(160 days)
Not Found
No.
The device description does not mention any AI models, and the "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated for the "treatment of Major Depressive Disorder in adult patients" and is described as a "computerized medical device" that produces "pulsed magnetic fields...to induce neural action potentials...for the treatment of Major Depressive Disorder."
No.
The device description and intended use clearly state that the Ultimate rTMS is for "treatment of Major Depressive Disorder" and "produces non-invasive, repetitive pulsed magnetic fields...for the treatment of Major Depressive Disorder." While it can be used in "diagnostics centers," its function is therapeutic, not diagnostic.
No
The device description clearly states it is a "computerized medical device" that "produces non-invasive, repetitive pulsed magnetic fields" by discharging a "high voltage capacitor through stimulation coil." This involves physical components that generate magnetic fields, which is hardware, not purely software. The performance studies also detail tests of electric and magnetic fields, further confirming its physical nature.
No
The device is a repetitive transcranial magnetic stimulation (rTMS) system used to induce neural action potentials for the treatment of Major Depressive Disorder. It does not perform in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications 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 medications in the current episode.
Product codes
OBP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Left Dorsolateral Prefrontal Cortex
Indicated Patient Age Range
adult patients
Intended User / Care Setting
patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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):
Electrical 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.
Key Metrics
Output Intensity Stability among Pulses in a Burst (Max Change %) for BY90A: 0.563, BF90A: 0.580, BY90B: 0.679. For the predicate device C-B70: 0.615. All show less than 1% variation.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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).
Page 2
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).
Page 3
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:
Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
Brain Ultimate, Inc., Traditional 510 (k)
Ultimate rTMS
Page 1 of 13
510(k) Summary
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 changing (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 this is made of commonly used textile materials and is 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: 3 No. of Bursts: 200 Inter-pulse: 20 msec | Burst Pulses: 3 No. of Bursts: 200 Inter-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 | BY90A BF90A BY90B | Cool-B70 | C-B60 C-B65 | N/A |
| Configuration | BY90A：Figure-of-eight coil BF90A：Figure-of-eight coil BY90B：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 cooling BF90A:Forced Air cooling BY90B:Liquid cooling | Cool-B70: Liquid cooling | C-B60: None C-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 |
|---|---|---|---|---|
| Coil parameters | BY90A Inner diameter - 34 mm Outer diameter - 85 mm N = 2 wings x 2 layers x 5 turns BF90A Inner diameter - 34 mm Outer diameter - 85 mm N = 2 wings x 2 layers x 5 turns BY90B Inner diameter - 30 mm Outer diameter -90 mm N = 2 wings x 2 layers x 6 turns | Coil Cool-B70 Inner diameter - 35 mm Outer diameter - 75 mm N = 2 wings x 2 layers x 5 turns | Coil C-B60 Inner diameter - 35 mm Outer diameter - 75 mm Winding height - 12 mm N = 2 wings x 2 layers x 5 turns Coil Cool-B65 Inner diameter - 35 mm Outer diameter - 75 mm Winding height - 12 mm N = 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. |
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 – 2.4 41% Intensity Setting → 1 SMT | 0 – 2.1 47% Intensity Setting → 1 SMT | 0 - 1.7 58.8% 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: 1.35 BF90A: 1.26 BY90B: 1.22 | C-B70: 1.88 | C-B65: 1.84 | |
| Max magnetic field strength 2 cm from coil (T) | At 25% Intensity: BY90A: 0.172 BF90A: 0.182 BY90B: 0.117 At 50% Intensity: BY90A: 0.291 | At 25% Intensity: C-B70: 0.144 At 50% Intensity: C-B70: 0.283 | At 25% Intensity: C-B65: 0.133 At 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: 0.287 BY90B: 0.244 At 75% Intensity: BY90A: 0.403 BF90A: 0.395 BY90B: 0.369 At 100% Intensity: BY90A: 0.498 BF90A: 0.494 BY90B: 0.481 | At 75% Intensity: C-B70: 0.418 At 100% Intensity: C-B70: 0.549 | At 75% Intensity: C-B65: 0.413 At 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: 13.44 BF90A: 13.76 BY90B: 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: 3.59 BF90A: 4.27 BY90B: 6.78 | C-B70: 5.25 | C-B65: 5.29 | |
| Output Intensity Stability among Pulses in a Burst (Max Change %) | BY90A: 0.563 BF90A: 0.580 BY90B: 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 |
Page 12
Brain Ultimate, Inc., Traditional 510 (k)
Ultimate rTMS
Page 8 of 13
| 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 |