(322 days)
Not Found
No
The summary describes a hardware-based rTMS system and does not mention any software features or algorithms that would suggest the use of AI or ML.
Yes
The device is indicated for the "treatment of Major Depressive Disorder," which signifies a therapeutic purpose.
No
The device description and intended use clearly state that the Neurosoft TMS is indicated for the treatment of Major Depressive Disorder. There is no mention of it being used for diagnosis, prognosis, or monitoring.
No
The device description explicitly states it is a "repetitive transcranial magnetic stimulation (rTMS) system" and a "computerized medical device" that "produces non-invasive, repetitive pulsed magnetic fields." This indicates the presence of hardware components beyond just software. The performance studies also mention testing of hardware aspects like electrical safety, electromagnetic compatibility, and magnetic field characteristics.
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. IVDs are used to diagnose diseases or conditions by examining samples from the human body (like blood, urine, tissue).
- Device Description: The device description clearly states it's a repetitive transcranial magnetic stimulation (rTMS) system that produces magnetic fields to induce neural action potentials. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information.
Therefore, the Neurosoft TMS is a therapeutic medical device, not an In Vitro Diagnostic device.
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 Major 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 O
- O Cooled figure-of-eight coil AFEC-02-100-C
- Figure-of-eight coil FEC-02-100 (optional) o
- o Figure-of-eight coil AFEC-02-100 (optional)
- . K8 coil holder
- K3 flexible arm for coil positioning
- Trolley with casters ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prefrontal cortex, Frontal Cortex
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-clinical performance data included electrical safety and electromagnetic compatibility testing compliant with AAMI/ANSI ES 60601-1:2005/(R)2012 and IEC 60601-1-2: 2007. Biocompatibility evaluation for coils met ISO 10993-1 (2009) standards. Software verification and validation testing demonstrated the software performs as intended. Risk assessment complied with ISO14971. Testing of magnetic field characteristics, magnetic field plots, and acoustic output measurements were conducted as per FDA's guidance document "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems" to demonstrate safety and performance.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2016
TeleEMG, LLC % Barry Ashar President MakroMed, Inc. 88 Stiles Road Salem, New Hampshire 03079
Re: K160309
Trade/Device Name: Neurosoft TMS Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: January 26, 2016 Received: February 4, 2016
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
William J.
Heetderks -A
Digitally signed by William J. Heetderks -A
DN: c=US, o=U.S. Government, ou=HHS,
ou=NIH, ou=People,
0.9.2342.19200300.100.1.1=0010149848,
cn=William J. Heetderks -A
Date: 2016.12.22 14:55:04 -05'00'
for Carlos L. Peña, PhD, MS 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) K160309
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: November 16, 2016
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 |
(Note: During its development Neurosoft TMS was also known as Neuro-MS/D. As a result, many of its documents may be titled with Neuro-MS/D name. It is our intention to commercialize it as Neurosoft TMS. All product labeling now refer to this product as Neurosoft TMS. Some of the support documents included in this submission may still refer to Neuro-MS/D. The two names are fully interchangeable as they represent one and the same product)
3. PREDICATE DEVICES
- Tonica Electronik A/S, MagVita TMS Therapy System, K150641
- Magstim Company Limited, Rapid2 Therapy System, K143531 ●
4. 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 Major Depressive Disorder.
4
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 O
- O Cooled figure-of-eight coil AFEC-02-100-C
- Figure-of-eight coil FEC-02-100 (optional) o
- o Figure-of-eight coil AFEC-02-100 (optional)
- . K8 coil holder
- K3 flexible arm for coil positioning
- Trolley with casters ●
5. INTENDED 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.
6. STANDARDS
The Neurosoft TMS system has been tested and complies with the following standards:
- DIN EN ISO 13485: 2012 .
- ISO 10993-1: 2009 .
- ISO 14971: 2007 .
- AAMI/ANSI ES 60601-1:2005/(R)2012 ●
- IEC 60601-1-2: 2007 .
7. NON-CLINICAL PERFORMANCE DATA
Electrical safety and electromagnetic compatibility testing demonstrate that the Neurosoft TMS is compliant with AAMI/ANSI ES 60601-1:2005/(R)2012 and IEC 60601-1-2: 2007.
Only the coils in the delivery set of the Neurosoft TMS have direct contact with the patients. The biocompatibility evaluation demonstrates that the coils meet ISO 10993-1 (2009) standards.
5
Software verification and validation testing is described section 16 "Software" following the corresponding FDA software guidelines. It demonstrates that the software performs as intended and in accordance with specifications. The potential risks of the Neurosoft TMS have been identified and evaluated in compliance with ISO14971, and the risks were determined to be acceptable, or have been addressed with risk control measures.
Additionally, the non-clinical testing with the Neurosoft TMS included testing of the magnetic field characteristics of the system, as required by FDA's guidance document "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems". The magnetic field plots and acoustic output measurements were conducted to demonstrate safety and performance.
8. SUBSTANTIAL EQUIVALENCE
The Neurosoft TMS and the predicate devices have identical intended use /indication for use (see table 5-1), and the technological characteristics are very similar such that they in our view can be considered equivalent.
The design of the Neurosoft TMS is similar to that of the MagVita TMS Therapy System and the Rapid2 Therapy System, as all systems are based on applying transcranial magnetic stimulation by means of repetitive pulse trains at a predetermined frequency. All systems use the same mechanism of action, i.e., an electromechanical instrument that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the prefrontal cortex.
The basic software capabilities related to treatment administration in the 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 (see table 5-1) below:
6
| Criteria | Neurosoft TMS | MagVita TMS Therapy System | Rapid² Therapy System |
|---|---|---|---|
| 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 antidepressant | |||
| medication in the current | |||
| episode. | The MagVita TMS | ||
| Therapy System is | |||
| indicated for the treatment | |||
| of Major Depressive | |||
| Disorder in adult patients | |||
| who have failed to receive | |||
| satisfactory improvement | |||
| from prior antidepressant | |||
| medication in the current | |||
| episode. | The Rapid² Therapy | ||
| System is indicated for | |||
| the treatment of Major | |||
| Depressive Disorder in | |||
| adult patients who have | |||
| failed to achieve | |||
| satisfactory improvement | |||
| from prior antidepressant | |||
| medication in the current | |||
| episode. | |||
| 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 | 26 sec | 26 sec | 26 sec |
| Number of trains | 75 | 75 | 75 |
| Magnetic Pulses | |||
| per Session | 3000 | 3000 | 3000 |
| Treatment Session | |||
| Duration | ~ 37.0 min | 37.0 min | 37.5 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) | C-B60 | ||
| C-B65 | Magstim Double 70mm | ||
| Air Film Coil | |||
| 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 | C-B65: Liquid cooling | Forced Air | |
| 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 | Coil Cool-B65 | ||
| Inner diameter - 35 mm | |||
| Outer diameter - 75 mm | Area = 33000 mm² | ||
| Average Inductance 12 μH | |||
| Criteria | Neurosoft TMS | MagVita TMS Therapy System | Rapid2 Therapy System |
| Area = 184725 mm² | |||
| Average Inductance 10 μH | |||
| Flat spiral winding | |||
| N = 16 (4 turns/wing x 2 wings x 2 layers) | |||
| AFEC-02-100-C | |||
| Inner diameter - 36x51 mm1 | |||
| Outer diameter - 84x106 mm1 | |||
| Area = 184725 mm² | |||
| Average Inductance 10 μH | |||
| Flat spiral winding | |||
| N = 16 (4 turns/wing x 2 wings x 2 layers) | Winding height - 12 mm | ||
| N = 2x (2 x 5) | Flat spiral winding | ||
| N = 3x19 turns/wing x 2wings | |||
| FEC-02-100 | |||
| Inner diameter - 47x50 mm1 | |||
| Outer diameter - 97x100 mm1 | |||
| Area = 91560 mm² | |||
| Average Inductance 10 μH | |||
| Flat spiral winding | |||
| N = 16 (4 turns/wing x 2 wings x 2 layers) | |||
| AFEC-02-100 | |||
| Inner diameter - 36x51 mm1 | |||
| Outer diameter - 84x106 mm1 | |||
| Area = 87200 mm² | |||
| Average Inductance 10 μH | |||
| Flat spiral winding | |||
| N = 16 (4 turns/wing x 2 wings x 2 layers) | Coil C-B60 | ||
| Inner diameter - 35 mm | |||
| Outer diameter - 75 mm | |||
| Winding height - 12 mm | |||
| N = 2x (2 x 5) | |||
| Machine Output Parameters | |||
| 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 | 0 - 1.7 | 0.28 - 1.9 | |
| Waveform | Biphasic sinusoid | Biphasic sinusoid | Biphasic sinusoid |
| Active pulse width | |||
| (μs) | 280 | 290 | 300 |
| 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 | C-B65: 36 | ||
| C-B60: 35 | N/A | ||
| The system will | |||
| automatically be | |||
| disabled when the | |||
| coil temperature | |||
| exceeds: | 41 °C (106 °F) | 41 °C (106 °F) | 40 °C (104 °F) |
| Frequency range | 0.1 - 30 (Stand-alone) | 0.1 - 30 or 0.1 - 100, | 0.1 - 30 |
| Criteria | Neurosoft TMS | MagVita TMS Therapy | |
| System | Rapid2 Therapy System | ||
| (Hz) | 0.1 - 100 (with PC) | depending on model | |
| Pulse train | |||
| duration range (s) | 0.5 - 100 | Rep Rate: 0.1 ...100Hz | |
| Pulses in Train: 1,2,3,4 ... | |||
| 1000 | |||
| Train duration = Pulses in | |||
| Train / Rep Rate | 1 - 20 | ||
| Inter-train interval | |||
| range (s) | 0 - 300 | 1 - 120 | 10 - 60 |
| Maximum trains | |||
| per session | 4800 = 2400 s [max session] / | ||
| (0.5 s [min train]+ 0 s [min | |||
| pause]) | 500 | ~140 | |
| Maximum number | |||
| of pulses per | |||
| session | 72,000(Stand-alone) = 2400 s | ||
| [max session] *30 Hz | |||
| 240,000(with PC) = 2400 s [max | |||
| session] *100 Hz | 500,000 = 1,000 (pulses | ||
| max per train) x 500 (trains | |||
| max per session) | 65,000 | ||
| Standards | |||
| Electrical | |||
| safety | Complies with AAMI/ANSI ES | ||
| 60601-1:2005/(R)2012 and IEC | |||
| 60601-1-2 | Complies with | ||
| IEC 60601-1, IEC 60601- | |||
| 1-1 and IEC 60601-1-2. | Complies with | ||
| EN 60601-1 and | |||
| EN 60601-1-2 | |||
| ISO Standards | |||
| met | Company complies with DIN EN | ||
| ISO 13485: 2012 | |||
| ISO 10993-1: 2009 | |||
| ISO 14971: 2007 | Company complies with | ||
| ISO 13485:2012. | Company complies with | ||
| ISO 13485: 2003 | |||
| ISO 10993-1: 2009 | |||
| ISO 14971 |
Table 5-1. Side-by-Side Comparison of the Proposed Device with Cited Predicate Devices
7
8
1 see Fig. 1
Image /page/8/Figure/2 description: The image shows a diagram with several measurements labeled. The diagram appears to be a technical drawing of a mechanical component. The measurements are labeled as 'A', 'B', 'a', and 'b'.
Image /page/8/Figure/3 description: The image shows the text "Fig.1 Coil for magnetic stimulator". The text is in black font and is centered in the image. The text is likely a figure caption for a scientific paper or presentation.
9. CONCLUSION
The Neurosoft TMS and the predicate devices have identical intended use /indication for use, target population, treatment procedure, treatment position and all recommended standard
9
treatment protocol parameters (intensity, frequency, number of pulses in a train, number of trains in a session, number of treatment sessions).
All coils compared in Table 5.1 share the same transducer design (figure-of-eight). The tested magnetic properties of the 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.
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.