(88 days)
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.
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 .
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.
The document outlines the 510(k) summary for the ZapStim Controller Application (Z1023), a software application intended for use with the Neurosoft TMS system for treating Major Depressive Disorder (MDD). The key focus of the submission is to demonstrate substantial equivalence to the predicate device, Neurosoft TMS (K173441).
Here's an analysis of the provided information regarding acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison of the ZapStim Controller Application's functionalities and output parameters with those of the predicate Neurosoft TMS system. The study aims to demonstrate that the ZapStim software, when controlling the Neurosoft TMS hardware, performs equivalently to the predicate device's own control interface.
| Acceptance Criteria Category | Specific Criteria (Implicitly from Predicate Comparison) | Reported Device Performance (ZapStim Controller Application) |
|---|---|---|
| Functional Equivalence | - Ability to start, stop, and pause a train sequence on the Neurosoft CloudTMS (predicate device).- Ability to determine the train sequence.- Ability to determine the train length.- Ability to determine the inter-train length.- Control stimulation frequency.- Control pulse train duration.- Control inter-train interval.- Control trains per session. | - "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." |
| Accuracy of Delivered Treatment Parameters | - No statistically significant difference between the frequency set by the ZapStim Software and the frequency delivered by the CloudTMS machine at all tested frequencies.- No change in the waveform shape of the stimulation pulse delivered by the CloudTMS system when using the ZapStim Software (biphasic nature maintained). | - "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." |
| Safety and Effectiveness (Non-inferiority) | - The technological differences between ZapStim Controller Application and the predicate device should not raise new issues regarding effectiveness or safety. (This is an overarching goal of the comparison and testing.) | - "These technological differences between the ZapStim Controller Application and the predicate do not raise any new issues on effectiveness or safety." (This is a statement from the submitter, supported by the verification and validation testing.)- "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)." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The study described appears to be a non-clinical performance evaluation (bench testing), focusing on the functional and accuracy aspects of the software controlling the hardware. Such studies typically involve testing across the operational range of parameters rather than patient-specific data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The ground truth in this context is the expected functional output and accuracy of the TMS system when controlled by the software, as measured by instruments during testing. It does not involve expert interpretation of medical images or patient data.
4. Adjudication Method for the Test Set
This is not applicable as the study is a non-clinical performance evaluation focused on objective measurements rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not conducted. The ZapStim Controller Application is software that controls an existing FDA-cleared TMS hardware system. The study focuses on the functional equivalence and accuracy of this control software, not on human reader performance or diagnostic accuracy. Therefore, there is no effect size related to human reader improvement with AI assistance.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-loop Performance) Was Done
Yes, the described study is essentially a standalone performance evaluation of the software's control capabilities. The "device" in this context is the software (ZapStim Controller Application) interacting with and controlling the existing Neurosoft TMS hardware. The tests verify that the software correctly sends commands and that the hardware executes them accurately, without direct human intervention in the loop during the performance measurement phase, beyond initiating the tests.
7. The Type of Ground Truth Used
The ground truth used in this non-clinical study is based on objective measurements and engineering specifications of the TMS system's output. For example:
- The functional ground truth is whether the software successfully initiates, pauses, and stops treatment sequences, and correctly communicates parameter settings (frequency, train duration, inter-train interval, trains per session) to the hardware.
- The accuracy ground truth for frequency delivery is the precisely measured output frequency of the TMS machine using calibrated instruments.
- The waveform ground truth is the expected biphasic shape of the stimulation pulse, measured by appropriate equipment.
8. The Sample Size for the Training Set
The document does not provide information on a training set sample size. The ZapStim Controller Application isn't described as a machine learning (ML) or artificial intelligence (AI) device that requires training data in the conventional sense. It's control software with predefined logic to interact with hardware.
9. How the Ground Truth for the Training Set Was Established
Since there is no explicit mention of a "training set" for an ML/AI algorithm, this information is not provided and likely not applicable in the context of this device's regulatory submission.
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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 isindicated for treatment of MajorDepressive Disorder (MDD) inadult patients who have failed toreceive satisfactory improvementfrom prior antidepressantmedication in their current episode. | The Neurosoft TMS is indicated forthe treatment of Major DepressiveDisorder (MDD) in adult patients whohave failed to receive satisfactoryimprovement from prior antidepressantmedication in the current episode. |
|---|---|---|
| FDA-cleared standard treatment | ||
| Magnetic FieldIntensity | 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 persession | 3000 | 3000 |
| Treatment SessionDuration | ~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 bestimulated | Frontal Cortex | Frontal Cortex |
| *These variables are not directly controlled by the subject device | ||
| Coils | ||
| Coils (includingoptional accessories) | FEC-02-100-C, AFEC-02-100-CFEC-02-100 (optional), AFEC-02-100(optional) | |
| Configuration | Figure-of-eight-coil | |
| Core material | Air core | |
| Cooling | The subject device utilizes the samehardware 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-CInner diameter: 47x50 mm¹Outer diameter: 97x100 mm¹Area = 184725 mm²Average Inductance 10 μHFlat spiral windingN = 16 turns (2 layers x 2 wings) | |
| The subject device utilizes the samehardware as the predicate device | AFEC-02-100-CInner diameter: 36x51 mm¹Outer diameter: 84x106 mm¹Area = 184725 mm²Average Inductance 10 μH |
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| Flat spiral windingN = 16 turns (2 layers x 2 wings)FEC-02-100Inner diameter: 47x50 mm¹Outer diameter: 97x100 mm¹Area = 91560 mm²Average Inductance 10 μΗFlat spiral windingN = 16 turns (2 layers x 2 wings)AFEC-02-100Inner diameter: 36x51 mm¹Outer diameter: 84x106 mm¹Area = 87200 mm²Average Inductance 10 μΗFlat spiral windingN = 16 turns (2 layers x 2 wings) | ||
|---|---|---|
| Machine Output Parameters | ||
| Amplitude inStandard MotorThreshold (SMT) units | The subject device utilizes the samehardware as the predicate device¹ | FEC-02-100-C 0 - 1.89AFEC-02-100-C 0 - 2.38FEC-02-100 0 - 1.92AFEC-02-100 0 - 2.33 |
| Waveform | Biphasic sinusoid | Biphasic sinusoid |
| Active pulse width(μs) | 280 | |
| Max initial dB/dt(kT/s) near the coilsurface | The subject device utilizes the samehardware as the predicate device¹ | FEC-02-100-C 25AFEC-02-100-C 38FEC-02-100 25AFEC-02-100 32 |
| The system willautomatically bedisabled when thecoil temperatureexceeds: | 41 °C (106 °F) | |
| Frequency range (Hz) | 1 - 20 Hz | 0.1 - 30 (Stand-alone)0.1 - 100 (with PC) |
| Pulse train durationrange (s) | 0.5 - 100 | 0.5 - 100 |
| Inter-train intervalrange (s) | 0 - 300 | 0 - 300 |
| Maximum trains persession | 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 [maxsession] *30 Hz |
| Maximum number ofpulses per session | The subject device utilizes the samehardware as the predicate device¹ | 240000 (with PC) = 2400 s [maxsession] *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 | PCZapStim Controller ApplicationSoftware | Neurosoft TMS System HardwareNeuro-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.
§ 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.