Vision Monitor - MonpackONE

K211643 · Metrovision · GWE · Jul 26, 2021 · Neurology

Device Facts

• Record ID: K211643
• Device Name: Vision Monitor - MonpackONE
• Applicant: Metrovision
• Product Code: GWE · Neurology
• Decision Date: Jul 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1890
• Device Class: Class 2

Intended Use

The Vision Monitor MonPackONE system is an electrodiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and the visual nervous system. It displays digitized electroretinogram (ERG), visual evoked potential (VEP) and sensory electro-oculogram (EOG) signals, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals.

Device Story

Electrodiagnostic system; generates photic stimuli via LCD screen; records electrical signals from retina/visual nervous system via up to 5 EEG electrode channels. Used in hospitals, clinics, and physician offices by ophthalmologists and trained medical professionals. Software processes raw data using spatial filtering and artifact rejection; produces waveforms, power spectra, color plots, and 3D topographical maps. Real-time display provided during 1-20 minute acquisition. Output assists clinicians in interpreting retinal/visual pathway function; supports clinical decision-making for ophthalmic conditions.

Clinical Evidence

Bench testing only. Testing included hardware, firmware, and software verification/validation per IEC 62304:2015; functional testing per ISCEV recommendations for ERG, VEP, and EOG; and electrode compatibility testing. Safety testing confirmed compliance with ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 62366-1, and ANSI Z80.36-2016.

Technological Characteristics

Electrodiagnostic system; LCD-based photic stimulator; 5-channel amplifier for EEG electrodes. Connectivity: standard clinical interface. Software: algorithm-based signal processing. Standards: ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 62366-1, IEC 62304, ANSI Z80.36-2016. Light source: visual and near infra-red.

Indications for Use

Indicated for patients with ophthalmic conditions requiring quantification of the electrophysiological response of the retina and visual cortex.

Regulatory Classification

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.

Predicate Devices

• RETI-Port/SCAN systems (K023525)

Submission Summary (Full Text)

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July 26, 2021

Metrovision Jacques Charlier CEO 4 rue des Platanes Perenchies, Hauts de France 59840 France

Re: K211643

Trade/Device Name: Vision Monitor - MonpackONE Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked Response Photic Stimulator Regulatory Class: Class II Product Code: GWE, HLT Dated: May 18, 2021 Received: May 27, 2021

## 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

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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 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) K211643

Device Name Vision Monitor - MonPackONE

#### Indications for Use (Describe)

The Vision Monitor MonPackONE system is an electrodiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and the visual nervous system. It displays digitized electroretinogram (ERG), visual evoked potential (VEP) and sensory electro-oculogram (EOG) signals, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) SUMMARY K211643 for the Vision Monitor MonPackONE Prepared July 22, 2021

| Company name: | METROVISION |
|---------------|-------------------------------|
| | 4 rue des Platanes |
| | 59840 PERENCHIES |
| | France |
| | Telephone: + 33 3 20 17 19 50 |

Contact Person: Jacques CHARLIER, CEO Email: [e-mail]

Name of the device: VISION MONITOR MonPackONE

Classification name: 21 CFR 882.1890, Evoked response photic stimulator

Regulatory class: Class II

Product Code: GWE Subsequent product code, based on other device functions in Class II : HLT

## A. Legally Marketed Predicate Device

The Vision Monitor MonPackONE 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 MonPackONE 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 LCD-screen at a various number of elements in separately stimulated fields. Various modes are available for preferential stimulation of different retinal mechanism and isolation of signal from different retinal layers. Data is recorded by up to 5 recording channels using conventional EEG electrodes (not provided with the device).

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 user. Once the resulting individual waveforms 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 topoqraphical representation.

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## C. Intended Use/ Indications for Use

The Vision Monitor MonPackONE system is an electrodiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and the visual nervous system. It displays digitized electroretinogram (ERG), visual evoked potential (VEP) and sensory electro-oculogram (EOG) signals, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals.

## Substantial equivalence

| Attribute | Submission device<br>MonPackONE<br>Metrovision | RETI-Port/SCAN<br>Roland Consult |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|----------------------------------|
| Intended use:<br>Generate photic signals<br>and measure and display<br>the electrical response<br>signals generated by the<br>retina and the visual<br>nervous system | YES | YES |
| Intended users:<br>Ophthalmologists and<br>trained medical<br>technicians and<br>professionals | YES | YES |
| Indications for use:<br>Quantification of the<br>electrophysiological<br>response of the retina<br>and visual cortex | YES | YES |
| Intended population:<br>Patients with ophthalmic<br>conditions | YES | YES |
| Intended use<br>environment:<br>Hospitals, clinics and<br>physician offices | YES | YES |
| Physiological data<br>collected:<br>ERG and VEP<br>waveforms | YES | YES |
| Compliance with<br>recognized standards:<br>ISO/EN 60601-1-2 | YES | YES |

### Safety

The stimulator and the amplifier comply with ISO/EN 60601-1-2

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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 MonPackONE 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 MonPackONE included these three major categories of testing:

## Technical tests:

Internal hardware, firmware and Softwares component tests, packaging and labelling tests. Softwares verification and validation have been tested against their specifications and according to IEC 62304: 2015.

## Functional tests:

The different functions needed to realize electroretinograms (ERG), visual evoked potentials (VEP) and sensory electro-oculograms (EOG) were tested according to the recommendations of the International Society of Clinical Electrophysiology of Vision (ISCEV).

### Compatibility tests:

Compatibility of the equipment and software with the major types of electrodes was tested for the different exams performed by the equipment.

### Conclusion

The VISION MONITOR MonPackONE 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 MonPackONE and its predicate do not present any new issues of safety or effectiveness.

Bench testing has demonstrated that the VISION MONITOR MonPackONE is substantially equivalent to the predicate RETI-Port/SCAN 21.