(432 days)
Not Found
No
The description mentions "algorithms for spatial filtering and artifact rejection" and "software verification," but there is no mention of AI, ML, or related concepts like neural networks, deep learning, or training/test sets. The analysis appears to be based on traditional signal processing and software algorithms.
No.
The device is used to generate photic stimulations and register responses for diagnostic purposes, not to provide therapy.
Yes
The device "generates photic stimulations and registers the responses including electrical responses generated by the retina and the visual nervous system in addition to psychophysical and pupillary responses." It displays various medical measurements like "electroretinogram (ERG), visual evoked potential (VEP), sensory electro-oculogram (EOG), light and dark adapted perimetry thresholds, dark adaptometry, full field stimulus threshold (FST), photo aversion thresholds (PAT), pupillometry." These functions are "controlled and interpreted by trained medical professionals," indicating its use in assessing a patient's medical condition.
No
The device description explicitly mentions hardware components such as a hemispherical cupola, recording channels for EEG electrodes, a press button for psychophysical responses, and an eye tracker for pupillometry. It also mentions testing against hardware standards like IEC 60601-1 and IEC 60601-1-2, and includes technical tests for internal hardware and firmware.
Based on the provided information, the Vision Monitor MonCvONE system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Vision Monitor MonCvONE system is a non-invasive device that directly interacts with the patient's visual system (retina and visual nervous system) to measure responses to stimuli. It does not analyze biological samples like blood, urine, or tissue.
- The intended use describes direct measurement of physiological responses. The system generates stimuli and registers electrical, psychophysical, and pupillary responses directly from the patient. This is a form of physiological measurement, not in vitro analysis.
- The device description confirms direct interaction with the patient. It mentions presenting stimuli to the patient and recording data using electrodes and an eye tracker, all of which are applied externally to the patient.
Therefore, the Vision Monitor MonCvONE system falls under the category of a non-invasive medical device used for physiological measurement and diagnosis related to the visual system, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vision Monitor MonCvONE system is a non-invasive medical device used to generate photic stimulations and to register the electrical responses generated by the retina and the visual nervous system in addition to psychophysical and pupillary responses. It displays digitized electroretinogram (ERG), visual evoked potential (VEP), sensory electrooculogram (EOG), power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals.
Product codes (comma separated list FDA assigned to the subject device)
GWE, HLT
Device Description
Photopic stimuli are presented to the patient on a hemispherical cupola. Various modes are available for preferential stimulation of different visual functions. Electrophysiological data is recorded by up to 5 recording channels using conventional EEG electrodes (not provided with the device). Psychophysical responses are recorded with a press button and pupillometry responses recorded with an eye tracker.
During the period of time that the system is acquiring data (1-20 minutes), there is a real time display of the raw and processed data presented to the operator. Once the resulting individual responses are acquired, the signals are analyzed by software using algorithms for spatial filtering and artifact rejection. Data may be presented in a number of forms, including waves recorded at each of the points tested, color plots, or 3D topographical representation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
retina, visual nervous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals / Hospitals, clinics and physician offices
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)
The non-clinical testing completed for the VISION MONITOR MonCvONE included these three major categories of testing:
Technical tests which include: internal hardware, firmware and Softwares component tests. packaging and labelling tests. Softwares verification have been tested against their specifications and according to IEC 62304: 2015
012 Vision electrophysiology software test report
013 Sensory EOG software test report
Functional tests:
014_Flash and pattern ERG and VEP functional tests.pdf
015 Sensory EOG functional tests.pdf
Compatibility tests with PC and accessories used: 016 PC compatibility 017 Accessories compatibility
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 882.1890 Evoked response photic stimulator.
(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).
0
November 21, 2022
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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
Metrovision Jacques Charlier CEO 4 rue des Platanes Perenchies, Hauts de France 59840 France
Re: K212936
Trade/Device Name: Vision Monitor- MonCvONE Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked Response Photic Stimulator Regulatory Class: Class II Product Code: GWE, HLT Dated: October 12, 2022 Received: October 17, 2022
Dear Jacques Charlier:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Elvin Y. I
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K212936
Device Name Vision Monitor - MonCvONE
Indications for Use (Describe)
The Vision Monitor MonCvONE system is a non-invasive medical device used to generate photic stimulations and to register the electrical responses generated by the retina and the visual nervous system in addition to psychophysical and pupillary responses. It displays digitized electroretinogram (ERG), visual evoked potential (VEP), sensory electrooculogram (EOG), power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals.
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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510(k) SUMMARY for the Vision Monitor MonCvONE Prepared October 12th 2022
- Company name: METROVISION 4 rue des Platanes 59840 PERENCHIES France Telephone: + 33 3 20 17 19 50
- Contact Person: Jacques CHARLIER, CEO Email: charlier@metrovision.fr
Name of the device: VISION MONITOR MonCvONE
Classification name: 21 CFR 882.1890, Evoked response photic stimulator
Regulatory class: Class II
Product Code: GWE Secondary product code: HLT Other functions (510(k) exempt): HPT, HLG, OUM
A. Legally Marketed Predicate Device
The Vision Monitor MonCvONE system is substantially equivalent to RETI-Port/SCAN systems manufactured by ROLAND CONSULT 510(k) number K023525.
They are all hardware and software products. The Vision Monitor MonCvONE system is substantially equivalent to the predicate device with regard to device features and specifications as well as intended use. All devices are visual evoked response test systems with similar operating requirements that are based on standard clinical procedures. Devices consist of hardware and software to provide photic stimulations and analysis of the evoked response data collected.
B. Device description
Photopic stimuli are presented to the patient on a hemispherical cupola. Various modes are available for preferential stimulation of different visual functions. Electrophysiological data is recorded by up to 5 recording channels using conventional EEG electrodes (not provided with the device). Psychophysical responses are recorded with a press button and pupillometry responses recorded with an eye tracker.
During the period of time that the system is acquiring data (1-20 minutes), there is a real time display of the raw and processed data presented to the operator. Once the resulting individual responses are acquired, the signals are analyzed by software using algorithms for spatial filtering and artifact rejection. Data may be presented in a number of forms, including waves recorded at each of the points tested, color plots, or 3D topographical representation.
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C. Intended Use/ Indications for Use
The Vision Monitor MonCvONE system is a non-invasive medical device used to generate photic stimulations and to register the responses including electrical responses generated by the retina and the visual nervous system in addition to psychophysical and pupillary responses. It displays digitized electroretinogram (ERG), visual evoked potential (VEP), sensory electro-oculogram (EOG), light and dark adapted perimetry thresholds, dark adaptometry, full field stimulus threshold (FST), photo aversion thresholds (PAT), pupillometry as curves, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals.
Substantial equivalence
| Attribute | Submission device
MonCvONE
Metrovision | RETI-Port/SCAN
Roland Consult |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|----------------------------------|
| Intended use:
Generate photic signals
and measure and display
the electrical response
signals generated by the
retina and the visual
nervous system | YES | YES |
| Intended users:
Ophthalmologists and
trained medical
technicians and
professionals | YES | YES |
| Indications for use:
Quantification of the
electrophysiological
response of the retina
and visual cortex | YES | YES |
| Intended population:
Patients with ophthalmic
conditions | YES | YES |
| Intended use
environment:
Hospitals, clinics and
physician offices | YES | YES |
| Physiological data
collected:
ERG and VEP
waveforms | YES | YES |
| Compliance with
recognized standards:
ISO/EN 60601-1-2 | YES | YES |
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The Indications for Use statement for the MonCvONE device is not identical to the predicate device. The MonCvONE includes additional means of response including psychophysical responses and pupillometry that provide additional information contributing to the interpretation of responses from patients with ophthalmic conditions. However, the differences do not alter the intended diagnosis use of the device nor do they affect the safety and effectiveness of the device relative to the predicate.
Safety
The stimulator and the amplifier comply with ISO/EN 60601-1-2 The patient eye is exposed to visual light and near infra-red light with levels of exposure that have been measured and represents no risk to the patient.
Performance Data
The VISION MONITOR MonCvONE was tested to the following standards:
- → ISO 14971: 2012 Medical devices Application of risk management to medical devices
- → IEC 60601-1: 2012 Medical devices General requirements for safety and essential performances
- → IEC 60601-1-2: 2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- → IEC 62366-1: 2015 Medical devices Application of usability engineering
- -> IEC 62304: 2015 Medical device. Software life cycle
- → ANSI Z80.36-2016 Light hazard protection for ophthalmic instruments
The non-clinical testing completed for the VISION MONITOR MonCvONE included these three maior categories of testing:
Technical tests which include: internal hardware, firmware and Softwares component tests. packaging and labelling tests. Softwares verification have been tested against their specifications and according to IEC 62304: 2015
012 Vision electrophysiology software test report
013 Sensory EOG software test report
Functional tests:
014_Flash and pattern ERG and VEP functional tests.pdf
015 Sensory EOG functional tests.pdf
Compatibility tests with PC and accessories used: 016 PC compatibility 017 Accessories compatibility
Other functions
This medical device product has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this application, if the product has functions that are not subject to FDA premarket review, FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review.
Conclusion
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The VISION MONITOR MonCvONE and the RETI-Port/SCAN 21 have the same intended use and very similar indications, technological characteristics and principles of operation. Any technological differences between the VISION MONITOR MonCvONE and its predicate do not present any new issues of safety or effectiveness.
Bench testing has demonstrated that the VISION MONITOR MonCvONE is as safe, as effective and performs as well or better than the legally marketed device.