(160 days)
The Ultimate rTMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.
The Ultimate rTMS is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Major Depressive Disorder.
It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions.
The Ultimate rTMS principle of operation is based on the discharge of high voltage capacitor through stimulation coil; the pulsed magnetic field generated by the discharge current penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons.
Area of the brain to be simulated for MDD treatment is Left Dorsolateral Prefrontal Cortex.
This 510(k) clearance letter details the substantial equivalence of the Ultimate rTMS device to its predicate devices, Mag Vita TMS Therapy System. The provided information primarily focuses on non-clinical performance and technological comparisons, rather than a clinical trial with human subjects. Therefore, some information requested in your prompt regarding clinical study elements (like sample size for test sets, ground truth establishment for test sets, expert adjudication, or MRMC studies) is not explicitly detailed or applicable in the provided document.
Here's the breakdown of the acceptance criteria and the study (non-clinical performance tests) that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed in a separate table, but rather implied through the "Equivalence Comments" in the "Technological Comparison" and the "Non-clinical and/or Clinical Tests Summary & Conclusions" sections. The core acceptance criterion is substantial equivalence to the predicate devices, meaning the Ultimate rTMS device performs similarly and does not raise new safety or effectiveness concerns.
Here's a table summarizing the key performance metrics and their comparison to predicates, which serve as the "acceptance criteria" through equivalence:
| Criteria | Acceptance Criteria (Equivalent to Predicate) | Reported Ultimate rTMS Performance |
|---|---|---|
| Magnetic Field Intensity (SMT units) | Comparable to predicate (e.g., 0-2.1 to 0-2.4 SMT range, with 1 SMT achieved at similar % intensity settings). | BY90A, BF90A, BY90B Coils: 0 – 2.4 SMT (41% intensity → 1 SMT). (Predicate MagVita: 0 – 2.1 SMT, 47% intensity → 1 SMT). Comment: Slightly lower intensity setting needed for Ultimate rTMS to achieve same induced current, indicating favorable performance. |
| Waveform | Biphasic sinusoid. | Biphasic sinusoid. |
| Active Pulse Width (µs) | Comparable to predicate (e.g., 290 µs ± 5% for MagVita) within typical variations among cleared TMS devices. | BY90A, BF90A, BY90B Coils: 320 µs ± 10%. (Predicate MagVita: 290 µs ± 5%). Comment: Difference is comparable to other cleared devices. Higher pulse width means lower intensity needed to reach MT, aligned with SMT comparison. |
| Max Magnetic Field Strength 2 cm (T) | Comparable values to predicate across intensity settings, with equivalent slope and intercept values. | At 25% Intensity: BY90A: 0.172 T, BF90A: 0.182 T, BY90B: 0.117 T. At 50% Intensity: BY90A: 0.291 T, BF90A: 0.287 T, BY90B: 0.244 T. At 75% Intensity: BY90A: 0.403 T, BF90A: 0.395 T, BY90B: 0.369 T. At 100% Intensity: BY90A: 0.498 T, BF90A: 0.494 T, BY90B: 0.481 T. (Predicates values provided for comparison). Comment: Values are in a narrow range and show equivalent behavior despite slight differences. |
| Max Initial dB/dt (kT/s) (near/2cm from coil) | Sufficiently close to predicate values. | Near Coil (z=0cm): BY90A: 13.44, BF90A: 13.76, BY90B: 12.10. 2cm from Coil (z=2cm): BY90A: 3.59, BF90A: 4.27, BY90B: 6.78. (Predicates values provided for comparison). Comment: Considered equivalent; differences compensated by differing % power for 120% MT. |
| Output Intensity Stability within Burst | Max change < 1% among pulses in a burst (essential for iTBS protocol). | BY90A: 0.563%, BF90A: 0.580%, BY90B: 0.679%. (Predicate C-B70: 0.615%). Comment: All coils show less than 1% variation, meeting the established requirement. |
| Coil Temperature Safety Feature | System automatically disabled when coil temperature exceeds a threshold (e.g., 41°C / 106°F for predicates). | Shuts down system when coil temperature exceeds 40°C (104°F). Comment: Provides slightly enhanced safety compared to 41°C for predicate. |
| Positioning Method Reliability | Based on direct relationship of cortical brain anatomy to scalp, and at least as effective as predicate. | "The reliability of the positioning method used by the subject device is based on the direct relationship of the underlying cortical brain anatomy to the patient's scalp, as is the method used in the predicate devices. The method for identifying the correct treatment position in the subject device is at least as effective as the method employed by the predicate device." |
| Safety and EMC Standards Compliance | Compliance with IEC 60601-1 and IEC 60601-1-2. Patient caps biocompatibility (exempt from ISO 10993-1). | Complies with IEC 60601-1:2005/(R)2012 and IEC 60601-1-2:2014. Patient caps are textile, exempt from ISO 10993-1. |
| Coil Material Safety | Equivalent materials and no additional safety concerns. | Copper tubing (GIS-C1100) and polycarbonate (Covestro Makrolon PC 2805). Comment: Equivalent to predicate materials, no additional safety concerns. |
| Coil Configuration | Figure-of-eight coil. | Figure-of-eight coil (BY90A, BF90A, BY90B). BY90B has 120° angle. Comment: Same figure-of-eight configuration across all coils. Differences are typical variations among manufacturers. |
| Coil Cooling | Equivalent cooling methods to predicates (liquid, forced air, or uncooled). | BY90A: Liquid cooling; BF90A: Forced Air cooling; BY90B: Liquid cooling. Comment: Equivalent to predicate options. |
Study Details (Non-Clinical Performance Tests)
The document refers to non-clinical performance tests rather than a clinical study with human participants. These tests were conducted to demonstrate the substantial equivalence of the Ultimate rTMS device to its predicate devices concerning its physical and electrical characteristics.
-
Sample Size Used for the Test Set and Data Provenance:
- Test Set: No specific "sample size" of devices or units is mentioned for the non-clinical tests. These are typically characterization tests performed on representative units of the device and its components (coils).
- Data Provenance: The data originates from internal tests conducted by Brain Ultimate, Inc., or its contracted labs, as indicated by the "Coils Test Report" mentioned. The country of origin is not explicitly stated but implied to be where Brain Ultimate, Inc. operates (Alpharetta, GA, United States). These are prospective engineering tests performed specifically for this 510(k) submission.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This question is not applicable as the "ground truth" for non-clinical performance tests is established by engineering and physics principles, not expert human interpretation of medical images or patient outcomes. The "ground truth" is typically the measured physical properties themselves, compared against established ranges or predicate device specifications.
-
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies where human experts interpret data (e.g., radiology reads) and their agreement/disagreement needs resolution. For non-clinical performance tests, measurements are taken by instruments, and compliance is determined by comparing measured values against predefined engineering specifications and predicate device data.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, this was not done. The document explicitly states "Non-Clinical and/or Clinical Tests Summary & Conclusions," and the subsequent details focus entirely on non-clinical performance (electric/magnetic field characteristics, safety standards, etc.). There is no mention of a human reader study or clinical effectiveness trial for the Ultimate rTMS device in this 510(k) summary. Therefore, an effect size of how human readers improve with AI vs. without AI assistance is not applicable here.
-
Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:
- Yes, in essence, the non-clinical performance studies represent a standalone evaluation. The device's physical and electrical characteristics are evaluated intrinsically, without human interaction influencing the outputs or measurements. The software mentioned (part of the TMS stimulator) enables the device's function, and its performance (e.g., maintaining pulse stability) is tested as part of the overall system.
-
Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" is objective physical measurements and established engineering parameters. These include:
- Measured electrical and magnetic field characteristics (amplitude, waveform, pulse width, field strength, dB/dt).
- Compliance with recognized international standards (IEC 60601-1, IEC 60601-1-2).
- Comparison to the established performance characteristics of the legally marketed predicate devices.
- For the non-clinical tests, the "ground truth" is objective physical measurements and established engineering parameters. These include:
-
Sample Size for the Training Set:
- Not applicable. This device is a hardware system, not an AI/ML algorithm that requires a "training set" of data in the conventional sense. The "knowledge" embedded in the device comes from engineering design, specifications, and physical principles, not machine learning from a dataset.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no "training set" or corresponding ground truth establishment process for a machine learning model. The device's functionality is based on its physical construction and control software.
FDA 510(k) Clearance Letter - Ultimate rTMS
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 17, 2025
Brain Ultimate, Inc.
℅ Barry Ashar
President
Makromed, Inc.
88 Stiles Road
Salem, New Hampshire 03079
Re: K243460
Trade/Device Name: Ultimate rTMS
Regulation Number: 21 CFR 882.5805
Regulation Name: Repetitive transcranial magnetic stimulation system
Regulatory Class: Class II
Product Code: OBP
Dated: March 20, 2025
Received: March 20, 2025
Dear Barry Ashar:
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" (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).
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K243460 - Barry Ashar Page 2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 systems (QS) regulation (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).
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K243460 - Barry Ashar 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K243460
Device Name: Ultimate rTMS
Indications for Use (Describe)
The Ultimate rTMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Page 5
Brain Ultimate, Inc., Traditional 510 (k)
Ultimate rTMS
Page 1 of 13
510(k) Summary
510(k) #: Prepared on: 2024-11-06
Contact Details
21 CFR 807.92(a)(1)
| Field | Value |
|---|---|
| Applicant Name | Brain Ultimate, Inc. |
| Applicant Address | 5910 Shiloh Road East Alpharetta GA 30005 United States |
| Applicant Contact Telephone | (770) 378-6785 |
| Applicant Contact | Mr. Frank Ge |
| Applicant Contact Email | Frank.Ge@brainultimate.com |
Device Name
21 CFR 807.92(a)(2)
| Field | Value |
|---|---|
| Device Trade Name | Ultimate rTMS |
| Common Name | Repetitive transcranial magnetic stimulation system |
| Classification Name | Transcranial Magnetic Stimulator |
| Regulation Number | 882.5805 |
| Product Code(s) | OBP |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | OBP |
| K171481 | Mag Vita TMS Therapy System | OBP |
Device Description Summary
21 CFR 807.92(a)(4)
The Ultimate rTMS is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Major Depressive Disorder.
It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions.
The Ultimate rTMS principle of operation is based on the discharge of high voltage capacitor through stimulation coil; the pulsed magnetic field generated by the discharge current penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons.
Area of the brain to be simulated for MDD treatment is Left Dorsolateral Prefrontal Cortex.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Ultimate rTMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.
Page 6
Brain Ultimate, Inc., Traditional 510 (k)
Ultimate rTMS
Page 2 of 13
Indications for Use Comparison
21 CFR 807.92(a)(5)
The subject device of this 510(k) submission has the exact same Indication for Use as that of the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
Introduction
The subject device, the Ultimate rTMS, and the predicate device, Mag Vita TMS Therapy System, (K173620) are computerized electromechanical medical devices that produce and deliver non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Major Depressive Disorder. Both devices have identical intended use / indication for use, identical treatment target and use identical treatment parameters of 19-minutes, 37-minutes and iTBS protocols.
Design
The design of the subject Ultimate rTMS device is similar to that of the predicate Mag Vita TMS Therapy System, as both systems are based on applying transcranial magnetic stimulation by means of repetitive pulse trains at a predetermined frequency. Both systems use the same mechanism of action, i.e., an electromechanical instrument that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the prefrontal cortex. Coils for subject Ultimate rTMS and the predicate device are of similar nature and share the same transducer design (figure-of-eight).
Operational Characteristics
For the subject Ultimate rTMS and its predicate device, their basic operational procedures including system setup, patient preparations, motor threshold determination, coil positioning and treatment with predefined treatment stimulation parameters are the same.
Technological Characteristics
Both the subject and predicate devices have similar components consisting of TMS stimulator with software, electromagnetic coil and a flexible arm for positioning of the treatment coil. The reliability of the positioning method used by the subject device is based on the direct relationship of the underlying cortical brain anatomy to the patient's scalp, as is the method used in the predicate devices. The method for identifying the correct treatment position in the subject device is at least as effective as the method employed by the predicate device.
Non-clinical Performance Characteristics
- Electrical/mechanical/thermal safety and electromagnetic compatibility of both the subject and predicate devices are in compliance with the following standards:
- IEC 60601-1:2005/(R)2012
- IEC 60601-1-2:2014
- Patient caps are the only accessory of this device that comes in contact with the patient's intact skin for a duration of less than 24 hours. As they are made of commonly used textile materials they are exempt from ISO 10993-1:2018 Biocompatibility testing per FDA's Guidance Document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", dated September 8, 2023.
- The characteristics of the electric and magnetic fields generated by the subject device's coils (BY90A, BF90A, and BY90B), including linearity of output, biphasic sinusoidal waveform, pulse width and intensity, magnetic field spatial distribution and magnetic field strength gradient, are equivalent to that of the predicate device.
- The subject device meets the same requirement as the predicate device that the actual individual stimuli of a theta burst are of equal intensity to ensure that a constant dose of stimuli is delivered during iTBS treatment (maximum 1% drop in machine output among the three stimuli in a burst).
Conclusion
The subject device is equivalent in its performance and does not introduce any new safety considerations in comparison to the predicate device. There are no identified differences between the subject device and the predicate that impact on safety or efficacy.
Page 7
Brain Ultimate, Inc., Traditional 510 (k)
Ultimate rTMS
Page 3 of 13
| Criteria | (Subject Device) Ultimate rTMS | (Primary Predicate) MagVita TMS Therapy System (K173620) | (Secondary Predicate) MagVita TMS Therapy System (K171481) | Equivalence Comments |
|---|---|---|---|---|
| Intended Use (Indication for Use) | The Ultimate rTMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. | The MagVita TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. | The MagVita TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. | Identical Indication for Use |
Recommended Standard Treatments
| Criteria | (Subject Device) Ultimate rTMS | (Primary Predicate) MagVita TMS Therapy System (K173620) | (Secondary Predicate) MagVita TMS Therapy System (K171481) | Equivalence Comments |
|---|---|---|---|---|
| Magnetic Field Intensity | 120% of the MT (iTBS, 19/37 mins protocols) | 120% of the MT (iTBS protocol) | 120% of the MT (19/37 mins protocol) | Identical recommended treatment parameters. The subject device provides iTBS, 19-min and 37-min protocols. The primary predicate device provides iTBS protocol. The secondary predicate device |
| Repetition Rate | 50 Hz / 10 Hz (iTBS, 19/37 mins protocols) | 50 Hz (iTBS protocol) | 10 Hz (19/37 mins protocols) | |
| Train duration | 2 sec / 4 sec (iTBS, 19/37 mins protocols) | 2 sec (iTBS protocol) | 4 sec (19/37 mins protocols) | |
| Inter-train interval | 8 sec / 11-26 sec (iTBS, 19/37 mins protocols) | 8 sec (iTBS protocol) | 11-26 sec (19/37 mins protocols) | |
| iTBS Burst | Burst Pulses: 3No. of Bursts: 200Inter-pulse: 20 msec | Burst Pulses: 3No. of Bursts: 200Inter-pulse: 20 msec | N/A | |
| Number of trains | 20 / 75 (iTBS, 19/37 mins protocols) | 20 (iTBS protocol) | 75 (19/37 mins protocols) |
Page 8
Brain Ultimate, Inc., Traditional 510 (k)
Ultimate rTMS
Page 4 of 13
| Criteria | (Subject Device) Ultimate rTMS | (Primary Predicate) MagVita TMS Therapy System (K173620) | (Secondary Predicate) MagVita TMS Therapy System (K171481) | Equivalence Comments |
|---|---|---|---|---|
| Magnetic Pulses per Session | 600 / 3000 (iTBS, 19/37 mins protocols) | 600 (iTBS protocol) | 3000 (19/37 mins protocols) | provides 19-min and 37-min protocols. |
| Treatment Session Duration | 3 min 09 sec / 19/37 min (iTBS, 19/37 mins protocols) | 3 min 09 sec (iTBS protocol) | 19/37 min (19/37 mins protocols) | |
| Treatment Schedule | 5 Sessions/Week for 6 Weeks | 5 Sessions/Week for 6 Weeks | 5 Sessions/Week for 6 Weeks | |
| Area of brain to be stimulated | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex |
Coils
| Criteria | (Subject Device) Ultimate rTMS | (Primary Predicate) MagVita TMS Therapy System (K173620) | (Secondary Predicate) MagVita TMS Therapy System (K171481) | Equivalence Comments |
|---|---|---|---|---|
| Coils | BY90ABF90ABY90B | Cool-B70 | C-B60C-B65 | N/A |
| Configuration | BY90A：Figure-of-eight coilBF90A：Figure-of-eight coilBY90B：Figure-of-eight coil With angle 120° | Figure-of-eight coil | Figure-of-eight coil | Same figure-of-eight configuration in all coils. See Note A. |
| Materials of Construction | Coil windings: copper tubing (commercial brand GIS-C1100)Coil housing: polycarbonate (commercial brand Covestro Makrolon PC 2805) | Coil windings: copper tubing (commercial brand unknown)Coil housing: polycarbonate (commercial brand unknown) | Coil windings: copper tubing (commercial brand unknown)Coil housing: polycarbonate (commercial brand unknown) | Equivalent, with no additional concerns for safety and effectiveness. |
| Core material | Air core | Air core | Air core | Same core material design. |
Page 9
Brain Ultimate, Inc., Traditional 510 (k)
Ultimate rTMS
Page 5 of 13
| Criteria | (Subject Device) Ultimate rTMS | (Primary Predicate) MagVita TMS Therapy System (K173620) | (Secondary Predicate) MagVita TMS Therapy System (K171481) | Equivalence Comments |
|---|---|---|---|---|
| Cooling | BY90A:Liquid coolingBF90A:Forced Air coolingBY90B:Liquid cooling | Cool-B70: Liquid cooling | C-B60: NoneC-B65: Liquid cooling | Equivalent. The subject and secondary predicate devices offer liquid-cooled and forced air-cooled or uncooled coils. Primary predicate device offers liquid-cooled coil. |
Coil parameters
| Criteria | (Subject Device) Ultimate rTMS | (Primary Predicate) MagVita TMS Therapy System (K173620) | (Secondary Predicate) MagVita TMS Therapy System (K171481) | Equivalence Comments |
|---|---|---|---|---|
| BY90A | Inner diameter - 34 mmOuter diameter - 85 mmN = 2 wings x 2 layers x 5 turns | Coil Cool-B70Inner diameter - 35 mmOuter diameter - 75 mmN = 2 wings x 2 layers x 5 turns | Coil C-B60Inner diameter - 35 mmOuter diameter - 75 mmWinding height - 12 mmN = 2 wings x 2 layers x 5 turns | Equivalent, with no additional concerns for safety and effectiveness. See Note A for equivalence explanation of coil parameters such as dimensions and windings. |
| BF90A | Inner diameter - 34 mmOuter diameter - 85 mmN = 2 wings x 2 layers x 5 turns | Coil Cool-B65Inner diameter - 35 mmOuter diameter - 75 mmWinding height - 12 mmN = 2 wings x 2 layers x 5 turns | ||
| BY90B | Inner diameter - 30 mmOuter diameter -90 mmN = 2 wings x 2 layers x 6 turns |
Page 10
Brain Ultimate, Inc., Traditional 510 (k)
Ultimate rTMS
Page 6 of 13
Machine Output Parameters
| Criteria | (Subject Device) Ultimate rTMS | (Primary Predicate) MagVita TMS Therapy System (K173620) | (Secondary Predicate) MagVita TMS Therapy System (K171481) | Equivalence Comments |
|---|---|---|---|---|
| Amplitude in Standard Motor Threshold (SMT) units | 0 – 2.441% Intensity Setting → 1 SMT | 0 – 2.147% Intensity Setting → 1 SMT | 0 - 1.758.8% Intensity Setting → 1 SMT | Equivalent, with no additional concerns for safety and effectiveness. See Note B for equivalence explanation of Intensity/Amplitude. |
| Waveform | Biphasic sinusoid | Biphasic sinusoid | Biphasic sinusoid | Identical waveform. |
| Active pulse width (μs) | 320 | 290 | 290 | Equivalent, with no additional concerns for safety and effectiveness. See Note C for equivalence explanation of Pulse Width and Amplitude. |
| Pulse amplitude (V) | BY90A: 1.35BF90A: 1.26BY90B: 1.22 | C-B70: 1.88 | C-B65: 1.84 | |
| Max magnetic field strength 2 cm from coil (T) | At 25% Intensity:BY90A: 0.172BF90A: 0.182BY90B: 0.117At 50% Intensity:BY90A: 0.291 | At 25% Intensity:C-B70: 0.144At 50% Intensity:C-B70: 0.283 | At 25% Intensity:C-B65: 0.133At 50% Intensity:C-B65: 0.272 | Equivalent, with no additional concerns for safety and effectiveness. |
Page 11
Brain Ultimate, Inc., Traditional 510 (k)
Ultimate rTMS
Page 7 of 13
| Criteria | (Subject Device) Ultimate rTMS | (Primary Predicate) MagVita TMS Therapy System (K173620) | (Secondary Predicate) MagVita TMS Therapy System (K171481) | Equivalence Comments |
|---|---|---|---|---|
| BF90A: 0.287BY90B: 0.244At 75% Intensity:BY90A: 0.403BF90A: 0.395BY90B: 0.369At 100% Intensity:BY90A: 0.498BF90A: 0.494BY90B: 0.481 | At 75% Intensity:C-B70: 0.418At 100% Intensity:C-B70: 0.549 | At 75% Intensity:C-B65: 0.413At 100% Intensity:C-B65: 0.542 | See Note D for equivalence explanation of Max magnetic field strength. | |
| Max initial dB/dt (kT/s) near the coil surface (z = 0 cm) | BY90A: 13.44BF90A: 13.76BY90B: 12.10 | C-B70: 13.27 | C-B65: 13.36 | Equivalent, with no additional concerns for safety and effectiveness. See Note E for equivalence explanation of dB/dt. |
| Max initial dB/dt (kT/s) 2 cm from coil surface (z = 2 cm) | BY90A: 3.59BF90A: 4.27BY90B: 6.78 | C-B70: 5.25 | C-B65: 5.29 | |
| Output Intensity Stability among Pulses in a Burst (Max Change %) | BY90A: 0.563BF90A: 0.580BY90B: 0.679 | C-B70: 0.615 | N/A | Equivalent, with no additional concerns for safety and effectiveness. As established in the predicate device's K173620, it is essential that Output Intensity of |
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| Criteria | (Subject Device) Ultimate rTMS | (Primary Predicate) MagVita TMS Therapy System (K173620) | (Secondary Predicate) MagVita TMS Therapy System (K171481) | Equivalence Comments |
|---|---|---|---|---|
| pulses in a burst remain stable with max change of < 1%. | ||||
| The system will automatically be disabled when the coil temperature exceeds: | 40°C (104°F) | 41°C (106°F) | 41°C (104°F) | Regardless of the intensity setting (at Maximum output or otherwise), both the subject and predicate device have a coil temperature safety feature that shuts down the system when the threshold temperature is reached. Ultimate rTMS system provides a slightly enhanced safety by not letting the coil temperature exceed 40°C compared to 41°C for MagVita TMS system. |
| Frequency range (Hz) | 0.1 - 100 | 0.1 - 30 or 0.1 - 100, depending on model | 0.1 - 100 | The differences in these parameters are simply the differences in the overall capabilities of these machines. These capabilities encompass the recommended |
| Pulse train duration range (s) | Rep Rate: 0.1 ...100HzPulses in Train: 1,2,3,4 ... 2000Train duration = Pulses in Train / Rep Rate | Rep Rate: 0.1 ...100HzPulses in Train: 1,2,3,4 ... 1000Train duration = Pulses in Train / Rep Rate | Rep Rate: 0.1 ...100HzPulses in Train: 1,2,3,4 ... 1000Train duration = Pulses in Train / Rep Rate |
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| Criteria | (Subject Device) Ultimate rTMS | (Primary Predicate) MagVita TMS Therapy System (K173620) | (Secondary Predicate) MagVita TMS Therapy System (K171481) | Equivalence Comments |
|---|---|---|---|---|
| Inter-train interval range (s) | 0 - 60 | 1 - 120 | 1 - 120 | treatment parameters for MDD listed above. In other words, these variations among different manufacturers' models do not impact their ability to deliver the treatment parameters recommended for MDD. All machines use identical treatment parameters. |
| Maximum trains per session | 250 | 500 | 500 | |
| Maximum number of pulses per session | 500,000 = 2000 x 250(Pulses In Train:2000Maximum Trains:250 | 500,000 = 1000 x 500(Pulses in Train:1000Maximum Trains: 500 | 500,000 = 1000 x 500(Pulses in Train:1000Maximum Trains: 500 |
Standards
| Criteria | (Subject Device) Ultimate rTMS | (Primary Predicate) MagVita TMS Therapy System (K173620) | (Secondary Predicate) MagVita TMS Therapy System (K171481) | Equivalence Comments |
|---|---|---|---|---|
| Electrical safety | Complies with IEC 60601-1，IEC 60601-1-2. | Complies with IEC 60601-1, IEC 60601-1-2. | Complies with IEC 60601-1，IEC 60601-1-2. | N/A |
| ISO Standards met | Company complies with ISO 13485:2016.ISO14971 | Company complies with ISO 13485:2012. | Company complies with ISO 13485:2012. | N/A |
Note A:
- Applicator Diameter: ID/OD = 30-34 mm/85 mm for subject and 35 mm/75 mm for predicate device. These differences are typical of variations among different manufacturers of TMS devices or even among different models of the same manufacturer. As shown in Section18 Appendix 18-1 Coils Test Report, they do not lead to significant differences in the electric and magnetic fields generated by these applicators.
- Applicator Windings: Both the subject and the predicate device have the exact same windings of 2 wings x 2 layers x 5 turns in the windings, as illustrated below:
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Coil BY90B has 2 x 2 x 6 windings to better accommodate its geometric shape. These differences are typical of variations among different manufacturers of TMS devices or even among different models of the same manufacturer. As a comparison, a TMS device from another manufacturer (Rapid Therapy System, K143531) that is cleared for MDD treatment has a vastly different windings design of 3 x 19 x 2 windings. As shown in Section18 Appendix 18-1 Coils Test Report, they do not lead to significant differences in the electrical and magnetic fields generated by these applicators.
Note B:
- Subject Device (Brain Ultimate TMS):
- Intensity/Amplitude Setting = 0% → 0 SMT
- Intensity/Amplitude Setting = 41% → 1 SMT
- Intensity/Amplitude Setting = 100% → 2.4 SMT
- Predicate Device (MagVita TMS):
- Intensity/Amplitude Setting = 0% → 0 SMT
- Intensity/Amplitude Setting = 47% → 1 SMT
- Intensity/Amplitude Setting = 100% → 2.1 SMT
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- These are comparable values and within the variations seen among previously cleared TMS devices by the FDA. These values are in slight favor of Brain Ultimate TMS as they indicate that the subject device will need a slightly lower intensity setting to achieve the same level of induced current as the predicate device.
Note C:
The difference in pulse width (320 +/- 10% vs. 290 +/- 5%) between Brain Ultimate TMS and MagVita TMS is comparable to the differences in pulse widths of several TMS devices cleared by the FDA for MDD treatment, as shown in the table below:
| TMS Device | Pulse Width Spec (us) |
|---|---|
| Brain Ultimate | 320 +/- 10% (288-352) |
| MagVita | 290 +/- 5% (275-305) |
| NeuroStar | 185 +/- 10% (166-204) |
| Magstim | 330 +/- 10% (297-363) |
| Nexstim | 235 +/- 5 (230-240) |
In the above table:
- Subject = Brain Ultimate, Predicate = MagVita
Inherent differences in the design and construction of TMS devices of different manufacturers, or even different models of the same manufacturer, lead to the variations in pulse widths shown above. However, since a patient is always treated at 120% MT for MDD on any TMS device, and MT is a function of both the intensity/amplitude and pulse width (higher pulse width will require lower intensity/amplitude to reach MT), differences in pulse widths are easily compensated by the changes in intensity settings needed to achieve 120% MT stimulation.
Slightly higher pulse width of Ultimate rTMS compared to MagVita TMS would require slightly lower intensity/amplitude setting on Ultimate rTMS compared to Magvita TMS to achieve the same stimulation level. This is in alignment with Note B above that states that the subject device will need a slightly lower intensity setting to achieve the same level of induced current as the predicate device.
Note D:
- The Max magnetic field values for the subject and predicate device at 2 cm are in a narrow range and exhibit equivalent slope and intercept values when measured at 25%, 50%, 75% and 100% intensity settings, as shown here:
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(See more details in Section18 Appendix 18-1 Coils Test Report, pages 7-8).
- These measurements were made using the same intensity setting on both devices. For a treatment given to the same patient, each device will be set to 120% of the patient's MT, which does not translate to the exact same % power setting on each device. Different power setting on each device for the same MT will compensate for the observed differences in magnetic field strength values in the table.
- These differences are typical of variations among different manufacturers of TMS devices or even among different models of the same manufacturer.
Note E:
- The dB/dt values for the subject and predicate device, at both z = 0 mm and z = 20 mm, are sufficiently close to each other to be considered equivalent. They were measured using the same intensity setting on both devices. For a treatment given to the same patient, each device will be set to 120% of the patient's MT, which does not translate to the exact same % power setting on each device. Different power setting on each device for the same MT will compensate for the observed differences in dB/dt values in the table.
- These differences are typical of variations among different manufacturers of TMS devices or even among different models of the same manufacturer.
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Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
The following special control is applicable to the subject device (Product Code: OBP) of this 510(k) submission: "Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems."
The following performance tests specified in this guidance document were performed and the results were compared for a determination of substantial equivalence between the subject device (Ultimate rTMS System) and the predicate device (MagVita TMS System):
Electric Field:
a. SMT Comparison
b. Electrical Field Strength Decay over z-axis distance from coil center (in the direction of head center)
Magnetic Field:
a. Output Waveform for pulse width and amplitude
b. Magnetic Field Strength Linearity as a function of machine intensity setting
c. Magnetic Field Spatial Distribution
d. Magnetic Field Gradient (dB/dt)
Also, an additional test (Intensity Variation of Pulses within a Burst) not specified in the guidance document but essential for establishing substantial equivalence for iTBS protocol was performed.
Not Applicable
CONCLUSION STATEMENT
The Ultimate rTMS and the predicate device have identical intended use/indication for use, target population, treatment procedure, treatment position and all recommended standard treatment protocol parameters (intensity, frequency, number of pulses in a train, number of trains in a session, number of treatment sessions).
Both the subject device and the primary predicate device share the same Figure-of-eight coil design. The tested magnetic properties of the Ultimate rTMS and the primary predicate device are substantially equivalent for the Less-than-1% Variation in intensity of individual pulses in a burst are equivalent for the subject and predicate device as both show less than 1% variation.
The reliability of the positioning method used by the Ultimate rTMS is based on the direct relationship of the underlying cortical brain anatomy to the patient's scalp, as is the method used in the predicate device. The method for identifying the correct treatment position in the subject device is at least as effective as the method employed by the predicate device.
The Ultimate rTMS does not introduce any new safety considerations in comparison to the predicate device. All other identified differences between the subject device and the predicate device are minor and without any known impact on safety or efficacy.
Based on the information and supporting documentation provided in the premarket notification, the Ultimate rTMS is substantially equivalent to the cited primary predicate device. Testing demonstrates that the Ultimate rTMS fulfills prospectively defined design and performance specifications.
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.