(181 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 medication in the current episode.
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 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)
- Coil Figure-of-eight coil (BY90A)
- Coil Figure-of-eight coil-With angle 120°(BY90B)
- Trolley (optional)
- Coil holder (optional)
- PC (optional)
- PC keyboard (optional)
The provided text describes a 510(k) premarket notification for the Brain Ultimate, Inc. Ultimate rTMS device. The main purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a full clinical study with acceptance criteria.
Therefore, the document does not contain an acceptance criteria table from a clinical trial, nor does it describe a study specifically designed to prove device performance against such criteria. Instead, it focuses on non-clinical performance data and a comparison to predicate devices to establish substantial equivalence.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document as it is a 510(k) submission primarily focused on demonstrating substantial equivalence to predicate devices, not on proving performance against a specific set of clinical acceptance criteria for a new clinical indication. The document presents a side-by-side comparison of the Ultimate rTMS with predicate devices, outlining technical specifications and treatment parameters, not clinical acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable/provided as the submission states: "CLINICAL PERFORMANCE DATA: Not applicable. Clinical performance data was not relied upon to demonstrate substantial equivalence." The testing described is non-clinical performance data related to electrical safety, electromagnetic compatibility, biocompatibility, software verification/validation, risk management, and magnetic field characteristics. These tests do not involve human subjects or clinical data sets in the traditional sense of a "test set" for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. Since no clinical performance data was relied upon and no "test set" with ground truth established by experts is mentioned, this information is not relevant to this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. No clinical test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided. The device is an rTMS system for Major Depressive Disorder treatment, not an AI-assisted diagnostic or interpretative device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The Ultimate rTMS is a physical medical device (repetitive transcranial magnetic stimulation system), not a standalone algorithm. Its software is mentioned as undergoing verification and validation, but this refers to the software controlling the device, not a standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable/provided. As stated, "Clinical performance data was not relied upon to demonstrate substantial equivalence." Non-clinical tests were performed against established standards (e.g., IEC 60601-1, ISO 10993-1, ISO 14971) and against the characteristics of predicate devices. "Ground truth" in the context of clinical performance is not discussed.
8. The sample size for the training set
This information is not applicable/provided. No machine learning or AI algorithm requiring a training set is described for performance evaluation in the supplied text.
9. How the ground truth for the training set was established
This information is not applicable/provided. As no training set is described, the method for establishing its ground truth is also not applicable.
Summary of the Study and Device Proof of Meeting Criteria (based on provided text):
The document describes a 510(k) premarket notification for the Ultimate rTMS device. The "study" referenced is a combination of non-clinical performance testing and a comparison to legally marketed predicate devices to demonstrate substantial equivalence, not to prove the device meets specific clinical acceptance criteria in a de novo clinical trial.
The non-clinical performance data included:
- Electrical safety and electromagnetic compatibility testing: Compliance with IEC 60601-1:2012 and IEC 60601-1-2: 2014.
- Biocompatibility evaluation: The positioning cap meets ISO 10993-1:2018 standards.
- Software verification and validation testing: Demonstrated that the software performs as intended and in accordance with specifications, following FDA software guidelines.
- Risk management: Identified and evaluated potential risks in compliance with ISO14971:2019, with risks determined acceptable or addressed.
- Magnetic field characteristics testing: Conducted in accordance with FDA's "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems." This included testing linearity of output levels, magnetic field strength gradients, output waveform, and magnetic field spatial distribution for the Ultimate rTMS coils against a predicate device.
The demonstration of meeting "acceptance criteria" is primarily centered on showing that the Ultimate rTMS is substantially equivalent to predicate devices (MagVita TMS Therapy System, K171481, and Rapid² Therapy System, K143531). This equivalence is based on:
- Identical intended use/indication for use: Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
- Identical treatment parameters: Recommended standard treatment (Magnetic Field Intensity, Frequency, Train duration, Inter-train interval, Number of trains, Magnetic Pulses per Session, Sessions/week, Treatment Schedule, Area of brain to be stimulated).
- Similar technological characteristics: Both use the same mechanism of action (electromechanical instrument producing pulsed magnetic fields to induce electrical currents in the prefrontal cortex).
- Comparison of coils: All coils share the same figure-of-eight transducer design and air core material. Differences in coil dimensions, windings, and cooling mechanisms were analyzed and deemed not to impact safety or effectiveness.
- Comparison of machine output parameters: Amplitude, waveform (biphasic sinusoid for all), active pulse width, pulse amplitude, max magnetic field strength, and max initial dB/dt were compared and deemed substantially equivalent, with minor differences not impacting safety or effectiveness. For instance, the Ultimate rTMS has a slightly lower intensity setting to achieve the same induced current as the predicate device, which is compensated for by adjusting intensity settings for 120% MT treatment. Coil temperature safety shut-off (40°C for Ultimate rTMS vs 41°C for predicate) was considered a slightly enhanced safety feature.
- Compliance with relevant standards: ISO 13485, ISO 10993-1, ISO 14971, IEC 60601-1, and IEC 60601-1-2.
The conclusion is that based on the non-clinical testing and side-by-side comparison, the Ultimate rTMS is substantially equivalent and does not introduce new safety concerns compared to the predicate devices.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: (603) 890-3311 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)MagVita TMS TherapySystem (K171481) | (Secondary Predicate)Rapid² Therapy System(K143531) | Equivalence Comments | |
|---|---|---|---|---|---|
| Intended Use(Indication forUse) | The Ultimate rTMS isindicated for the treatment ofMajor Depressive Disorder inadult patients who have failedto receive satisfactoryimprovement from priorantidepressant medication inthe current episode. | The MagVita TMSTherapy System isindicated for thetreatment of MajorDepressive Disorder inadult patients who havefailed to receivesatisfactoryimprovement from priorantidepressantmedication in thecurrent episode. | The Rapid² TherapySystem is indicated forthe treatment of MajorDepressive Disorder inadult patients whohave failed to achievesatisfactoryimprovement fromprior antidepressantmedication in thecurrent episode. | Identical Indication forUse | |
| Recommended Standard Treatment | |||||
| Magnetic FieldIntensity | 120% of the MT | 120% of the MT | 120% of the MT | Identical recommendedtreatment parameters. | |
| Frequency | 10 Hz | 10 Hz | 10 Hz | The subject and primarypredicate devices providetwo treatment options –18.8- and 37.0-minutestreatment 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 Pulsesper Session | 3000 | 3000 | 3000 | ||
| Criteria | Ultimate rTMS | (Primary Predicate)MagVita TMS TherapySystem (K171481) | (Secondary Predicate)Rapid² Therapy System(K143531) | Equivalence Comments | |
| Treatment SessionDuration | 18.8-37.0 min | 18.8-37.0 min | 37.5 min | using 11 sec and 26 secinter-train intervals. | |
| Sessions/week | 5 | 5 | 5 | ||
| TreatmentSchedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6weeks | 5 daily sessions for 6weeks | ||
| Area of brain to bestimulated | Left Dorsolateral PrefrontalCortex | Left DorsolateralPrefrontal Cortex | Left DorsolateralPrefrontal Cortex | ||
| Coils | Coils | ||||
| Coils (includingoptionalaccessories) | BY90ABF90ABY90B | C-B60C-B65 | Magstim Double 70mmAir Film Coil | 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-eightconfiguration in all coils.See Note A. | |
| Core material | Air core | Air core | Air core | Same core materialdesign. | |
| Cooling | BY90A:Liquid coolingBF90A:Forced Air coolingBY90B:Liquid cooling | C-B65: Liquid coolingC-B60: None | Forced Air | Ultimate rTMS offersliquid-cooled and forced | |
| BF90A:Forced Air cooling | C-B60: None | air-cooled coils. Primary | |||
| BY90B:Liquid cooling | predicate offers liquid-cooled coil andsecondary predicateoffers air-cooled coil. | ||||
| Criteria | Ultimate rTMS | (Primary Predicate)MagVita TMS TherapySystem (K171481) | (Secondary Predicate)Rapid² Therapy System(K143531) | Equivalence Comments | |
| Coil parameters | BY90A:Inner diameter - 34 mmOuter diameter - 85 mmN = 2 wings x 2 layers x 5 turnsBF90A: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 5turns | Area = 33000 mm²Average Inductance 12 µHFlat spiral windingN = 2 wings x 3 layers x19 turns | Equivalent, with noadditional concerns forsafety and effectiveness.See Note A forequivalence explanationof coil parameters suchas dimensions andwindings. | |
| BY90B:Inner diameter - 30 mmOuter diameter -90 mmN = 2 wings x 2 layers x 6 turns | Coil C-B60Inner diameter - 35 mmOuter diameter - 75 mmWinding height - 12 mmN = 2 wings x 2 layers x 5turns | ||||
| Machine Output Parameters | |||||
| Amplitude inStandard MotorThreshold (SMT)units | 0 - 1.952.6% Intensity Setting → 1SMT | 0 - 1.758.8% Intensity Setting →1 SMT | 0.28 - 1.961.7% Intensity Setting→ 1 SMT | Equivalent, with noadditional concerns forsafety and effectiveness.See Note B forequivalence explanationof Intensity/Amplitude. | |
| Waveform | Biphasic sinusoid | Biphasic sinusoid | Biphasic sinusoid | Identical waveform. | |
| Active pulse width(µs) | 320 | 290 | 300 | Equivalent, with noadditional concerns forsafety and effectiveness. | |
| Pulse amplitude(V) | BY90A: 1.35BF90A: 1.26BY90B: 1.22 | C-B65: 1.84 | N/A | safety and effectiveness.See Note C forequivalence explanationof Pulse Width andAmplitude. | |
| Criteria | Ultimate rTMS | (Primary Predicate)MagVita TMS TherapySystem (K171481) | (Secondary Predicate)Rapid² Therapy System(K143531) | Equivalence Comments | |
| Max magneticfield strength 2 cmfrom coil (T) | At 25% Intensity:BY90A: 0.172BF90A: 0.182BY90B: 0.117 | At 25% Intensity:C-B65: 0.133 | Equivalent, with noadditional concerns forsafety and effectiveness. | ||
| At 50% Intensity:BY90A: 0.291BF90A: 0.287BY90B: 0.244 | At 50% Intensity:C-B65: 0.272 | See Note D forequivalence explanationof Max magnetic fieldstrength. | |||
| At 75% Intensity:BY90A: 0.403BF90A: 0.395BY90B: 0.369 | At 75% Intensity:C-B65: 0.413 | ||||
| At 100% Intensity:BY90A: 0.498BF90A: 0.494BY90B: 0.481 | At 100% Intensity:C-B65: 0.542 | ||||
| Max initial dB/dt(kT/s) near the coilsurface(z = 0 cm) | BY90A: 13.44BF90A: 13.76BY90B: 12.10 | C-B65: 13.36 | N/A | Equivalent, with noadditional concerns forsafety and effectiveness. | |
| Max initial dB/dt(kT/s) 2 cm fromcoil surface(z = 2 cm) | BY90A: 3.59BF90A: 4.27BY90B: 6.78 | C-B65: 5.29 | N/A | See Note E forequivalence explanationof dB/dt. | |
| The system willautomatically bedisabled when the | 40 °C (104 °F) | 41 °C (106 °F) | 40 °C (104 °F) | Regardless of theintensity setting (atMaximum output orotherwise), both the | |
| Criteria | Ultimate rTMS | (Primary Predicate)MagVita TMS TherapySystem (K171481) | (Secondary Predicate)Rapid² Therapy System(K143531) | Equivalence Comments | |
| coil temperatureexceeds: | subject and predicatedevice have a coiltemperature safetyfeature that shuts downthe system when thethreshold temperature isreached. Ultimate rTMSsystem provides aslightly enhanced safetyby not letting the coiltemperature exceed 40°C compared to 41 °C forMagVita TMS system.The differences in theseparameters are simplythe differences in theoverall capabilities ofthese machines. Thesecapabilities encompassthe recommendedtreatment parameters forMDD listed above. Inother words, thesevariations amongdifferent manufacturers'models do not impacttheir ability to deliver thetreatment parametersrecommended for MDD. | ||||
| Frequency range(Hz) | 0.1 - 10 | 0.1 - 30 or 0.1 - 100,depending on model | 0.1 - 30 | ||
| Pulse trainduration 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 inTrain / Rep Rate | 1 - 20 | ||
| Inter-train intervalrange (s) | 0~60s | 1 - 120 | 10 - 60 | ||
| Maximum trainsper session | 250 | 500 | ~140 | ||
| Maximum numberof pulses persession | 5000(Pluses In Train:20*Maximun Trains:250=Maximun Number:5000) | 500,000 = 1,000 (pulsesmax per train) x 500(trainsmax per session) | 65,000 | ||
| Criteria | Ultimate rTMS | (Primary Predicate)MagVita TMS TherapySystem (K171481) | (Secondary Predicate)Rapid² Therapy System(K143531) | Equivalence Comments | |
| All machines useidentical treatmentparameters. | |||||
| Electricalsafety | Complies withIEC 60601-1, IEC 60601-1-2. | Complies withIEC 60601-1, IEC 60601-1-1 and IEC 60601-1-2. | Complies withEN 60601-1 andEN 60601-1-2 | N/A | |
| ISO Standardsmet | Company complies withISO 13485:2016.ISO14971 | Company complies withISO 13485:2012. | Company complies withISO 13485: 2003ISO 10993-1: 2009ISO 14971 | N/A |
Table 5-1. Side-by-Side Comparison of the Proposed Device with Cited Predicate Devices
Brain Ultimate, Inc., Traditional 510 (k) Ultimate rTMS
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Brain Ultimate, Inc., Traditional 510 (k) Ultimate rTMS
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Brain Ultimate, Inc., Traditional 510 (k) Ultimate rTMS
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Brain Ultimate, Inc., Traditional 510 (k)
CONFIDENTIAL
Ultimate rTMS
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Brain Ultimate, Inc., Traditional 510 (k)
CONFIDENTIAL
Ultimate rTMS
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Note A:
- Applicator Diameter: ID/OD = 30-34 mm/85 mm for subject and 35 mm/75 mm for predicate device. The results from our । performance testing indicate that the difference in applicator diameter does not result in significant variances in the electrical and magnetic fields. This minor difference will not impact safety or effectiveness.
- Applicator Windings: Even though previously listed as 2 x 10 for the NQ TMS and 2 x (2 x 5) for the MagVita TMS, these are exactly the same windings design of the subject and predicate device, representing 2 wings x 5 turns in the windings, as illustrated below:
Image /page/12/Figure/4 description: The image shows a 3D rendering of several curved pipes or tubes arranged in a symmetrical pattern. The pipes are light gray and appear to be bundled together, with their ends aligned. In the center of the image, there is a yellow and red coordinate system, possibly indicating the origin or a reference point within the 3D space.
Brain Ultimate, Inc., Traditional 510 (k) Ultimate rTMS
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Coil BY90B has 2 x 2 x 6 windings to better accommodate its geometric shape. The results from our performance testing indicate that the difference in applicator windings does not result in significant variances in the electrical and magnetic fields. This minor difference will not impact safety or effectiveness.
Note B:
- Subject Device (Brain Ultimate TMS): -Intensity/Amplitude Setting = 0% → 0 SMT Intensity/Amplitude Setting = 100% → 1.9 SMT
- Predicate Device (MagVita TMS): । Intensity/Amplitude Setting = 0% → 0 SMT Intensity/Amplitude Setting = 100% → 1.7 SMT
In the FDA rTMS guidance, 1.0 SMT is the output setting of a rTMS device that corresponds to an induced electric field of 130V/m at a point located at the fixed distance of the target along the central axis of the coil from the surface of the scalp into the cortex. This induced electric field is measured with a pick-up loop with the dipole oriented along the front-to-back
- Since the relationship between intensity setting and induced current is linear, the above values translate to the following । comparison between the subject and predicate device: Subject Device Intensity/Amplitude Setting corresponding to 1 SMT = 52.6% (1/1.9) Predicate Device Intensity/Amplitude Setting corresponding to 1 SMT = 58.8% (1/1.7)
- These values indicate the Brain Ultimate TMS will need a slightly lower intensity setting to achieve the same level of induced । current as the predicate device. Therefore, this difference is minor and will not impact safety or efficacy.
Note C:
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. Therefore, the pulse width is substantially equivalent to the predicate devices and this minor difference will not impact safety or effectiveness.
| Brain Ultimate, Inc., Traditional 510 (k) | CONFIDENTIAL |
|---|---|
| Ultimate rTMS |
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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:
| Magnetic field strength(point x=30,y=0,z=20) | ||||
|---|---|---|---|---|
| Magnetic filed strength,T | 25% | 50% | 75% | 100% |
| BF90A | 0.182 | 0.287 | 0.395 | 0.494 |
| BY90A | 0.172 | 0.291 | 0.403 | 0.498 |
| BY90B | 0.117 | 0.244 | 0.369 | 0.481 |
| B65 | 0.133 | 0.272 | 0.413 | 0.542 |
| pulse intensity % |
(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.
- Therefore, our performance testing demonstrates that this difference does not impact safety or effectiveness. —
Note E:
- The dB/dt values for the subject and predicate device, at both z = 0 cm and z = 20 cm, 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.
Brain Ultimate, Inc., Traditional 510 (k) Ultimate rTMS
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10. CONCLUSION
The Ultimate rTMS and the predicate devices 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).
All coils compared in Table 5.1 share the same transducer design (figure-of-eight). The tested magnetic properties of the Ultimate rTMS and the predicate devices are substantial equivalent for the coils.
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 devices. The method for identifying the correct treatment position in the Ultimate rTMS is at least as effective as the method employed by the predicate devices.
The Ultimate rTMS does not introduce any new safety considerations in comparison to the predicate device. All other identified differences between the two systems 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 predicate devices. 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.