(322 days)
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 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.
This document describes a 510(k) premarket notification for the Neurosoft TMS device. The core of this submission is to demonstrate substantial equivalence to predicate devices, namely the Tonica Electronik A/S MagVita TMS Therapy System and the Magstim Company Limited Rapid2 Therapy System. The document does not describe an acceptance criteria study with direct device performance measurement against these criteria, but instead relies on showing feature-by-feature similarity to already-approved predicate devices.
Therefore, the requested information elements cannot be fully populated as they would typically apply to a clinical trial or performance study against predefined metrics. However, an interpretation of "acceptance criteria" and "reported device performance" in this context would be the comparative features and specifications between the Neurosoft TMS and its predicate devices, as presented in Table 5-1.
Here's an analysis based on the provided text, addressing the points where information is available or can be inferred:
1. A table of acceptance criteria and the reported device performance
In the context of a 510(k) submission showing substantial equivalence, the "acceptance criteria" are implied by the characteristics of the predicate devices. The "reported device performance" is the Neurosoft TMS's specifications, which are presented as being equivalent, or not raising new safety/efficacy concerns, compared to the predicates.
| Criteria (Implied "Acceptance Criteria" from Predicate Devices) | Neurosoft TMS Reported Performance (Substantial Equivalence Claim) |
|---|---|
| Intended Use (Treatment of MDD in adult patients who failed prior antidepressant medication) | Identical |
| Magnetic Field Intensity (120% of MT) | 120% of MT |
| Frequency (10 Hz) | 10 Hz |
| Train duration (4 sec) | 4 sec |
| Inter-train interval (26 sec) | 26 sec |
| Number of trains (75) | 75 |
| Magnetic Pulses per Session (3000) | 3000 |
| Treatment Session Duration (~37.0 - 37.5 min) | ~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 |
| Coil Configuration (Figure-of-eight coil) | Figure-of-eight coil |
| Coil Core material (Air core) | Air core |
| Waveform (Biphasic sinusoid) | Biphasic sinusoid |
| Active pulse width (μs) (~290-300 µs) | 280 µs (claimed to be substantially equivalent) |
| Max initial dB/dt (kT/s) near the coil surface (Various, e.g., 35-36 kT/s for predicates) | FEC-02-100-C 25, AFEC-02-100-C 38, FEC-02-100 25, AFEC-02-100 32 (claimed to be substantially equivalent) |
| Coil temperature auto-disable (40-41 °C) | 41 °C (106 °F) |
| Electrical safety standards compliance (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2) | AAMI/ANSI ES 60601-1:2005/(R)2012 and IEC 60601-1-2 |
| ISO Standards met (ISO 13485, ISO 10993-1, ISO 14971) | DIN EN ISO 13485: 2012, ISO 10993-1: 2009, ISO 14971: 2007 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical performance data for the Neurosoft TMS focusing on electrical safety, EMC, biocompatibility, software verification/validation, risk analysis, and magnetic field characteristics. There is no mention of a "test set" in the context of a clinical study, as the submission relies on substantial equivalence to predicate devices, which are already approved for clinical use.
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)
Not applicable. This document does not describe a clinical study where ground truth would be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no clinical test set is described, no adjudication method would be required.
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
Not applicable. This device is a Repetitive Transcranial Magnetic Stimulation (rTMS) system, a treatment device, not an image analysis or diagnostic aid involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes non-clinical performance data for the Neurosoft TMS:
- Electrical safety and electromagnetic compatibility testing (compliant with AAMI/ANSI ES 60601-1:2005/(R)2012 and IEC 60601-1-2: 2007).
- Biocompatibility evaluation of coils (meet ISO 10993-1 (2009)).
- Software verification and validation testing (performs as intended and in accordance with specifications, described in section 16, not provided here).
- Risk analysis (compliance with ISO14971).
- Magnetic field characteristics (plots and acoustic output measurements conducted as per FDA guidance).
These are performed on the device itself and its components, representing "standalone" performance in terms of its technical and safety specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests:
- Electrical safety/EMC: Ground truth is defined by the requirements of the cited standards (e.g., AAMI/ANSI ES 60601-1, IEC 60601-1-2).
- Biocompatibility: Ground truth is defined by the requirements of ISO 10993-1 (2009).
- Software verification/validation: Ground truth is the defined software specifications and requirements.
- Magnetic field characteristics: Ground truth is derived from physical measurements and comparison to established parameters of predicate devices and FDA guidance.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based diagnostic device that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
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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
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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
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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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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.
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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.
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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:
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| Criteria | Neurosoft TMS | MagVita TMS Therapy System | Rapid² Therapy System |
|---|---|---|---|
| Intended Use | The Neurosoft TMS is indicatedfor the treatment of MajorDepressive Disorder in adultpatients who have failed toreceive satisfactory 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. | The Rapid² TherapySystem is indicated forthe treatment of MajorDepressive Disorder inadult patients who havefailed to achievesatisfactory 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 | 26 sec | 26 sec | 26 sec |
| Number of trains | 75 | 75 | 75 |
| Magnetic Pulsesper Session | 3000 | 3000 | 3000 |
| Treatment SessionDuration | ~ 37.0 min | 37.0 min | 37.5 min |
| Sessions/week | 5 | 5 | 5 |
| TreatmentSchedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6weeks | 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) | C-B60C-B65 | Magstim Double 70mmAir 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-CInner diameter - 47x50 mm1Outer diameter - 97x100 mm1 | Coil Cool-B65Inner diameter - 35 mmOuter diameter - 75 mm | Area = 33000 mm²Average Inductance 12 μH |
| Criteria | Neurosoft TMS | MagVita TMS Therapy System | Rapid2 Therapy System |
| Area = 184725 mm²Average Inductance 10 μHFlat spiral windingN = 16 (4 turns/wing x 2 wings x 2 layers)AFEC-02-100-CInner diameter - 36x51 mm1Outer diameter - 84x106 mm1Area = 184725 mm²Average Inductance 10 μHFlat spiral windingN = 16 (4 turns/wing x 2 wings x 2 layers) | Winding height - 12 mmN = 2x (2 x 5) | Flat spiral windingN = 3x19 turns/wing x 2wings | |
| FEC-02-100Inner diameter - 47x50 mm1Outer diameter - 97x100 mm1Area = 91560 mm²Average Inductance 10 μHFlat spiral windingN = 16 (4 turns/wing x 2 wings x 2 layers)AFEC-02-100Inner diameter - 36x51 mm1Outer diameter - 84x106 mm1Area = 87200 mm²Average Inductance 10 μHFlat spiral windingN = 16 (4 turns/wing x 2 wings x 2 layers) | Coil C-B60Inner diameter - 35 mmOuter diameter - 75 mmWinding height - 12 mmN = 2x (2 x 5) | ||
| Machine Output Parameters | |||
| 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 | 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 coilsurface | FEC-02-100-C 25AFEC-02-100-C 38FEC-02-100 25AFEC-02-100 32 | C-B65: 36C-B60: 35 | N/A |
| The system willautomatically bedisabled when thecoil temperatureexceeds: | 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 TherapySystem | Rapid2 Therapy System |
| (Hz) | 0.1 - 100 (with PC) | depending on model | |
| Pulse trainduration range (s) | 0.5 - 100 | Rep Rate: 0.1 ...100HzPulses in Train: 1,2,3,4 ...1000Train duration = Pulses inTrain / Rep Rate | 1 - 20 |
| Inter-train intervalrange (s) | 0 - 300 | 1 - 120 | 10 - 60 |
| Maximum trainsper session | 4800 = 2400 s [max session] /(0.5 s [min train]+ 0 s [minpause]) | 500 | ~140 |
| Maximum numberof pulses persession | 72,000(Stand-alone) = 2400 s[max session] *30 Hz240,000(with PC) = 2400 s [maxsession] *100 Hz | 500,000 = 1,000 (pulsesmax per train) x 500 (trainsmax per session) | 65,000 |
| Standards | |||
| Electricalsafety | Complies with AAMI/ANSI ES60601-1:2005/(R)2012 and IEC60601-1-2 | Complies withIEC 60601-1, IEC 60601-1-1 and IEC 60601-1-2. | Complies withEN 60601-1 andEN 60601-1-2 |
| ISO Standardsmet | Company complies with DIN ENISO 13485: 2012ISO 10993-1: 2009ISO 14971: 2007 | Company complies withISO 13485:2012. | Company complies withISO 13485: 2003ISO 10993-1: 2009ISO 14971 |
Table 5-1. 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 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
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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.
§ 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.