(119 days)
Not Found
No
The document describes a standard TMS device and its components. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
Yes
The device is indicated for the "treatment of Major Depressive Disorder," which is a therapeutic application.
No
The device description and intended use clearly state that it is for the "treatment of Major Depressive Disorder," and its mechanism involves "activating neurons." There is no mention of it being used to diagnose or detect a disease.
No
The device description explicitly lists hardware components such as a "TMS Stimulator and Cooling Unit", "Treatment Coil (Applicator)", "Coil Arm (Applicator Arm)", and "Treatment Cap". The performance studies also include testing of electrical, mechanical, and thermal safety, magnetic field properties, and electric field properties, which are all related to hardware performance.
Based on the provided information, 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 by directly stimulating brain structures. IVDs are used to diagnose diseases or conditions by examining samples taken from the body (like blood, urine, or tissue).
- Device Description: The device description clearly outlines a system that applies magnetic pulses to the brain for therapeutic purposes. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing diagnostic information.
The device is a therapeutic device that uses Transcranial Magnetic Stimulation (TMS) for the treatment of depression.
N/A
Intended Use / Indications for Use
The NQ TMS for MDD 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 (comma separated list FDA assigned to the subject device)
OBP
Device Description
The NeuroQoreTMS System (NQ TMS for MDD) enables direct non-invasive activation of brain structures. TMS is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain the induced field is above a certain threshold, and is directed in an appropriate orientation relative to the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure.
The NeuroQoreTMS System is composed of the following main components: · TMS Stimulator and Cooling Unit · Treatment Coil (Applicator) (Figure-of-eight) · Coil Arm (Applicator Arm) · Treatment Cap
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Frontal 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance tests specified in this quidance document were performed and the results were compared for a determination of substantial equivalence between the subject device (NQ TMS System) and the predicate device (MagVita TMS System): Electric Field: a. SMT Comparison b. Electrical Field Strength Decay over z-axis distance from coil center (in the direction of head center); Magnetic Field: a. Output Waveform for pulse width and amplitude - b. Magnetic Field Strength Linearity as a function of machine intensity setting c. Magnetic Field Spatial Distribution - d. Magnetic Field Gradient (dB/dt); Electrical/Mechanical/Thermal Safety (IEC 60601-1) Electromagnetic Compatibility (IEC 60601-1-2) Biocompatibility (ISO 10993-1) Software Validation (FDA Guidance).
The subject device (NQ TMS for MDD System) and the predicate device (MagVita TMS System) have identical intended use/indication for use, target population, treatment position and all recommended standard treatment protocol parameters (intensity, frequency, number of pulses in a train, number of trains in a session, number of treatment sessions).
Both, the proposed device and predicate device share Figure-of-eight coil design. The tested electric field and magnetic fleld properties of the NQ TMS for MDD and the predicate devices are substantial equivalent for the coils.
The reliability of the positioning method used by the NQ TMS for MDD is based on the underlying cortical brain anatomy to the patient's scalp, as is the method used in the predicate device. The method for identifying the correct treatment position in the NQ TMS for MDD is the same as the method employed by the predicate devices.
The NQ TMS System does not introduce any new safety considerations in comparison to the predicated with the ridentified differences between the proposed device and the predicates are minor any known impact on safety or efficacy. Based on the information and supporting documentation provided in the NQTMS for MDD is substantially equivalent to the cited predicate device. Testing demonstrates that the NQ TMS for MDD fulfills prospectively defined design and performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
December 29, 2023
NeuroQore, Inc. % Barry Ashar President Makromed, Inc. 88 Stiles Road Salem, New Hampshire 03079
Re: K232688
Trade/Device Name: NO TMS for MDD (NOv1-MU-01) Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: November 29, 2023 Received: November 30, 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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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,
Image /page/1/Picture/6 description: The image shows the name "Robert M. Stefani -S" in a clear, sans-serif font. The name is arranged in two lines, with "Robert M." on the first line and "Stefani -S" on the second line. The text is black against a white background, with a light blue vertical bar on the right side of the image.
Digitally signed by Robert M. Stefani -S Date: 2023.12.29 14:36:47 -05'00'
for Pamela Scott, MS Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
NQ TMS for MDD (NQv1-MU-01)
Indications for Use (Describe)
The NQ TMS for MDD 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)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
| 510(k) #: K232688 | 510(k) Summary | Prepared on: 2023-11-29 | |||
|---|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||||
| Applicant Name | NeuroQore, Inc. | ||||
| Applicant Address | 479 Jessie Street San Francisco CA 94103 United States | ||||
| Applicant Contact Telephone | 949.397.1333 | ||||
| Applicant Contact | Mr. Mehran Talebinejad | ||||
| Applicant Contact Email | mt@neuroqore.com | ||||
| Correspondent Name | Makromed, Inc. | ||||
| Correspondent Address | 88 Stiles Road Salem NH 03079 United States | ||||
| Correspondent Contact Telephone | 603.674.9074 | ||||
| Correspondent Contact | Mr. Barry Ashar | ||||
| Correspondent Contact Email | bashar@makromed.com | ||||
| Device Name | 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | NQ TMS for MDD (NQv1-MU-01) | ||||
| Common Name | Repetitive transcranial magnetic stimulation system | ||||
| Classification Name | Transcranial Magnetic Stimulator | ||||
| Regulation Number | 882.5805 | ||||
| Product Code | OBP | ||||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K171481 | MagVita TMS Therapy System | OBP | |||
| K150641 | MagVita TMS Therapy System | OBP |
5
Device Description Summary
21 CFR 807.92(a)(4)
The NeuroQoreTMS System (NQ TMS for MDD) enables direct non-invasive activation of brain structures. TMS is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain the induced field is above a certain threshold, and is directed in an appropriate orientation relative to the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure.
The NeuroQoreTMS System is composed of the following main components: · TMS Stimulator and Cooling Unit
· Treatment Coil (Applicator) (Figure-of-eight)
· Coil Arm (Applicator Arm)
· Treatment Cap
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The NQ TMS for MDD 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.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The subject device of this 510(k) submission has the exact same Indication for Use as that of the predicate device.
6
Technological Comparison
21 CFR 807.92(a)(6)
Introduction
The proposed device, the NQ TMS for MDD, and the predicate device, MagVita TMS Therapy System (K171481, K150641) are computerized electromechanical medical devices that produce and deliver non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Major Depressive Disorder.
Design
The design of the NQ TMS for MDD is similar to that of the MagVita TMS Therapy Systems are based on applying transcranial magnetic stimulation by means of repetitive pulse trains at a predetermined frequency. Both systems use the same mechanism of action, i.e., an electroment that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the prefrontal cortex. The coils used in both systems for generating the magnetic field use the same transducer design (figure-of-eight).
Operational Characteristics
For both the subject and the predicate device, their basic operational procedures including system setup, patient preparations, motor threshold determination, coil positioning and treatment with predefined treatment stimulation parameters are essentially the same. Both devices use the following 19-minutes MDD treatment protocol:
Magnetic Field Intensity: 120% of the MT Frequency: 10 Hz Train Duration: 4 seconds Inter-train Interval: 11 seconds Number of Trains: 75 Magnetic Pulses per Session: 3000 Treatment Session Duration: 18.8 minutes Sessions/week: 5 Treatment Schedule: 5 daily sessions for 6 weeks Area of Brain to be Stimulated: Frontal Cortex
Technological Characteristics
The NQ TMS for MDD and the predicate device have components consisting of TMS stimulator with software, electromagnetic coil and a flexible arm for positioning of the treatment coil.
All the necessary electromagnetic compatibility and electrical safety tests for the NQ TMS for MDD were performed. The results demonstrate that it is in compliance with both the standards IEC 60601-1; therefore, it is as safe as the predicate device.
The tested magnetic properties of the NQ TMS for MDD and the predicate device are substantial equivalent for the coils.
The reliability of the positioning method used by the NQ TMS for MDD is based on the underlying cortical brain anatomy to the patient's scalp, as is the method used in the predicate device. The method for identifying the correct treatment position in the NQ TMS for MDD is at least as effective as the method employed by the predicate device.
The basic software capabilities related to treatment administration in the NQ TMS for MDD are the same as those in the predicate device.
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| Criteria | NeuroQore rTMS
(Subject Device) | MagVita TMS Therapy
System (K171481)
(Predicate Device) | Equivalence Comments |
|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
(Indication for
Use) | The NQ TMS for MDD is
indicated for the treatment
of Major Depressive
Disorder in adult patients
who have failed to receive
satisfactory improvement
from prior antidepressant
medication in the current
episode. | The MagVita TMS
Therapy System is
indicated for the treatment
of Major Depressive
Disorder in adult patients
who have failed to receive
satisfactory improvement
from prior antidepressant
medication in the current
episode. | Identical Indication for Use |
| Recommended Standard Treatment | | | |
| Magnetic Field
Intensity | 120% of the MT | 120% of the MT | Identical recommended
treatment parameters. |
| Frequency | 10 Hz | 10 Hz | The subject and predicate
device provide the same
treatment option of 18.8-
minutes treatment duration,
using 11 sec inter-train
intervals. |
| Train duration | 4 sec | 4 sec | |
| Inter-train
interval | 11 sec | 11-26 sec | |
| Number of trains | 75 | 75 | |
| Magnetic Pulses
per Session | 3000 | 3000 | The subject device does
not provide the legacy 37-
minutes treatment using 26 |
| Treatment
Session Duration | 18.8 min | 18.8-37.0 min | sec inter-train intervals,
which has been superseded |
| Sessions/week | 5 | 5 | in the past few years by the |
| Criteria | NeuroQore rTMS
(Subject Device) | MagVita TMS Therapy
System (K171481)
(Predicate Device) | Equivalence Comments |
| Treatment
Schedule | 5 daily sessions for 6
weeks | 5 daily sessions for 6
weeks | 18.8 minutes treatment
prevailing in the current
clinical practices. |
| Area of brain to
be stimulated | Frontal Cortex | Frontal Cortex | |
| | | Coils | |
| Coils | NQv1-AC-01 | C-B65 | N/A |
| Configuration | Figure-of-eight coil | Figure-of-eight coil | Same figure-of-eight
configuration in both coils. |
| Core material | Air core | Air core | Same core material design. |
| Cooling | Liquid cooling | Liquid cooling | Same liquid-cooling
mechanism in both coils. |
| Coil parameters | Inner diameter - 25 mm
Outer diameter - 100 mm
N = 2 wings x 1 layers x
15 turns | Inner diameter - 35 mm
Outer diameter - 75 mm
N = 2 wings x 2 layers x 5
turns | Equivalent, with no
additional concerns for
safety and effectiveness.
See Note A for equivalence
explanation of coil
parameters such as
dimensions and windings. |
| Machine Output Parameters | | | |
| Amplitude in
Standard Motor | 0% Intensity Setting → 0
SMT | 0% Intensity Setting → 0
SMT | Equivalent, with no
additional concerns for
safety and effectiveness. |
| Criteria | NeuroQore rTMS
(Subject Device) | MagVita TMS Therapy
System (K171481)
(Predicate Device) | Equivalence Comments |
| Threshold (SMT)
units | 44.3% Intensity Setting →
1.0 SMT
100% Intensity Setting →
2.7 SMT | 37.8% Intensity Setting →
1.0 SMT
100% Intensity Setting →
3.0 SMT | See Note B for equivalence
explanation of
Intensity/Amplitude. |
| Waveform | Biphasic triangular | Biphasic sinusoid | Equivalent, with no
additional concerns for
safety and effectiveness.
See Note C for equivalence
explanation of Waveform. |
| Active pulse
width (μs) | 300 | 290 | Equivalent, with no
additional concerns for
safety and effectiveness. |
| Pulse amplitude
(V) | 38.56 | 39.12 | See Note D for equivalence
explanation of Pulse Width
and Amplitude. |
| Max magnetic
field strength 2
cm from coil (T) | At 30% Intensity:
0.088 | At 30% Intensity:
0.126 | Equivalent, with no
additional concerns for
safety and effectiveness.
See Note E for equivalence
explanation of Max
magnetic field strength. |
| | At 50% Intensity:
0.229 | At 50% Intensity:
0.246 | |
| | At 70% Intensity:
0.332 | At 70% Intensity:
0.326 | |
| | At 100% Intensity:
0.490 | At 100% Intensity:
0.510 | |
| Criteria | NeuroQore rTMS
(Subject Device) | MagVita TMS Therapy
System (K171481)
(Predicate Device) | Equivalence Comments |
| Max initial dB/dt
(kT/s) near the
coil surface
(z = 0 cm) | 15.28 | 15.51 | Equivalent, with no
additional concerns for
safety and effectiveness.
See Note F for equivalence
explanation of dB/dt. |
| Max initial dB/dt
(kT/s) 2 cm from
coil surface
(z = 2 cm) | 5.30 | 5.59 | |
| Coil
Temperature at
Max Intensity
The system will
be automatically
disabled when
the coil
temperature
exceeds: | 41 °C (106 °F) | 41 °C (106 °F) | Regardless of the intensity
setting (at Maximum
output or otherwise), both
the subject and predicate
device have a coil
temperature safety feature
that shuts down the system
when the threshold
temperature is reached. |
| Frequency range
(Hz) | 0.1 to 20 | 0.1 to 30 or 0.1 to 100,
depending on model | The differences in these
parameters are simply the
differences in the overall
capabilities of these
machines. These
capabilities encompass the |
| Pulse train
duration range
(s) | 1 to 4 | Rep Rate: 0.1 ...100Hz
Pulses in Train: 1,2,3,4 ...
1000
Train duration = Pulses in
Train / Rep Rate | differences in the overall
capabilities of these
machines. These
capabilities encompass the
recommended treatment |
| Criteria | NeuroQore rTMS
(Subject Device) | MagVita TMS Therapy
System (K171481)
(Predicate Device) | Equivalence Comments |
| Inter-train
interval range (s) | 1 to 11 | 1 to 120 | 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. Both machines use identical treatment parameters. |
| Maximum trains
per session | 75 | 500 | |
| Maximum
number of pulses
per session | 3000 | 500,000 = 1,000 (pulses max per train) x 500
(trains max per session) | |
| Standards | | | |
| 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. | N/A |
| ISO Standards
met | Company complies with
ISO 13485:2016.
ISO14971 | Company complies with
ISO 13485:2012. | N/A |
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CONFIDENTIAL
Page 5- 8
12
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following special control is applicable to the subject device (Product Code: OBP) of this 510(k) submission: "Guidance for Industry and FDA Special Controls Guidance Document: Repettive Transcranial Magnetic Stimulation (rTMS) Systems."
The following performance tests specified in this quidance document were performed and the results were compared for a determination of substantial equivalence between the subject device (NQ TMS System) and the predicate device (MagVita TMS System): Electric Field:
a. SMT Comparison
b. Electrical Field Strength Decay over z-axis distance from coil center (in the direction of head center)
Magnetic Field:
a. Output Waveform for pulse width and amplitude
-
b. Magnetic Field Strength Linearity as a function of machine intensity setting
c. Magnetic Field Spatial Distribution -
d. Magnetic Field Gradient (dB/dt)
Electrical/Mechanical/Thermal Safety (IEC 60601-1) Electromagnetic Compatibility (IEC 60601-1-2) Biocompatibility (ISO 10993-1) Software Validation (FDA Guidance)
Conclusion Statement
The subject device (NQ TMS for MDD System) and the predicate device (MagVita TMS System) have identical intended use/indication for use, target population, treatment position and all recommended standard treatment protocol parameters (intensity, frequency, number of pulses in a train, number of trains in a session, number of treatment sessions).
Both, the proposed device and predicate device share Figure-of-eight coil design. The tested electric field and magnetic fleld properties of the NQ TMS for MDD and the predicate devices are substantial equivalent for the coils.
The reliability of the positioning method used by the NQ TMS for MDD is based on the underlying cortical brain anatomy to the patient's scalp, as is the method used in the predicate device. The method for identifying the correct treatment position in the NQ TMS for MDD is the same as the method employed by the predicate devices.
The NQ TMS System does not introduce any new safety considerations in comparison to the predicated with the ridentified differences between the proposed device and the predicates are minor any known impact on safety or efficacy. Based on the information and supporting documentation provided in the NQTMS for MDD is substantially equivalent to the cited predicate device. Testing demonstrates that the NQ TMS for MDD fulfills prospectively defined design and performance specifications.