Ultimate rTMS; Yingchi rTMS

K230735 · Brain Ultimate, Inc. · OBP · Sep 13, 2023 · Neurology

Device Facts

• Record ID: K230735
• Device Name: Ultimate rTMS; Yingchi rTMS
• Applicant: Brain Ultimate, Inc.
• Product Code: OBP · Neurology
• Decision Date: Sep 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5805
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Ultimate rTMS is a non-invasive neuromodulation system for Major Depressive Disorder. It consists of a stimulation generator (high-voltage capacitor, power supply, microcomputer control, cooling system) and a stimulation coil (figure-of-eight design). The device delivers brief, rapidly alternating magnetic pulses through the skull to induce electrical currents in the left dorsolateral prefrontal cortex, modulating neuronal activity. Operated by clinicians in a clinical setting, the system uses predefined treatment parameters (10 Hz frequency, 120% motor threshold intensity). The provider sets the treatment protocol via the control system; the device delivers pulses to the target area. The output is a magnetic field that facilitates or inhibits neuronal function, intended to provide therapeutic benefit for depression. The system includes safety features like automatic shutdown if coil temperature exceeds 40°C.

Clinical Evidence

No clinical data was relied upon to demonstrate substantial equivalence. Evidence consists of bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), biocompatibility of the positioning cap (ISO 10993-1), and magnetic field characterization (linearity, spatial distribution, and acoustic output) per FDA guidance for rTMS systems.

Technological Characteristics

Class II rTMS system. Components: stimulation generator, stimulation coil (figure-of-eight, air-core), cooling system (liquid or forced air), and optional trolley/arm. Energy source: high-voltage capacitor discharge. Waveform: biphasic sinusoid. Connectivity: standalone system with microcomputer control. Standards: ISO 13485:2016, ISO 14971:2007/2019, IEC 60601-1:2005/(R)2012, IEC 60601-1-2:2014, ISO 10993-1:2018. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for treatment of Major Depressive Disorder in adults who failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MagVita TMS Therapy System (K171481)
• Rapid2 Therapy System (K143531)

Submission Summary (Full Text)

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Wednesday, September 13, 2023

Brain Ultimate, Inc. % Barry Ashar President Makromed, Inc. 88 Stiles Road Salem, New Hampshire 03079

Re: K230735

Trade/Device Name: Ultimate rTMS; Yingchi rTMS Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive transcranial magnetic stimulation system Regulatory Class: Class II Product Code: OBP Dated: August 10, 2023 Received: August 14, 2023

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 (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 located 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Pamela D. Scott -S

Pamela D. 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

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## Indications for Use

510(k) Number (if known) K230735

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 medication in the current episode.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary for the Brain Ultimate, Inc. Ultimate rTMS (per 21 CFR 807.92 (c))

#### 1. SUBMITTER/510(K) HOLDER

Brain Ultimate, Inc. 1185 Park Glenn Drive Alpharetta, GA 30005, USA

Contact Person: Barry V. Ashar, Makromed, Inc. Telephone: [phone] Date Prepared: March 9, 2023

#### 2. DEVICE NAME

| Proprietary Name: | Ultimate rTMS (also, Yingchi rTMS) |
|----------------------|-----------------------------------------------------|
| Regulation Name: | Repetitive transcranial magnetic stimulation system |
| Regulation Number: | 21 CFR §882.5805 |
| Classification Name: | Transcranial Magnetic Stimulator |
| Device Class: | Class II |
| Product Code: | OBP |

#### 3. PREDICATE DEVICES

- . Tonica Electronik A/S, MagVita TMS Therapy System, K171481
- Magstim Company Limited, Rapid2 Therapy System, K143531 ●

#### 4. DEVICE DESCRIPTION

Transcranial Magnetic Stimulation (TMS) is a painless and non-invasive neuromodulation technique. It directs a magnetic pulse through the intact skull bone to stimulate the underlying brain tissue. The magnetic pulse induces a current flow that activates neurons close to the surface either facilitating or inhibiting their function depending on the protocol.

The Ultimate rTMS is composed of stimulation generator and stimulation coil. The stimulation generator contains a high voltage energy storage capacitor charging and discharging system, an auxiliary power

Brain Ultimate, Inc., Traditional 510 (k) Ultimate rTMS

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supply, a microcomputer control system, and a cooling system. The stimulation coil is composed of a stimulation coil, a cooling system, a data collection system, and a communication system.

- Magnetic Stimulator
- Cooling unit
- . Coils
- Coil Figure-of-eight coil (BF90A) o
- Coil Figure-of-eight coil (BY90A) O
- o Coil Figure-of-eight coil-With angle 120°(BY90B)
- . Trolley (optional)
- . Coil holder (optional)
- . PC (optional)
- . PC keyboard (optional)

#### 5. INTENDED 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.

#### 6. STANDARDS

The Ultimate rTMS system has been tested and complies with the following standards:

- . DIN EN ISO 13485: 2016
- 10993-1:2018
- ISO 14971: 2007
- . IEC 60601-1:2005/(R)2012
- . IEC 60601-1-2:2014

#### 7. NON-CLINICAL PERFORMANCE DATA

Electrical safety and electromagnetic compatibility testing demonstrate that the Ultimate rTMS is compliant with IEC 60601-1:2012 and IEC 60601-1-2: 2014.

Only positioning cap in the delivery set of the Ultimate rTMS have direct contact with the patients. The biocompatibility evaluation demonstrates that the positioning cap meet ISO 10993-1:2018 standards.

Software verification and validation testing is described section 16 "Software" following the corresponding FDA software guidelines. It demonstrates that the software performs as intended and in accordance with specifications. The potential risks of the Ultimate rTMS have been identified and

Brain Ultimate, Inc., Traditional 510 (k) Ultimate rTMS

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evaluated in compliance with ISO14971:2019, and the risks were determined to be acceptable, or have been addressed with risk control measures.

Additionally, the non-clinical testing with the Ultimate rTMS included testing of the magnetic field characteristics of the system, as required by FDA's guidance document "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems". The magnetic field plots and acoustic output measurements were conducted to demonstrate safety and performance.

## 8. CLINICAL PERFORMANCE DATA

Not applicable. Clinical performance data was not relied upon to demonstrate substantial equivalence.

#### 9. SUBSTANTIAL EQUIVALENCE

The Ultimate rTMS and the predicate devices have identical intended use /indication for use and identical treatment parameters and treatment target (see table 5-1). Their technological characteristics are very similar so that they can be considered equivalent.

The design of the Ultimate rTMS is similar to that of the MagVita TMS Therapy System and the Rapid² Therapy System, as all systems are based on applying transcranial magnetic stimulation by means of repetitive pulse trains at a predetermined frequency. All 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.

The basic software capabilities related to treatment administration in the Ultimate rTMS are the same as these in the predicate devices.

To establish substantial equivalence, we have performed comparison of the magnetic field characteristics of the three subject device coils and one predicate device coil with their respective systems, in accordance with section 4 of the FDA's Class II Special Controls Guidance Document – Repetitive Transcranial Magnetic Stimulation (rTMS) Systems. These include linearity of output levels, magnetic field strength gradients, output waveform and magnetic field spatial distribution. Performance testing was conducted to compare the spatial magnetic field distribution of the subject device using all three coils against the predicate device. The same measurement set up was utilized for both systems and that the magnetic field measurements of the four coils (3 subject coils and 1 predicate) were compared on the same plots at multiple locations constituting a holistic quantitative assessment of the two devices.

The Ultimate rTMS and the predicate devices have the same components consisting of TMS stimulator with software, electromagnetic coil and a flexible arm for positioning of the treatment coil. The basic

Brain Ultimate, Inc., Traditional 510 (k) Ultimate rTMS

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operational procedures including system setup, patient preparations, motor threshold determination, coil positioning and treatment with predefined treatment stimulation parameters are essentially the same. A thorough comparison among the Ultimate rTMS and the predicate devices is shown in a tabular form (see table 5-1) below:

Brain Ultimate, Inc., Traditional 510 (k) Ultimate rTMS

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| Criteria | Ultimate rTMS | (Primary Predicate)<br>MagVita TMS Therapy<br>System (K171481) | (Secondary Predicate)<br>Rapid² Therapy System<br>(K143531) | Equivalence Comments | |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Intended Use<br>(Indication for<br>Use) | The Ultimate rTMS is<br>indicated for the treatment of<br>Major Depressive Disorder in<br>adult patients who have failed<br>to receive satisfactory<br>improvement from prior<br>antidepressant medication in<br>the current episode. | The MagVita TMS<br>Therapy System is<br>indicated for the<br>treatment of Major<br>Depressive Disorder in<br>adult patients who have<br>failed to receive<br>satisfactory<br>improvement from prior<br>antidepressant<br>medication in the<br>current episode. | The Rapid² Therapy<br>System is indicated for<br>the treatment of Major<br>Depressive Disorder in<br>adult patients who<br>have failed to achieve<br>satisfactory<br>improvement from<br>prior antidepressant<br>medication in the<br>current episode. | Identical Indication for<br>Use | |
| Recommended Standard Treatment | | | | | |
| Magnetic Field<br>Intensity | 120% of the MT | 120% of the MT | 120% of the MT | Identical recommended<br>treatment parameters. | |
| Frequency | 10 Hz | 10 Hz | 10 Hz | The subject and primary<br>predicate devices provide<br>two treatment options –<br>18.8- and 37.0-minutes<br>treatment durations, | |
| Train duration | 4 sec | 4 sec | 4 sec | | |
| Inter-train interval | 11-26 sec | 11-26 sec | 26 sec | | |
| Number of trains | 75 | 75 | 75 | | |
| Magnetic Pulses<br>per Session | 3000 | 3000 | 3000 | | |
| Criteria | Ultimate rTMS | (Primary Predicate)<br>MagVita TMS Therapy<br>System (K171481) | (Secondary Predicate)<br>Rapid² Therapy System<br>(K143531) | Equivalence Comments | |
| Treatment Session<br>Duration | 18.8-37.0 min | 18.8-37.0 min | 37.5 min | using 11 sec and 26 sec<br>inter-train intervals. | |
| Sessions/week | 5 | 5 | 5 | | |
| Treatment<br>Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6<br>weeks | 5 daily sessions for 6<br>weeks | | |
| Area of brain to be<br>stimulated | Left Dorsolateral Prefrontal<br>Cortex | Left Dorsolateral<br>Prefrontal Cortex | Left Dorsolateral<br>Prefrontal Cortex | | |
| Coils | Coils | | | | |
| Coils (including<br>optional<br>accessories) | BY90A<br>BF90A<br>BY90B | C-B60<br>C-B65 | Magstim Double 70mm<br>Air Film Coil | N/A | |
| Configuration | BY90A : Figure-of-eight coil<br>BF90A : Figure-of-eight coil<br>BY90B : Figure-of-eight coil-<br>With angle 120° | Figure-of-eight coil | Figure-of-eight coil | Same figure-of-eight<br>configuration in all coils.<br>See Note A. | |
| Core material | Air core | Air core | Air core | Same core material<br>design. | |
| Cooling | BY90A:Liquid cooling<br>BF90A:Forced Air cooling<br>BY90B:Liquid cooling | C-B65: Liquid cooling<br><br>C-B60: None | Forced Air | Ultimate rTMS offers<br>liquid-cooled and forced | |
| | BF90A:Forced Air cooling | C-B60: None | | air-cooled coils. Primary | |
| | BY90B:Liquid cooling | | | predicate offers liquid-<br>cooled coil and<br>secondary predicate<br>offers air-cooled coil. | |
| Criteria | Ultimate rTMS | (Primary Predicate)<br>MagVita TMS Therapy<br>System (K171481) | (Secondary Predicate)<br>Rapid² Therapy System<br>(K143531) | Equivalence Comments | |
| Coil parameters | BY90A:Inner diameter - 34 mm<br>Outer diameter - 85 mm<br>N = 2 wings x 2 layers x 5 turns<br>BF90A:Inner diameter - 34 mm<br>Outer diameter - 85 mm<br>N = 2 wings x 2 layers x 5 turns | Coil Cool-B65<br>Inner diameter - 35 mm<br>Outer diameter - 75 mm<br>Winding height - 12 mm<br>N = 2 wings x 2 layers x 5<br>turns | Area = 33000 mm²<br>Average Inductance 12 µH<br>Flat spiral winding<br>N = 2 wings x 3 layers x<br>19 turns | Equivalent, with no<br>additional concerns forsafety and effectiveness.<br>See Note A for<br>equivalence explanation<br>of coil parameters such<br>as dimensions and<br>windings. | |
| | BY90B:Inner diameter - 30 mm<br>Outer diameter -90 mm<br>N = 2 wings x 2 layers x 6 turns | Coil C-B60<br>Inner diameter - 35 mm<br>Outer diameter - 75 mm<br>Winding height - 12 mm<br>N = 2 wings x 2 layers x 5<br>turns | | | |
| | | Machine Output Parameters | | | |
| Amplitude in<br>Standard Motor<br>Threshold (SMT)<br>units | 0 - 1.9<br>52.6% Intensity Setting → 1<br>SMT | 0 - 1.7<br>58.8% Intensity Setting →<br>1 SMT | 0.28 - 1.9<br>61.7% Intensity Setting<br>→ 1 SMT | Equivalent, with no<br>additional concerns for<br>safety and effectiveness.<br>See Note B for<br>equivalence explanation<br>of Intensity/Amplitude. | |
| Waveform | Biphasic sinusoid | Biphasic sinusoid | Biphasic sinusoid | Identical waveform. | |
| Active pulse width<br>(µs) | 320 | 290 | 300 | Equivalent, with no<br>additional concerns for<br>safety and effectiveness. | |
| Pulse amplitude<br>(V) | BY90A: 1.35<br>BF90A: 1.26<br>BY90B: 1.22 | C-B65: 1.84 | N/A | safety and effectiveness.<br>See Note C for<br>equivalence explanation<br>of Pulse Width and<br>Amplitude. | |
| Criteria | Ultimate rTMS | (Primary Predicate)<br>MagVita TMS Therapy<br>System (K171481) | (Secondary Predicate)<br>Rapid² Therapy System<br>(K143531) | Equivalence Comments | |
| Max magnetic<br>field strength 2 cm<br>from coil (T) | At 25% Intensity:<br>BY90A: 0.172<br>BF90A: 0.182<br>BY90B: 0.117 | At 25% Intensity:<br>C-B65: 0.133 | | Equivalent, with no<br>additional concerns for<br>safety and effectiveness. | |
| | At 50% Intensity:<br>BY90A: 0.291<br>BF90A: 0.287<br>BY90B: 0.244 | At 50% Intensity:<br>C-B65: 0.272 | | See Note D for<br>equivalence explanation<br>of Max magnetic field<br>strength. | |
| | At 75% Intensity:<br>BY90A: 0.403<br>BF90A: 0.395<br>BY90B: 0.369 | At 75% Intensity:<br>C-B65: 0.413 | | | |
| | At 100% Intensity:<br>BY90A: 0.498<br>BF90A: 0.494<br>BY90B: 0.481 | At 100% Intensity:<br>C-B65: 0.542 | | | |
| Max initial dB/dt<br>(kT/s) near the coil<br>surface<br>(z = 0 cm) | BY90A: 13.44<br>BF90A: 13.76<br>BY90B: 12.10 | C-B65: 13.36 | N/A | Equivalent, with no<br>additional concerns for<br>safety and effectiveness. | |
| Max initial dB/dt<br>(kT/s) 2 cm from<br>coil surface<br>(z = 2 cm) | BY90A: 3.59<br>BF90A: 4.27<br>BY90B: 6.78 | C-B65: 5.29 | N/A | See Note E for<br>equivalence explanation<br>of dB/dt. | |
| The system will<br>automatically be<br>disabled when the | 40 °C (104 °F) | 41 °C (106 °F) | 40 °C (104 °F) | Regardless of the<br>intensity setting (at<br>Maximum output or<br>otherwise), both the | |
| Criteria | Ultimate rTMS | (Primary Predicate)<br>MagVita TMS Therapy<br>System (K171481) | (Secondary Predicate)<br>Rapid² Therapy System<br>(K143531) | Equivalence Comments | |
| coil temperature<br>exceeds: | | | | subject and predicate<br>device have a coil<br>temperature safety<br>feature that shuts down<br>the system when the<br>threshold temperature is<br>reached. Ultimate rTMS<br>system provides a<br>slightly enhanced safety<br>by not letting the coil<br>temperature exceed 40<br>°C compared to 41 °C for<br>MagVita TMS system.<br>The differences in these<br>parameters are simply<br>the differences in the<br>overall capabilities of<br>these machines. These<br>capabilities encompass<br>the recommended<br>treatment parameters for<br>MDD listed above. In<br>other words, these<br>variations among<br>different manufacturers'<br>models do not impact<br>their ability to deliver the<br>treatment parameters<br>recommended for MDD. | |
| Frequency range<br>(Hz) | 0.1 - 10 | 0.1 - 30 or 0.1 - 100,<br>depending on model | 0.1 - 30 | | |
| Pulse train<br>duration range (s) | Rep Rate: 0.1 ...100Hz<br>Pulses in Train: 1,2,3,4 ... 2000<br>Train duration = Pulses in Train<br>/ Rep Rate | Rep Rate: 0.1 ...100Hz<br>Pulses in Train: 1,2,3,4 ...<br>1000<br>Train duration = Pulses in<br>Train / Rep Rate | 1 - 20 | | |
| Inter-train interval<br>range (s) | 0~60s | 1 - 120 | 10 - 60 | | |
| Maximum trains<br>per session | 250 | 500…