(181 days)
No
The summary does not mention AI, ML, or any related concepts like algorithms for data analysis or decision making beyond basic microcomputer control.
Yes
The device is indicated for the "treatment of Major Depressive Disorder," which explicitly states a therapeutic purpose.
No
The device is indicated for the treatment of Major Depressive Disorder, not for diagnosing it.
No
The device description explicitly lists multiple hardware components including a stimulation generator, stimulation coil, magnetic stimulator, cooling unit, and coils.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of Major Depressive Disorder in adult patients. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a magnetic stimulator that applies magnetic pulses to the brain. This is a physical intervention, not a test performed on biological samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 medication in the current episode.
Product codes
OBP
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 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)
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
Not Found
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
Non-clinical performance data was submitted. Electrical safety and electromagnetic compatibility testing demonstrated compliance with IEC 60601-1:2012 and IEC 60601-1-2: 2014. Biocompatibility evaluation of the positioning cap demonstrated compliance with ISO 10993-1:2018 standards. Software verification and validation testing was performed. Risk assessment was conducted in compliance with ISO14971:2019. Non-clinical testing included magnetic field characteristics and acoustic output measurements as required by FDA's guidance document "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems". Performance testing was conducted to compare the spatial magnetic field distribution of the subject device (using three coils: BY90A, BF90A, BY90B) against the primary predicate device (using the C-B65 coil). Measurements were compared on the same plots at multiple locations.
Key Metrics
Not Found
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.
0
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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.
1
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
2
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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3
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
4
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
5
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
6
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
7
| Criteria | Ultimate rTMS | (Primary Predicate)
MagVita TMS Therapy
System (K171481) | (Secondary Predicate)
Rapid² Therapy System
(K143531) | 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 Rapid² Therapy
System is indicated for
the treatment of Major
Depressive Disorder in
adult patients who
have failed to achieve
satisfactory
improvement from
prior antidepressant
medication in the
current episode. | Identical Indication for
Use | |
| Recommended Standard Treatment | | | | | |
| Magnetic Field
Intensity | 120% of the MT | 120% of the MT | 120% of the MT | Identical recommended
treatment parameters. | |
| Frequency | 10 Hz | 10 Hz | 10 Hz | The subject and primary
predicate devices provide
two treatment options –
18.8- and 37.0-minutes
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
per Session | 3000 | 3000 | 3000 | | |
| Criteria | Ultimate rTMS | (Primary Predicate)
MagVita TMS Therapy
System (K171481) | (Secondary Predicate)
Rapid² Therapy System
(K143531) | Equivalence Comments | |
| Treatment Session
Duration | 18.8-37.0 min | 18.8-37.0 min | 37.5 min | using 11 sec and 26 sec
inter-train intervals. | |
| Sessions/week | 5 | 5 | 5 | | |
| Treatment
Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6
weeks | 5 daily sessions for 6
weeks | | |
| Area of brain to be
stimulated | Left Dorsolateral Prefrontal
Cortex | Left Dorsolateral
Prefrontal Cortex | Left Dorsolateral
Prefrontal Cortex | | |
| Coils | Coils | | | | |
| Coils (including
optional
accessories) | BY90A
BF90A
BY90B | C-B60
C-B65 | Magstim Double 70mm
Air Film Coil | 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. | |
| Core material | Air core | Air core | Air core | Same core material
design. | |
| Cooling | BY90A:Liquid cooling
BF90A:Forced Air cooling
BY90B:Liquid cooling | C-B65: Liquid cooling
C-B60: None | Forced Air | Ultimate rTMS offers
liquid-cooled and forced | |
| | BF90A:Forced Air cooling | C-B60: None | | air-cooled coils. Primary | |
| | BY90B:Liquid cooling | | | predicate offers liquid-
cooled coil and
secondary predicate
offers air-cooled coil. | |
| Criteria | Ultimate rTMS | (Primary Predicate)
MagVita TMS Therapy
System (K171481) | (Secondary Predicate)
Rapid² Therapy System
(K143531) | 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 | Coil Cool-B65
Inner diameter - 35 mm
Outer diameter - 75 mm
Winding height - 12 mm
N = 2 wings x 2 layers x 5
turns | Area = 33000 mm²
Average Inductance 12 µH
Flat spiral winding
N = 2 wings x 3 layers x
19 turns | Equivalent, with no
additional concerns forsafety and effectiveness.
See Note A for
equivalence explanation
of coil parameters such
as dimensions and
windings. | |
| | BY90B:Inner diameter - 30 mm
Outer diameter -90 mm
N = 2 wings x 2 layers x 6 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 | | | |
| | | Machine Output Parameters | | | |
| Amplitude in
Standard Motor
Threshold (SMT)
units | 0 - 1.9
52.6% Intensity Setting → 1
SMT | 0 - 1.7
58.8% Intensity Setting →
1 SMT | 0.28 - 1.9
61.7% 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 | 300 | Equivalent, with no
additional concerns for
safety and effectiveness. | |
| Pulse amplitude
(V) | BY90A: 1.35
BF90A: 1.26
BY90B: 1.22 | C-B65: 1.84 | N/A | safety and effectiveness.
See Note C for
equivalence explanation
of Pulse Width and
Amplitude. | |
| Criteria | Ultimate rTMS | (Primary Predicate)
MagVita TMS Therapy
System (K171481) | (Secondary Predicate)
Rapid² Therapy System
(K143531) | Equivalence Comments | |
| Max magnetic
field strength 2 cm
from coil (T) | At 25% Intensity:
BY90A: 0.172
BF90A: 0.182
BY90B: 0.117 | At 25% Intensity:
C-B65: 0.133 | | Equivalent, with no
additional concerns for
safety and effectiveness. | |
| | At 50% Intensity:
BY90A: 0.291
BF90A: 0.287
BY90B: 0.244 | At 50% Intensity:
C-B65: 0.272 | | See Note D for
equivalence explanation
of Max magnetic field
strength. | |
| | At 75% Intensity:
BY90A: 0.403
BF90A: 0.395
BY90B: 0.369 | At 75% Intensity:
C-B65: 0.413 | | | |
| | At 100% Intensity:
BY90A: 0.498
BF90A: 0.494
BY90B: 0.481 | At 100% Intensity:
C-B65: 0.542 | | | |
| Max initial dB/dt
(kT/s) near the coil
surface
(z = 0 cm) | BY90A: 13.44
BF90A: 13.76
BY90B: 12.10 | C-B65: 13.36 | N/A | Equivalent, with no
additional concerns for
safety and effectiveness. | |
| Max initial dB/dt
(kT/s) 2 cm from
coil surface
(z = 2 cm) | BY90A: 3.59
BF90A: 4.27
BY90B: 6.78 | C-B65: 5.29 | N/A | See Note E for
equivalence explanation
of dB/dt. | |
| The system will
automatically be
disabled when the | 40 °C (104 °F) | 41 °C (106 °F) | 40 °C (104 °F) | Regardless of the
intensity setting (at
Maximum output or
otherwise), both the | |
| Criteria | Ultimate rTMS | (Primary Predicate)
MagVita TMS Therapy
System (K171481) | (Secondary Predicate)
Rapid² Therapy System
(K143531) | Equivalence Comments | |
| coil temperature
exceeds: | | | | 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.
The differences in these
parameters are simply
the differences in the
overall capabilities of
these machines. These
capabilities encompass
the recommended
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. | |
| Frequency range
(Hz) | 0.1 - 10 | 0.1 - 30 or 0.1 - 100,
depending on model | 0.1 - 30 | | |
| Pulse train
duration range (s) | Rep Rate: 0.1 ...100Hz
Pulses in Train: 1,2,3,4 ... 2000
Train duration = Pulses in Train
/ Rep Rate | Rep Rate: 0.1 ...100Hz
Pulses in Train: 1,2,3,4 ...
1000
Train duration = Pulses in
Train / Rep Rate | 1 - 20 | | |
| Inter-train interval
range (s) | 0~60s | 1 - 120 | 10 - 60 | | |
| Maximum trains
per session | 250 | 500 | ~140 | | |
| Maximum number
of pulses per
session | 5000
(Pluses In Train:20
*Maximun Trains:250
=Maximun Number:5000) | 500,000 = 1,000 (pulses
max per train) x 500
(trains
max per session) | 65,000 | | |
| Criteria | Ultimate rTMS | (Primary Predicate)
MagVita TMS Therapy
System (K171481) | (Secondary Predicate)
Rapid² Therapy System
(K143531) | Equivalence Comments | |
| | | | | All machines use
identical treatment
parameters. | |
| Electrical
safety | Complies with
IEC 60601-1, IEC 60601-1-2. | Complies with
IEC 60601-1, IEC 60601-1-1 and IEC 60601-1-2. | Complies with
EN 60601-1 and
EN 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: 2003
ISO 10993-1: 2009
ISO 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
8
Brain Ultimate, Inc., Traditional 510 (k) Ultimate rTMS
9
Brain Ultimate, Inc., Traditional 510 (k) Ultimate rTMS
10
Brain Ultimate, Inc., Traditional 510 (k)
CONFIDENTIAL
Ultimate rTMS
11
Brain Ultimate, Inc., Traditional 510 (k)
CONFIDENTIAL
Ultimate rTMS
12
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
13
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 |
14
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
15
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.