(37 days)
No
The description focuses on the physical and electrical principles of operation (capacitor discharge, magnetic fields, induced currents) and lists hardware components. There is no mention of AI, ML, algorithms for data analysis, or any features that would suggest intelligent processing or adaptation based on data.
Yes
The device is indicated for the treatment of Major Depressive Disorder, which is a medical condition, and it works by inducing neural action potentials for this treatment.
No
This device is indicated for the treatment of Major Depressive Disorder, not for diagnosis.
No
The device description explicitly lists multiple hardware components, including a main unit, cooling unit, power supply, coils, coil holders, and a trolley. This indicates it is a hardware-based medical device, not software-only.
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 applying magnetic stimulation to the prefrontal cortex. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a system that generates magnetic fields to induce electrical currents in neurons. This is a physical therapy/treatment device, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
In summary, the Neurosoft TMS is a therapeutic device that directly interacts with the patient's body for treatment purposes, which is the opposite of an in vitro diagnostic device that analyzes samples outside of the body.
N/A
Intended Use / Indications for Use
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.
Product codes
OBP
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:
- O 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
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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);
1
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
2
Indications for Use
510(k) Number (if known) K173441
Device Name Neurosoft TMS
Indications for Use (Describe)
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.
| 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 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
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
4
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:
- 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
5
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 Therapy
System
(K171481) |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Neurosoft TMS is
indicated for the treatment of
Major Depressive Disorder in
adult patients who have failed
to receive satisfactory
improvement from prior | The Neurosoft TMS is
indicated for the treatment of
Major Depressive Disorder
in adult patients who have
failed to receive satisfactory
improvement from prior | The MagVita TMS
Therapy System is
indicated for the
treatment of Major
Depressive Disorder in
adult patients who have |
| Criteria | Neurosoft TMS | Neurosoft TMS
(K160309) | MagVita TMS Therapy
System
(K171481) |
| | antidepressant medication in
the current episode. | antidepressant medication in
the current episode. | failed to receive
satisfactory improvement
from prior antidepressant
medication in the current
episode. |
| Recommended standard treatment | | | |
| Magnetic Field
Intensity | 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 Pulses
per Session | 3000 | 3000 | 3000 |
| Treatment Session
Duration | 18.8 min-37.0 min | 37.0 min | 18.8 min-37.0 min. |
| 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 | Frontal Cortex | Frontal Cortex | Frontal Cortex |
| | | Coils | |
| Coils (including
optional
accessories) | FEC-02-100-C, AFEC-02-100-
C
FEC-02-100 (optional), AFEC-
02-100 (optional) | FEC-02-100-C, AFEC-02-
100-C
FEC-02-100 (optional),
AFEC-02-100 (optional) | C-B60
C-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-C
Inner diameter - 47x50 mm¹
Outer diameter - 97x100 mm¹
Area = 184725 mm²
Average Inductance 10 µH
Flat spiral winding
N = 16 turns (2 layers x 2
wings) | FEC-02-100-C
Inner diameter - 47x50 mm¹
Outer diameter - 97x100
mm¹
Area = 184725 mm²
Average Inductance 10 µH
Flat spiral winding
N = 16 turns (2 layers x 2 | Coil Cool-B65
Inner diameter - 35 mm
Outer diameter - 75 mm
Winding height - 12 mm
N = 2x (2 x 5) |
| Criteria | Neurosoft TMS
(K160309) | Neurosoft TMS | MagVita TMS Therapy System
(K171481) |
| | AFEC-02-100-C
Inner diameter - 36x51 mm¹
Outer diameter - 84x106 mm¹
Area = 184725 mm²
Average Inductance 10 μH
Flat spiral winding
N = 16 turns (2 layers x 2 wings) | wings) | |
| | FEC-02-100
Inner diameter - 47x50 mm¹
Outer diameter - 97x100 mm¹
Area = 91560 mm²
Average Inductance 10 μH
Flat spiral winding
N = 16 turns (2 layers x 2 wings) | FEC-02-100
Inner diameter - 47x50 mm¹
Outer diameter - 97x100 mm¹
Area = 91560 mm²
Average Inductance 10 μH
Flat spiral winding
N = 16 turns (2 layers x 2 wings) | Coil C-B60
Inner diameter - 35 mm
Outer diameter - 75 mm
Winding height - 12 mm
N = 2x (2 x 5) |
| | AFEC-02-100
Inner diameter - 36x51 mm¹
Outer diameter - 84x106 mm¹
Area = 87200 mm²
Average Inductance 10 μH
Flat spiral winding
N = 16 turns (2 layers x 2 wings) | AFEC-02-100
Inner diameter - 36x51 mm¹
Outer diameter - 84x106 mm¹
Area = 87200 mm²
Average Inductance 10 μH
Flat spiral winding
N = 16 turns (2 layers x 2 wings) | |
| Amplitude in
Standard Motor
Threshold (SMT)
units | FEC-02-100-C 0 - 1.89
AFEC-02-100-C 0 - 2.38
FEC-02-100 0 - 1.92
AFEC-02-100 0 - 2.33 | FEC-02-100-C 0 - 1.89
AFEC-02-100-C 0 - 2.38
FEC-02-100 0 - 1.92
AFEC-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 coil
surface | FEC-02-100-C 25
AFEC-02-100-C 38
FEC-02-100 25
AFEC-02-100 32 | FEC-02-100-C 25
AFEC-02-100-C 38
FEC-02-100 25
AFEC-02-100 32 | C-B65: 36
C-B60: 35 |
| The system will
automatically be
disabled when the | 41 °C (106 °F) | 41 °C (106 °F) | 41 °C (106 °F) |
| Criteria | Neurosoft TMS | Neurosoft TMS
(K160309) | MagVita TMS Therapy
System
(K171481) |
| coil temperature
exceeds: | | | |
| 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 train
duration range (s) | 0.5 - 100 | 0.5 - 100 | Rep Rate: 0.1 ...100Hz
Pulses in Train: 1,2,3,4
... 1000
Train duration = Pulses
in Train / Rep Rate |
| Inter-train interval
range (s) | 0 - 300 | 0 - 300 | 1 - 120 |
| Maximum trains
per session | 4800 = 2400 s [max session] /
(0.5 s [min train]+ 0 s [min
pause]) | 4800 = 2400 s [max session]
/ (0.5 s [min train]+ 0 s [min
pause]) | 500 |
| Maximum number
of pulses per
session | 72000(Stand-alone)=2400 s
[max session] *30 Hz
240000(with PC)=2400 s [max
session] *100 Hz | 72000(Stand-alone)=2400 s
[max session] *30 Hz
240000(with PC)=2400 s
[max session] *100 Hz | N/A |
| Standards | | | |
| Electrical
safety | Complies with
IEC 60601-1 and
IEC 60601-1-2 | Complies with
IEC 60601-1 and
IEC 60601-1-2 | Complies with
IEC 60601-1, IEC 60601-
1-1 and IEC 60601-1-2. |
| ISO Standards
met | Company complies with DIN
EN ISO 13485: 2012
ISO 10993-1: 2009
ISO 14971: 2007 | Company complies with DIN
EN ISO 13485: 2012
ISO 10993-1: 2009
ISO 14971: 2007 | Company complies with
ISO 13485:2012. |
Table: Side-by-Side Comparison of the Proposed Device with Cited Predicate Devices
6
7
8
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
9
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.