(158 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or functionalities that rely on AI or ML algorithms for data processing, analysis, or interpretation. The description focuses on standard signal processing, visualization, and co-registration techniques.
No.
The device is used for non-invasive measurement, display, and interpretation of brain signals to aid in diagnosis and neurosurgical planning, not for treatment.
Yes
The device is described as aiding physicians in localizing active areas in the brain, including epileptic activity, and providing information that can be used in conjunction with "other diagnostic data" for neurosurgical planning. It helps clinicians "assess patient anatomy, physiology, electrophysiology and pathology," all of which are diagnostic functions.
No
The device is described as an "analysis software package" that processes data from a separate MEG device (K040051). While the submission focuses on the software, the device's function is dependent on hardware (the MEG system) to acquire the initial signals. The software is an accessory to a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic purposes.
- Device Function: The RICOH MEG device and its associated software measure and analyze in vivo signals (magnetoencephalographic signals from the brain). It does not analyze specimens taken from the body.
- Intended Use: The intended use describes measuring brain activity and aiding in localization and neurosurgical planning. This is a diagnostic process performed directly on the patient, not on a sample in a lab.
Therefore, the RICOH MEG device falls under the category of a medical device that performs a diagnostic function, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OLX, OLY
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MEG signals, EEG signals, MRI images
Anatomical Site
Brain, Head and Scalp
Indicated Patient Age Range
Adult
Intended User / Care Setting
Trained physicians/clinicians
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)
- Software verification and validation: in accordance with IEC62304.
- Bench testing:
- [1]Matching Module design test: Verify that the Matching Module meets the design specifications by a black box test. Tested using MEG system, verifying image correction and alignment techniques of co-registration to MRI/3D digitizer data. Results: Satisfied the pass / fail criteria. Pass. Planned test cases: 39, Tested cases: 39, Failures occurred: 0, Failures corrected: 0.
- [2] Analysis System design test: Verify that the Analysis System meets the design specifications by a black box test. Tested using MEG system, verifying that updated functions do not affect continued performance. Results: Satisfied the pass / fail criteria. Pass. Planned test cases: 20, Tested cases: 20, Failures occurred: 0, Failures corrected: 0.
- [3] Analysis System Validation: Performed validation by a person who can substitute the intended user, without prior training. Validated product validity, usability validity, and software validity based on Intended Use. Results: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall Sensitivity: 10fT/√Hz
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1400 Electroencephalograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" in a square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in two lines.
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
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 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,
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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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: | +81-76-258-7012 |
| Facsimile: | +81-76-258-7026 |
| Contact Person: | Satoshi Yuuki |
| E-Mail: | satoshi.yuuki@jp.ricoh.com |
| 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, | ||
| 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.
4
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.
RICOH MEG | EAGLE TECHNOLOGY, INC.
MEGvision EQ1000C Series
(K040051) | SE Device
Elekta Neuromag Oy
Elekta Neuromag
(K041264) |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The RICOH MEG is intended
for use as a
magnetoencephalographic
(MEG) device which non-
invasively detects and displays
biomagnetic signals produced
by electrically active nerve
tissue in the brain. When
interpreted by a trained
clinician, the data enhances the
diagnostic capability by
providing useful information
about the location relative to
brain anatomy of active nerve
tissue responsible for critical
brain functions. | The MEGvision non-
invasively measures the
magnetoencephalographic
(MEG) signals produced by the
electrical activities by the tissue
activities of the brain. These
signals, position, direction, and
sensitivity of the sensors are
acquired and displayed, and
may be interpreted by trained
clinicians to help localize these
active areas. The locations may
be correlated to anatomical
structure of the brain. | The Elekta Neuromag TM is
intended for use as a
magnetoencephalographic
(MEG) device which non-
invasively detects and
displays biomagnetic signals
produced by electrically
active nerve tissue in the
brain. When interpreted by a
trained clinician, the data
enhances the diagnostic
capability by providing useful
information about the location
relative to brain anatomy of
active nerve tissue
responsible for critical brain
functions. |
5
| Feature | RICOH COMPANY, LTD.
RICOH MEG | EAGLE TECHNOLOGY, INC.
MEGvision EQ1000C Series
(K040051) | SE Device
Elekta Neuromag Oy
Elekta Neuromag
(K041264) |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for 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
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. | The MEGvision is intended for
use as a
magnetoencephalographic
(MEG) device which non-
invasively detects and displays
biomagnetic signals produced
by electrically active nerve
tissue in the brain. When
interpreted by a trained
technician, the data enhances
the diagnostic capability by
providing useful information
about the location relative to
brain anatomy of active nerve
tissue responsible for critical
brain functions. | The Elekta NeuromagTM 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 averaging devices.
MEG is also used to non-
invasively 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. |
| Feature | RICOH COMPANY, LTD.
RICOH MEG | EAGLE TECHNOLOGY, INC.
MEGvision EQ1000C Series
(K040051) | SE Device
Elekta Neuromag Oy
Elekta Neuromag
(K041264) |
| Number of
SQUID
detectors/
channels for
MEG data | 64 to 320 | 64 to 320 | 306 |
| Operating
Principle | dc SQUID | dc SQUID | dc SQUID |
| Number of
auxiliary
channels for
other types
of data | -16 ADC channels
-Up to 128 EEG channels (EEG
system is independent of the
MEG system). | Up to 166 ADC channels | Up to 124 unipolar and 4
bipolar EEG channels.
Up to 8 ADC channels. |
| Pickup Coil
Design | 1 axial first order gradiometer
per location | 1 axial first order gradiometer
per location | Mix of planar gradiometers
and magnetometers |
| Intersensor
spacing | 20mm to 25mm
(160 sensor configuration) | 20mm to 25mm
(160 sensor configuration) | 34 mm average distance
between centers of each
sensing location. |
| Gradiometer
placement | 64 to 320 | 64 to 320 | 102 |
| Cryogen
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
gantry. The gantry has two
fixed, predefined, tilt angles
corresponding to supine and
upright measurement
positions. |
| Patient
Position | Supine | Supine | Supine and upright |
| Head
Position
Indicator
(HPI) | Included | Included | Included |
| Computer | Personal computer with
Windows OS | Personal computer with
Windows OS | HP workstation with UNIX
OS |
| Networking
Capabilities | Ethernet connections to other
network system available | Ethernet connections to other
network system available | Ethernet connections to other
network system available |
| Magneticall
y Shielded
Room
Accessories | Interior DC lights, video camera
and two-way intercom for
patients | Interior DC lights, video camera
and two-way intercom for
patients | Interior DC lights, video
camera and two-way intercom
for patients |
| Coregistrati
on of MEG
data to MRI
data | A method based on the method
of picking up the position of the
HPI coils from the MRI images.
A method based on the method
using the position of the HPI
coils and the anatomical
landmarks on the head, which
measured by a 3D digitizer. | A method based on the method
of picking up the position of the
HPI coils from the MRI images. | A method based on the
method using the position of
the HPI coils and the
anatomical landmarks on the
head, which measured by a
3D digitizer. |
| Site of
patient | Head and Scalp | Head and Scalp | Head and Scalp |
| Overall
Sensitivity | 10fT/ $\sqrt{\text{Hz}}$ | 10fT/ $\sqrt{\text{Hz}}$ | 10fT/ $\sqrt{\text{Hz}}$ |
| Feature | RICOH COMPANY, LTD.
RICOH MEG | EAGLE TECHNOLOGY, INC.
MEGvision EQ1000C Series
(K040051) | SE Device
Elekta Neuromag Oy
Elekta Neuromag
(K041264) |
| SQUID
Readout | Flux locked loop | Flux locked loop | Flux locked loop |
| Offline
Average
Function to
Process
Raw Data | Yes | Yes | Yes |
| Method of
Calculation
/ Forward
head model
(i.e
idealized v.
individual
head model) | Spherical conductor model for
idealized head shapes. | Spherical conductor model for
idealized head shapes. | Spherical conductor model
for idealized head shapes.
Individual realistic head
models using the Boundary
Element Method (BEM). |
| Source
Estimate
Methods /
Inverse
head model | Equivalent Current Dipole
(ECD) for clinical analysis.
Single- and multi-dipole time
varying source estimates. | Equivalent Current Dipole
(ECD) for clinical analysis.
Single- and multi-dipole time
varying source estimates. | Equivalent Current Dipole
(ECD) for clinical analysis.
Single- and multi-dipole time
varying source estimates. |
| Patient
Population | Adult | Adult | Adult |
| Power
Source | Mains power | Mains power | same |
| Data
Acquisition | Inbuilt | Inbuilt | Inbuilt |
6
7
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
- Software verification and validation in accordance with IEC62304; •
- . Bench testing (see below)
8
| Bench test | Purpose of Testing | Remark | Summary of results |
|---|---|---|---|
| [1]Matching | |||
| Module | |||
| design test | Verify that the Matching | ||
| Module meets the design | |||
| specifications by a black box | |||
| test. | Test using MEG system | ||
| Verify that the Matching | |||
| Module meets module | |||
| design specifications | |||
| regarding | |||
| e image correction and | |||
| alignment techniques of co- | |||
| registration to MRI/3D | |||
| digitizer data. | Satisfied the pass / fail | ||
| criteria. Pass. | |||
| Planned test | |||
| cases :39 Tested | |||
| cases :39 | |||
| Failures occurred :0 | |||
| Failures corrected :0 | |||
| [2] Analysis | |||
| System | |||
| design test | Verify that the Analysis System | ||
| meets the design specifications | |||
| by a black box test. | Test using MEG system | ||
| Verify that the updated | |||
| function does not affect the | |||
| continued performance of the | |||
| rest of our device. | Satisfied the pass / fail | ||
| criteria. Pass. | |||
| Planned test | |||
| cases :20 Tested | |||
| cases :20 | |||
| Failures occurred :0 | |||
| Failures corrected :0 | |||
| [3] Analysis | |||
| System | |||
| Validation | Perform the validation by a | ||
| person who can substitute the | |||
| intended user. | |||
| Substitutes: Person in charge | |||
| of validation. *A person who | |||
| can operate the product without | |||
| training. A person who has the | |||
| knowledge to be able to instruct | |||
| the user on the operation of the | |||
| product. | |||
| Provision of training: no | |||
| training is required prior to the | |||
| evaluation and therefore will | |||
| not be conducted. | |||
| Method of collection of | |||
| validation records: the person | |||
| in charge of validation validates | |||
| and records according to the | |||
| implementation. | Test using MEG system | ||
| Validate product validity, | |||
| usability validity, and | |||
| software validity based on the | |||
| Intended Use. | Pass/Fail | ||
| Description: Pass |
VIII. Conclusions
Given the modifications made to the device, bench testing was performed to support substantial equivalence. The non-clinical data provided demonstrate that the device should perform as intended in the specified use conditions, and that the device performs comparably to the predicate devices that are currently marketed for the same intended use. In addition, potential hazards have been addressed by the Risk Management process to ensure risk mitigation during use of the device.