E3 and Profile
Device Facts
| Record ID | K221471 |
|---|---|
| Device Name | E3 and Profile |
| Applicant | Diagnosys, LLC |
| Product Code | GWE · Neurology |
| Decision Date | Nov 22, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1890 |
| Device Class | Class 2 |
Indications for Use
The E3 and Profile 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, for use with patients who are experiencing visual system abnormalities.
Device Story
Electrodiagnostic system; generates photic stimuli via LEDs or monitor; records electrical signals (ERG, VEP, EOG) via external EEG electrodes; used in hospitals, clinics, and physician offices by ophthalmologists and trained medical professionals. Device transforms raw input signals into digitized waveforms, power spectra, and 3D topographical maps; software performs spatial filtering and artifact rejection. Real-time display provided during 1-20 minute acquisition. Output assists clinicians in diagnosing visual system abnormalities by quantifying retinal and visual nervous system function.
Clinical Evidence
No clinical data. Bench testing only. Includes technical hardware/firmware/software verification, functional testing per ISCEV recommendations, compatibility testing with electrodes, and safety/performance testing per IEC 60601-1, IEC 60601-1-2, IEC 62366-1, IEC 62304, and ISO 10993 series.
Technological Characteristics
Materials: Aluminum, molded/machined parts, PCBAs, PC, LCD monitor, LED/LCD light sources. Energy: LCD monitor with LED backlight, LEDs. Form factor: Ganzfeld stimulator, amplifier, built-in camera, desktop/stand options. Connectivity: PC-based. Software: IEC 62304 compliant. Standards: ISO/EN 60601-1-2, IEC 60601-1, IEC 60601-2-26, ANSI Z80.36-2021, ISO 10993.
Indications for Use
Indicated for patients with ophthalmic conditions experiencing visual system abnormalities; used for quantification of electrophysiological response of 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
- Vision Monitor MonPackONE system (K211643)
Submission Summary (Full Text)
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Diagnosys LLC Jeffrey Farmer CEO 55 Technology Drive, Suite 100 Lowell, Massachusetts 01851
Re: K221471
Trade/Device Name: E3 and Profile Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked Response Photic Stimulator Regulatory Class: Class II Product Code: GWE, HLT Dated: October 27, 2022 Received: October 28, 2022
Dear Jeffrey Farmer:
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
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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) K221471
Device Name E3 and Profile
# Indications for Use (Describe)
The E3 and Profile 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, for use with patients who are experiencing visual system abnormalities.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| <span style="white-space: nowrap;"> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="white-space: nowrap;"> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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Image /page/3/Picture/0 description: The image contains the logo for Diagnosys. The logo features the word "diagnosys" in a lowercase, sans-serif font, with the tagline "leading the wave" underneath in a smaller font. Above the word "diagnosys" is a stylized blue wave graphic, which adds a visual element to the logo.
510(k) SUMMARY for the E3 and Profile PER 21 CFR 807.92
Date prepared: October 24, 2022
| Company name: | Diagnosys LLC |
|---------------|--------------------------------|
| | 55 Technology Drive, Suite 100 |
| | Lowell, MA 01851 |
| | USA |
| | Telephone: 1-978-458-1600 |
| | Fax: 1-978-458-1755 |
Contact Person: Jeffrey Farmer, CEO Email: jeff(@diagnosysllc.com
Name of the device: E3, Profile
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 E3 and Profile (also known as the Espion Ophthalmic Electrophysiology System) is substantially equivalent to the Vision Monitor MonPackONE system manufactured by MetroVision 510(k) number K211643. They are both hardware and software products. The E3 and Profile is substantially equivalent to the predicate devices 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 that is collected.
# B. Device Description
Photopic stimuli are presented to the patient using LEDs or a monitor, using 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 lavers. 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,
.diagnosysllc.com
US: Diagnosys U.C.: 55 Technology Drive Suite 100 Lowell MA 01851 978-458-1600 Sa
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Image /page/4/Picture/0 description: The image contains the logo for Diagnosys. The logo features the word "diagnosys" in a lowercase, sans-serif font, with a blue wave-like line above it. Below the word "diagnosys" is the tagline "leading the wave" in a smaller, italicized font. The overall design is simple and modern, with a focus on the company name and its message.
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.
# C. Intended Use/Indications for Use
The E3 and Profile 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, for use with patients who are experiencing visual system abnormalities.
| Substantial equivalence<br>Attribute | Submission device E3, Profile<br>Diagnosys LLC | MonPackONE<br>Metrovision |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|---------------------------|
| Intended use:<br>Generate photic signals and<br>measure and display the<br>electrical response signals<br>generated by the retina and<br>the visual nervous system | YES | YES |
| Intended users:<br>Ophthalmologists and<br>trained medical technicians<br>and professionals | YES | YES |
| Indications for use:<br>Quantification of the<br>electrophysiological<br>response of the retina and<br>visual cortex | YES | YES |
| Intended population:<br>Patients with ophthalmic<br>conditions | YES | YES |
| Intended use environment:<br>Hospitals, clinics and<br>physician offices | YES | YES |
| Physiological data<br>collected:<br>ERG, VEP, EOG waveforms | YES | YES |
| Compliance with<br>recognized standards:<br>ISO/EN 60601-1-2 | YES | YES |
#### Substantial equivalence
US: Diagnosys II C: 55 Technology Drive Suite 100 Lowell MA 01851: 978-458-1600; sales@diagnosys.llc.com
EU: Diagnosys Vision Ltd; Office 117, DOC Buildin, K67 E5A0, Ireland; +44 (0) 1223 52069; mail@diagnosysuis
www.diagnosysllc.com
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Image /page/5/Picture/0 description: The image contains the logo for Diagnosys. The logo features the word "diagnosys" in a lowercase, sans-serif font, with the tagline "leading the wave" underneath in a smaller, italicized font. Above the word "diagnosys" is a curved, blue line that resembles a wave, reinforcing the tagline.
| Materials | Aluminum, molded parts, machined parts, PCBAs, PC, LCD monitor, LED and LCD light sources | Aluminum, molded parts, machined parts, PCBAs, PC, LCD monitor, LED and LCD light sources |
|-----------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Design | LCD display, Ganzfeld stimulator, amplifier, built in camera, desktop and electric stand option, PC | LCD display, Ganzfeld stimulator, amplifier, built in camera, desktop and electric stand option, PC |
| Energy Source | LCD monitor with LED backlight; LEDs | LCD monitor with LED backlight; LEDs |
| Other design features | Protocols to run all ISCEV clinical protocols; movable head and chin rests | Protocols to run all ISCEV clinical protocols; movable head and chin rests |
# 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 E3 and Profile was tested and/or assessed to the following standards:
1. IEC 60601-1:2012. Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
2. ISO 14971: 2012 Medical devices - Application of risk management to medical devices.
3. IEC 60601-1-2:2014. Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests.
4. IEC 62366-1: 2015. Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices.
5. IEC 60601-1-6:2010. AMD1:2013. Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability.
6. IEC 60601-2-26:2012. Medical Electrical Equipment - Part 2-26: Particular Requirements For The Basic Safety And Essential Performance Of Electroencephalographs.
7. IEC 62304:2015. Medical Device Software - Software Life Cycle Processes.
8. ANSI Z80.36-2021 Light hazard protection for ophthalmic instruments.
9. ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
10. ISO 10993-5. Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. 11. ISO 10993-10. Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
US: Diagnosys U.C.: 55 Technology Drive Suite 100 Lowell MA 01851 978-458-1600: sal on Ltd; Office 117, DOC Building, Balheary Road, Swords, Dublin, K6 UK: Diagnosys UK Ltd: 5 Trust Court. Chivers Way. Vision Park Histon. Cambridge, CB24 9PW. UK: +44 (0) 1223 520699; majl@djagnosysuk.
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Image /page/6/Picture/0 description: The image shows the logo for Diagnosys. The logo features the word "diagnosys" in a bold, sans-serif font, with the tagline "leading the wave" underneath in a smaller font. Above the word "diagnosys" is a blue, curved line that resembles a wave. The color scheme is primarily blue and white.
12. ISO 10993-23. Biological evaluation of medical devices - Part 23: Tests for irritation.
The non-clinical testing completed for the E3 and Profile included these three major categories of testing:
#### Technical tests:
Internal hardware, firmware and software component tests, packaging and labeling tests. Software verification and validation have been tested against their specifications and according to IEC 62304: 2015.
## Functional tests:
The different functions needed to measure 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 E3 and Profile and the Vision MonPackONE system have the same intended use and indications, technological characteristics and principles of operation. Any technological differences between the E3 and Profile and its predicate does not present any new issues of safety or effectiveness. Testing has demonstrated that the E3 and Profile is substantially equivalent to the predicate device.
.diagnosysllc.com
