(313 days)
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.
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 provided text describes the 510(k) premarket notification for the Neural Navigator device. While it asserts substantial equivalence based on performance testing, it does not explicitly define "acceptance criteria" in a quantitative table with specific thresholds as would be typical for a detailed study report. However, it implicitly presents performance metrics and their comparison to predicate devices, which serve as the basis for acceptance.
Here's an attempt to extract and rephrase the information to fit the requested format, acknowledging the limitations of the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit acceptance criteria with defined pass/fail thresholds. Instead, it compares the Neural Navigator's performance to its predicate devices, implying that performance comparable to or better than the predicate is considered acceptable.
| Parameter | Implicit Acceptance Criterion (Compared to Predicate) | Reported Neural Navigator Performance |
|---|---|---|
| Tracking System Accuracy | <= 1.6 mm (mean error in localization of the tool) | 1.4 mm RMS, 0.5 degrees RMS (accuracy of localization of tool). "Static accuracy better than or equal to 1.4 mm" |
| System Accuracy | <= 5.73 mm (mean) | Simulations confirm navigation accuracy of 4.55 mm with 4 markers, and below 3.5 mm with 6 markers. Clinical study observed accuracy of 4.74 mm for both coil orientations. |
| Coil Compatibility | Comparable to predicate device's compatibility | Clamp tightly wraps around TMS coil handle, holds sensor in socket within 0.1 mm tolerance, material is Polyoxymethylene (POM). Verified through material specs and dimensions, and validated in clinical study. "The predicate devices are similarly compatible to Nexstim branded coils." |
| Navigation Principle | Same as predicate (Anatomy & calibrated EF) | "Tests confirm navigation based on MRI and navigation based on EF maximum." "The navigation principle of predicate devices is also based on anatomy and calibrated EF." |
| Product Safety Standards | Compliance with relevant IEC and ISO standards | Compliant Test Reports for IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 80002-1, IEC 62366, IEC 62304, ISO 14971. "The predicate device is compliant to the same safety standards." |
| Imaging Modality | MR Based | "The imaging modality is also MR based in predicate devices." |
| Selection of Targets | Same as predicate (Anatomical & functional landmarks) | "The same is also used in predicate devices." |
2. Sample Sizes Used for the Test Set and Data Provenance
- Clinical Study for Coil Compatibility Validation and System Accuracy: 10 healthy volunteers.
- Data Provenance: The document does not specify the country of origin for the clinical study data or if it was retrospective or prospective. Given it is a 510(k) submission, it is likely prospective testing specifically for this submission.
- Monte Carlo Simulations: 10,000 runs for both mapping algorithm and ensuing navigation. The provenance for this is computational simulation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth. The clinical study involved "MEP mapping," which typically involves expert neurophysiology interpretation. However, details on the adjudicators or their qualifications are not provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical test set. The ground truth seems to be implicitly derived from the MEP mapping procedure itself, which is a physiological measurement, rather than subjective interpretation requiring multiple readings.
5. Was a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Done?
No, an MRMC comparative effectiveness study with human readers assisting AI versus without AI assistance was not performed or reported. This device is a neuronavigation system for coil placement, not an AI-assisted diagnostic imaging tool where such a study would typically be conducted. The study is focused on the accuracy of the navigation system itself.
6. Was a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Done?
Yes, the document reports on elements of standalone performance:
- Tracking System Accuracy: Tested independently by NDI (the tracking system manufacturer).
- System Accuracy (simulations): 10,000 Monte Carlo simulations were run, representing an algorithm-only evaluation of accuracy under various noise conditions.
- Clinical Study: While it involves humans (volunteers), the focus is on the accuracy of the device's navigation in placing the TMS coil, which is a direct measure of the algorithm's performance in guiding coil placement, rather than human interpretation aided by the algorithm. The "human-in-the-loop" is the operator using the device, but the performance metric is the device's ability to accurately guide.
7. The Type of Ground Truth Used
- System Accuracy (Clinical Study): The ground truth for the clinical study measuring system accuracy via MEP mapping is based on a physiological response (Motor Evoked Potentials - MEPs). The assumption is that successful MEPs indicate accurate targeting of the motor cortex.
- Tracking System Accuracy: Ground truth is established by the independent testing of the tracking system by its manufacturer, likely using known spatial measurements.
- System Accuracy (Simulations): Ground truth is an ideal or expected outcome defined within the simulation model.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set size or methodology. This type of device, which is based on established physics and medical imaging principles (e.g., MRI-based 3D localization, tissue segmentation), may not involve a "training set" in the sense of a machine learning model where data is used to optimize algorithms. The algorithms are likely engineered based on physiological and anatomical models.
9. How the Ground Truth for the Training Set Was Established
As no "training set" is mentioned for a machine learning context, the method for establishing its ground truth is not applicable or described in the provided text. The foundational principles and calibrations for the device's operations (e.g., MRI space to patient space registration, calibrated electric field maximum) are inherent to its design and validated through the performance tests mentioned above.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is a logo for a company called "Soterixmedical". The logo features the company name in bold, black letters, with the word "Soterix" stacked on top of the word "medical". Above and behind the company name is a graphic of blue bars of varying heights, arranged in a diamond shape. To the right of the blue bars, the words "BETTER. SMARTER." are written in a smaller, sans-serif font.
REF:UTF/0510 ISSUE:1 REV:0 DATE: 03/30/20 APP'D Adalla
510(K) SUMMARY
| Submission Date: | 01/06/20 |
|---|---|
| Submitter Information: | |
| Company Name: | Soterix Medical, Inc. |
| Company Address: | 237 W 35th StreetSuite 1401New York, NY 10001 |
| Contact Person: | Abhishek Datta |
| Phone: 888-990-8327Fax: 212-315-3232 |
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)Nexstim PlcClass II (Primary Predicate) |
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Image /page/4/Picture/0 description: The image is a logo for a company called "Soterix medical". The logo features the company name in two different fonts and colors. The word "Soterix" is in black, while the word "medical" is in blue. Above the company name, there is the text "BETTER. SMARTER." in a smaller font. Behind the company name, there is a graphic of blue and white bars that resemble a graph or chart.
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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.
REF:UTF/0510 ISSUE:1 REV:0 DATE: APP'D /
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 | NeuralNavigator | NBT System 2(PrimaryPredicate) | NBS System4 (ReferencePredicate) |
|---|---|---|---|
| 510(k) | Proposed Device | K171902 | K112881 |
| Device Nameand Model | Neural Navigator | NBT System 2 | NBS System 4 |
| Manufacturer | Brain Science Tools BV | Nexstim Plc | Nexstim Oy |
| IndicationsFor Use | The Neural Navigator is aneuronavigation systemindicated for accuratepositioning of the treatmentcoil of the CloudTMSTherapy System withrespect to target brainregions based on dataobtained from MRImeasurements. Specifically,the Neural Navigator isindicated for use with thefollowing CloudTMSTherapy System coilsmanufactured by NeurosoftLtd: AFEC-02-100 andAFEC-02-100-C. | The NBT System2 is indicated forthe treatment ofMajorDepressiveDisorder in adultpatients whohave failed toachievesatisfactoryimprovementfrom priorantidepressantmedication in thecurrent episode. | The NBS System4 is indicated for the non-invasive mapping of theprimary motor cortex ofthe brain to its corticalgyrus. The NBS System4 provides informationthat may be used inthe assessment of theprimary motor cortex forpre- 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(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(PrimaryPredicate) | NBS System4 (ReferencePredicate) |
|---|---|---|---|
| CompatibleCoils | Neurosoft●AFEC-02-100-CCoilNeurosoftAFEC-02-100 Coil | Nexstim Focal●CoilNexstim Cooled●Coil | Nexstim Focal●CoilNexstim HighIntensity CoilNexstimCooled Coil |
| Regulatory Class | Class II | Class II | Class II |
| Product Code | HAW | HAW, OBP, GWF,IKN | HAW, GWF, IKN |
| Tracking SystemAccuracy | 1.4 mm RMS, 0.5degrees RMS(accuracy oflocalization of tool) | 1.6 mm (meanerror inlocalization of thetool) | 1.6 mm (mean errorin localization of thetool) |
| System Accuracy | 3mm +/- 2.1 mm(when navigatingwith hand-heldprobe), 5mm +/- 2.1mm (when navigatingwith TMS coil) | 5.73 mm (mean)11.46 mm (95% CI) | 5.73 mm (mean)11.46 mm (95% CI) |
| Parameter | Neural Navigator | NBT System 2(PrimaryPredicate) | NBS System4 (ReferencePredicate) |
| NavigationPrinciple | Based on Anatomy(MRI picture) andcalibrated electricfield maximum | Based on Anatomy(MRI picture) andcalculated electricfield | Based on Anatomy(MRI picture) andcalculated electricfield |
| OperatingConditions | 5°C - 40°C; between10%-90% non-condensing humidity.Max allowed heightfor usage is 2000 mabove sea level. Airpressure 79 kPa-106kPa | 15°C- 30°C;between 30%-75%non-condensinghumidity.Air Pressure 80 kPa-106 kPa | 15°C- 30°C;between 30%-75%non-condensinghumidity.Air Pressure 80 kPa-106 kPa |
| Intended Users | Trained Clinicalprofessionals | Trained Clinicalprofessionals | Trained Clinicalprofessionals |
| Electrical Rating | 100-240 VAC,50/60 Hz | 120-240 VAC,50/60 Hz | 120-240 VAC,50/60 Hz |
| Dimensions(Electronics Unit) | 18.5 cm x 29.2cm x 6.4 cm | 27.3 cm x 6.9 cm x6.9 cm(tracking unit) | 27.3 cm x 6.9 cm x6.9 cm(tracking unit) |
| PowerConsumption | 50 VA | 1000 VA | 1000 VA |
| Position TrackerModel Name | BrainTRAK | Polaris TrackingSystem | Polaris TrackingSystem |
| Prescription Use | Yes | Yes | Yes |
| Imaging Modalities | MR Based | MR Based | MR Based |
| Parameter | Neural Navigator | NBT System 2(PrimaryPredicate) | NBS System4 (ReferencePredicate) |
| MR imageloading inDICOM, Nifti,and Analyze | Yes | Yes | Yes |
| Selection ofTargets viaAnatomical andFunctionalLandmarks | Yes | Yes | Yes |
| DICOMConformance | DICOMconformancestatement available. | DICOMconformancestatement available. | DICOMconformancestatement available. |
| PlanningFeatures | Stimulation targets todeliver TMS to specificarea; includes visibility,location and descriptionof the target. | Stimulation targets todeliver TMS tospecific area; includesvisibility, location anddescription of thetarget. | Stimulation targets todeliver TMS tospecific area; includesvisibility, location anddescription of thetarget. |
| 2D Viewing | Yes: axial, coronal,siggatal slices throughconfigurable cut planesin 3D scene | Yes | Yes |
| 3D Viewing | Yes: 3D viewing ofskin, brain surface andactivation maps, usingsurface renderingtechniques | Yes | Yes |
| ElectricalSafety | IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6 | IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6 | IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6 |
| ISOStandardsMet | ISO 13485,IEC 62304,IEC 62366,IEC 14971,IEC 80002-1,ISO 15223-1 | ISO 13485,IEC 62304,IEC 62366,ISO 14971,ISO 10993-1, | ISO 13485,IEC 62304,IEC 62366,ISO 14971ISO 10993-1, |
| Parameter | Neural Navigator | NBT System 2(PrimaryPredicate) | NBS System 4 (ReferencePredicate) |
| ScannerInterface | DICOM import of MRimages; load fMRI/PETimages through importwizard. Full dicomconformance statementavailable. Mappingresults exported asXML text file. | Mapping results exportedas DICOM images withvoxel coloring accordingto motor responseamplitudes. Screencaptures of 3D mappingviews stored as DICOMimages. | DICOM importof MR images;load fMRI/PETimages throughimport tab. |
| RegistrationFeatures | Cross-hairs toregister specific MRIlandmarks,digitization pen andhead tracker sensors;registration integritytest to determineinaccuracies. | Cross-hairs to registerspecific MRIlandmarks, digitizationpen and head trackerLED indicators; mayperform advancedregistration digitizingnine scalp points;registration integritytest to determineinaccuracies. | Cross-hairs to registerspecific MRIlandmarks, digitizationpen and head trackerLED indicators; mayperform advancedregistration digitizingnine scalp points;registration integritytest to determineinaccuracies. |
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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/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 |
|---|---|---|
| NavigationPrinciple (Based onAnatomy andcalibrated EFmaximum) | Main navigation principle is 'pointbased registration' between MRI spaceand patient space, and the calibration ofnavigation tools. It is tested via:1) Monte Carlo simulations of themapping algorithm and the ensuingnavigation are run 10,000 times usingrealistic position measurement noiseconditions.2) Clinical study using the CloudTMScoil (MEP mapping in 10 healthyvolunteers).Both studies compared the targeted sitewith ground-truth | Tests confirm navigationbased on MRI and navigationbased on EF maximum.The navigation principle ofpredicate devices is also basedon anatomy and calibrated EF |
| Coil Compatibility- Verification | 1) Clamp tightly wraps around TMS coil handle.2) Clamp tightly holds sensor in a socket. Coil clamp socket dimensions should be within 0.1 mm tolerance of required dimensions.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.The predicate devices are similarly compatible to Nexstim branded coils |
| Coil Compatibility- 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.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 mm2) accuracy of 4.74 mm for both coil orientations observed.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.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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REF:UTF/0510 ISSUE:1
| Labeling: | The labeling of the Neural Navigator device is substantiallyequivalent to that of the predicate devices. |
|---|---|
| Conclusions from testing: | The Neural Navigator device is substantially equivalent to thepredicate devices. The Neural Navigator device is similar inıntended use to the MRI guided co1l placement component of itspredicate device. Bench and clinical testing supports the conclusionthat the performance parameters of the Neural Navigator device 1ssubstantially equivalent to the predicate devices, and anydifferences between the devices do not pose new questions of safetyand effectiveness. |
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Adalla
§ 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).