(313 days)
No
The description mentions "custom automatic tissue segmentation routine" but does not explicitly state or imply the use of AI/ML for this or any other function. The performance studies focus on navigation accuracy and compatibility, not on the performance of an AI/ML algorithm.
No.
The device is a neuronavigation system used for accurate positioning of a treatment coil, not for delivering therapy itself. It is explicitly indicated for use with the CloudTMS Therapy System, which is the therapeutic device.
No
The device is a neuronavigation system used for accurate positioning of a treatment coil for Transcranial Magnetic Stimulation (TMS), and to locate areas of the brain for depression therapy. It is not indicated for diagnosis of a disease or condition.
No
The device description explicitly mentions combining MRI-based localization with non-invasive TMS and simultaneous EMG measurement, implying the use of hardware components beyond just software for these functions. The performance studies also detail testing related to coil compatibility and tracking system accuracy, which are hardware-dependent aspects.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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." This describes a system used for guiding a medical procedure (TMS therapy), not for performing tests on biological samples to diagnose or monitor a condition.
- Device Description: The description focuses on importing MRI data, generating 3D head models, and assisting in locating brain areas for TMS stimulation. This is a navigation and guidance system, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
The device is a neuronavigation system used in conjunction with a therapeutic device (CloudTMS Therapy System) to improve the accuracy of the therapy delivery. This falls under the category of medical devices used for guidance and positioning during procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
HAW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR Based
Anatomical Site
cortical motor areas of the brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained Clinical professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test: Navigation Principle (Based on Anatomy and calibrated EF maximum)
Test Method Summary: Main navigation principle is 'point based registration' between MRI space and patient space, and the calibration of navigation tools. It is tested via: 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 the CloudTMS coil (MEP mapping in 10 healthy volunteers). Both studies compared the targeted site with ground-truth
Results: 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
Test: Coil Compatibility - Verification
Test Method Summary: 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)
Results: 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
Test: Coil Compatibility - Validation
Test Method Summary: Clinical Study using the CloudTMS coil (MEP mapping in 10 healthy volunteers)
Results: The predicate devices are similarly compatible to Nexstim branded coils
Test: Tracking System Accuracy
Test Method Summary: 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)
Results: Test report confirmation. The tracking system accuracy of the predicate devices are 1.6 mm.
Test: System Accuracy
Test Method Summary: 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)
Results: 1) Simulations confirm navigation accuracy of 4.55 mm with 4 markers. With 6 markers, accuracy drops to below 3.5 mm 2) accuracy of 4.74 mm for both coil orientations observed. The system accuracy of the predicate devices are 5.73mm
Test: Product Safety Standards
Test Method Summary: 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
Results: Compliant Test Reports. The predicate device is compliant to the same safety standards
Test: Imaging Modality
Test Method Summary: 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)
Results: The imaging modality is also MR based in predicate devices
Test: Selection of targets via anatomical and functional landmarks
Test Method Summary: System Testing and Clinical Study
Results: The same is also used in predicate devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Tracking System Accuracy: 1.4 mm RMS, 0.5 degrees RMS (accuracy of localization of tool)
System Accuracy: 3mm +/- 2.1 mm (when navigating with hand-held probe), 5mm +/- 2.1 mm (when navigating with TMS coil)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
1
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
2
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 Street |
| Suite 1401 | |
| New York, NY 10001 | |
| Contact Person: | Abhishek Datta |
| Phone: 888-990-8327 | |
| Fax: 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 Plc | |
| Class 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.
REF:UTF/0510 ISSUE:1 REV:0 DATE: 03/30/20 APP'D
| 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 | Neural
Navigator | NBT System 2
(Primary
Predicate) | NBS System
4 (Reference
Predicate) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Proposed Device | K171902 | K112881 |
| Device Name
and Model | Neural Navigator | NBT System 2 | NBS System 4 |
| Manufacturer | Brain Science Tools BV | Nexstim Plc | Nexstim Oy |
| Indications
For 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. | The NBT System
2 is indicated for
the treatment of
Major
Depressive
Disorder in adult
patients who
have failed to
achieve
satisfactory
improvement
from prior
antidepressant
medication in the
current episode. | The NBS System
4 is indicated for the non-
invasive mapping of the
primary motor cortex of
the brain to its cortical
gyrus. The NBS System
4 provides information
that may be used in
the assessment of the
primary motor cortex for
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
(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
(Primary
Predicate) | NBS System
4 (Reference
Predicate) |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatible
Coils | Neurosoft
●
AFEC-02-100-C
Coil
Neurosoft
AFEC-02-100 Coil | Nexstim Focal
●
Coil
Nexstim Cooled
●
Coil | Nexstim Focal
●
Coil
Nexstim High
Intensity Coil
Nexstim
Cooled Coil |
| Regulatory Class | Class II | Class II | Class II |
| Product Code | HAW | HAW, OBP, GWF,
IKN | HAW, GWF, IKN |
| Tracking System
Accuracy | 1.4 mm RMS, 0.5
degrees RMS
(accuracy of
localization of tool) | 1.6 mm (mean
error in
localization of the
tool) | 1.6 mm (mean error
in localization of the
tool) |
| System Accuracy | 3mm +/- 2.1 mm
(when navigating
with hand-held
probe), 5mm +/- 2.1
mm (when navigating
with 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
(Primary
Predicate) | NBS System
4 (Reference
Predicate) |
| Navigation
Principle | Based on Anatomy
(MRI picture) and
calibrated electric
field maximum | Based on Anatomy
(MRI picture) and
calculated electric
field | Based on Anatomy
(MRI picture) and
calculated electric
field |
| Operating
Conditions | 5°C - 40°C; between
10%-90% non-
condensing humidity.
Max allowed height
for usage is 2000 m
above sea level. Air
pressure 79 kPa-106
kPa | 15°C- 30°C;
between 30%-75%
non-condensing
humidity.
Air Pressure 80 kPa-
106 kPa | 15°C- 30°C;
between 30%-75%
non-condensing
humidity.
Air Pressure 80 kPa-
106 kPa |
| Intended Users | Trained Clinical
professionals | Trained Clinical
professionals | Trained Clinical
professionals |
| 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 29.2
cm x 6.4 cm | 27.3 cm x 6.9 cm x
6.9 cm
(tracking unit) | 27.3 cm x 6.9 cm x
6.9 cm
(tracking unit) |
| Power
Consumption | 50 VA | 1000 VA | 1000 VA |
| Position Tracker
Model Name | BrainTRAK | Polaris Tracking
System | Polaris Tracking
System |
| Prescription Use | Yes | Yes | Yes |
| Imaging Modalities | MR Based | MR Based | MR Based |
| Parameter | Neural Navigator | NBT System 2
(Primary
Predicate) | NBS System
4 (Reference
Predicate) |
| MR image
loading in
DICOM, Nifti,
and Analyze | Yes | Yes | Yes |
| Selection of
Targets via
Anatomical and
Functional
Landmarks | Yes | Yes | Yes |
| DICOM
Conformance | DICOM
conformance
statement available. | DICOM
conformance
statement available. | DICOM
conformance
statement available. |
| Planning
Features | Stimulation targets to
deliver TMS to specific
area; includes visibility,
location and description
of the target. | Stimulation targets to
deliver TMS to
specific area; includes
visibility, location and
description of the
target. | Stimulation targets to
deliver TMS to
specific area; includes
visibility, location and
description of the
target. |
| 2D Viewing | Yes: axial, coronal,
siggatal slices through
configurable cut planes
in 3D scene | Yes | Yes |
| 3D Viewing | Yes: 3D viewing of
skin, brain surface and
activation maps, using
surface rendering
techniques | Yes | Yes |
| Electrical
Safety | 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 |
| ISO
Standards
Met | 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 14971
ISO 10993-1, |
| Parameter | Neural Navigator | NBT System 2
(Primary
Predicate) | NBS System 4 (Reference
Predicate) |
| Scanner
Interface | DICOM import of MR
images; load fMRI/PET
images through import
wizard. Full dicom
conformance statement
available. Mapping
results exported as
XML text file. | Mapping results exported
as DICOM images with
voxel coloring according
to motor response
amplitudes. Screen
captures of 3D mapping
views stored as DICOM
images. | DICOM import
of MR images;
load fMRI/PET
images through
import tab. |
| Registration
Features | Cross-hairs to
register specific MRI
landmarks,
digitization pen and
head tracker sensors;
registration integrity
test to determine
inaccuracies. | Cross-hairs to register
specific MRI
landmarks, digitization
pen and head tracker
LED indicators; may
perform advanced
registration digitizing
nine scalp points;
registration integrity
test to determine
inaccuracies. | Cross-hairs to register
specific MRI
landmarks, digitization
pen and head tracker
LED indicators; may
perform advanced
registration digitizing
nine scalp points;
registration integrity
test to determine
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 | ||
| Principle (Based on | ||
| Anatomy and | ||
| calibrated EF | ||
| maximum) | Main navigation principle is 'point | |
| based registration' between MRI space | ||
| and patient space, and the calibration of | ||
| navigation tools. It is tested via: |
- Monte Carlo simulations of the
mapping algorithm and the ensuing
navigation are run 10,000 times using
realistic position measurement noise
conditions. - Clinical study using the CloudTMS
coil (MEP mapping in 10 healthy
volunteers).
Both studies compared the targeted site
with ground-truth | 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 |
| Coil Compatibility
- Verification | 1) Clamp tightly wraps around TMS coil handle.
- Clamp tightly holds sensor in a socket. Coil clamp socket dimensions should be within 0.1 mm tolerance of required dimensions.
- 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.
- 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
- 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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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
equivalent to that of the predicate devices. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusions from testing: | The Neural Navigator device is substantially equivalent to the
predicate devices. The Neural Navigator device is similar in
ıntended use to the MRI guided co1l placement component of its
predicate device. Bench and clinical testing supports the conclusion
that the performance parameters of the Neural Navigator device 1s
substantially equivalent to the predicate devices, and any
differences between the devices do not pose new questions of safety
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.
REF:UTF/0510 ISSUE:1 REV:0
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