(294 days)
The MagVenture TMS Atlas Neuro Navigation System is a neuronavigation system indicated for accurate positioning of the treatment coil of the MagVenture TMS Therapy system with respect to target brain regions based on data obtained from MRI measurements. Specifically, the MagVenture TMS Atlas Neuro Navigation System is indicated for use with the following MagVenture treatment coils manufactured by Tonica Elektronik A/S: C-B60, Cool-B70, Cool DB80, MCF-B65, MCF-B70, and C-B70.
The MagVenture TMS Atlas Neuro Navigation System (TMS Atlas system) combines MRI-based, 3-D visualization of cortical areas of the brain with non-invasive TMS in order to target brain areas accurately, and to locate the target for depression therapy. The TMS Atlas software is used to import a patient's MR image slices through standard DICOM communication protocols, and automatically generates an accurate 3-D model of the patient's head, and a custom automatic tissue segmentation routine to reveal anatomical structures of the brain surface in 3D.
The provided text describes the acceptance criteria and supporting studies for the MagVenture TMS Atlas Neuro Navigation System.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Tracking System Accuracy | Static accuracy better than or equal to 1.4 mm RMS, 0.5 degrees RMS (accuracy of localization of tool) | 1.4 mm RMS, 0.5 degrees RMS (accuracy of localization of tool) | Tracking System Accuracy Test (from NDI reports) |
| System Accuracy (Navigation) | Navigation accuracy < 5 mm (using TMS coil) | Monte Carlo Simulations: 4.55 mm mean (with 4 markers), 3.5 mm (with 6 markers) | Monte Carlo Simulations |
| Navigation accuracy < 5 mm (when navigating with hand-held probe) | 3 mm +/- 2.1 mm (when navigating with hand-held probe) | (Derived from comparison table, not directly from study results in the text) | |
| Navigation algorithm can navigate accurately with an accuracy of < 5mm in a real-world setting | Phantom Testing: Target A (left temporal) mean 3.5 mm; Target B (vertex) mean 2.0 mm (Anatomical marker set), 4.6 mm, 2.6 mm (Carved "X" marker set) | Phantom Study | |
| Complete system achieves navigation accuracy for TMS coil placement within 5mm | User is able to navigate the TMS coil to a defined brain target within 5mm | Human Volunteer Study (complete navigation session) | |
| Coil Compatibility | Absence of significant spatial distortion in position measurements. Successful coil calibration. Effective temporal filtering during TMS discharge. Achieve positioning accuracy necessary for each TMS coil to function as per their cleared Indications and Intended Use. | All tested TMS coil and stimulator combinations do not distort the magnetic field. Coil calibration performed successfully for all. Compatible with tested TMS discharge protocols. Achieved navigation accuracy of the system is < 4mm for compatible coils. Specific coil accuracy: CB60 (<3mm), CB70 (2mm), CoolB65 (2mm), CoolB70 (3mm), CoolDB80 (2mm), MCFB65 (4mm), MCFB70 (2mm). | Compatibility Testing |
| Product Safety Standards | Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 80002-1, IEC 62366, IEC 62304, ISO 14971 | Compliant Test Reports | Product Safety Standards Testing |
| Software Verification & Validation | Software complies with predetermined specifications and relevant standards/guidance documents. | Test results indicate compliance. | Software V&V reports |
2. Sample Size Used for the Test Set and Data Provenance
The document describes several tests:
- Monte Carlo Simulations:
- Sample Size: 10,000 runs using realistic position measurement noise conditions.
- Data Provenance: Simulated data based on literature for realistic noise conditions. This is a computational study, not directly using patient data.
- Tracking System Accuracy:
- Sample Size: Not explicitly stated, but mentioned as "for every shipment (100% incoming inspection)." This suggests continuous testing of components.
- Data Provenance: Test report provided by NDI (tracking system manufacturer).
- Coil Compatibility:
- Sample Size: All claimed MagVenture TMS coils (C-B60, Cool-B65, Cool-B70, Cool D-B80, MCF-B65, MCF-B70, and C-B70) were tested.
- Data Provenance: Bench testing performed on physical coils and stimulators.
- Phantom Navigation Testing:
- Sample Size: 30 iterations for each of the four tests (Target A with anatomical markers, Target A with carved "X" markers, Target B with anatomical markers, Target B with carved "X" markers).
- Data Provenance: Phantom head (real-world setting simulation).
- Human Volunteer Navigation Session:
- Sample Size: "a human volunteer" (singular).
- Data Provenance: Prospective data from a human volunteer. The volunteer had a pre-existing anatomical (T1 weighted) MRI scan and a segmented gray matter map.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for any of the described test sets.
- For Monte Carlo simulations, the "ground-truth" was likely defined computationally within the simulation model.
- For the phantom study, the "ground truth" measurement was obtained independently on the phantom head, but the method for establishing this ground truth and whether it involved experts is not detailed.
- For the human volunteer study, predefined brain targets were used, but the method for defining these targets (e.g., if experts identified them) is not specified.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test sets. The results appear to be based on direct measurements or computational outputs rather than expert agreement on ambiguous cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, the document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The studies focus on the standalone performance of the device and its components, or its accuracy in comparison to a ground truth, rather than comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, standalone performance was assessed:
- Monte Carlo simulations assessed the mapping algorithm and navigation accuracy computationally without human interaction beyond setting up the simulation parameters.
- Coil compatibility testing evaluated the physical and electromagnetic properties related to the navigation system's function for various coils.
- The reported "Tracking system accuracy" (1.4 mm RMS, 0.5 degrees RMS) refers to the accuracy of the BrainTRAK position tracker itself, a component of the system.
While the "System Accuracy" involves a complete system which implies integration, the foundational "Navigation Principle" itself is also verified algorithmically.
7. The Type of Ground Truth Used
- Monte Carlo Simulations: Computational "ground-truth" defined within the simulation model for comparison with the targeted site.
- Tracking System Accuracy: Intrinsic accuracy of the NDI tracking system, likely measured against known physical standards.
- Coil Compatibility: Intrinsic physical properties and measurements related to magnetic field distortion and successful calibration.
- Phantom Navigation Testing: "ground-truth' measurement on a phantom head obtained independently of the complete TMS Atlas system. The nature of this ground truth (e.g., precise physical markings, pre-defined coordinates) is not further elaborated.
- Human Volunteer Navigation Session: "defined brain target" based on the volunteer's anatomical (T1 weighted) MRI scan and a segmented gray matter map.
8. The Sample Size for the Training Set
The document describes the MagVenture TMS Atlas Neuro Navigation System as a neuronavigation system that performs automatic tissue segmentation from MRI data. However, it does not explicitly mention a training set sample size for any machine learning models that might be used within this automatic segmentation routine or any other part of the system. The focus is on verification and validation of the integrated system and its components.
9. How the Ground Truth for the Training Set was Established
Given that a training set is not explicitly mentioned, the method for establishing its ground truth is also not described. The focus of the provided text is on demonstrating the performance and safety of the final device, rather than detailing the development process of its internal algorithms.
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March 17, 2023
Tonica Elektronik A/S % Lilja Astrup Head of RA. PM and Medical Affairs MagVenture A/S Lucernemarken 15 Farum, DK-3520 Denmark
Re: K221544
Trade/Device Name: MagVenture TMS Atlas Neuro Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: March 14, 2023 Received: March 14, 2023
Dear Lilja Astrup:
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. 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 located 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.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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 Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221544
Device Name
MagVenture TMS Atlas Neuro Navigation System
Indications for Use (Describe)
The MagVenture TMS Atlas Neuro Navigation System is a neuronavigation system indicated for accurate positioning of the treatment coil of the Mag Venture TMS Therapy system with respect to target brain regions based on data obtained from MRI measurements. Specifically, the MagVenture TMS Atlas Neuro Navigation System is indicated for use with the following MagVenture treatment coils manufactured by Tonica Elektronik A/S: C-B60, Cool-B70, Cool DB80, MCF-B65, MCF-B70, and C-B70.
| 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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Section 5 - 510(k) Summary
5.1. Submission applicant
Tonica Elektronik A/S Lucernemarken 15 DK-3520 Farum Denmark
5.2. Submission correspondent
Lilja G. Astrup Head of RA, PM and Medical Affairs MagVenture A/S Lucernemarken 15 DK-3520 Farum Denmark E-mail: lga@magventure.com Telephone: +45 5117 0825
5.3. Date prepared
05/25/2022.
5.4. Device identification
Trade/Proprietary Name: MagVenture TMS Atlas Neuro Navigation System Common Name: Stereotaxic Instrument Device Classification Name: Neurological Stereotaxic Instrument Regulation Number: 21 CFR 882.4560 Classification Product Code: HAW Class: II
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Review Panel:
5.5. Legally marketed predicate device
Neurology
| Device Name: | Neural Navigator |
|---|---|
| 510(k) Number: | K191422 |
| Classification Product Code: | HAW |
| Manufacturer: | Brain Science Tools BV |
5.6. Indication for use statement
The MagVenture TMS Atlas Neuro Navigation System is a neuronavigation system indicated for accurate positioning of the treatment coil of the MagVenture TMS Therapy system with respect to target brain regions based on data obtained from MRI measurements. Specifically, the Mag Venture TMS Atlas Neuro Navigation System is indicated for use with the following MayVenture treatment coils manufactured by Tonica Elektronik A/S: C-B60, Cool-B65, Cool- B70, Cool D-B80, MCF-B65, MCF-B70, and C-B70.
5.7. Device description
The Mag Venture TMS Atlas Neuro Navigation System (TMS Atlas system) combines MRI-based, 3-D visualization of cortical areas of the brain with non-invasive TMS in order to target brain areas accurately, and to locate the target for depression therapy. The TMS Atlas software is used to import a patient's MR image slices through standard DICOM communication protocols, and automatically generates an accurate 3-D model of the patient's head, and a custom automatic tissue segmentation routine to reveal anatomical structures of the brain surface in 3D.
5.8. Substantial equivalence discussion
The following table compares the MagVenture TMS Atlas Neuro Navigation System to the predicate device with respect to indications for use, principles of operation, technological characteristics and performance, and forms the basis for the determination of substantial equivalence.
The proposed device has the same intended use as the predicate device. The TMS Atlas system uses the same technological principle as the predicate device to accomplish its intended use,
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namely the accurate positioning of a TMS coil with respect to target brain regions. The proposed device does not raise any new or different questions of safety or effectiveness as compared to the predicate device.
Comparison of technological characteristics
| Attribute | MagVenture TMS Atlas NeuroNavigation System(Proposed device)[Tonica Elektronik A/S] | Neural Navigator(Predicate device)[Soterix Medical Inc.] |
|---|---|---|
| 510(k) Number | To be assigned | K191422 |
| Product Code | HAW | HAW |
| Indications For Use | The MagVenture TMS Atlas NeuroNavigation System is a neuronavigationsystem indicated for accurate positioningof the treatment coil of the MagVentureTMS Therapy system with respect totarget brain regions based on dataobtained from MRI measurements.Specifically, the MagVenture TMS AtlasNeuro Navigation System is indicated foruse with the following MagVenturetreatment coils manufactured by TonicaElektronik A/S: C-B60, Cool-B65, Cool-B70, Cool D-B80, MCF-B65, MCF-B70,and C-B70. | The Neural Navigator is aneuronavigation system indicated foraccurate positioning of the treatmentcoilof the CloudTMS Therapy System withrespect to target brain regions based ondata obtained from MRI measurements.Specifically,the Neural Navigator isindicated for use with the followingCloudTMS Therapy System coilsmanufactured by Neurosoft Ltd: AFEC-02-100 and AFEC-02-100-C. |
| Device description | The MagVenture TMS Atlas NeuroNavigation System (TMS Atlas system)combines MRI-based, 3-D visualizationof cortical areas of the brain with non-invasive TMS in order to target brainareas accurately, and to locate the targetfor depression therapy. The TMS Atlassystem software is used to importpatient's MR image slices throughstandard DICOM communicationprotocols, and automatically generates anaccurate 3-D model of the patient's head,and a custom automatic tissuesegmentation routine to reveal anatomicalstructures of the brain surface in 3D. | The Neural Navigator combines MRI-based, 3-D localization of cortical motorareas of the brain with non-invasive TMSand simultaneous EMG measurement tolocate areas of the brain that are capableof evoking muscle responses whenstimulated, and to locate the target areafor depression therapy. The NeuralNavigator software is used to import apatient's MR image slices throughstandard DICOM communicationprotocols, and automatically generates anaccurate 3-D model of the patient's headand a custom automatic tissuesegmentation routine to reveal anatomicalstructures of the brain surface in 3D. |
| Intended users | Trained clinical professionals | Trained clinical professionals |
| Attribute | MagVenture TMS Atlas NeuroNavigation System | Neural Navigator |
| (Proposed device) | (Predicate device) | |
| [Tonica Elektronik A/S] | [Soterix Medical Inc.] | |
| Prescription use | Yes | Yes |
| Neuro navigationprinciple | Based on Anatomy (MRI picture) andcalibrated electric field maximum | Based on Anatomy (MRI picture) andcalibrated electric field maximum |
| Imaging modalities | MR based | MR based |
| MR image loading inDICOM, Nifti, andAnalyze | Yes | Yes |
| Selection of Targetsvia Anatomical andFunctionalLandmarks | Yes | Yes |
| DICOM conformance | DICOM conformance statement available | DICOM conformance statement available |
| Planning features | Stimulation targets to deliver TMS tospecific area; includes visibility, locationand description of the target. | Stimulation targets to deliver TMS tospecific area; includes visibility, locationand description of the target. |
| 2D Viewing | Yes: axial, coronal, sagittal slices throughconfigurable cut planes in 3D scene | Yes: axial, coronal, sagittal slices throughconfigurable cut planes in 3D scene |
| 3D Viewing | Yes: 3D viewing of skin, brain surfaceand activation maps, using surfacerendering techniques | Yes: 3D viewing of skin, brain surfaceand activation maps, using surfacerendering techniques |
| Scanner interface | DICOM import of MR images; loadfMRI/PET images through import wizard.Full DICOM conformance statementavailable. Mapping results exported asXML text file. | DICOM import of MR images; loadfMRI/PET images through import wizard.Full DICOM conformance statementavailable. Mapping results exported asXML text file. |
| Registration features | Cross-hairs to register specific MRIlandmarks, digitization pen and headtracker sensors; registration integrity testto determine inaccuracies. | Cross-hairs to register specific MRIlandmarks, digitization pen and headtracker sensors; registration integrity testto determine inaccuracies. |
| Compatible coils | MagVenture C-B60;MagVenture Cool-B65;MagVenture Cool-B70;MagVenture Cool D-B80;MagVenture MCF-B65;MagVenture MCF-B70;MagVenture C-B70 | Neurosoft AFEC-02-100-C Coil;Neurosoft AFEC-02-100 Coil |
| Attribute | MagVenture TMS Atlas NeuroNavigation System(Proposed device)[Tonica Elektronik A/S] | Neural Navigator(Predicate device)[Soterix Medical Inc.] |
| Tracking systemaccuracy# | 1.4 mm RMS, 0.5 degrees RMS (accuracyof localization of tool) | 1.4 mm RMS, 0.5 degrees RMS (accuracyof localization of tool) |
| System accuracy* | 3mm +/- 2.1 mm (when navigating withhand-held probe), 5mm +/- 2.1 mm (whennavigating with TMS coil) | 3mm +/- 2.1 mm (when navigating withhand-held probe), 5mm +/- 2.1 mm (whennavigating with TMS coil) |
| Operation conditions | 5°C - 40°C; between 10%-90% non-condensing humidity. Max allowed heightfor usage is 2000 m above sea level. Airpressure 79 kPa-106 kPa | 5°C - 40°C; between 10%-90% non-condensing humidity. Max allowed heightfor usage is 2000 m above sea level. Airpressure 79 kPa-106 kPa |
| Electrical rating | 100-240 VAC, 50/60 Hz | 100-240 VAC, 50/60 Hz |
| Dimensions(Electronics Unit) | 18.5 cm x 29.2 cm x 6.4 cm | 18.5 cm x 29.2 cm x 6.4 cm |
| Power consumption | 50 VA | 50 VA |
| Electrical safety | IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6 | IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6 |
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Image /page/6/Picture/1 description: The image contains the text "Tonica Elektronik A/S" in blue font. To the right of the text are two puzzle pieces, one red and one blue. The puzzle pieces are interlocked, with the blue piece on top of the red piece. The image appears to be a logo for Tonica Elektronik A/S.
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Tracking system accuracy: accuracy of the BrainTRAK position tracker *System accuracy: accuracy of the complete TMS Atlas system
5.9. Basis for substantial equivalence
Bench performance testing, including system and design verification and validation testing, demonstrated that the performance parameters of the proposed TMS Atlas device are substantially equivalent to those of the predicate device. A summary of the performance testing is provided in the table below.
Overview of performance testing
| Test | Test method summary | Results |
|---|---|---|
| Navigation Principle(Based on Anatomy andcalibrated EF maximum) | Main navigation principle is 'point basedregistration' between MRI space and patientspace, and the calibration of navigationtools. It is tested via Monte Carlosimulations of the mapping algorithm andthe ensuing navigation are run 10,000 timesusing realistic position measurement noise | Tests confirm navigation based onMRI and navigation based on EFmaximum.The navigation principle of thepredicate device is also based onanatomy and calibrated EF. |
| Test | Test method summary | Results |
| conditions. The study compared the targetedsite with ground-truth. | ||
| Coil Compatibility- Validation | System validation test report to evaluatecompatibility of the claimed MagVentureTMS coils and MagVenture stimulators withthe TMS Atlas system as a complete system. | Testing demonstrates compatibilityof the subject device to eachclaimed compatible TMS coil, as acomplete system. It ensures that thesubject device achieves thepositioning accuracy that isnecessary for each TMS coil tofunction as per their clearedIndications and Intended use.The predicate device is similarlycompatible to the Neurosoftbranded coils. |
| Tracking System Accuracy# | Static accuracy better than or equal to 1.4mm as evidenced by test report provided byNDI (tracking system manufacturer) forevery shipment (100% incoming inspection) | Test report confirmation. Thetracking system accuracy of thepredicate device is the same. |
| System Accuracy* | Monte Carlo simulations of the mappingalgorithm and the ensuing navigation are run10,000 times using realistic positionmeasurement noise conditions. | Simulations confirm navigationaccuracy of 4.55 mm with 4markers. With 6 markers, accuracydrops to below 3.5 mmThe system accuracy of thepredicate device is the same. |
| Compatibility testing to evaluatecompatibility of the claimed MagVentureTMS coils and MagVenture stimulators withthe TMS Atlas system as a complete system. | Testing demonstrates compatibilityof the subject device to eachclaimed compatible TMS coil, as acomplete system. It ensures that thesubject device achieves thepositioning accuracy that isnecessary for each TMS coil tofunction as per their clearedIndications and Intended use. Theachieved navigation accuracy of thesystem is < 4mm.The system accuracy of thepredicate device is the same. | |
| Navigation testing that uses a phantom toevaluate whether the complete TMS Atlassystem can accurately move the TMS coils tothe correct location on the brain surfacewithin claimed degree of accuracy whenimplemented in a real-word setting. | Testing demonstrates that thenavigation algorithm can navigateaccurately with an accuracy of <5mm when implemented in a realworld setting.The system accuracy of thepredicate device is the same. |
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| Test | Test method summary | Results |
|---|---|---|
| Product safety standards | Proposed device was tested to the followingstandards: IEC 60601-1, IEC 60601-1-2, IEC60601-1-6, IEC 80002-1, IEC 62366, IEC62304, ISO 14971 | Compliant Test Reports.The predicate device is compliantto the same safety standards. |
| Imaging modality | System Testing (testing of integratedproduct in a setting normally encountered bythe intended user) | The imaging modality is also MRbased in the predicate device |
| Selection of targets viaanatomical and functionallandmarks | System Testing | The same is also used in the predicatedevice |
Tracking system accuracy: accuracy of the BrainTRAK position tracker *System accuracy: accuracy of the complete TMS Atlas system
5.10. Labeling
The labeling of the MagVenture TMS Atlas Neuro Navigation System is substantially equivalent to that of the predicate device.
5.11. Software verification and validation
Software for the MagVenture TMS Atlas Neuro Navigation System was designed and developed according to a robust software development process, and were rigorously verified and validated.
Software information is provided in accordance with internal documentation and the following Standards and guidance documents:
- FDA guidance: The content of premarket submissions for software contained in medical devices, May 11, 2005;
- FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, January 11, 2002;
- FDA guidance: Content of premarket submissions for management of cybersecurity in medical devices, October 18, 2018.
- IEC 62304:2006, Medical device software Software life cycle processes. -
Test results indicate that the TMS Atlas system software complies with its predetermined specifications, and the standards and guidance documents.
5.11.1 System accuracy testing
Monte Carlo simulations
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Image /page/10/Picture/1 description: The image contains the text "Tonica Elektronik A/S" in blue font. To the right of the text, there are two puzzle pieces, one red and one blue, interlocked together. The puzzle pieces are simple in design and add a visual element to the image.
Verification and validation bench testing for navigation accuracy of the TMS Atlas system included Monte Carlo simulations. These simulations evaluate the accuracy of spatial alignment and the accuracy of interpolation for target locations not captured (accuracy of neuro navigation). They test the alignment algorithm in realistic conditions, and the robustness against measurement noise in the positions captured.
Monte Carlo simulations of the mapping algorithm and the ensuing navigation ran 10.000 times, using realistic position measurements noise conditions (as obtained from literature). The computer simulations confirm that at a realistic 3mm measurement noise level and with 4 markers, the navigation accuracy is 4.55mm mean, which is better than the 5 mm formally required.
Compatibility of TMS coils with the complete navigation system
Compatibility testing was performed to validate compatibility of the complete TMS Atlas navigation system with specific claimed TMS coils. These coils include the MagVenture coils C-B60, Cool-B65, Cool-B70, Cool D-B80, MCF-B65, MCF-B70, and C-B70. Three aspects are tested. for each coil model supported:
- absence of significant spatial distortion in position measurements
- coil calibration -
- required temporal filtering during TMS discharge (a running TMS protocol) -
The results indicate that all tested TMS coil and stimulator combinations, with devices powered on but not discharging, do not distort the magnetic field required for electromagnetic tracking. Coil calibration could be performed successfully for all TMS coil and stimulator combinations are also compatible with the tested TMS discharge protocols, in that the spatial tracking signal distortion caused by magnetic stimuli can be effectively filtered out in real time.
As such, the compatibility testing demonstrates that the complete system achieves positioning accuracy that has been cleared for each respective TMS coil for which compatibility is claimed. It ensures that the TMS Atlas System will achieve the positioning accuracy that is necessary for each TMS coil to function as per their cleared Indications and Intended Use. The achieved navigation accuracy of the system is < 4mm.
| TMS coil | Test 1 | Test 2 | Test 3 | Accuracy (mean) | Result |
|---|---|---|---|---|---|
| CB60 | <3mm | - | - | <3mm | PASS |
| CB70 | 2mm | - | - | 2mm | PASS |
| CoolB65 | 1mm | 3mm | 2mm | 2mm | PASS |
| CoolB70 | 3mm | - | - | 3mm | PASS |
Results of the coil calibration tests, the average of 3 tests combined and pass/fail results for each TMS coil
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Image /page/11/Picture/1 description: The image shows the logo for Tonica Elektronik A/S. The text "Tonica Elektronik A/S" is written in blue. To the right of the text are two puzzle pieces, one red and one blue, that are connected together.
| CoolDB80 | 1mm | 3mm | 3mm | 2mm | PASS |
|---|---|---|---|---|---|
| MCFB65 | 4mm | 4mm | 4mm | 4mm | PASS |
| MCFB70 | 1mm | 2mm | 2mm | 2mm | PASS |
Navigation testing of the complete TMS Atlas system that uses a phantom
Navigation testing that uses a phantom was performed to demonstrate that the complete TMS Atlas Neuro Navigation System can accurately move the TMS coils to the correct location on the brain surface within a degree of accuracy of 5mm when implemented in a real-world setting. Testing covered all systems contributing to the navigated output, including MRI imaging and the physical movement of the TMS coil.
Sources of error were identified and included in the testing. These include sources originating from the components of the system such as the MRI scan, TMS coil calibration, craniotopic markers, coil clamp and fixture, TMS discharges, and treatment chair. All measurements were taken independently of the complete system using a 'ground truth' measurement on a phantom head in order to detect the additive effects of sources of errors.
Based on the accuracy assessment that used a phantom, it is concluded that the navigation algorithm can navigate accurately when implemented in in a real world setting. All TMS coil and stimulator combinations tested are compatible with the TMS Atlas system. The complete TMS Atlas system accuracy is within the pre-defined accuracy acceptance criteria of 5 mm.
| Target A (left temporal) | Target B (vertex) | |||
|---|---|---|---|---|
| Test I: Anatomicalmarker set(mm) | Test II: Carved “X”marker set(mm) | Test III: Anatomicalmarker set(mm) | Test IV: Carved “X”marker set(mm) | |
| Mean | 3.5 mm | 4.6 mm | 2.0 mm | 2.6 mm |
| STDEV | 0.9 mm | 0.6 mm | 1.2 mm | 0.8 mm |
| Result | PASS | PASS | PASS | PASS |
Distances from target (ground truth) to coil center in the four different tests. Results presented as mean based on 30 iterations.
Navigation session with the complete TMS Atlas system
The purpose of the validation study was to show that a navigation session with the complete TMS
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Traditional 510(k) Premarket Submission MagVenture TMS Atlas Neuro Navigation System TONICA ELEKTRONIK A/S
Image /page/12/Picture/1 description: The image shows the logo for Tonica Elektronik A/S. The text "Tonica Elektronik A/S" is written in blue, with the words stacked on top of each other. To the right of the text are two puzzle pieces, one blue and one red, that are interlocked.
Atlas Neuro Navigation session achieves the navigation accuracy for TMS coil placement.
A complete navigation session is performed on a human volunteer from whom an anatomical (T1 weighted) MRI scan and a segmented gray matter map (brain) is available. Pre-defined acceptance criteria were established. Results show that the user is able to navigate the TMS coil to a defined brain target within the acceptable navigation accuracy of 5mm.
The testing concludes that the MagVenture TMS Atlas Neuro Navigation system, as a complete system, achieves the navigation accuracy for TMS coil placement when using the device as intended.
5.12. Statement of substantial equivalence
The MagVenture TMS Atlas Neuro Navigation System is substantially equivalent to the predicate device. The TMS Atlas device has the same intended use as the Neural Navigator predicate device, and the same or similar technological characteristics. Bench performance testing support the conclusion that the performance characteristics of the TMS Atlas device are substantially equivalent to the predicate device. Any differences between the devices do not raise new or different questions of safety and effectiveness.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).