Neural Navigator

K191422 · Soterix Medical, Inc. · HAW · Apr 6, 2020 · Neurology

Device Facts

• Record ID: K191422
• Device Name: Neural Navigator
• Applicant: Soterix Medical, Inc.
• Product Code: HAW · Neurology
• Decision Date: Apr 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Neural Navigator is a neuronavigation system indicated for accurate positioning of the treatment coil of the CloudTMS Therapy System with respect to target brain regions based on data obtained from MRI measurements. Specifically, the Neural Navigator is indicated for use with the following CloudTMS Therapy System coils manufactured by Neurosoft Ltd: AFEC-02-100 and AFEC-02-100-C.

Device Story

Neural Navigator is a neuronavigation system for TMS coil positioning. Inputs: patient MRI image slices (DICOM) and real-time tracking data. Operation: software imports MRI data to generate 3D head models and perform automatic tissue segmentation; uses BrainTRAK position tracker to map coil location relative to brain anatomy. Output: visual guidance for coil placement on target brain regions. Used in clinical settings by trained professionals. Benefits: enables precise, MRI-guided TMS coil positioning for therapy, improving targeting accuracy compared to manual placement. Affects clinical decision-making by providing anatomical and functional landmarks for treatment planning.

Clinical Evidence

Clinical study conducted with 10 healthy volunteers using the CloudTMS coil to perform MEP mapping. Primary endpoint: navigation accuracy of the system. Results showed a system accuracy of 4.74 mm for both coil orientations, which is comparable to the predicate device's accuracy of 5.73 mm. Bench testing included Monte Carlo simulations (10,000 runs) confirming navigation accuracy of <3.5 mm with 6 markers.

Technological Characteristics

Neuronavigation system using MRI-based 3D localization. Materials: Polyoxymethylene (POM) for coil clamps. Tracking: BrainTRAK position tracker. Connectivity: DICOM import for MRI/fMRI/PET data. Software: Automatic 3D head model generation and tissue segmentation. Electrical: 100-240 VAC, 50/60 Hz. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304, IEC 62366, ISO 14971, ISO 13485.

Indications for Use

Indicated for accurate positioning of CloudTMS Therapy System treatment coils (AFEC-02-100, AFEC-02-100-C) relative to target brain regions using MRI data. Intended for use by trained clinical professionals.

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

• Nexstim Navigated Brain Therapy (NBT) System 2 (K171902)

Reference Devices

• Nexstim Navigated Brain Stimulation (NBS) System 4 (K112881)

Submission Summary (Full Text)

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April 6, 2020

Soterix Medical, Inc. Abhishek Datta Chief Technology Officer 237 W 35 St. 1401 New York, New York 10001

#### Re: K191422

Trade/Device Name: Neural Navigator Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: January 6, 2020 Received: January 7, 2020

#### Dear Abhishek Datta:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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 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) K191422

Device Name The Neural Navigator

Indications for Use (Describe)

The Neural Navigator is a neuronavigation system indicated for accurate positioning of the treatment coil of the CloudTMS Therapy System with respect to target brain regions based on data obtained from MRI measurements. Specifically, the Neural Navigator is indicated for use with the following CloudTMS Therapy System coils manufactured by Neurosoft Ltd: AFEC-02-100 and AFEC-02-100-C.

Type of Use (Select one or both, as applicable)

| <div> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-----------------------------------------------------------------------------------------------------|
| <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(K) SUMMARY

| Submission Date: | 01/06/20 |
|------------------------|-------------------------------------------------------|
| Submitter Information: | |
| Company Name: | Soterix Medical, Inc. |
| Company Address: | 237 W 35th Street<br>Suite 1401<br>New York, NY 10001 |
| Contact Person: | Abhishek Datta |
| | Phone: [phone]<br>Fax: [phone] |

## Device Information:

| Trade Name: | The Neural Navigator |
|----------------------|------------------------------------------------------------------------------------------------------------|
| Common Name: | Neural Navigator |
| Classification Name: | HAW - Stereotaxic Instrument (21 CFR 882.4560) |
| Device Class: | Class II |
| Predicate Devices: | 1. Nexstim Navigated Brain Therapy (NBT) System 2 (K171902)<br>Nexstim Plc<br>Class II (Primary Predicate) |

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| | 2. Nexstim Navigated Brain Stimulation (NBS) System 4 (K112881) |
|-----------------------------|-----------------------------------------------------------------|
| Nexstim Oy | |
| Class II (Reference Device) | |

The Neural Navigator combines MRI-based, 3-D localization of cortical Device Description: motor areas of the brain with non-invasive TMS and simultaneous EMG measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated, and to locate the target area for depression therapy. The Neural Navigator 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 Neural Navigator is a neuronavigation system indicated for accurate Intended Use/Indications: positioning of the treatment coil of the CloudTMS Therapy System with respect to target brain regions based on data obtained from MRI measurements. Specifically, the Neural Navigator is indicated for use with the following CloudTMS Therapy System coils manufactured by Neurosoft Ltd: AFEC-02-100 and AFEC-02-100-C.

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Image /page/5/Picture/0 description: The image is a logo for a company called "Soterix medical". The word "Soterix" is in black, and the word "medical" is in blue. Above the word "medical" is the phrase "BETTER. SMARTER." in black. Behind the words is a series of blue vertical bars of varying heights.

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## SOTERIX MEDICAL, INC. 510(k) Application Neural Navigator

Technological Comparison: The Neural Navigator uses the same technological principle as the predicate devices to accomplish its intended use, namely the accurate positioning of a TMS or rTMS coil with respect to target brain regions. In conjunction with a rTMS device approved for the treatment of major depressive disorder, the Neural Navigator's intended use is similar to that of the primary predicate, that also combines a TMS device and MRI guidance of coil placement. A full comparison of technological characteristics is provided in the table below.

| Parameter | Neural<br>Navigator | NBT System 2<br>(Primary<br>Predicate) | NBS System<br>4 (Reference<br>Predicate) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Proposed Device | K171902 | K112881 |
| Device Name<br>and Model | Neural Navigator | NBT System 2 | NBS System 4 |
| Manufacturer | Brain Science Tools BV | Nexstim Plc | Nexstim Oy |
| Indications<br>For Use | The Neural Navigator is a<br>neuronavigation system<br>indicated for accurate<br>positioning of the treatment<br>coil of the CloudTMS<br>Therapy System with<br>respect to target brain<br>regions based on data<br>obtained from MRI<br>measurements. Specifically,<br>the Neural Navigator is<br>indicated for use with the<br>following CloudTMS<br>Therapy System coils<br>manufactured by Neurosoft<br>Ltd: AFEC-02-100 and<br>AFEC-02-100-C. | The NBT System<br>2 is indicated for<br>the treatment of<br>Major<br>Depressive<br>Disorder in adult<br>patients who<br>have failed to<br>achieve<br>satisfactory<br>improvement<br>from prior<br>antidepressant<br>medication in the<br>current episode. | The NBS System<br>4 is indicated for the non-<br>invasive mapping of the<br>primary motor cortex of<br>the brain to its cortical<br>gyrus. The NBS System<br>4 provides information<br>that may be used in<br>the assessment of the<br>primary motor cortex for<br>pre- procedural planning. |

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Image /page/6/Picture/0 description: The image is a logo for Soterix Medical. The logo has the words "Soterixmedical" in black and blue. The word "Soterix" is in black, and the word "medical" is in blue. Above the word "Soterixmedical" is the phrase "BETTER. SMARTER." in black. To the left of the words is a graphic of blue bars of varying heights.

SOTERIX MEDICAL, INC.

510(k) Application Neural Navigator

REF:UTF/0510 ISSUE:1 REV:0

DATE: 03/30/20 APP'D Adalla

| Parameter | Neural Navigator | NBT System 2<br>(Primary Predicate) | NBS System 4 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The Neural Navigator combines MRI-based, 3-D localization of cortical motor areas of the brain with non-invasive TMS and simultaneous EMG measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated, and to locate the target area for depression therapy. The Neural Navigator 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 Nexstim NBT System 2 combines MRI-based, 3-D localization of cortical motor areas of the brain with non-invasive TMS and simultaneous EMG measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated, and to locate the target area for depression therapy. The Nexstim NBT System 2 software is used to import a model of the patient's MR image slices through standard DICOM communication protocols, and generates an accurate 3-D model of the patient's head which can be "peeled back" to reveal the anatomical structures of the brain. | The NBS System 4 combines MRI based, 3D localization of cortical motor areas of the brain with non-invasive TMS and simultaneous EMG measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated. The NEXSPEECH is intended to be used in conjunction with the NBS System 4 for localization and assessment of cortical areas of speech function for pre-procedural planning. |

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Image /page/7/Picture/0 description: The image contains the logo for Soterix Medical. The logo features the text "Soterix" in black, followed by "medical" in blue. Above the text is a series of blue bars of varying heights, resembling a graph. To the right of the bars, the words "Better. Smarter." are written in a smaller font.

REF:UTF/0510 ISSUE:1 REV:0 DATE: 03/30/20 APP'D Adella

| Parameter | Neural Navigator | NBT System 2<br>(Primary<br>Predicate) | NBS System<br>4 (Reference<br>Predicate) |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatible<br>Coils | Neurosoft<br>●<br>AFEC-02-100-C<br>Coil<br>Neurosoft<br>AFEC-02-100 Coil | Nexstim Focal<br>●<br>Coil<br>Nexstim Cooled<br>●<br>Coil | Nexstim Focal<br>●<br>Coil<br>Nexstim High<br>Intensity Coil<br>Nexstim<br>Cooled Coil |
| Regulatory Class | Class II | Class II | Class II |
| Product Code | HAW | HAW, OBP, GWF,<br>IKN | HAW, GWF, IKN |
| Tracking System<br>Accuracy | 1.4 mm RMS, 0.5<br>degrees RMS<br>(accuracy of<br>localization of tool) | 1.6 mm (mean<br>error in<br>localization of the<br>tool) | 1.6 mm (mean error<br>in localization of the<br>tool) |
| System Accuracy | 3mm +/- 2.1 mm<br>(when navigating<br>with hand-held<br>probe), 5mm +/- 2.1<br>mm (when navigating<br>with TMS coil) | 5.73 mm (mean)<br>11.46 mm (95% CI) | 5.73 mm (mean)<br>11.46 mm (95% CI) |
| Parameter | Neural Navigator | NBT System 2<br>(Primary<br>Predicate) | NBS System<br>4 (Reference<br>Predicate) |
| Navigation<br>Principle | Based on Anatomy<br>(MRI picture) and<br>calibrated electric<br>field maximum | Based on Anatomy<br>(MRI picture) and<br>calculated electric<br>field | Based on Anatomy<br>(MRI picture) and<br>calculated electric<br>field |
| Operating<br>Conditions | 5°C - 40°C; between<br>10%-90% non-<br>condensing humidity.<br>Max allowed height<br>for usage is 2000 m<br>above sea level. Air<br>pressure 79 kPa-106<br>kPa | 15°C- 30°C;<br>between 30%-75%<br>non-condensing<br>humidity.<br>Air Pressure 80 kPa-<br>106 kPa | 15°C- 30°C;<br>between 30%-75%<br>non-condensing<br>humidity.<br>Air Pressure 80 kPa-<br>106 kPa |
| Intended Users | Trained Clinical<br>professionals | Trained Clinical<br>professionals | Trained Clinical<br>professionals |
| Electrical Rating | 100-240 VAC,<br>50/60 Hz | 120-240 VAC,<br>50/60 Hz | 120-240 VAC,<br>50/60 Hz |
| Dimensions<br>(Electronics Unit) | 18.5 cm x 29.2<br>cm x 6.4 cm | 27.3 cm x 6.9 cm x<br>6.9 cm<br>(tracking unit) | 27.3 cm x 6.9 cm x<br>6.9 cm<br>(tracking unit) |
| Power<br>Consumption | 50 VA | 1000 VA | 1000 VA |
| Position Tracker<br>Model Name | BrainTRAK | Polaris Tracking<br>System | Polaris Tracking<br>System |
| Prescription Use | Yes | Yes | Yes |
| Imaging Modalities | MR Based | MR Based | MR Based |
| Parameter | Neural Navigator | NBT System 2<br>(Primary<br>Predicate) | NBS System<br>4 (Reference<br>Predicate) |
| MR image<br>loading in<br>DICOM, Nifti,<br>and Analyze | Yes | Yes | Yes |
| Selection of<br>Targets via<br>Anatomical and<br>Functional<br>Landmarks | Yes | Yes | Yes |
| DICOM<br>Conformance | DICOM<br>conformance<br>statement available. | DICOM<br>conformance<br>statement available. | DICOM<br>conformance<br>statement available. |
| Planning<br>Features | Stimulation targets to<br>deliver TMS to specific<br>area; includes visibility,<br>location and description<br>of the target. | Stimulation targets to<br>deliver TMS to<br>specific area; includes<br>visibility, location and<br>description of the<br>target. | Stimulation targets to<br>deliver TMS to<br>specific area; includes<br>visibility, location and<br>description of the<br>target. |
| 2D Viewing | Yes: axial, coronal,<br>siggatal slices through<br>configurable cut planes<br>in 3D scene | Yes | Yes |
| 3D Viewing | Yes: 3D viewing of<br>skin, brain surface and<br>activation maps, using<br>surface rendering<br>techniques | Yes | Yes |
| Electrical<br>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 | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-1-6 |
| ISO<br>Standards<br>Met | ISO 13485,<br>IEC 62304,<br>IEC 62366,<br>IEC 14971,<br>IEC 80002-1,<br>ISO 15223-1 | ISO 13485,<br>IEC 62304,<br>IEC 62366,<br>ISO 14971,<br>ISO 10993-1, | ISO 13485,<br>IEC 62304,<br>IEC 62366,<br>ISO 14971<br>ISO 10993-1, |
| Parameter | Neural Navigator | NBT System 2<br>(Primary<br>Predicate) | NBS System 4 (Reference<br>Predicate) |
| Scanner<br>Interface | DICOM import of MR<br>images; load fMRI/PET<br>images through import<br>wizard. Full dicom<br>conformance statement<br>available. Mapping<br>results exported as<br>XML text file. | Mapping results exported<br>as DICOM images with<br>voxel coloring according<br>to motor response<br>amplitudes. Screen<br>captures of 3D mapping<br>views stored as DICOM<br>images. | DICOM import<br>of MR images;<br>load fMRI/PET<br>images through<br>import tab. |
| Registration<br>Features | Cross-hairs to<br>register specific MRI<br>landmarks,<br>digitization pen and<br>head tracker sensors;<br>registration integrity<br>test to determine<br>inaccuracies. | Cross-hairs to register<br>specific MRI<br>landmarks, digitization<br>pen and head tracker<br>LED indicators; may<br>perform advanced<br>registration digitizing<br>nine scalp points;<br>registration integrity<br>test to determine<br>inaccuracies. | Cross-hairs to register<br>specific MRI<br>landmarks, digitization<br>pen and head tracker<br>LED indicators; may<br>perform advanced<br>registration digitizing<br>nine scalp points;<br>registration integrity<br>test to determine<br>inaccuracies. |

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Image /page/8/Picture/0 description: The image shows the logo for Soterix Medical. The logo has the word "Soterix" in black and "medical" in blue. Above the word "Soterix" are several blue bars of varying heights, and to the right of the bars are the words "Better. Smarter." in black.

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Image /page/9/Picture/0 description: The image contains the logo for Soterix Medical. The logo has the words "Better. Smarter." on the top right. The word "Soterix" is in black, and the word "medical" is in blue. There are blue bars of varying heights to the left of the words.

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Image /page/10/Picture/0 description: The image is a logo for Soterix Medical. The logo features the company name in bold, sans-serif font, with "Soterix" in black and "medical" in blue. Above the company name is the text "BETTER. SMARTER." in a smaller font size. To the left of the text is a series of blue bars of varying heights, arranged in a row.

## Basis for Equivalence: Performance Testing:

Bench and clinical testing demonstrated that the performance parameters of the Neural Navigator device are substantially equivalent to those of the predicate devices. A summary of the performance testing is provided in the table below.

| Test | Test Method Summary | Results |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Navigation<br>Principle (Based on<br>Anatomy and<br>calibrated EF<br>maximum) | Main navigation principle is 'point<br>based registration' between MRI space<br>and patient space, and the calibration of<br>navigation tools. It is tested via:<br>1) Monte Carlo simulations of the<br>mapping algorithm and the ensuing<br>navigation are run 10,000 times using<br>realistic position measurement noise<br>conditions.<br>2) Clinical study using the CloudTMS<br>coil (MEP mapping in 10 healthy<br>volunteers).<br>Both studies compared the targeted site<br>with ground-truth | Tests confirm navigation<br>based on MRI and navigation<br>based on EF maximum.<br><br>The navigation principle of<br>predicate devices is also based<br>on anatomy and calibrated EF |
| Coil Compatibility<br>- Verification | 1) Clamp tightly wraps around TMS coil handle.<br>2) Clamp tightly holds sensor in a socket. Coil clamp socket dimensions should be within 0.1 mm tolerance of required dimensions.<br>3) Material composition is Polyoxymethylene (POM) | Material Specs match Dimensions match (with 0.1 mm). Holding of the sensor at a fixed location with respect to TMS coil allows proper tracking of coil position and orientation.<br>The predicate devices are similarly compatible to Nexstim branded coils |
| Coil Compatibility<br>- Validation | Clinical Study using the CloudTMS coil (MEP mapping in 10 healthy volunteers) | The predicate devices are similarly compatible to Nexstim branded coils |
| Tracking System Accuracy | Static accuracy better than or equal to 1.4 mm as evidenced by test report provided by NDI (tracking system manufacturer) for every shipment (100% incoming inspection) | Test report confirmation. The tracking system accuracy of the predicate devices are 1.6 mm. |
| System Accuracy | 1) Monte Carlo simulations of the mapping algorithm and the ensuing navigation are run 10,000 times using realistic position measurement noise conditions.<br><br>2) Clinical Study using CloudTMS coil (MEP mapping in 10 healthy volunteers) | 1) Simulations confirm navigation accuracy of 4.55 mm with 4 markers. With 6 markers, accuracy drops to below 3.5 mm<br>2) accuracy of 4.74 mm for both coil orientations observed.<br><br>The system accuracy of the predicate devices are 5.73mm |
| Product Safety Standards | Subject device was tested to the following standards: IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6,IEC 80002-1,IEC 62366,IEC 62304,ISO 14971 | Compliant Test Reports.<br><br>The predicate device is compliant to the same safety standards |
| Imaging Modality | System Testing (testing of integrated product in a setting normally encountered by the intended user) and Clinical Study using CloudTMS coil (MEP mapping in 10 healthy volunteers) | The imaging modality is also MR based in predicate devices |
| Selection of targets via anatomical and functional landmarks | System Testing and Clinical Study | The same is also used in predicate devices |

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Image /page/11/Picture/0 description: The image shows the logo for Soterix Medical. The logo consists of the word "Soterix" in black font and the word "medical" in blue font. Above the word "Soterix" is the phrase "Better. Smarter." in a smaller font. To the left of the text is a graphic of blue bars of varying heights.

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Image /page/12/Picture/0 description: The image shows the logo for Soteria Medical. The logo has a series of blue bars that increase in height from left to right. To the right of the bars, the words "Better. Smarter." are written in black. Below the bars, the word "Soterix" is written in black, and the word "medical" is written in blue.

## REF:UTF/0510 ISSUE:1

| Labeling: | The labeling of the Neural Navigator device is substantially<br>equivalent to that of the predicate devices. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusions from testing: | The Neural Navigator device is substantially equivalent to the<br>predicate devices. The Neural Navigator device is similar in<br>ıntended use to the MRI guided co1l placement component of its<br>predicate device. Bench and clinical testing supports the conclusion<br>that the performance parameters of the Neural Navigator device 1s<br>substantially equivalent to the predicate devices, and any<br>differences between the devices do not pose new questions of safety<br>and effectiveness. |

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Image /page/13/Picture/0 description: The image shows the logo for Soterix Medical. The words "Better. Smarter." are in black font above the company name. The word "Soterix" is in black font, while the word "medical" is in blue font. There are blue bars above the company name.

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Adalla