(88 days)
Neurosoft TMS system, K173441
No
The description focuses on the software acting as a controller and interface for a pre-existing TMS system, without mentioning any adaptive learning, predictive capabilities, or data analysis that would typically indicate AI/ML. The software simply relays pre-defined treatment protocols.
Yes
The ZapStim Controller Application is intended for use with a TMS system to deliver an FDA-cleared treatment protocol for Major Depressive Disorder (MDD). It controls aspects of the treatment administered by the TMS system, which physically delivers the therapy to the patient.
No
Explanation: The device is a software application designed to control a TMS system for delivering treatment for Major Depressive Disorder. Its function is to administer therapy, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
While the device is primarily software, it is explicitly described as controlling a third-party hardware medical device (Neurosoft TMS system) and is distributed predownloaded onto a commercial off-the-shelf PC, which is part of the overall system. It is not a standalone software application performing a medical function without interacting with dedicated medical hardware.
Based on the provided information, the ZapStim Controller Application is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ZapStim's Function: The ZapStim Controller Application is a software application that controls a Transcranial Magnetic Stimulation (TMS) system. TMS is a non-invasive therapy that uses magnetic pulses to stimulate nerve cells in the brain.
- Intended Use: The intended use of ZapStim is to deliver a specific treatment protocol for Major Depressive Disorder (MDD) by controlling a TMS system. It does not involve the analysis of any biological specimens.
Therefore, the ZapStim Controller Application falls under the category of a therapeutic device (specifically, a software component controlling a therapeutic device), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ZapStim Controller Application is intended for use with the Neurosoft TMS system and is indicated for use in delivering the FDA cleared treatment protocol for treatment of Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in their current episode.
Product codes
OBP
Device Description
ZapStim Controller Application is a software application that is indicated to be used by clinicians for the treatment of Major Depressive Disorder. The software resides on a computer system and functions by controlling a third party TMS system (Neurosoft Cloud TMS system, K173441). ZapStim Controller Application software is to be used in place of the Neurosoft TMS User interface for setting certain aspects of the treatment administered by the TMS system. The third party TMS system will physically deliver the therapy to the patient. The ZapStim Controller Application is compatible with the Neurosoft TMS System, K173441, and it is intended to be used in tandem with the Neurosoft TMS System to provide treatment.
The software includes a user interface that allows the user to control limited aspects of the treatment administered by the TMS system. The system is currently intended to deliver the FDA cleared treatment protocol for MDD as stated in the indications for use.
The ZapStim software is compatible and is to be used in tandem with the specific Neurosoft TMS System components listed below:
- Main unit of the magnetic stimulator .
- Cooling unit
- Extra power supply unit
- Cooled figure-of-eight coil AFEC-02-100-C
- USB A to B cable .
See 510(k) submission K173441 for further information on the Neurosoft TMS device.
The ZapStim Controller Application consists of the following main components:
- . ZapStim Application (ZapStim.exe)
- . Simulator Driver (stimneurosoft.exe)
Both components are utilized when using the device.
The ZapStim Controller Application is to be distributed predownloaded onto a commercial off the shelf PC.
The ZapStim Controller Application is to be accessed on the PC is to be connected via USB to the Neurosoft TMS System. The ZapStim Controller Application can be used to select the treatment protocol to be administered, which at this time will only be the FDA cleared treatment protocol for MDD in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in their current episode. The user cannot edit the treatment protocol using the ZapStim Controller Application. The user can also start, pause, and end the administration of treatment using the ZapStim Controller Application.
The ZapStim Controller Application relays the treatment protocol information to the Neurosoft TMS System, which then administers the magnetic stimulation.
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
clinicians
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 verification results (RP-5021-1.0.7746) demonstrate that the ZapStim software interface functions with the Neurosoft Cloud TMS hardware as intended and as required. The tests run during verification show that ZapStim Software can perform the functions of starting, stopping, and pausing a train sequence on the Neurosoft CloudTMS (predicate device) as well as determining the train sequency, train length, and intertrain length; these are all functions that the predicate device is also capable of performing. The verification results show that the ZapStim software can control stimulation frequency, pulse train duration, inter-train interval, and trains per session of the CloudTMS system.
The validation results (RP-5022-1.0.7746) demonstrate ZapStim software's ability to control the functions listed above of the r TMS Stimulator system does not negatively alter the accuracy set for treatment. At all frequencies tested, there was no statistically significant difference between the frequency set by the ZapStim Software and the frequency delivered by the CloudTMS machine. Waveforms showing the biphasic nature of the stimulation pulse delivered were also included in the validation tests to demonstrate that using the ZapStim Software does not change the waveform shape of the pulse delivered by the CloudTMS system.
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.
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February 9, 2024
Revital Lab Inc. Conway Ho President 2349 Aragon Canyon St Las Vegas, Nevada 89135
Re: K233631
Trade/Device Name: ZapStim Controller Application (Z1023) Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: November 8, 2023 Received: November 13, 2023
Dear Conway Ho:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Pamela D. Scott -S
Pamela Scott, MS Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K233631
Device Name ZapStim Controller Application (Z1023)
Indications for Use (Describe)
ZapStim Controller Application is intended for use with the Neurosoft TMS system and is indicated for use in delivering the FDA cleared treatment protocol for treatment of Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in their current episode.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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ZapStim Controller Application (K233631) 510(k) Summary
1. CONTACT DETAILS
Applicant Name: Revital Lab Inc. Applicant Address: 2349 Aragon Canyon St Las Vegas NV 89135 United States Application Contact Telephone: 5624831414 Applicant Contact: Mr. Conway Ho Applicant Contact Email: info@revitallabinc.com
2. DEVICE NAME
Device Trade Name: ZapStim Controller Application (Z1023) Common Name: Repetitive transcranial magnetic stimulation system Classification Name: Transcranial Magnetic Stimulator Regulation Number: 882.5805 Product Code: OBP
3. LEGALLY MARKETED PREDICATE DEVICES
Predicate #: K173441 Predicate Trade Name (Primarv Predicate is listed first): Neurosoft TMS (also CloudTMS) Product Code: OBP
4. DEVICE DESCRIPTION SUMMARY
ZapStim Controller Application is a software application that is indicated to be used by clinicians for the treatment of Major Depressive Disorder. The software resides on a computer system and functions by controlling a third party TMS system (Neurosoft Cloud TMS system, K173441). ZapStim Controller Application software is to be used in place of the Neurosoft TMS User interface for setting certain aspects of the treatment administered by the TMS system. The third party TMS system will physically deliver the therapy to the patient. The ZapStim Controller Application is compatible with the Neurosoft TMS System, K173441, and it is intended to be used in tandem with the Neurosoft TMS System to provide treatment.
The software includes a user interface that allows the user to control limited aspects of the treatment administered by the TMS system. The system is currently intended to deliver the FDA cleared treatment protocol for MDD as stated in the indications for use.
The ZapStim software is compatible and is to be used in tandem with the specific Neurosoft TMS System components listed below:
- Main unit of the magnetic stimulator .
- Cooling unit
- Extra power supply unit ●
- Cooled figure-of-eight coil AFEC-02-100-C ●
- USB A to B cable .
See 510(k) submission K173441 for further information on the Neurosoft TMS device.
The ZapStim Controller Application consists of the following main components:
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- . ZapStim Application (ZapStim.exe)
- . Simulator Driver (stimneurosoft.exe)
Both components are utilized when using the device.
The ZapStim Controller Application is to be distributed predownloaded onto a commercial off the shelf PC.
The ZapStim Controller Application is to be accessed on the PC is to be connected via USB to the Neurosoft TMS System. The ZapStim Controller Application can be used to select the treatment protocol to be administered, which at this time will only be the FDA cleared treatment protocol for MDD in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in their current episode. The user cannot edit the treatment protocol using the ZapStim Controller Application. The user can also start, pause, and end the administration of treatment using the ZapStim Controller Application.
The ZapStim Controller Application relays the treatment protocol information to the Neurosoft TMS System, which then administers the magnetic stimulation.
5. INTENDED USE/INDICATIONS FOR USE
ZapStim controller application is intended for use with the Neurosoft TMS System and is indicated for use in delivering the FDA cleared treatment of major depressive disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in their current episode.
6. INDICATIONS FOR USE COMPARISON
ZapStim Controller Application and the predicate device have a similar intended use/indication for use statement. The subject device is a SaMD and is a subset of the predicate device. The purpose of the software app for both the predicate and subject device is to control the transcranial magnetic stimulation hardware, select the treatment protocol (frequency, train length, intertrain length) and start/stop the delivery of stimulation. Therefore, the intended use is the same for the subject and predicate devices, except that the subject device does not include the hardware components of the predicate device.
7. TECHNOLOGICAL COMPARISON
The ZapStim Controller Application device is a SaMD and does not include a TMS stimulator. The ZapStim Controller Application is intended to control the predicate device's hardware by selecting the treatment protocol (frequency, train length, intertrain length) and starting/stopping the delivery of stimulation during treatment. The subject and predicate software are of the same technology; however, it is designed and developed by different manufacturers.
The other component of the ZapStim (computer) is an accessory of the subject device, which is used to operate the software and interface with the predicate hardware. The ZapStim Controller Application is intended to be used to select the treatment protocol (frequency, train length) and start/stop the delivery of stimulation.
These technological differences between the ZapStim Controller Application and the predicate do not raise any new issues on effectiveness or safety.
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| Intended Use | ZapStim Controller Application is
indicated for treatment of Major
Depressive Disorder (MDD) in
adult patients who have failed to
receive satisfactory improvement
from prior antidepressant
medication in their current episode. | The Neurosoft TMS is indicated for
the treatment of Major Depressive
Disorder (MDD) in adult patients who
have failed to receive satisfactory
improvement from prior antidepressant
medication in the current episode. |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA-cleared standard treatment | | |
| Magnetic Field
Intensity | 120% of the MT* | 120% of the MT |
| Frequency | 10 Hz | 10 Hz |
| Train duration | 4 sec | 4 sec |
| Inter-train interval | 26 sec | 11-26 sec |
| Number of trains | 75 | 75 |
| Magnetic Pulses per
session | 3000 | 3000 |
| Treatment Session
Duration | ~37 min | 18.8-37.0 min |
| Sessions/week | 5* | 5 |
| Treatment Schedule | 5 daily sessions for 6 weeks* | 5 daily sessions for 6 weeks |
| Area of brain to be
stimulated | Frontal Cortex | Frontal Cortex |
| | *These variables are not directly controlled by the subject device | |
| | Coils | |
| Coils (including
optional accessories) | | FEC-02-100-C, AFEC-02-100-C
FEC-02-100 (optional), AFEC-02-100
(optional) |
| Configuration | | Figure-of-eight-coil |
| Core material | | Air core |
| Cooling | The subject device utilizes the same
hardware as the predicate device | FEC-02-100-C & AFEC-02-100-C:
Liquid cooling |
| | | FEC-02-100 & AFEC-02-100
(optional accessories): 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) |
| | The subject device utilizes the same
hardware as the predicate device | AFEC-02-100-C
Inner diameter: 36x51 mm¹
Outer diameter: 84x106 mm¹
Area = 184725 mm²
Average Inductance 10 μH |
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| 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 μΗ
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 μΗ
Flat spiral winding
| N = 16 turns (2 layers x 2 wings) | ||
|---|---|---|
| Machine Output Parameters | ||
| Amplitude in | ||
| Standard Motor | ||
| Threshold (SMT) units | The subject device utilizes the same | |
| hardware as the predicate device¹ | 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 | ||
| Waveform | Biphasic sinusoid | Biphasic sinusoid |
| Active pulse width | ||
| (μs) | 280 | |
| Max initial dB/dt | ||
| (kT/s) near the coil | ||
| surface | The subject device utilizes the same | |
| hardware as the predicate device¹ | FEC-02-100-C 25 | |
| AFEC-02-100-C 38 | ||
| FEC-02-100 25 | ||
| AFEC-02-100 32 | ||
| The system will | ||
| automatically be | ||
| disabled when the | ||
| coil temperature | ||
| exceeds: | 41 °C (106 °F) | |
| Frequency range (Hz) | 1 - 20 Hz | 0.1 - 30 (Stand-alone) |
| 0.1 - 100 (with PC) | ||
| Pulse train duration | ||
| range (s) | 0.5 - 100 | 0.5 - 100 |
| Inter-train interval | ||
| range (s) | 0 - 300 | 0 - 300 |
| 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]) | ||
| 72000 (Stand-alone) = 2400 s [max | ||
| session] *30 Hz | ||
| Maximum number of | ||
| pulses per session | The subject device utilizes the same | |
| hardware as the predicate device¹ | 240000 (with PC) = 2400 s [max | |
| session] *100 Hz | ||
| ¹The ZapStim controller application can control the following parameters: Stimulation frequency, pulse |
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| train duration, inter-train interval, and trains per session. The software can control the hardware to the | ||
|---|---|---|
| same parameters as the predicate device. | ||
| Components | ||
| Components | PC | |
| ZapStim Controller Application | ||
| Software | Neurosoft TMS System Hardware | |
| Neuro-MS.NET Software |
8. NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY & CONCLUSIONS
The verification results (RP-5021-1.0.7746) demonstrate that the ZapStim software interface functions with the Neurosoft Cloud TMS hardware as intended and as required. The tests run during verification show that ZapStim Software can perform the functions of starting, stopping, and pausing a train sequence on the Neurosoft CloudTMS (predicate device) as well as determining the train sequency, train length, and intertrain length; these are all functions that the predicate device is also capable of performing. The verification results show that the ZapStim software can control stimulation frequency, pulse train duration, inter-train interval, and trains per session of the CloudTMS system.
The validation results (RP-5022-1.0.7746) demonstrate ZapStim software's ability to control the functions listed above of the r TMS Stimulator system does not negatively alter the accuracy set for treatment. At all frequencies tested, there was no statistically significant difference between the frequency set by the ZapStim Software and the frequency delivered by the CloudTMS machine. Waveforms showing the biphasic nature of the stimulation pulse delivered were also included in the validation tests to demonstrate that using the ZapStim Software does not change the waveform shape of the pulse delivered by the CloudTMS system.
Comparison of the intended use, indications for use, technological characteristics, and performance testing demonstrate the substantial equivalence of the subject device ZapStim SW to the legally marketed predicate device, Neurosoft (K173441).
Substantial equivalence between the predicate device (K173441) and the subject device is shown through the verification and validation testing performed on the NT rTMS Software. The subject device is substantially equivalent to the predicated device, K173441.