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.

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

AI/ML Overview

The provided text is a 510(k) summary for the NQ TMS for MDD (NQv1-MU-01) device, comparing it to a predicate device, the MagVita TMS Therapy System (K171481). The purpose of this summary is to demonstrate substantial equivalence, not to present a study proving the device meets specific clinical acceptance criteria in terms of efficacy on patients.

Therefore, the document does not contain information about:

Specific clinical acceptance criteria (e.g., a certain percentage improvement in depression scores).
Any studies on human subjects to prove the device meets such clinical acceptance criteria.
Sample sizes for test sets where clinical efficacy against a ground truth was evaluated.
Number and qualifications of experts for ground truth establishment.
Adjudication methods for a test set.
MRMC comparative effectiveness studies.
Standalone performance in a clinical context (other than engineering performance).
Type of ground truth used regarding patient outcomes.
Sample size for training sets, or how ground truth for a training set was established.

Instead, the document focuses on demonstrating technical and operational equivalence to a previously cleared predicate device. The "acceptance criteria" discussed are primarily engineering and performance specifications to confirm that the subject device operates safely and similarly to the predicate.

Here's the information that can be extracted from the provided text regarding the closest equivalent to "acceptance criteria" and the "study" demonstrating it:

1. A table of acceptance criteria and the reported device performance

The document provides a comparative table of technological characteristics between the subject device (NeuroQore rTMS) and the predicate device (MagVita TMS Therapy System). The "acceptance criteria" in this context are the engineering and operational parameters of the predicate device, and the "reported device performance" is how closely the subject device's parameters match or are considered equivalent.

Criteria	NeuroQore rTMS (Subject Device) Performance	Predicate Device (MagVita TMS Therapy System K171481) Performance	Equivalence Comments
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 to Subject Device	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	The subject device does not provide the legacy 37-minutes treatment using 26 sec inter-train intervals, which has been superseded in the past few years by the 18.8 minutes treatment prevailing in the current clinical practices. Both machines use identical treatment parameters (for the 18.8 min treatment).
Number of trains	75	75
Magnetic Pulses per Session	3000	3000
Treatment Session Duration	18.8 min	18.8-37.0 min
Sessions/week	5	5
Treatment Schedule	5 daily sessions for 6 weeks	5 daily sessions for 6 weeks
Area of brain to be stimulated	Frontal Cortex	Frontal Cortex
Coils
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/Outer diameter, turns)	Inner D: 25mm, Outer D: 100mm, N: 2 wings x 1 layer x 15 turns	Inner D: 35mm, Outer D: 75mm, 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 Threshold (SMT) units	0% Intensity → 0 SMT, 44.3% Intensity → 1.0 SMT, 100% Intensity → 2.7 SMT	0% Intensity → 0 SMT, 37.8% Intensity → 1.0 SMT, 100% Intensity → 3.0 SMT	Equivalent, with no additional concerns for safety and effectiveness. (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. (See Note D for equivalence explanation of Pulse Width and Amplitude).
Pulse amplitude (V)	38.56	39.12	Equivalent, with no additional concerns for safety and effectiveness. (See Note D for equivalence explanation of Pulse Width and Amplitude).
Max magnetic field strength 2 cm from coil (T)	At 30%: 0.088, At 50%: 0.229, At 70%: 0.332, At 100%: 0.490	At 30%: 0.126, At 50%: 0.246, At 70%: 0.326, At 100%: 0.510	Equivalent, with no additional concerns for safety and effectiveness. (See Note E for equivalence explanation of Max magnetic field strength).
Max initial dB/dt (kT/s) (coil surface z=0)	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) (2cm from coil z=2)	5.30	5.59
Coil Temperature at Max Intensity (shutdown)	41 °C (106 °F)	41 °C (106 °F)	Regardless of the intensity setting, both devices 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 recommended treatment parameters for MDD listed above. Both machines use identical treatment parameters for MDD.
Pulse train duration range (s)	1 to 4	Rep Rate: 0.1-100Hz, Pulses in Train: 1-1000, Train duration = P/RR
Inter-train interval range (s)	1 to 11	1 to 120
Maximum trains per session	75	500
Maximum number of pulses per session	3000	500,000
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 (Both comply with relevant standards for safety)
ISO Standards met	ISO 13485:2016, ISO14971	ISO 13485:2012	N/A (Both comply with relevant quality management system standards)

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 provided in the document. The testing described is primarily non-clinical, focusing on device performance characteristics rather than clinical outcomes in human subjects.

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 provided. Ground truth in this context refers to the established technical specifications of the predicate device and relevant international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. This concept is not applicable to the non-clinical testing performed.

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 type of study is not discussed as the device is a therapeutic rTMS system, not an AI-assisted diagnostic tool or reader support system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The "studies" conducted are standalone engineering and performance tests of the device's electrical, magnetic, mechanical, thermal, and software functionalities. These tests confirm the device's intrinsic operating characteristics meet specifications and are comparable to the predicate. The document states:

"The following performance tests specified in this guidance document were performed and the results were compared for a determination of substantial equivalence between the subject device (NQ TMS System) and the predicate device (MagVita TMS System): Electric Field, Magnetic Field, Electrical/Mechanical/Thermal Safety (IEC 60601-1), Electromagnetic Compatibility (IEC 60601-1-2), Biocompatibility (ISO 10993-1), Software Validation (FDA Guidance)."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests is based on:

Established engineering principles and measurements: For electric field, magnetic field, pulse characteristics, temperatures, etc.
International standards: Such as IEC 60601-1 series for electrical safety and electromagnetic compatibility, ISO 10993-1 for biocompatibility, and ISO 13485/14971 for quality management and risk management.
The performance specifications of the legally marketed predicate device: Which the subject device aims to be substantially equivalent to.

8. The sample size for the training set

This information is not provided. The device is an rTMS system, and the document focuses on its engineering specifications relative to a predicate, not on a machine learning algorithm that would typically require training data.

9. How the ground truth for the training set was established

This information is not provided for the same reasons as #8.

Summary

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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).

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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

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K232688

Device Name

NQ TMS for MDD (NQv1-MU-01)

Indications for Use (Describe)

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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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

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Device Description Summary

21 CFR 807.92(a)(4)

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)

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.

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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 TherapySystem (K171481)(Predicate Device)	Equivalence Comments
Intended Use(Indication forUse)	The NQ TMS for MDD isindicated for the treatmentof Major DepressiveDisorder in adult patientswho have failed to receivesatisfactory improvementfrom prior antidepressantmedication in the currentepisode.	The MagVita TMSTherapy System isindicated for the treatmentof Major DepressiveDisorder in adult patientswho have failed to receivesatisfactory improvementfrom prior antidepressantmedication in the currentepisode.	Identical Indication for Use
Recommended Standard Treatment
Magnetic FieldIntensity	120% of the MT	120% of the MT	Identical recommendedtreatment parameters.
Frequency	10 Hz	10 Hz	The subject and predicatedevice provide the sametreatment option of 18.8-minutes treatment duration,using 11 sec inter-trainintervals.
Train duration	4 sec	4 sec
Inter-traininterval	11 sec	11-26 sec
Number of trains	75	75
Magnetic Pulsesper Session	3000	3000	The subject device doesnot provide the legacy 37-minutes treatment using 26
TreatmentSession 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 TherapySystem (K171481)(Predicate Device)	Equivalence Comments
TreatmentSchedule	5 daily sessions for 6weeks	5 daily sessions for 6weeks	18.8 minutes treatmentprevailing in the currentclinical practices.
Area of brain tobe 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-eightconfiguration in both coils.
Core material	Air core	Air core	Same core material design.
Cooling	Liquid cooling	Liquid cooling	Same liquid-coolingmechanism in both coils.
Coil parameters	Inner diameter - 25 mmOuter diameter - 100 mmN = 2 wings x 1 layers x15 turns	Inner diameter - 35 mmOuter diameter - 75 mmN = 2 wings x 2 layers x 5turns	Equivalent, with noadditional concerns forsafety and effectiveness.See Note A for equivalenceexplanation of coilparameters such asdimensions and windings.
Machine Output Parameters
Amplitude inStandard Motor	0% Intensity Setting → 0SMT	0% Intensity Setting → 0SMT	Equivalent, with noadditional concerns forsafety and effectiveness.
Criteria	NeuroQore rTMS(Subject Device)	MagVita TMS TherapySystem (K171481)(Predicate Device)	Equivalence Comments
Threshold (SMT)units	44.3% Intensity Setting →1.0 SMT100% Intensity Setting →2.7 SMT	37.8% Intensity Setting →1.0 SMT100% Intensity Setting →3.0 SMT	See Note B for equivalenceexplanation ofIntensity/Amplitude.
Waveform	Biphasic triangular	Biphasic sinusoid	Equivalent, with noadditional concerns forsafety and effectiveness.See Note C for equivalenceexplanation of Waveform.
Active pulsewidth (μs)	300	290	Equivalent, with noadditional concerns forsafety and effectiveness.
Pulse amplitude(V)	38.56	39.12	See Note D for equivalenceexplanation of Pulse Widthand Amplitude.
Max magneticfield strength 2cm from coil (T)	At 30% Intensity:0.088	At 30% Intensity:0.126	Equivalent, with noadditional concerns forsafety and effectiveness.See Note E for equivalenceexplanation of Maxmagnetic 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 TherapySystem (K171481)(Predicate Device)	Equivalence Comments
Max initial dB/dt(kT/s) near thecoil surface(z = 0 cm)	15.28	15.51	Equivalent, with noadditional concerns forsafety and effectiveness.See Note F for equivalenceexplanation of dB/dt.
Max initial dB/dt(kT/s) 2 cm fromcoil surface(z = 2 cm)	5.30	5.59
CoilTemperature atMax IntensityThe system willbe automaticallydisabled whenthe coiltemperatureexceeds:	41 °C (106 °F)	41 °C (106 °F)	Regardless of the intensitysetting (at Maximumoutput or otherwise), boththe subject and predicatedevice have a coiltemperature safety featurethat shuts down the systemwhen the thresholdtemperature is reached.
Frequency range(Hz)	0.1 to 20	0.1 to 30 or 0.1 to 100,depending on model	The differences in theseparameters are simply thedifferences in the overallcapabilities of thesemachines. Thesecapabilities encompass the
Pulse trainduration range(s)	1 to 4	Rep Rate: 0.1 ...100HzPulses in Train: 1,2,3,4 ...1000Train duration = Pulses inTrain / Rep Rate	differences in the overallcapabilities of thesemachines. Thesecapabilities encompass therecommended treatment
Criteria	NeuroQore rTMS(Subject Device)	MagVita TMS TherapySystem (K171481)(Predicate Device)	Equivalence Comments
Inter-traininterval 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 trainsper session	75	500
Maximumnumber of pulsesper session	3000	500,000 = 1,000 (pulses max per train) x 500(trains max per session)
Standards
Electricalsafety	Complies withIEC 60601-1, IEC 60601-1-2.	Complies withIEC 60601-1, IEC 60601-1-1 and IEC 60601-1-2.	N/A
ISO Standardsmet	Company complies withISO 13485:2016.ISO14971	Company complies withISO 13485:2012.	N/A

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CONFIDENTIAL

Page 5- 8

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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.

Regulation Number and Section

§ 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.