RICOH MEG

K210199 · Ricoh Company, Ltd. · OLX · Jul 2, 2021 · Neurology

Device Facts

• Record ID: K210199
• Device Name: RICOH MEG
• Applicant: Ricoh Company, Ltd.
• Product Code: OLX · Neurology
• Decision Date: Jul 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The RICOH MEG non-invasively measures the magnetoencephalographic (MEG) 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, and somatosensory activity in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epilentic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning.

Device Story

RICOH MEG is a magnetoencephalography system measuring biomagnetic signals from brain nerve tissue; utilizes 64-320 dc SQUID detectors; liquid helium cooled. System records signals via computerized acquisition; displays MEG/EEG data, topographic maps, and registered MRI images. Operated by trained physicians in clinical settings. Device includes analysis software for source localization using Equivalent Current Dipole (ECD) methods. Clinicians interpret localized active areas correlated with anatomical MRI data to assist in neurosurgical planning. Benefits include non-invasive identification of functional brain regions and epileptic foci, aiding surgical decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Validation included software verification per IEC62304 and black-box testing of the Matching Module and Analysis System, confirming design specifications and usability requirements were met with zero failures.

Technological Characteristics

System uses 64-320 dc SQUID detectors with axial first-order gradiometers; 10fT/√Hz sensitivity; liquid helium cooling. Features include 16 ADC channels and up to 128 EEG channels. Connectivity via Ethernet. Software runs on Windows-based PC. Co-registration uses HPI coils and 3D digitizer. Source estimation via Equivalent Current Dipole (ECD).

Indications for Use

Indicated for adult patients requiring non-invasive localization of electrically active brain tissue (visual, auditory, somatosensory, or epileptic activity) to aid 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

• MEGvision, EQ1000C Series (K040051)
• Elekta Neuromag (K041264)

Submission Summary (Full Text)

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July 2, 2021

## RICOH COMPANY, Ltd.

Satoshi Yuuki Specialist 2-3, Hokuyodai Kanazawa-shi, Ishikawa 920-0177 Japan

## Re: K210199

Trade/Device Name: RICOH MEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLX, OLY Dated: May 17, 2021 Received: May 26, 2021

## Dear Satoshi Yuuki:

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 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).

Sincerely,

for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K210199

Device Name RICOH MEG

### Indications for Use (Describe)

The RICOH MEG non-invasively measures the magnetoencephalographic (MEG) 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, and somatosensory activity in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epilentic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning.

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

| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|----------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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This 510(k) summary is prepared in accordance with 21 CFR 807.92.

#### I. Submitter Information

| Name: | RICOH COMPANY, Ltd. |
|-----------------|-------------------------------------------------------|
| Address: | 2-3, Hokuyodai, Kanazawa-shi, Ishikawa 920-0177 Japan |
| Phone: | [phone] |
| Facsimile: | [phone] |
| Contact Person: | Satoshi Yuuki |
| E-Mail: | [e-mail] |
| Date: | Jan 12 2021 |

#### II. Device

| Trade Name: | RICOH MEG |
|-------------------------|-----------------------------|
| Common Name: | Magnetoencephalograph (MEG) |
| Classification Name(s): | Electroencephalograph |
| Regulation numbers: | 21 CFR 882.1400 |
| Primary product code: | OLX |
| Secondary product code: | OLY |
| Device class: | II |

#### III. Predicate Device(s)

| Device Name | 510(k) No. | Manufacturer |
|------------------------------|------------|------------------------|
| MEGvision,<br>EQ1000C Series | K040051 | Eagle Technology, Inc. |
| Elekta Neuromag | K041264 | Elekta Neuromag Oy |

#### Device Description IV.

The RICOH MEG Analysis is an analysis software package used for processing and analyzing MEG data. It displays digitized MEG signals, EEG signals, topographic maps, and registered MRI images. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic MEGvision Software of Eagle Technology, Inc. (K040051).

The RICOH MEG Analysis is designed to aid clinicians in the assessment of patient anatomy, physiology, electrophysiology and pathology and to visualize source localization of MEG signals.

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#### v. Indications For Use

The RICOH MEG non-invasively measures the magnetoencephalographic (MEG) 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, and somatosensory activity in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning.

#### VI. Comparison of Technological Characteristics with the Predicate Devices

At a high level, the following technological differences exist between the subject and predicate devices:

- Use of a third party digitizer to provide additional method of co-registering MRI and MEG data;
- Number of auxiliary channels for other types of data (i.e., addition of cables and ● interface allowing subject device to receive and send digital EEG signals);
- . Removal of evoked mode recording with post averaging:
- . Updated display to show EEG time series at corresponding latency (if EEG data simultaneously acquired);
- . Addition of DICOM data output with information regarding magnetic field anlaysis

| Feature | RICOH COMPANY, LTD.<br>RICOH MEG | EAGLE TECHNOLOGY, INC.<br>MEGvision EQ1000C Series<br>(K040051) | SE Device<br>Elekta Neuromag Oy<br>Elekta Neuromag<br>(K041264) |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | The RICOH MEG is intended<br>for use as a<br>magnetoencephalographic<br>(MEG) device which non-<br>invasively detects and displays<br>biomagnetic signals produced<br>by electrically active nerve<br>tissue in the brain. When<br>interpreted by a trained<br>clinician, the data enhances the<br>diagnostic capability by<br>providing useful information<br>about the location relative to<br>brain anatomy of active nerve<br>tissue responsible for critical<br>brain functions. | The MEGvision non-<br>invasively measures the<br>magnetoencephalographic<br>(MEG) signals produced by the<br>electrical activities by the tissue<br>activities of the brain. These<br>signals, position, direction, and<br>sensitivity of the sensors are<br>acquired and displayed, and<br>may be interpreted by trained<br>clinicians to help localize these<br>active areas. The locations may<br>be correlated to anatomical<br>structure of the brain. | The Elekta Neuromag TM is<br>intended for use as a<br>magnetoencephalographic<br>(MEG) device which non-<br>invasively detects and<br>displays biomagnetic signals<br>produced by electrically<br>active nerve tissue in the<br>brain. When interpreted by a<br>trained clinician, the data<br>enhances the diagnostic<br>capability by providing useful<br>information about the location<br>relative to brain anatomy of<br>active nerve tissue<br>responsible for critical brain<br>functions. |

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| Feature | RICOH COMPANY, LTD.<br>RICOH MEG | EAGLE TECHNOLOGY, INC.<br>MEGvision EQ1000C Series<br>(K040051) | SE Device<br>Elekta Neuromag Oy<br>Elekta Neuromag<br>(K041264) |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for use | The RICOH MEG non-<br>invasively measures the<br>magnetoencephalographic<br>(MEG) produced by electrically<br>active tissue of the brain. These<br>signals are recorded by a<br>computerized data acquisition<br>system, displayed, and may<br>then be interpreted by trained<br>physicians to help localize these<br>active areas. The locations may<br>then be correlated with<br>anatomical information of the<br>brain. MEG is routinely used to<br>identify the locations of visual,<br>auditory, and somatosensory<br>activity in the brain when used<br>in conjunction with evoked<br>response averaging devices.<br>MEG is also used to non-<br>invasively locate regions of<br>epileptic activity within the<br>brain. The localization<br>information provided by the<br>device may be used, in<br>conjunction with other<br>diagnostic data, as an aid in<br>neurosurgical planning. | The MEGvision is intended for<br>use as a<br>magnetoencephalographic<br>(MEG) device which non-<br>invasively detects and displays<br>biomagnetic signals produced<br>by electrically active nerve<br>tissue in the brain. When<br>interpreted by a trained<br>technician, the data enhances<br>the diagnostic capability by<br>providing useful information<br>about the location relative to<br>brain anatomy of active nerve<br>tissue responsible for critical<br>brain functions. | The Elekta NeuromagTM non-<br>invasively measures the<br>magnetoencephalographic<br>(MEG) signals (and,<br>optionally,<br>electroencephalographic<br>(EEG) signals) produced by<br>electrically active tissue of the<br>brain. These signals are<br>recorded by a computerized<br>data acquisition system,<br>displayed, and may then be<br>interpreted by trained<br>physicians to help localize<br>these active areas. The<br>locations may then be<br>correlated with anatomical<br>information of the brain.<br>MEG is routinely used to<br>identify the locations of<br>visual, auditory,<br>somatosensory, and motor<br>cortex in the brain when used<br>in conjunction with evoked<br>response averaging devices.<br>MEG is also used to non-<br>invasively locate regions of<br>epileptic activity within the<br>brain. The localization<br>information provided by<br>MEG may be used, in<br>conjunction with other<br>diagnostic data, in<br>neurosurgical planning. |
| Feature | RICOH COMPANY, LTD.<br>RICOH MEG | EAGLE TECHNOLOGY, INC.<br>MEGvision EQ1000C Series<br>(K040051) | SE Device<br>Elekta Neuromag Oy<br>Elekta Neuromag<br>(K041264) |
| Number of<br>SQUID<br>detectors/<br>channels for<br>MEG data | 64 to 320 | 64 to 320 | 306 |
| Operating<br>Principle | dc SQUID | dc SQUID | dc SQUID |
| Number of<br>auxiliary<br>channels for<br>other types<br>of data | -16 ADC channels<br>-Up to 128 EEG channels (EEG<br>system is independent of the<br>MEG system). | Up to 166 ADC channels | Up to 124 unipolar and 4<br>bipolar EEG channels.<br>Up to 8 ADC channels. |
| Pickup Coil<br>Design | 1 axial first order gradiometer<br>per location | 1 axial first order gradiometer<br>per location | Mix of planar gradiometers<br>and magnetometers |
| Intersensor<br>spacing | 20mm to 25mm<br>(160 sensor configuration) | 20mm to 25mm<br>(160 sensor configuration) | 34 mm average distance<br>between centers of each<br>sensing location. |
| Gradiometer<br>placement | 64 to 320 | 64 to 320 | 102 |
| Cryogen<br>used: | Liquid helium | Liquid helium | Liquid helium |
| Coverage | Whole cortex | Whole cortex | Whole cortex |
| Gantry | Floor mounted fixed gantry | Floor mounted fixed gantry | Floor mounted, standard<br>gantry. The gantry has two<br>fixed, predefined, tilt angles<br>corresponding to supine and<br>upright measurement<br>positions. |
| Patient<br>Position | Supine | Supine | Supine and upright |
| Head<br>Position<br>Indicator<br>(HPI) | Included | Included | Included |
| Computer | Personal computer with<br>Windows OS | Personal computer with<br>Windows OS | HP workstation with UNIX<br>OS |
| Networking<br>Capabilities | Ethernet connections to other<br>network system available | Ethernet connections to other<br>network system available | Ethernet connections to other<br>network system available |
| Magneticall<br>y Shielded<br>Room<br>Accessories | Interior DC lights, video camera<br>and two-way intercom for<br>patients | Interior DC lights, video camera<br>and two-way intercom for<br>patients | Interior DC lights, video<br>camera and two-way intercom<br>for patients |
| Coregistrati<br>on of MEG<br>data to MRI<br>data | A method based on the method<br>of picking up the position of the<br>HPI coils from the MRI images.<br>A method based on the method<br>using the position of the HPI<br>coils and the anatomical<br>landmarks on the head, which<br>measured by a 3D digitizer. | A method based on the method<br>of picking up the position of the<br>HPI coils from the MRI images. | A method based on the<br>method using the position of<br>the HPI coils and the<br>anatomical landmarks on the<br>head, which measured by a<br>3D digitizer. |
| Site of<br>patient | Head and Scalp | Head and Scalp | Head and Scalp |
| Overall<br>Sensitivity | 10fT/ $\sqrt{\text{Hz}}$ | 10fT/ $\sqrt{\text{Hz}}$ | 10fT/ $\sqrt{\text{Hz}}$ |
| Feature | RICOH COMPANY, LTD.<br>RICOH MEG | EAGLE TECHNOLOGY, INC.<br>MEGvision EQ1000C Series<br>(K040051) | SE Device<br>Elekta Neuromag Oy<br>Elekta Neuromag<br>(K041264) |
| SQUID<br>Readout | Flux locked loop | Flux locked loop | Flux locked loop |
| Offline<br>Average<br>Function to<br>Process<br>Raw Data | Yes | Yes | Yes |
| Method of<br>Calculation<br>/ Forward<br>head model<br>(i.e<br>idealized v.<br>individual<br>head model) | Spherical conductor model for<br>idealized head shapes. | Spherical conductor model for<br>idealized head shapes. | Spherical conductor model<br>for idealized head shapes.<br>Individual realistic head<br>models using the Boundary<br>Element Method (BEM). |
| Source<br>Estimate<br>Methods /<br>Inverse<br>head model | Equivalent Current Dipole<br>(ECD) for clinical analysis.<br>Single- and multi-dipole time<br>varying source estimates. | Equivalent Current Dipole<br>(ECD) for clinical analysis.<br>Single- and multi-dipole time<br>varying source estimates. | Equivalent Current Dipole<br>(ECD) for clinical analysis.<br>Single- and multi-dipole time<br>varying source estimates. |
| Patient<br>Population | Adult | Adult | Adult…