The MeRT (Magnetic EEG/ECG Resonance Therapy) System has two components: the MRT-005 machine learning -derived algorithm designed to analyze resting-state eyes-closed electroencephalogram/electrocardiogram (EEG/ECG) data to derive personalized stimulation frequency parameters for use with the second component, Transcranial Magnetic Stimulation (TMS) devices.
The system derives a recommended individualized pulse rate within the range of 8-13 Hz. This personalized frequency parameter is then used to individualize the TMS treatment settings for neuromodulation.
MRT-005 software does not generate or apply magnetic stimulation but provides computed treatment parameters to a compatible legally marketed TMS device for delivery of treatment.
**Intended Use:** The MeRT System is intended to be used as a TMS system for neurological and psychiatric disorders and conditions.
MeRT System
510(k) Summary
1 of 10
{5}
**Indications for Use:** The MeRT System is intended to be used as an adjunct for the treatment of adult patients suffering from Post Traumatic Stress Disorder (PTSD).
# **Comparison to Predicate Device:**
The MeRT System has the same intended use and technological characteristics, and falls within the same 21 CFR § 882.5802 regulation as the predicate device, MagVenture TMS Therapy System for OCD (K251119). Both the predicate and subject devices have the same technological characteristics related to the associated TMS stimulator, electromagnetic coil, articulated arm (for positioning of the treatment coil) and proprietary software. Further, the operational aspects associated with patient treatment, including system setup, patient preparation, motor threshold determinations, coil positioning and predefined treatment stimulation parameters are essentially the same. In regard to the MeRT System’s indications for use, post-traumatic stress disorder (“PTSD”) is a neurological and psychiatric disorder or condition, as is obsessive compulsive disorder (“OCD”) associated with the predicate device’s indications for use. There is extensive evidence of similar underlying neurophysiological mechanisms of action in the two disorders, suggesting the potential for similar response to neuromodulation. The differences in design and indications for use when comparing the MeRT System and the cited predicate are not significant and do not result in differing questions of safety and effectiveness. As can be seen in the table below, the identical performance specifications can be found in the TMS Stimulator, coils for motor threshold determination and treatment coil, power source, pulse type, pulse width, cooling, max coil temperature, peak magnetic field strength, peak magnetic field gradient. Differences in performance specifications arise in the treatment protocol pulse rate per session, as the subject device personalizes the treatment protocol introducing individualized selection which results in delivery of a range of pulses per session dependent on the derived personalized treatment pulse rate. All special controls associated with 21 CFR § 882.5802 have been fulfilled and the safety and effectiveness of the MeRT System is supported by outcomes of the Randomized Controlled Trial.
A comparison of the subject and predicate devices is presented in the following table.
A comparison of the subject and predicate devices
| Element of Comparison | Subject Device: MeRT System K260402 | MagVenture TMS Therapy System for OCD K251119 | Comparison to Predicate |
| --- | --- | --- | --- |
| **ELEMENTS OF INTENDED USE** | | | |
| Intended Use | Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions | Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions. | Same |
MeRT System
510(k) Summary
2 of 10
{6}
| Indications for Use | The MeRT System is intended to be used as an adjunct for the treatment of adult patients suffering from Post Traumatic Stress Disorder (PTSD). | The MagVenture TMS Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). | Similar, PTSD and OCD are both neurological or psychiatric disorders or conditions. Each indication is supported by clinical evidence of neuromodulation and there are no new questions of safety or effectiveness. Clinical evidence of effectiveness, combined with verification and validation data fulfill the special controls and support substantial equivalence. |
| --- | --- | --- | --- |
| Prescription or OTC | Prescription (Rx) use only | Prescription (Rx) use only | Same |
| Use Environment | Healthcare (Clinical) environment | Healthcare (Clinical) environment | Same |
| TMS Delivery | Delivered by MagVenture TMS device, controlled by system software configured per MRT-005 algorithm derived treatment protocol, operating within the MagVenture range of parameters. | Delivered by MagVenture TMS device, controlled by system software within range of predefined treatment parameters. | Same, both systems are controlled by system software to deliver TMS treatment. The subject device introduces an algorithm to derive recommended treatment protocols used to configure the TMS device to deliver treatment within the equipment's inherent range of treatment parameters. |
| Target Population | Adult | Adult | Same |
| Treatment Schedule | Weeks 1-5: 1 Treatment session per day for 5 days Total 20-25 treatment sessions | Weeks 1-5: 1 Treatment session per day for 5 days Total 25 treatment sessions Week 6: 1 treatment session per day for 4 days | Same. Identical for weeks 1-4, for a total of 20-25 sessions. The predicate uses an additional week of 4-8 sessions. |
MeRT System
510(k) Summary
3 of 10
{7}
| | | Total 4-8 additional sessions | |
| --- | --- | --- | --- |
| Area of the brain to be stimulated | Dorsomedial prefrontal cortex | Left Dorsomedial prefrontal cortex | Same. MeRT is midline stimulation of the same regions as the predicate device. |
| **TECHNOLOGICAL CHARACTERISTICS** | | | |
| Main System Components | - MeRT software (web application, driver) - TMS Stimulator with system software and GUI - Coil for motor threshold determination - Treatment coil | - TMS Stimulator with system software and GUI - Coil for motor threshold determination - Treatment coil | Same. MeRT System adds the MeRT software components. The MeRT System's compatible TMS Stimulator, coils for motor threshold determination and treatment coil are identical to the predicate device. |
| Treatment Protocol Pulse Rate | Personalized TMS pulse rate (8–13 Hz) via derivation from EEG analysis | Fixed 10 Hz protocol or Fixed theta burst (3 pulses at 50Hz) | Similar – The subject device personalizes the treatment protocol within a range, while the predicate device delivers a fixed treatment frequency. Pulse rate range of the MeRT System is within range of the predicate TMS capabilities (0.1-30 for MagPro R30 and 0.1-100 for MagPro X100 Hz); MeRT System introduces individualized selection to enhance clinical targeting. |
| Magnetic field intensity | 80% of MT | 100% of MT | Similar. The magnetic field intensity of the subject device is below that of the predicate. |
| Repetition Rate | 8-13 Hz | 10 Hz | Similar |
| Train duration | 6 sec | 4 sec | Similar |
| Inter-train interval | 54 sec | 26 sec | Similar |
| No. Of trains | 30 | 75 | Similar |
| Pulses per session | 1440-2340 | 3000 | Similar. MeRT System has a range of pulses per session dependent on the |
MeRT System
510(k) Summary
4 of 10
{8}
| | | | personalized treatment frequency. |
| --- | --- | --- | --- |
| Session duration | 30 min | 36.5 min | Similar |
| Coil Type | Figure-of-eight design with dual windings and an air core. | Figure-of-eight design with dual windings and an air core. | Same |
| Windings | 2x75mm | Depending on coil variant: 2x75mm 2x97mm 2x95mm | Same |
| Pulse type | Biphasic | Biphasic | Same |
| Pulse width | 290μs (±5%) | 290μs (±5%) | Same |
| Cooling | Forced liquid cooling | Forced liquid cooling | Same |
| Max coil temperature | 43°C | 43°C | Same |
| Power Source | Power supply Mobile console: 110Vac, 20A | Power supply Mobile console: 110Vac, 20A | Same |
| Frequency range at 100% | 8-13Hz | R30: 0.1-30 Hz X100: 0.1-100 Hz | Same. The MRT-005 algorithm recommended treatment protocol pulse frequency is within the range of the predicate device. |
| Range of % MT | 80% | 0-140% | Same. The MeRT System range of %MT is within the range of the predicate device. |
| Pulse train duration range (sec) | 6 | 1-33 | Similar, well within the range of stimulation of the predicate device. |
| Available stimulation in terms of SMT | Range from 0-2.2 SMT depending on coil capabilities | Range from 0-2.2 SMT depending on coil capabilities | Same |
| Peak magnetic field strength (T) at a depth of 2 cm | Range from 0.46-0.55T depending on coil capabilities | Range from 0.46-0.55T depending on coil capabilities | Same |
MeRT System
510(k) Summary
5 of 10
{9}
| Peak magnetic field gradient dB/dt (kT/s) at a depth of 2cm | Range from 9-12 kT/s depending on coil capabilities | Range from 9-12 kT/s depending on coil capabilities | Same |
| --- | --- | --- | --- |
| EEG Integration + TMS Protocol | EEG data integrated for personalized frequency | Fixed EEG frequency data, not personalized | Similar. Personalized EEG/ECG data represents additional information upon which treatment is based. Personalized EEG/ECG-driven protocol introduces no new risks; validated through software verification and clinical rationale and demonstrated in clinical study. |
| Output | Delivers TMS stimulation. | Delivers TMS stimulation | Same, both systems deliver TMS stimulation. |
| Cloud Hosting Environment | AWS Cloud | On-device hardware | Different – MeRT is cloud-based with secure, validated infrastructure; predicate is hardware-integrated. |
| Cybersecurity | Encrypted data, HIPAA-compliant cloud services | Not applicable | MeRT addresses cybersecurity via best practices; not relevant to predicate device design. |
| Algorithm | Proprietary IAF detection and frequency selection derived from EEG | Not applicable | Adds decision-support capability; validated and tested for safe implementation and clinically tested for safety and effectiveness. |
| Interoperability | Interfaces with compatible legally marketed TMS devices | Self-contained TMS system | MeRT requires interoperability between the MeRT software components to the compatible TMS system; predicate device contains integrated components. Interoperability is demonstrated through verification and validation. |
| Clinical Target | PTSD symptom reduction (e.g., PCL-5 improvement) | OCD symptom reduction (e.g., Y-BOCS) | Same – PTSD and OCD are neurological and psychiatric disorders and conditions, with the same underlying pathophysiology. Both devices target patients in |
MeRT System
510(k) Summary
6 of 10
{10}
| | | | this population to decrease symptoms. |
| --- | --- | --- | --- |
| TMS Patient Contacting Components | Coil in contact with scalp | Coil in contact with scalp | Same |
| EEG Patient Contacting Components | EEG headset and electrodes | Not applicable | The MRT-005 algorithm assesses an EEG file, acquired using a legally marketed EEG device, to generate recommended personalized TMS treatment protocol. |
| Software Validation | IEC 62304 compliant, fully validated | IEC 62304 compliant, fully validated | Same – MeRT System and the TMS device both follow standard software lifecycle and risk management processes. |
| Safety & Performance Data | Clinical performance, interoperability, algorithm validation | Electromagnetic and clinical testing | Same – Both demonstrate safety and effectiveness within non-clinical and clinical workflows. |
### Nonclinical Testing Summary:
The following performance data are provided in support of the substantial equivalence determination between the subject device, MeRT System, to the predicate device, K251119 MagVenture TMS Therapy System.
- Software verification and validation
- Integration testing demonstrates interoperability between MeRT software and compatible TMS devices
- Electrical Safety and Electromagnetic Compatibility Evaluation
- Usability Evaluation
### Clinical Testing Summary:
A Prospective, Double Blind, Randomized Sham-Controlled, Clinical Trial to Evaluate the Safety and Effectiveness of Biometrics-Guided Magnetic EEG-Resonance Therapy (MeRT) Treatment of Post-Traumatic Stress Disorder
The escalating prevalence of Post-Traumatic Stress Disorder (PTSD) in both military and civilian populations has become a critical public health issue. Currently, the standard of care for treatment of PTSD includes pharmacological and psychotherapeutic interventions; however, these demonstrate only modest effectiveness and are frequently associated with treatment-limiting adverse effects. At present, there is no FDA-cleared medical device for PTSD that has the rigor of
MeRT System
510(k) Summary
7 of 10
{11}
a double-blind, randomized, sham-controlled trial to treat this debilitating condition. There is an urgent need for innovative, effective, non-pharmacologic treatment options for PTSD patients that offer favorable safety profiles compared with pharmacologic approaches to address this underserved patient population. In November 2024, Wave Neuroscience received FDA Breakthrough Device Designation, recognizing the potential for treatment with the MeRT (Magnetic EEG/ECG Resonance Therapy) System to address this unmet need.
The MRT-005 algorithm derives the individual's alpha pulse rate using EEG/ECG data with the goal of enhancing clinical targeting. This approach individualizes TMS parameters based on endogenous oscillatory characteristics as identified by the MRT-005 algorithm. By aligning stimulation frequency with each individual's alpha pulse rate using the MRT-005 algorithm, the system is designed to engage frequency-dependent neuromodulatory mechanisms and support normalization of brain function patterns and decrease symptom severity associated with PTSD. The pivotal trial was designed to evaluate the safety and effectiveness of the MeRT System as a whole, and was not structured to isolate the independent contribution of EEG-guided frequency selection relative to TMS delivered at a fixed frequency. As such, the relative contribution of the individualized frequency parameter to the observed treatment outcomes was not part of the study design.
The safety and effectiveness of treatment with the MeRT System was evaluated in a recently completed multi-site double-blind, randomized, sham-controlled pivotal trial, the results of which were presented in support of FDA clearance. The trial included adults (≥18 years) with a diagnosis of PTSD using the CAPS-5 and with a symptom severity score ≥30 on the PCL-5. The Intention to Treat (ITT) population included 158 participants, 77 of whom were assigned to the active treatment group and 81 to the sham treatment group. The study protocol included 20-25 treatment sessions (active or sham). Overall, 84% of the participants completed treatment.
The analysis of results demonstrated that active treatment with MeRT led to a statistically significant improvement in PTSD symptom severity compared with sham treatment. Treatment effects were consistent across both self-administered and clinician-administered PTSD outcome measures: the PTSD Checklist for DSM-5 (PCL-5; p < 0.046) and the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; p < 0.0006). The PCL-5, a self-administered scale, was the study's primary outcome measure largely due to its ease of use across multiple time points. The CAPS-5 was used both to confirm PTSD diagnosis for study inclusion and as a prespecified secondary outcome measure of the change in PTSD symptom severity. Analysis of CAPS-5 results was performed after the primary PCL-5 endpoint showed statistical significance. In this study, the CAPS-5 showed an even stronger ability than the PCL-5 to demonstrate the significance of the treatment effect of the MeRT System.
MeRT System
510(k) Summary
8 of 10
{12}
The absolute magnitude of the active group pre-post treatment improvement (27 points) for the PCL-5 main outcome substantially exceeded the Department of Veterans Affairs, National Center for PTSD estimate of the minimal clinically important difference (MCID) of 8.5 to 12.5 points. The observed statistically significant differences between the active and sham groups represented a treatment effect size of approximately -0.32 in the PCL-5 and -0.51 in the CAPS-5 severity score. These are squarely within the upper range of the estimated treatment effect sizes for the two FDA-approved pharmacologic interventions for PTSD, which range from approximately -0.30 to -0.56.
Interpretation of clinical meaningfulness was informed by the FDA Patient Reported Outcomes guidance which states that clinically meaningful change thresholds are anchored at the individual level, defined as the smallest within-person change patients perceive as beneficial, and that are not intended as required between group differences. Consistent with this, the National Center for PTSD suggested PCL-5 point change threshold applies to within-person improvement in actively treated individuals, not between-group difference. In this trial, the magnitude of within-group improvement in the active treatment arm substantially exceeded established individual-level thresholds for clinically meaningful change.
Exploratory EEG analyses suggest a relationship between changes in posterior coherence and change in symptom severity in the active but not in the sham group, supporting changes in brain function in the active treatment group only. Post-hoc analyses demonstrated that the significant decrease in the PCL-5 score observed immediately post-treatment continued to improve during the follow-up period extending 2-4 months, supporting persistence of the effectiveness demonstrated in the active group. Additional post-hoc analyses defined remission using post-treatment CAPS-5 scores based on established criteria (as in K180173). Using this criteria, a significant difference was found between the active and sham groups (p < 0.008), with greater remission in the active group. At F2, 68.2% of participants in the active group met criteria for remission.
At the agency's suggestion, a post-hoc analysis of the relationship between outcome and pulse rate/session was conducted, dividing the full range of pulse rates derived for the active population into thirds (Low, Medium and High pulses/session groups). No significant differences were found between groups stratified by pulses/session for the PCL-5 or the CAPS; however, the Low pulse group (n=7) was underpowered, which limits conclusions in this subgroup. Importantly, the absence of a statistically significant treatment effect in this stratum should not be interpreted as evidence of equivalence between the individualized frequency (8-13 Hz) to a fixed frequency, as non-significance in an underpowered subgroup cannot be equated with established equivalence. The results of this post-hoc data analysis do not alter the overall safety and effectiveness conclusions from the Clinical Trial which was supported by the statistically significant results observed in the ITT population.
MeRT System
510(k) Summary
9 of 10
{13}
Post-hoc stratified analyses also revealed that the comparison of CAPS-5 outcomes between the High and Medium pulse frequency strata approached statistical significance (p=0.067). While this difference did not reach the conventional threshold for significance, it is reported here in the interest of a complete and transparent account of the stratified analyses. This finding does not alter the overall safety and effectiveness conclusions, which remain supported by the statistically significant results observed in the ITT population.
With respect to safety, there were no statistically significant differences between the active and sham treatment groups, with a similar number of participants reported Treatment-Emergent Adverse Events (TEAEs); and a similar total number of TEAEs reported in both treatment groups. There was no serious adverse event in this study. Based on zero serious adverse events in the active treatment group, the upper bound of the 95% confidence interval for the serious adverse event rate is estimated to be less than 4%.
The results of this trial support that treatment with the MeRT System is associated with statistically significant and clinically meaningful reductions in PTSD symptom severity, with a very favorable safety profile. These results highlight the potential of the MeRT System to add an innovative, safe, effective, non-pharmacological treatment option for the PTSD population.
### **Conclusions:**
The MeRT System and predicate device, MagVenture TMS Therapy System (K251119) are substantially equivalent with respect to intended use, safety and performance. All applicable special controls associated with 21 CFR § 882.5802 have been fulfilled and the safety and effectiveness of the MeRT System is supported by outcomes of the Randomized Controlled Trial. In accordance with 21 CFR § 807.100(b), the subject device and the predicate, cleared by FDA and legally marketed in the United States, are substantially equivalent.
MeRT System
510(k) Summary
10 of 10
