(294 days)
Not Found
No
The description mentions "custom automatic tissue segmentation routine" and "mapping algorithm," but there is no explicit mention of AI, ML, deep learning, or any related terms. The performance studies focus on traditional navigation accuracy and compatibility testing, not on the performance metrics typically associated with AI/ML models (e.g., AUC, sensitivity, specificity).
No.
The device is a neuronavigation system used for accurate positioning of a treatment coil, not the primary therapeutic device itself.
No.
The MagVenture TMS Atlas Neuro Navigation System is indicated for accurate positioning of a treatment coil, not for diagnosing a condition or disease.
No
The device description explicitly states it is a "system" that "combines MRI-based, 3-D visualization... with non-invasive TMS". The performance studies also include "System Accuracy" and "Compatibility testing" with "MagVenture TMS coils and MagVenture stimulators", indicating hardware components are part of the overall system, even if the "TMS Atlas software" is a key part.
Based on the provided information, the MagVenture TMS Atlas Neuro Navigation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "accurate positioning of the treatment coil of the MagVenture TMS Therapy system with respect to target brain regions based on data obtained from MRI measurements." This describes a system used in vivo (on a living patient) to guide a medical procedure (TMS therapy).
- Device Description: The description reinforces this by stating it "combines MRI-based, 3-D visualization of cortical areas of the brain with non-invasive TMS in order to target brain areas accurately." This is about guiding treatment on a patient.
- Anatomical Site: The anatomical site is "Brain regions," which is part of the living body.
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on bodily specimens.
The device is a neuronavigation system used to guide the application of TMS therapy on a patient's brain, making it a medical device used in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The MagVenture TMS Atlas Neuro Navigation System is a neuronavigation system indicated for accurate positioning of the treatment coil of the MagVenture TMS Therapy system with respect to target brain regions based on data obtained from MRI measurements. Specifically, the MagVenture TMS Atlas Neuro Navigation System is indicated for use with the following MagVenture treatment coils manufactured by Tonica Elektronik A/S: C-B60, Cool-B70, Cool DB80, MCF-B65, MCF-B70, and C-B70.
Product codes
HAW
Device Description
The MagVenture TMS Atlas Neuro Navigation System (TMS Atlas system) combines MRI-based, 3-D visualization of cortical areas of the brain with non-invasive TMS in order to target brain areas accurately, and to locate the target for depression therapy. The TMS Atlas software is used to import a patient's MR image slices through standard DICOM communication protocols, and automatically generates an accurate 3-D model of the patient's head, and a custom automatic tissue segmentation routine to reveal anatomical structures of the brain surface in 3D.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR based
Anatomical Site
Cortical areas of the brain, brain surface
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
Monte Carlo simulations of the mapping algorithm and the ensuing navigation are run 10,000 times using realistic position measurement noise conditions.
Navigation testing that uses a phantom: Not specified, but tested with a phantom head.
Navigation session with the complete TMS Atlas system: performed on a human volunteer from whom an anatomical (T1 weighted) MRI scan and a segmented gray matter map (brain) is available.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Navigation Principle: Monte Carlo simulations of the mapping algorithm and the ensuing navigation are run 10,000 times using realistic position measurement noise conditions. Tests confirm navigation based on MRI and navigation based on EF maximum.
- Coil Compatibility - Validation: System validation test report to evaluate compatibility of the claimed MagVenture TMS coils and MagVenture stimulators with the TMS Atlas system as a complete system. Testing demonstrates compatibility of the subject device to each claimed compatible TMS coil, as a complete system. It ensures that the subject device achieves the positioning accuracy that is necessary for each TMS coil to function as per their cleared Indications and Intended use. The achieved navigation accuracy of the system is
§ 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).
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March 17, 2023
Tonica Elektronik A/S % Lilja Astrup Head of RA. PM and Medical Affairs MagVenture A/S Lucernemarken 15 Farum, DK-3520 Denmark
Re: K221544
Trade/Device Name: MagVenture TMS Atlas Neuro Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: March 14, 2023 Received: March 14, 2023
Dear Lilja Astrup:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Pamela D. Scott -S
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221544
Device Name
MagVenture TMS Atlas Neuro Navigation System
Indications for Use (Describe)
The MagVenture TMS Atlas Neuro Navigation System is a neuronavigation system indicated for accurate positioning of the treatment coil of the Mag Venture TMS Therapy system with respect to target brain regions based on data obtained from MRI measurements. Specifically, the MagVenture TMS Atlas Neuro Navigation System is indicated for use with the following MagVenture treatment coils manufactured by Tonica Elektronik A/S: C-B60, Cool-B70, Cool DB80, MCF-B65, MCF-B70, and C-B70.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5 - 510(k) Summary
5.1. Submission applicant
Tonica Elektronik A/S Lucernemarken 15 DK-3520 Farum Denmark
5.2. Submission correspondent
Lilja G. Astrup Head of RA, PM and Medical Affairs MagVenture A/S Lucernemarken 15 DK-3520 Farum Denmark E-mail: lga@magventure.com Telephone: +45 5117 0825
5.3. Date prepared
05/25/2022.
5.4. Device identification
Trade/Proprietary Name: MagVenture TMS Atlas Neuro Navigation System Common Name: Stereotaxic Instrument Device Classification Name: Neurological Stereotaxic Instrument Regulation Number: 21 CFR 882.4560 Classification Product Code: HAW Class: II
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Review Panel:
5.5. Legally marketed predicate device
Neurology
| Device Name: | Neural Navigator |
|---|---|
| 510(k) Number: | K191422 |
| Classification Product Code: | HAW |
| Manufacturer: | Brain Science Tools BV |
5.6. Indication for use statement
The MagVenture TMS Atlas Neuro Navigation System is a neuronavigation system indicated for accurate positioning of the treatment coil of the MagVenture TMS Therapy system with respect to target brain regions based on data obtained from MRI measurements. Specifically, the Mag Venture TMS Atlas Neuro Navigation System is indicated for use with the following MayVenture treatment coils manufactured by Tonica Elektronik A/S: C-B60, Cool-B65, Cool- B70, Cool D-B80, MCF-B65, MCF-B70, and C-B70.
5.7. Device description
The Mag Venture TMS Atlas Neuro Navigation System (TMS Atlas system) combines MRI-based, 3-D visualization of cortical areas of the brain with non-invasive TMS in order to target brain areas accurately, and to locate the target for depression therapy. The TMS Atlas software is used to import a patient's MR image slices through standard DICOM communication protocols, and automatically generates an accurate 3-D model of the patient's head, and a custom automatic tissue segmentation routine to reveal anatomical structures of the brain surface in 3D.
5.8. Substantial equivalence discussion
The following table compares the MagVenture TMS Atlas Neuro Navigation System to the predicate device with respect to indications for use, principles of operation, technological characteristics and performance, and forms the basis for the determination of substantial equivalence.
The proposed device has the same intended use as the predicate device. The TMS Atlas system uses the same technological principle as the predicate device to accomplish its intended use,
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namely the accurate positioning of a TMS coil with respect to target brain regions. The proposed device does not raise any new or different questions of safety or effectiveness as compared to the predicate device.
Comparison of technological characteristics
| Attribute | MagVenture TMS Atlas Neuro
Navigation System
(Proposed device)
[Tonica Elektronik A/S] | Neural Navigator
(Predicate device)
[Soterix Medical Inc.] |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | To be assigned | K191422 |
| Product Code | HAW | HAW |
| Indications For Use | The MagVenture TMS Atlas Neuro
Navigation System is a neuronavigation
system indicated for accurate positioning
of the treatment coil of the MagVenture
TMS Therapy system with respect to
target brain regions based on data
obtained from MRI measurements.
Specifically, the MagVenture TMS Atlas
Neuro Navigation System is indicated for
use with the following MagVenture
treatment coils manufactured by Tonica
Elektronik A/S: C-B60, Cool-B65, Cool-
B70, Cool D-B80, MCF-B65, MCF-B70,
and C-B70. | The Neural Navigator is a
neuronavigation system indicated for
accurate positioning of the treatmentcoil
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 description | The MagVenture TMS Atlas Neuro
Navigation System (TMS Atlas system)
combines MRI-based, 3-D visualization
of cortical areas of the brain with non-
invasive TMS in order to target brain
areas accurately, and to locate the target
for depression therapy. The TMS Atlas
system software is used to import
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 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. |
| Intended users | Trained clinical professionals | Trained clinical professionals |
| Attribute | MagVenture TMS Atlas Neuro
Navigation System | Neural Navigator |
| | (Proposed device) | (Predicate device) |
| | [Tonica Elektronik A/S] | [Soterix Medical Inc.] |
| Prescription use | Yes | Yes |
| Neuro navigation
principle | Based on Anatomy (MRI picture) and
calibrated electric field maximum | Based on Anatomy (MRI picture) and
calibrated electric field maximum |
| Imaging modalities | MR based | MR based |
| MR image loading in
DICOM, Nifti, and
Analyze | Yes | Yes |
| Selection of Targets
via Anatomical and
Functional
Landmarks | Yes | Yes |
| DICOM conformance | 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. |
| 2D Viewing | Yes: axial, coronal, sagittal slices through
configurable cut planes in 3D scene | Yes: axial, coronal, sagittal slices through
configurable cut planes in 3D scene |
| 3D Viewing | Yes: 3D viewing of skin, brain surface
and activation maps, using surface
rendering techniques | Yes: 3D viewing of skin, brain surface
and activation maps, using surface
rendering techniques |
| 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. | DICOM import of MR images; load
fMRI/PET images through import wizard.
Full DICOM conformance statement
available. Mapping results exported as
XML text file. |
| 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 sensors; registration integrity test
to determine inaccuracies. |
| Compatible coils | MagVenture C-B60;
MagVenture Cool-B65;
MagVenture Cool-B70;
MagVenture Cool D-B80;
MagVenture MCF-B65;
MagVenture MCF-B70;
MagVenture C-B70 | Neurosoft AFEC-02-100-C Coil;
Neurosoft AFEC-02-100 Coil |
| Attribute | MagVenture TMS Atlas Neuro
Navigation System
(Proposed device)
[Tonica Elektronik A/S] | Neural Navigator
(Predicate device)
[Soterix Medical Inc.] |
| Tracking system
accuracy# | 1.4 mm RMS, 0.5 degrees RMS (accuracy
of localization of tool) | 1.4 mm RMS, 0.5 degrees RMS (accuracy
of localization of tool) |
| System accuracy* | 3mm +/- 2.1 mm (when navigating with
hand-held probe), 5mm +/- 2.1 mm (when
navigating with TMS coil) | 3mm +/- 2.1 mm (when navigating with
hand-held probe), 5mm +/- 2.1 mm (when
navigating with TMS coil) |
| Operation 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 | 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 |
| Electrical rating | 100-240 VAC, 50/60 Hz | 100-240 VAC, 50/60 Hz |
| Dimensions
(Electronics Unit) | 18.5 cm x 29.2 cm x 6.4 cm | 18.5 cm x 29.2 cm x 6.4 cm |
| Power consumption | 50 VA | 50 VA |
| Electrical safety | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-1-6 | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-1-6 |
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Image /page/6/Picture/1 description: The image contains the text "Tonica Elektronik A/S" in blue font. To the right of the text are two puzzle pieces, one red and one blue. The puzzle pieces are interlocked, with the blue piece on top of the red piece. The image appears to be a logo for Tonica Elektronik A/S.
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Tracking system accuracy: accuracy of the BrainTRAK position tracker *System accuracy: accuracy of the complete TMS Atlas system
5.9. Basis for substantial equivalence
Bench performance testing, including system and design verification and validation testing, demonstrated that the performance parameters of the proposed TMS Atlas device are substantially equivalent to those of the predicate device. A summary of the performance testing is provided in the table below.
Overview of performance testing
| Test | Test method summary | Results |
|---|---|---|
| Navigation Principle | ||
| (Based on Anatomy 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 | Tests confirm navigation based on | |
| MRI and navigation based on EF | ||
| maximum. | ||
| The navigation principle of the | ||
| predicate device is also based on | ||
| anatomy and calibrated EF. | ||
| Test | Test method summary | Results |
| conditions. The study compared the targeted | ||
| site with ground-truth. | ||
| Coil Compatibility |
- Validation | System validation test report to evaluate
compatibility of the claimed MagVenture
TMS coils and MagVenture stimulators with
the TMS Atlas system as a complete system. | Testing demonstrates compatibility
of the subject device to each
claimed compatible TMS coil, as a
complete system. It ensures that the
subject device achieves the
positioning accuracy that is
necessary for each TMS coil to
function as per their cleared
Indications and Intended use.
The predicate device is similarly
compatible to the Neurosoft
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 device is the same. |
| System Accuracy* | Monte Carlo simulations of the mapping
algorithm and the ensuing navigation are run
10,000 times using realistic position
measurement noise conditions. | Simulations confirm navigation
accuracy of 4.55 mm with 4
markers. With 6 markers, accuracy
drops to below 3.5 mm
The system accuracy of the
predicate device is the same. |
| | Compatibility testing to evaluate
compatibility of the claimed MagVenture
TMS coils and MagVenture stimulators with
the TMS Atlas system as a complete system. | Testing demonstrates compatibility
of the subject device to each
claimed compatible TMS coil, as a
complete system. It ensures that the
subject device achieves the
positioning accuracy that is
necessary for each TMS coil to
function as per their cleared
Indications and Intended use. The
achieved navigation accuracy of the
system is