MagVenture TMS Atlas Neuro Navigation System

K221544 · Tonica Elektronik A/S · HAW · Mar 17, 2023 · Neurology

Device Facts

• Record ID: K221544
• Device Name: MagVenture TMS Atlas Neuro Navigation System
• Applicant: Tonica Elektronik A/S
• Product Code: HAW · Neurology
• Decision Date: Mar 17, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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.

Device Story

System combines MRI-based 3D visualization of cortical brain areas with non-invasive TMS; enables accurate targeting of brain regions for depression therapy. Inputs: patient MR image slices (DICOM). Processing: software generates 3D head model and performs automatic tissue segmentation to reveal brain surface anatomy; uses point-based registration between MRI space and patient space. Output: visual guidance for positioning TMS coil. Used in clinical settings by trained professionals. Benefits: ensures precise coil placement relative to target brain regions, facilitating effective TMS therapy delivery.

Clinical Evidence

Bench testing only. Includes Monte Carlo simulations (10,000 iterations) of mapping/navigation algorithms, phantom-based navigation accuracy testing (mean accuracy < 5mm), and compatibility validation for specific TMS coils. Human volunteer study confirmed navigation accuracy within 5mm.

Technological Characteristics

MR-based neuronavigation system. Features: DICOM import, 3D surface rendering, point-based registration, digitization pen, head tracker sensors. Electrical: 100-240 VAC, 50/60 Hz. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 80002-1, IEC 62366, IEC 62304, ISO 14971. Software: custom automatic tissue segmentation routine.

Indications for Use

Indicated for accurate positioning of MagVenture TMS Therapy treatment coils relative to target brain regions using MRI data. Intended for use by trained clinical professionals in patients undergoing TMS therapy.

Regulatory Classification

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.

Predicate Devices

• Neural Navigator (K191422)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|------------------------------------------------------------------------------------------------|--|
| <div style="display:inline-block;"><b>☑</b></div> Prescription Use (Part 21 CFR 801 Subpart D) | |
| <div style="display:inline-block;">☐</div> 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: [e-mail] Telephone: [phone]

## 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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Image /page/4/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 blue and one red, that are partially connected.

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 Neuro<br>Navigation System<br>(Proposed device)<br>[Tonica Elektronik A/S] | Neural Navigator<br>(Predicate device)<br>[Soterix Medical Inc.] |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | To be assigned | K191422 |
| Product Code | HAW | HAW |
| Indications For Use | The MagVenture TMS Atlas Neuro<br>Navigation System is a neuronavigation<br>system indicated for accurate positioning<br>of the treatment coil of the MagVenture<br>TMS Therapy system with respect to<br>target brain regions based on data<br>obtained from MRI measurements.<br>Specifically, the MagVenture TMS Atlas<br>Neuro Navigation System is indicated for<br>use with the following MagVenture<br>treatment coils manufactured by Tonica<br>Elektronik A/S: C-B60, Cool-B65, Cool-<br>B70, Cool D-B80, MCF-B65, MCF-B70,<br>and C-B70. | The Neural Navigator is a<br>neuronavigation system indicated for<br>accurate positioning of the treatmentcoil<br>of the CloudTMS Therapy System with<br>respect to target brain regions based on<br>data obtained from MRI measurements.<br>Specifically,the Neural Navigator is<br>indicated for use with the following<br>CloudTMS Therapy System coils<br>manufactured by Neurosoft Ltd: AFEC-<br>02-100 and AFEC-02-100-C. |
| Device description | The MagVenture TMS Atlas Neuro<br>Navigation System (TMS Atlas system)<br>combines MRI-based, 3-D visualization<br>of cortical areas of the brain with non-<br>invasive TMS in order to target brain<br>areas accurately, and to locate the target<br>for depression therapy. The TMS Atlas<br>system software is used to import<br>patient's MR image slices through<br>standard DICOM communication<br>protocols, and automatically generates an<br>accurate 3-D model of the patient's head,<br>and a custom automatic tissue<br>segmentation routine to reveal anatomical<br>structures of the brain surface in 3D. | The Neural Navigator combines MRI-<br>based, 3-D localization of cortical motor<br>areas of the brain with non-invasive TMS<br>and simultaneous EMG measurement to<br>locate areas of the brain that are capable<br>of evoking muscle responses when<br>stimulated, and to locate the target area<br>for depression therapy. The Neural<br>Navigator software is used to import a<br>patient's MR image slices through<br>standard DICOM communication<br>protocols, and automatically generates an<br>accurate 3-D model of the patient's head<br>and a custom automatic tissue<br>segmentation routine to reveal anatomical<br>structures of the brain surface in 3D. |
| Intended users | Trained clinical professionals | Trained clinical professionals |
| Attribute | MagVenture TMS Atlas Neuro<br>Navigation System | Neural Navigator |
| | (Proposed device) | (Predicate device) |
| | [Tonica Elektronik A/S] | [Soterix Medical Inc.] |
| Prescription use | Yes | Yes |
| Neuro navigation<br>principle | Based on Anatomy (MRI picture) and<br>calibrated electric field maximum | Based on Anatomy (MRI picture) and<br>calibrated electric field maximum |
| Imaging modalities | MR based | MR based |
| MR image loading in<br>DICOM, Nifti, and<br>Analyze | Yes | Yes |
| Selection of Targets<br>via Anatomical and<br>Functional<br>Landmarks | Yes | Yes |
| DICOM conformance | DICOM conformance statement available | DICOM conformance statement available |
| Planning features | Stimulation targets to deliver TMS to<br>specific area; includes visibility, location<br>and description of the target. | Stimulation targets to deliver TMS to<br>specific area; includes visibility, location<br>and description of the target. |
| 2D Viewing | Yes: axial, coronal, sagittal slices through<br>configurable cut planes in 3D scene | Yes: axial, coronal, sagittal slices through<br>configurable cut planes in 3D scene |
| 3D Viewing | Yes: 3D viewing of skin, brain surface<br>and activation maps, using surface<br>rendering techniques | Yes: 3D viewing of skin, brain surface<br>and activation maps, using surface<br>rendering techniques |
| Scanner interface | DICOM import of MR images; load<br>fMRI/PET images through import wizard.<br>Full DICOM conformance statement<br>available. Mapping results exported as<br>XML text file. | DICOM import of MR images; load<br>fMRI/PET images through import wizard.<br>Full DICOM conformance statement<br>available. Mapping results exported as<br>XML text file. |
| Registration features | Cross-hairs to register specific MRI<br>landmarks, digitization pen and head<br>tracker sensors; registration integrity test<br>to determine inaccuracies. | Cross-hairs to register specific MRI<br>landmarks, digitization pen and head<br>tracker sensors; registration integrity test<br>to determine inaccuracies. |
| Compatible coils | MagVenture C-B60;<br>MagVenture Cool-B65;<br>MagVenture Cool-B70;<br>MagVenture Cool D-B80;<br>MagVenture MCF-B65;<br>MagVenture MCF-B70;<br>MagVenture C-B70 | Neurosoft AFEC-02-100-C Coil;<br>Neurosoft AFEC-02-100 Coil |
| Attribute | MagVenture TMS Atlas Neuro<br>Navigation System<br>(Proposed device)<br>[Tonica Elektronik A/S] | Neural Navigator<br>(Predicate device)<br>[Soterix Medical Inc.] |
| Tracking system<br>accuracy# | 1.4 mm RMS, 0.5 degrees RMS (accuracy<br>of localization of tool) | 1.4 mm RMS, 0.5 degrees RMS (accuracy<br>of localization of tool) |
| System accuracy* | 3mm +/- 2.1 mm (when navigating with<br>hand-held probe), 5mm +/- 2.1 mm (when<br>navigating with TMS coil) | 3mm +/- 2.1 mm (when navigating with<br>hand-held probe), 5mm +/- 2.1 mm (when<br>navigating with TMS coil) |
| Operation conditions | 5°C - 40°C; between 10%-90% non-<br>condensing humidity. Max allowed height<br>for usage is 2000 m above sea level. Air<br>pressure 79 kPa-106 kPa | 5°C - 40°C; between 10%-90% non-<br>condensing humidity. Max allowed height<br>for usage is 2000 m above sea level. Air<br>pressure 79 kPa-106 kPa |
| Electrical rating | 100-240 VAC, 50/60 Hz | 100-240 VAC, 50/60 Hz |
| Dimensions<br>(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,<br>IEC 60601-1-2,<br>IEC 60601-1-6 | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-1-6 |

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Image /page/7/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, that are partially overlapping. The puzzle pieces are simple in design and have rounded edges.

# 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<br>(Based on Anatomy and<br>calibrated EF maximum) | Main navigation principle is 'point based<br>registration' between MRI space and patient<br>space, and the calibration of navigation<br>tools. It is tested via Monte Carlo<br>simulations of the mapping algorithm and<br>the ensuing navigation are run 10,000 times<br>using realistic position measurement noise | Tests confirm navigation based on<br>MRI and navigation based on EF<br>maximum.<br>The navigation principle of the<br>predicate device is also based on<br>anatomy and calibrated EF. |
| Test | Test method summary | Results |
| | conditions. The study compared the targeted<br>site with ground-truth. | |
| Coil Compatibility<br>- Validation | System validation test report to evaluate<br>compatibility of the claimed MagVenture<br>TMS coils and MagVenture stimulators with<br>the TMS Atlas system as a complete system. | Testing demonstrates compatibility<br>of the subject device to each<br>claimed compatible TMS coil, as a<br>complete system. It ensures that the<br>subject device achieves the<br>positioning accuracy that is<br>necessary for each TMS coil to<br>function as per their cleared<br>Indications and Intended use.<br>The predicate device is similarly<br>compatible to the Neurosoft<br>branded coils. |
| Tracking System Accuracy# | Static accuracy better than or equal to 1.4<br>mm as evidenced by test report provided by<br>NDI (tracking system manufacturer) for<br>every shipment (100% incoming inspection) | Test report confirmation. The<br>tracking system accuracy of the<br>predicate device is the same. |
| System Accuracy* | Monte Carlo simulations of the mapping<br>algorithm and the ensuing navigation are run<br>10,000 times using realistic position<br>measurement noise conditions. | Simulations confirm navigation<br>accuracy of 4.55 mm with 4<br>markers. With 6 markers, accuracy<br>drops to below 3.5 mm<br>The system accuracy of the<br>predicate device is the same. |
| | Compatibility testing to evaluate<br>compatibility of the claimed MagVenture<br>TMS coils and MagVenture stimulators with<br>the TMS Atlas system as a complete system. | Testing demonstrates compatibility<br>of the subject device to each<br>claimed compatible TMS coil, as a<br>complete system. It ensures that the<br>subject device achieves the<br>positioning accuracy that is<br>necessary for each TMS coil to<br>function as per their cleared<br>Indications and Intended use. The<br>achieved navigation accuracy of the<br>system is < 4mm.<br>The system accuracy of the<br>predicate device is the same. |
| | Navigation testing that uses a phantom to<br>evaluate whether the complete TMS Atlas<br>system can accurately move the TMS coils to<br>the correct location on the brain surface<br>within claimed degree of accuracy when<br>implemented in a real-word setting. | Testing demonstrates that the<br>navigation algorithm can navigate<br>accurately with an accuracy of <<br>5mm when implemented in a real<br>world setting.<br>The system accuracy of the<br>predicate device is the same. |

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Image /page/8/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, suggesting a connection or partnership. The overall image appears to be a logo or branding element for the company.

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Image /page/9/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 blue and one red. The puzzle pieces are interlocked, with the blue piece on top and the red piece on the bottom. The overall image has a clean and professional look.

| Test | Test method summary | Results |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Product safety standards | Proposed device was tested to the following<br>standards: IEC 60601-1, IEC 60601-1-2, IEC<br>60601-1-6, IEC 80002-1, IEC 62366, IEC<br>62304, ISO 14971 | Compliant Test Reports.<br>The predicate device is compliant<br>to the same safety standards. |
| Imaging modality | System Testing (testing of integrated<br>product in a setting normally encountered by<br>the intended user) | The imaging modality is also MR<br>based in the predicate device |
| Selection of targets via<br>anatomical and functional<br>landmarks | System Testing | The same is also used in the predicate<br>device |

# 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: Anatomical<br>marker set<br>(mm) | Test II: Carved “X”<br>marker set<br>(mm) | Test III: Anatomical<br>marker set(mm) | Test IV: Carved “X”<br>marker set<br>(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

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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.