The Neurosoft TMS 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 Neurosoft TMS is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Maior Depressive Disorder.

The Neurosoft TMS principle of operation is based on the discharge of high voltage capacitor (1.8 kV) through stimulation coil; the pulsed magnetic field generated by the discharge current (up to 10 kA) penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons.

The Neurosoft TMS consists of the following main components:

Main unit of the magnetic stimulator
Cooling unit
Extra power supply unit
Coils
Cooled figure-of-eight coil FEC-02-100-C
Cooled figure-of-eight coil AFEC-02-100-C
Figure-of-eight coil FEC-02-100 (optional)
Figure-of-eight coil AFEC-02-100 (optional)
K8 coil holder
K3 flexible arm for coil positioning
Trolley with casters

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is not present as well, as this is a 510(k) summary, which often relies on comparison to predicate devices rather than de novo clinical studies for performance.

Important Note: The provided document is a 510(k) premarket notification summary for a medical device (Neurosoft TMS). Such submissions typically demonstrate substantial equivalence to a previously cleared predicate device, rather than proving direct clinical efficacy through new, large-scale clinical trials. Therefore, information regarding clinical effectiveness studies, particularly those involving human readers, ground truth establishment through expert consensus or pathology, and detailed statistical performance metrics like sensitivity/specificity for AI algorithms, are generally not present in these types of documents for TMS devices. The focus here is on non-clinical performance (safety, electrical, mechanical) and a comparison of technical specifications.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria for the Neurosoft TMS are primarily based on demonstrating substantial equivalence to its predicate devices, especially its own prior version (Neurosoft TMS K160309) and the MagVita TMS Therapy System (K171481). The key "performance" demonstrated relates to its technical specifications matching or being comparable to these cleared devices, and changes not introducing new safety concerns.

Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Neurosoft TMS)
Intended Use	Identical to predicate devices: Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.	"The Neurosoft TMS 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."
Technological Characteristics (Key rTMS Parameters)	Match or be comparable to predicate devices in: Magnetic Field Intensity, Frequency, Train duration, Inter-train interval, Number of trains, Magnetic Pulses per Session, Treatment Session Duration, Sessions/week, Treatment Schedule, Area of brain to be stimulated. Changes should not introduce new safety or efficacy issues.	Matches predicate (K160309) except for Inter-train interval: - Magnetic Field Intensity: 120% of the MT- Frequency: 10 Hz- Train duration: 4 sec- Inter-train interval: 11-26 sec (Modified from fixed 26 sec in K160309, comparable to MagVita)- Number of trains: 75- Magnetic Pulses per Session: 3000- Treatment Session Duration: 18.8 min-37.0 min (Due to variable inter-train interval)- Sessions/week: 5- Treatment Schedule: 5 daily sessions for 6 weeks- Area of brain to be stimulated: Frontal Cortex
Device Components	Comparable components (Main unit, Cooling unit, Power supply, Coils, Coil holders, Flexible arm, Trolley).	Lists identical and optional coils (FEC-02-100-C, AFEC-02-100-C, FEC-02-100, AFEC-02-100). "The Neurosoft TMS and the predicate devices have the same components..."
Coil Specifications	Comparable coil designs (figure-of-eight, air core, cooling methods) and parameters (Inner/Outer diameter, Area, Inductance, Amplitude in SMT units, Waveform, Active pulse width, Max initial dB/dt).	Detailed specifications for all listed coils provided, showing close similarity to K160309 and comparable ranges to MagVita.
Safety Standards	Compliance with relevant electrical safety and quality standards (e.g., IEC 60601-1, ISO 13485, ISO 14971).	"Complies with IEC 60601-1 and IEC 60601-1-2.""Company complies with DIN EN ISO 13485: 2012, ISO 10993-1: 2009, ISO 14971: 2007."
Non-clinical Performance	Satisfactory performance in required non-clinical tests as demonstrated for the predicate device (K160309).	"The non-clinical performance testing of Neurosoft TMS has been tested as required, and cleared by the FDA earlier on K160309. These tests demonstrate that the Neurosoft TMS is safe and effective for use in treatment of Major Depressive Disorder."
New Safety Concerns	The modifications (e.g., variable inter-train interval) should not introduce any new safety considerations.	"On the basis of the only modification of the treatment parameter, the Neurosoft TMS 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."

Study Information (Based on the Provided Document):

The document primarily refers to non-clinical performance data and relies on the substantial equivalence paradigm rather than a new clinical study for this specific 510(k) submission.

Sample sizes used for the test set and the data provenance:
- No specific sample size for a "test set" or clinical trial is provided. The document refers to "non-clinical performance testing."
- Data Provenance: Not specified in terms of country of origin. The testing is described as having been "tested as required, and cleared by the FDA earlier on K160309," implying the data underpinning the original clearance (and now referenced) would be from the manufacturer's internal testing as part of their regulatory submissions. The nature of these tests (e.g., electrical, mechanical, EMC) would be retrospective from the previous submission perspective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. As this is a 510(k) for a TMS device based on substantial equivalence and non-clinical data, there is no mention of a ground truth established by human experts for performance evaluation in the context of an AI/human reader study. The "ground truth" for a TMS device's safety and effectiveness is typically established through a combination of regulatory standards, engineering principles, and clinical data from predicate devices or general scientific consensus on the treatment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / None specified. No clinical test set involving human readers or expert adjudication is described in this document.
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:
- No MRMC study was done or reported in this document. This device is a direct treatment device (rTMS system), not an imaging analysis or diagnostic AI tool that would typically involve MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a hardware system for direct medical treatment; it is not an algorithm for diagnostic interpretation in the way AI/ML software as a medical device (SaMD) might be evaluated for standalone performance. The "algorithm" here refers to the internal programming of the TMS device to deliver stimulation according to parameters.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the device's fundamental function (producing magnetic fields of specific parameters), the "ground truth" would be physical measurements and engineering specifications.
- For the device's clinical indication (treatment of MDD), the "ground truth" used for prior clearances (and thus for this substantial equivalence claim) would be the clinical evidence supporting the predicate devices' efficacy (which may have originally involved clinical trials measuring patient outcomes or expert clinical assessments of depression severity). This document itself does not detail new outcomes data.
The sample size for the training set:
- Not applicable / Not specified. This document does not describe a machine learning model with a "training set."
How the ground truth for the training set was established:
- Not applicable. As no machine learning training set is described.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 13, 2017

TeleEMG, LLC % Barry Ashar President Makromed, Inc. 88 Stiles Road Salem, New Hampshire 03079

Re: K173441

Trade/Device Name: Neurosoft TMS (also CloudTMS) Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: October 23, 2017 Received: November 6, 2017

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. 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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1000-1050.

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

William J. Heetderks -S 2017.12.13 12:00:03 -05'00'

Carlos L. Peña. PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173441

Device Name Neurosoft TMS

Indications for Use (Describe)

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 TeleEMG, LLC Neurosoft TMS

(per 21 CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm)

1. SUBMITTER/510(K) HOLDER

TeleEMG. LLC 27 Arlington Rd., Building 2, Unit 1 Woburn, MA 01801, USA

Contact Person: Barry V. Ashar, Makromed, Inc. Telephone: (603) 890-3311 Date Prepared: October 12, 2017

2. DEVICE NAME

Proprietary Name:	Neurosoft TMS
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

TeleEMG LLC, Neurosoft TMS, K160309 ●
o Tonica Electronik A/S, MagVita TMS Therapy System, K171481

4. SPECIAL CONTROLS

The 510k submission addressed the special controls required by regulation and specified in the FDA guidance document titled "Class II Special Controls Guidance Document: Repeitive Transcranial Magnetic Stimulation (rTMS) Systems.

5. DEVICE DESCRIPTION

The Neurosoft TMS is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of

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sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Maior Depressive Disorder.

The Neurosoft TMS consists of the following main components:

0 Main unit of the magnetic stimulator
Cooling unit ●
Extra power supply unit ●
Coils ●
- Cooled figure-of-eight coil FEC-02-100-C o
- Cooled figure-of-eight coil AFEC-02-100-C o
- Figure-of-eight coil FEC-02-100 (optional) о
- o Figure-of-eight coil AFEC-02-100 (optional)
o K8 coil holder
K3 flexible arm for coil positioning o
Trolley with casters ●

6. INTENDED USE/INDICATION FOR USE

The Neurosoft TMS 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.

7. STANDARDS

The Neurosoft TMS system has been tested and complies with the following standards:

DIN EN ISO 13485: 2012 o
o ISO 10993-1
ISO 14971
IEC 60601-1 ●
IEC 60601-1-2 ●

7. NON-CLINICAL PERFORMANCE DATA

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The non-clinical performance testing of Neurosoft TMS has been tested as required, and cleared by the FDA earlier on K160309. These tests demonstrate that the Neurosoft TMS is safe and effective for use in treatment of Major Depressive Disorder.

8. SUBSTANTIAL EQUIVALENCE

The Neurosoft TMS is substantially equivalent to the predicate devices (our own Neurosoft TMS and MagVita TMS Therapy System). The Neurosoft TMS and the predicate devices have identical intended use /indication for use, and technological characteristics. The principles of operation, the output stimulation parameters and the materials are equivalent to the predicates. The modification to the device allows a range of intervals from 11 to 26 seconds, rather than the fixed 26 second duration, which will allow a reduction in treatment time from 37.5 minutes to a minimum of 18.8 minutes.

The design of the Neurosoft TMS is similar to that of our predecessor Neurosoft TMS and the MagVita TMS 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 Neurosoft TMS are the same as these in the predicate devices.

The Neurosoft TMS 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 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 Neurosoft TMS and the predicate devices is shown in a tabular form below:

Criteria	Neurosoft TMS	Neurosoft TMS(K160309)	MagVita TMS TherapySystem(K171481)
Intended Use	The Neurosoft TMS isindicated for the treatment ofMajor Depressive Disorder inadult patients who have failedto receive satisfactoryimprovement from prior	The Neurosoft TMS isindicated for the treatment ofMajor Depressive Disorderin adult patients who havefailed to receive satisfactoryimprovement from prior	The MagVita TMSTherapy System isindicated for thetreatment of MajorDepressive Disorder inadult patients who have
Criteria	Neurosoft TMS	Neurosoft TMS(K160309)	MagVita TMS TherapySystem(K171481)
	antidepressant medication inthe current episode.	antidepressant medication inthe current episode.	failed to receivesatisfactory improvementfrom prior antidepressantmedication in the currentepisode.
Recommended standard treatment
Magnetic FieldIntensity	120% of the MT	120% of the MT	120% of the MT
Frequency	10 Hz	10 Hz	10 Hz
Train duration	4 sec	4 sec	4 sec
Inter-train interval	11-26 sec	26 sec	11-26 sec
Number of trains	75	75	75
Magnetic Pulsesper Session	3000	3000	3000
Treatment SessionDuration	18.8 min-37.0 min	37.0 min	18.8 min-37.0 min.
Sessions/week	5	5	5
TreatmentSchedule	5 daily sessions for 6 weeks	5 daily sessions for 6 weeks	5 daily sessions for 6weeks
Area of brain to bestimulated	Frontal Cortex	Frontal Cortex	Frontal Cortex
		Coils
Coils (includingoptionalaccessories)	FEC-02-100-C, AFEC-02-100-CFEC-02-100 (optional), AFEC-02-100 (optional)	FEC-02-100-C, AFEC-02-100-CFEC-02-100 (optional),AFEC-02-100 (optional)	C-B60C-B65
Configuration	Figure-of-eight coil	Figure-of-eight coil	Figure-of-eight coil
Core material	Air core	Air core	Air core
Cooling	FEC-02-100-C & AFEC-02-100-C: Liquid cooling	FEC-02-100-C & AFEC-02-100-C: Liquid cooling	C-B65: Liquid cooling
	FEC-02-100 & AFEC-02-100(optional accessories): None	FEC-02-100 & AFEC-02-100(optional accessories): None	C-B60: None
Coil parameters	FEC-02-100-CInner diameter - 47x50 mm¹Outer diameter - 97x100 mm¹Area = 184725 mm²Average Inductance 10 µHFlat spiral windingN = 16 turns (2 layers x 2wings)	FEC-02-100-CInner diameter - 47x50 mm¹Outer diameter - 97x100mm¹Area = 184725 mm²Average Inductance 10 µHFlat spiral windingN = 16 turns (2 layers x 2	Coil Cool-B65Inner diameter - 35 mmOuter diameter - 75 mmWinding height - 12 mmN = 2x (2 x 5)
Criteria	Neurosoft TMS(K160309)	Neurosoft TMS	MagVita TMS Therapy System(K171481)
	AFEC-02-100-CInner diameter - 36x51 mm¹Outer diameter - 84x106 mm¹Area = 184725 mm²Average Inductance 10 μHFlat spiral windingN = 16 turns (2 layers x 2 wings)	wings)
	FEC-02-100Inner diameter - 47x50 mm¹Outer diameter - 97x100 mm¹Area = 91560 mm²Average Inductance 10 μHFlat spiral windingN = 16 turns (2 layers x 2 wings)	FEC-02-100Inner diameter - 47x50 mm¹Outer diameter - 97x100 mm¹Area = 91560 mm²Average Inductance 10 μHFlat spiral windingN = 16 turns (2 layers x 2 wings)	Coil C-B60Inner diameter - 35 mmOuter diameter - 75 mmWinding height - 12 mmN = 2x (2 x 5)
	AFEC-02-100Inner diameter - 36x51 mm¹Outer diameter - 84x106 mm¹Area = 87200 mm²Average Inductance 10 μHFlat spiral windingN = 16 turns (2 layers x 2 wings)	AFEC-02-100Inner diameter - 36x51 mm¹Outer diameter - 84x106 mm¹Area = 87200 mm²Average Inductance 10 μHFlat spiral windingN = 16 turns (2 layers x 2 wings)
Amplitude inStandard MotorThreshold (SMT)units	FEC-02-100-C 0 - 1.89AFEC-02-100-C 0 - 2.38FEC-02-100 0 - 1.92AFEC-02-100 0 - 2.33	FEC-02-100-C 0 - 1.89AFEC-02-100-C 0 - 2.38FEC-02-100 0 - 1.92AFEC-02-100 0 - 2.33	0 - 1.7
Waveform	Biphasic sinusoid	Biphasic sinusoid	Biphasic sinusoid
Active pulse width(μs)	280	280	290
Max initial dB/dt(kT/s) near the coilsurface	FEC-02-100-C 25AFEC-02-100-C 38FEC-02-100 25AFEC-02-100 32	FEC-02-100-C 25AFEC-02-100-C 38FEC-02-100 25AFEC-02-100 32	C-B65: 36C-B60: 35
The system willautomatically bedisabled when the	41 °C (106 °F)	41 °C (106 °F)	41 °C (106 °F)
Criteria	Neurosoft TMS	Neurosoft TMS(K160309)	MagVita TMS TherapySystem(K171481)
coil temperatureexceeds:
Frequency range(Hz)	0.1 - 30 (Stand-alone)0.1 - 100 (with PC)	0.1 - 30 (Stand-alone)0.1 - 100 (with PC)	0.1 - 30 or 0.1 - 100,depending on model
Pulse trainduration range (s)	0.5 - 100	0.5 - 100	Rep Rate: 0.1 ...100HzPulses in Train: 1,2,3,4... 1000Train duration = Pulsesin Train / Rep Rate
Inter-train intervalrange (s)	0 - 300	0 - 300	1 - 120
Maximum trainsper session	4800 = 2400 s [max session] /(0.5 s [min train]+ 0 s [minpause])	4800 = 2400 s [max session]/ (0.5 s [min train]+ 0 s [minpause])	500
Maximum numberof pulses persession	72000(Stand-alone)=2400 s[max session] 30 Hz240000(with PC)=2400 s [maxsession] 100 Hz	72000(Stand-alone)=2400 s[max session] 30 Hz240000(with PC)=2400 s[max session] 100 Hz	N/A
Standards
Electricalsafety	Complies withIEC 60601-1 andIEC 60601-1-2	Complies withIEC 60601-1 andIEC 60601-1-2	Complies withIEC 60601-1, IEC 60601-1-1 and IEC 60601-1-2.
ISO Standardsmet	Company complies with DINEN ISO 13485: 2012ISO 10993-1: 2009ISO 14971: 2007	Company complies with DINEN ISO 13485: 2012ISO 10993-1: 2009ISO 14971: 2007	Company complies withISO 13485:2012.

Table: Side-by-Side Comparison of the Proposed Device with Cited Predicate Devices

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1 see Fig. 1

Image /page/8/Figure/2 description: The image shows a diagram with several measurements labeled. The measurements are labeled as 'A', 'B', 'a', and 'b'. The diagram appears to be a schematic of some kind of mechanical component or part.

Fig.1 Coil for magnetic stimulator

9. CONCLUSION

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The Neurosoft TMS and the predicate devices 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).

All coils compared in the above Table share the same transducer design (figure-of-eight). The tested magnetic properties of the Neurosoft TMS and the predicate devices are substantial equivalent for the coils.

The reliability of the positioning method used by the Neurosoft TMS 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 Neurosoft TMS is at least as effective as the method employed by the predicate devices.

On the basis of the only modification of the treatment parameter, the Neurosoft TMS 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 Neurosoft TMS is substantially equivalent to the cited predicate devices. Testing demonstrates that the Neurosoft TMS 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.