TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)

K233985 · Megin OY · OLX · May 15, 2024 · Neurology

Device Facts

• Record ID: K233985
• Device Name: TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)
• Applicant: Megin OY
• Product Code: OLX · Neurology
• Decision Date: May 15, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TRIUX™ neo non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortices in the brain when used in conjunction with evoked response stimulators. MEG is also used to noninvasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning. TRIUX™ neo may be used for patients of all ages as appropriate for magnetoencephalography. MEGreview™ is used for detection and localization of epileptic spontaneous brain activity. In addition, MEGreview™ may be used for localization of eloquent cortex, such as visual, auditory, somatosensory, and motor functions. Results interpreted by a trained clinician in conjunction with other imaging modalities can contribute to presurgical evaluation. MEGreview™ is intended for patients of all ages as appropriate for magnetoencephalography.

Device Story

TRIUX™ neo measures MEG/EEG signals via 306 SQUID detectors in a cryogenic Dewar; system includes patient-support couch/chair and electronics outside magnetically shielded room. MEGflow™ software handles data acquisition/preprocessing; MEGreview™ software performs off-line visualization, signal processing, and source localization. Used in clinical settings by trained physicians/clinicians for presurgical evaluation. Inputs include biomagnetic/electrical brain signals; outputs are localized active brain regions overlaid on anatomical MRI. Device compensates for patient head movement using temporal Signal Space Separation (tSSS) and motion compensation (MC) algorithms. Clinicians interpret output to identify epileptic foci or eloquent cortex, aiding neurosurgical planning and potentially improving patient outcomes by enabling precise surgical targeting.

Clinical Evidence

Clinical investigations included 20 healthy adults and 10 children, plus 5 pediatric epilepsy patients. Studies evaluated evoked responses and interictal epileptiform discharges under stationary and moving head conditions. Results showed tSSS+MC processing yielded localization accuracy equivalent to stationary predicate recordings (mean difference <10mm). Phantom testing confirmed localization accuracy <5mm, comparable to predicate Xfit software.

Technological Characteristics

306 SQUID detectors; cryogenic Dewar with helium recycler; Polhemus FASTRAK digitization; Windows-based software; tSSS and MC algorithms for interference/motion suppression; supports MEG/EEG inputs; patient-centric database; REST-API; IEC 60601-1/60601-1-2 compliant.

Indications for Use

Indicated for patients of all ages requiring magnetoencephalography (MEG) for non-invasive localization of epileptic activity and eloquent cortex (visual, auditory, somatosensory, motor) to assist in neurosurgical planning.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

• Elekta Neuromag with MaxFilter (K091393)

Submission Summary (Full Text)

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May 15, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Megin Oy % Charles Neitzel Principal Consultant ROM+ 2790 Mosside Blvd. Suite 800 Monroeville, Pennsylvania 15146

Re: K233985

Trade/Device Name: TRIUX™ neo; MEGreview™ Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLX, OLY Dated: April 15, 2024 Received: April 15, 2024

Dear Charles Neitzel:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Jay R. Gupta -S

Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic 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

Submission Number (if known)

K233985

Device Name

TRIUX™ neo; MEGreview™

#### Indications for Use (Describe)

The TRIUX™ neo non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain.

MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortices in the brain when used in coniunction with evoked response stimulators. MEG is also used to noninvasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.

TRIUX™ neo may be used for patients of all ages as appropriate for magnetoencephalography.

MEGreview™ is used for detection and localization of epileptic spontaneous brain activity. In addition, MEGreview™ may be used for localization of eloquent cortex, such as visual, auditory, somatosensory, and motor functions. Results interpreted by a trained clinician in conjunction with other imaging modalities can contribute to presurgical evaluation.

MEGreview™ is intended for patients of all ages as appropriate for magnetoencephalography.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

## DATE PREPARED

May 15, 2024

## MANUFACTURER

- Megin Oy Keilasatama 5 02150 Espoo, Finland Telephone: [phone] Laura Vanonen QA&RA Manager
# REPRESENTATIVE/CONSULTANT

Charles Neitzel RQM+ 2790 Mosside Blvd, Suite 800 Monroeville, PA 15146 Telephone: [phone] Email: [e-mail]

## DEVICE INFORMATION

- Device trade name, or proprietary name: TRIUX™ neo and MEGreview™ ●
- Device common name: Magnetoencephalograph ●
- Classification: II ●
- . Classification Name: Electroencephalograph
- Regulation number: 21 CFR 882.1400
- Primary Product Code: OLX ●
- Secondary Product Code: OLY ●
- Panel: Neurology ●

## PREDICATE DEVICE IDENTIFICATION

TRIUX™ neo and MEGreview™ are substantially equivalent to the following predicate:

| 510(k) Number | Predicate Device Name / Manufacturer | Product Codes | Primary Predicate |
|---------------|------------------------------------------------------|---------------|-------------------|
| K091393 | Elekta Neuromag with MaxFilter<br>Elekta Neuromag Oy | OLX, OLY | ✓ |

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## DEVICE DESCRIPTION

#### TRIUX™ neo

TRIUX™ neo NM27000N (TRIUX™ neo below) is a magnetoencephalographic (MEG) device, designed to non-invasively detect and display biomagnetic signals produced by electrically active nerve tissue in the brain. This system enables diagnostic capabilities by providing information about the location of active nerve tissues relative to brain anatomy. It measures both MEG and electroencephalographic (EEG) signals, which are then recorded, displayed, and interpreted by trained clinicians to aid in neurosurgical planning and locating regions of epileptic activity.

TRIUX™ neo employs 306 SQUID (Superconducting Quantum Interference Device) detectors to measure magnetic signals with minimal distortion, allowing for localization of brain activity. The detectors are housed in a cryogenic Dewar vessel, along with an internal helium recycler to maintain optimal operating conditions.

The TRIUX™ neo svstem features a probe unit with a modular structure, a patient-support system with a couch and chair for various positioning needs, and an electronics setup housed outside the magnetically shielded room. The software component, MEGflow™ facilitates data acquisition, preprocessing, and analysis, and includes functionalities for clinical epilepsy workflows, MRI integration, and visualization tools.

# MEGreview™

MEGreview™ is a software for off-line visualization, and localization of brain activity measured with magnetoencephalography (MEG) and, optionally, visualization of brain activity measured with scalp electroencephalography (EEG). MEGreview™ provides workflows for epilepsy focus localization and functional mapping including signal processing, source localization, integration with anatomical MRI and visualization of the results overlayed on anatomical information, as well as reporting and exporting the results.

MEGreview™ is intended to be used with TRIUX™ neo or equivalent MEG devices.

## INDICATIONS FOR USE

#### TRIUX™ neo

The TRIUX™ neo non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain.

MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response stimulators. MEG is also used to non-invasively locate regions of epileptic activity

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within the brain. The localization information provided by MEG may be used. in conjunction with other diagnostic data, in neurosurgical planning.

TRIUX™ neo may be used for patients of all ages as appropriate for magnetoencephalography.

## MEGreview™

MEGreview™ is used for detection and localization of epileptic spontaneous brain activity. In addition, MEGreview™ may be used for localization of eloquent cortex, such as visual, auditory, somatosensory, and motor functions. Results interpreted by a trained clinician in conjunction with other imaging modalities can contribute to presurgical evaluation.

MEGreview™ is intended for patients of all ages as appropriate for magnetoencephalography.

## COMPARISON OF INDICATIONS FOR USE

TRIUX™ neo has identical Indications for use as the primary predicate Elekta Neuromag® with MaxFilter 2.1.

MEGreview™ has similar Indications for use as the primary predicate Elekta Neuromag® with MaxFilter 2.1. The predicate device is the whole MEG system including hardware and software for both data acquisition and analysis, and MEGreview™ is the analysis software only. While worded differently, the Indications for use for MEGreview™ is the same as for the analysis software part of the predicate device; source localization of active brain areas (epileptic spontaneous activity or eloquent cortex).

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices utilize the same principle of operation, which is to measure MEG signals which are interpreted by a trained clinician in conjunction with other imaging data to contribute to presurgical evaluation. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response averaging devices.

| Attribute | Subject device TRIUX™ neo | Predicate device K091393<br>Elekta Neuromag® with<br>MaxFilter 2.1 |
|----------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------|
| Operating system (user) | Windows | Unix |
| Digitization hardware | Polhemus FASTRAK and upgraded digitization chair | Polhemus FASTRAK and digitization chair |
| Patient Position | Supine, reclined and upright | Supine and reclined |
| Synchronized video recording during the scan | Yes | No |

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| GUI | Workflow-driven for entire<br>acquisition process (e.g., patient<br>creation, digitization, acquisition,<br>saving data, etc.) | No workflow |
|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Support for<br>interference<br>suppression | Yes, SSS-technology for<br>suppression of environment and<br>near-by interference (tSSS) and<br>motion disturbances | Yes, SSS-technology for<br>suppression of environment and<br>near-by interference (tSSS) |
| Data<br>compensation if<br>patient moves | Yes, SSS-based head movement<br>compensation | No movement compensation |
| Data storage | Patient-centric database that allows<br>the user to store and access<br>MEG/EEG scans, together with<br>relevant metadata. This includes<br>raw and preprocessed scans, video<br>MEG, anatomical scans (MRI) and<br>corresponding analysis results. | File-based |
| API | MEGflowTM scan acquisition<br>system and data management server<br>has been developed to support<br>"plug-in" mapping applications and<br>REST-API interface layer for data<br>acquisition, scan control, database<br>access, and user authentication. | No API |
| Auxiliary<br>Channels | - 12 auxiliary analog inputs<br>- 12 bipolar analog input channels<br>for physiological signals | - 8 auxiliary analog inputs<br>- 4 bipolar analog input channels<br>for physiological signals |
| Attribute | Subject device MEGreviewTM | Predicate device K091393<br>Elekta Neuromag® with<br>MaxFilter 2.1 |
| Operating system | Windows | Unix |
| Data access | Patient-centric | File-based |
| GUI | Workflow-driven | Several separate tools, no<br>workflow |
| Availability of<br>patient video | Synchronized video with data | No video available |
| Method of<br>Calculation /<br>Forward head<br>model (i.e.,<br>idealized v.<br>individual head<br>model) | Spherical conductor model for<br>idealized head shapes. | Spherical conductor model for<br>idealized head shapes. Boundary<br>element method (BEM) for<br>individual head shapes. |
| Source Estimate<br>Methods / Inverse<br>head model | Equivalent Current Dipole (ECD)<br>for clinical analysis. Single-dipole<br>time varying source estimates. | Equivalent Current Dipole (ECD)<br>for clinical analysis. Single- and<br>multi-dipole time varying source<br>estimates. |

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## SUMMARY OF TESTING

The following tests were performed to demonstrate safety based on current industry standards:

TRIUX™ neo

- General requirements for basic safety and essential performance of medical ● electrical equipment per IEC 60601-1
- Electromagnetic compatibility requirements and tests per IEC 60601-1-2 ●
- . Software verification per IEC 62304 requirements - including the verification of MaxFilter
- . Verification and Validation of the system and subsystem requirements

MEGreview™M

- Software verification per IEC 62304 ●
- Acceptance testing and system verification .
- Verification of MEGreview™ Localization Accuracy (see below)

#### Phantom testing

Phantom test data were utilized in validation studies of the head movement compensation (MC) function. Signals generated by eight artificial dipole sources (one by one) in a spherical phantom were recorded with continuous rotations around the Z-axis, or temporary movements by doing a rotation and translation repeated twice during a recording. The data were processed twice, first with the temporal Signal Space Separation (tSSS) method for interference suppression, and second time with combined tSSS and MC. A single equivalent current dipole (ECD) source in a spherical head model was applied for the source localization and the results were compared to exactly known dipole positions and amplitudes. The effect of the movement was clearly demonstrated in the dipole localizations without MC, resulting in large errors of dipole locations and amplitudes. The combined tSSS+MC restored the dipole localization accuracies to a similar level as from the corresponding phantom dipole sources when the phantom was not moved.

## Clinical Investigations

A clinical investigation was performed with MaxFilter™ software in processing brain signals in evoked response studies. Twenty healthy adult (age 23 - 38, mean 30 years) and ten child (age 3 - 12, mean 7 years) volunteers were studied with two magnetoencephalographic (MEG) systems. Four recordings were done with both systems and the subjects were asked to: keep a stationary head position, change the head position twice during the recording, move the head continuously, and move the head and mouth when two magnetized pieces were attached to the scalp. During the MEG recordings the subjects received interleaved auditory and somatosensory stimuli. The source localization results were compared to the localization obtained from recordings with stationary head position without MC as obtained using the predicate localization software. In all trials with somatosensory responses and in temporary movements with auditory responses, the combined tSSS+MC yielded similar results to the predicate, as indicated by mean difference

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in localization of the resulting dipoles of less than 10 mm. However, continuous head movements caused distortions of auditory evoked signals due to strong background activation of the motor cortex and muscles moving the head. Still, the somatosensory responses in these trials were much less affected than the auditory responses. The results show that evoked responses obtained after processing data with MaxFilter™ can be regarded as equivalent with those obtained with the predicate device, based on the acceptance criteria listed above. Another clinical investigation was carried out by analyzing MEG recordings from five pediatric epilepsy patients (age between 8 months and 15 years). Effects of movement were examined by studying MEG data exhibiting focal or multifocal interictal epileptiform discharges (IEDs). The results show that compensation of temporary head movements can provide localization of the irritative zone equivalent to that obtained when patients exhibit little-to-no motion. The findings demonstrate that the application of MC to pediatric MEG recordings containing variable degrees of spontaneous, temporary head movements (less than 25 mm head movement) can provide localization of the irritative zone equivalent to that obtained when patients exhibit little-to-no motion (less than 5 mm head movement).

## Verification of MEGreview™ localization accuracy

Measured phantom data and simulated epileptiform MEG signals were utilized for the verification of accuracy in MEGreview™M localization of equivalent current dipoles (ECD). All dipole localizations were compared to the results from Xfit software in the predicate device. The overall localization errors were very similar between MEGreview™ and Xfit. Both programs could localize phantom dipoles with less than 5 mm errors and with similar dipole amplitudes and statistical parameter values. Simulated epileptiform signals were superposed with resting state brain activity, and the localization accuracy was found to be equivalent between MEGreview™ and Xfit. The results demonstrate that the ECD localization accuracy of MEGreview™ is on a level which is clinically valuable.

#### Summarv

All software verification testing and bench testing have demonstrated that the subject device fulfills the essential performance, and the spatial accuracy is equal or better than ±5 mm with known source locations in phantom measurement.

Clinical investigations have demonstrated that the subject device enables successful localization of evoked responses and epileptiform events in presence of temporary head movements without compromising the dipole quality statistics or signal-to-noise ratio, and the localization of events is equivalent to the localization with predicate device.

Together, these clinical studies and technical evaluations suggest that in the case of limited head movement during a patient measurement compensation functionality, particularly when combined with spatiotemporal signal space separation, preserves the signal quality for data analysis and reduces the localization error.

The results of these tests indicate that TRIUX™ neo NM27000N and MEGreview™ are substantially equivalent to the predicate device K091393.

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# CONCLUSION

Based on the testing performed, including software testing and non-clinical performance bench testing, it can be concluded that TRIUX™ neo NM27000N and MEGreview™ are substantially equivalent to the predicate device. TRIUX™ neo NM27000N and MEGreview™ together have the same intended use and similar technological characteristics as the predicate device.