Who is the manufacturer of EDI VERIS SYSTEM?

Electro-Diagnostic Imaging, Inc. filed the 510(k) submission for EDI VERIS SYSTEM (K983983).

What is the FDA product code for EDI VERIS SYSTEM?

HLX. It is classified under 21 CFR 886.1630 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for EDI VERIS SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for EDI VERIS SYSTEM?

UTAS-E 2000 Visual Electrodiagnostic System (K760199); Tomey PE400 Portable ERG System (K932571); Maculoscope (K863956); Espion Systems (K863956).

Who can help prepare an FDA 510(k) submission like EDI VERIS SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EDI VERIS SYSTEM

K983983 · Electro-Diagnostic Imaging, Inc. · HLX · Feb 3, 1999 · Ophthalmic

Device Facts

Record ID	K983983
Device Name	EDI VERIS SYSTEM
Applicant	Electro-Diagnostic Imaging, Inc.
Product Code	HLX · Ophthalmic
Decision Date	Feb 3, 1999
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.1630
Device Class	Class 2

Intended Use

The VERIS system is an electodiagnostic 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) and visual evoked potential (VEP) signals, power spectra, and topographic maps. These functions are controlled and interpreted by trained medical professionals. The device is intended for use in the diagnosis and management of retinal ischemic diseases, diabetic retinopathy, and central or branch vein occlusion.

Device Story

VERIS System is an electrodiagnostic device for retinal and visual nervous system assessment. It presents photic stimuli via CRT screen (up to 60 degrees, 241 elements in separately stimulated fields) to elicit responses. Data is acquired via two recording channels using external EEG electrodes. Software processes raw signals using spatial filtering and artifact rejection algorithms. Output includes individual waveforms, power spectra, color plots, and 3D topographical maps. Used in hospitals, clinics, and physician offices by ophthalmologists and trained medical technicians. Healthcare providers interpret the displayed data to diagnose and manage retinal ischemic diseases, diabetic retinopathy, and vein occlusions.

Clinical Evidence

Bench testing only. The device demonstrated compliance with electrical safety standards EN60601-1-2:1993 and EN55011:1991.

Technological Characteristics

System utilizes CRT-based photic stimulation and external EEG electrodes for signal acquisition. Software performs spatial filtering and artifact rejection. Data output includes waveforms, power spectra, and 3D topographical maps. Complies with EN60601-1-2:1993 and EN55011:1991 standards.

Indications for Use

Indicated for patients with ophthalmic conditions, specifically for the diagnosis and management of retinal ischemic diseases, diabetic retinopathy, and central or branch vein occlusion.

Regulatory Classification

Identification

An AC-powered photostimulator is an AC-powered device intended to provide light stimulus which allows measurement of retinal or visual function by perceptual or electrical methods (e.g., stroboscope).

Predicate Devices

UTAS-E 2000 Visual Electrodiagnostic System (K760199)
Tomey PE400 Portable ERG System (K932571)
Maculoscope (K863956)
Espion Systems (K863956)

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Submission Summary (Full Text)

{0}------------------------------------------------ Electro-Diagnostic Imaging, Inc. 510(k) Notification November 4, 1998 Image /page/0/Picture/1 description: The image contains a sequence of handwritten alphanumeric characters. The sequence appears to be "K983983". The characters are written in a cursive style, with some connections between the numbers. #### 510(k) Summary for the VERIS System Prepared November 4. 1998 FEB 3 1599 Company Name: Electro-Diagnostic Imaging, Inc. 1206-D West Hillsdale Blvd. San Mateo, California 94403 Telephone 650 341 5054 Contact Person: Erich E. Sutter Ph.D. ### A. Legally Marketed Predicate Device The VERIS System is substantially equivalent to UTAS-E 2000 Visual Eletrodiagnostic System (K760199) manufactured by LKC Technologies, Inc., the Tomey PE400 Portable ERG System (K932571) manufactured by Tomey and the Maculoscope and The Espion Systems, (K863956) both manufactured by Doran (aka Diagnosys LLC). These are all hardware and software products. The EDI device 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 a photic stimulus and an analysis of the evoked response data collected. #### B. Device Description Photic stimuli are presented to the patient on a CRT screen up to 60 degrees at 241 elements in separately stimulated fields. Various modes are available for preferential stimulation of different retinal mechanisms and isolation of signal from different retinal layers. Data is acquired by 2 recording channels using conventional EEG electrodes (not provided with the device). During the period of time that the system is acquiring data (4-16 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 topographical representations. #### C. Intended Use The VERIS 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) and visual evoked potential (VEP) signals, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals. {1}------------------------------------------------ # D. Substantial Equivalence | Product Name | Predicate Devices | | | Submission Device | |---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Doran Maculoscope and The Espion System (K863956) | UTAS-E 2000 (and 3000) Visual Electrodiagnostic Systems (K760199) | Tomey PE400 Portable ERG and VEP System (K932571) | EDI VERIS ERG and VEP System | | | Intended Use | Generate photic signals and measure and display the electrical response signals generated by the retina and the visual nervous system | Generate photic signals and measure and display the electrical response signals generated by the retina and the visual nervous system | Generate photic signals and measure and display the electrical response signals generated by the retina and the visual nervous system | Generate photic signals and measure and display the electrical response signals generated by the retina and the visual nervous system | | Intended Users | Ophthalmologists and trained medical technicians | Ophthalmologists and trained medical technicians | Ophthalmologists and trained medical technicians | Ophthalmologists and trained medical technicians | | Indications for Use | Diagnosis and management of retinal ischemic diseases, diabetic retinopathy, central or branch vein occlusion | Diagnosis and management of retinal ischemic diseases, diabetic retinopathy, central or branch vein occlusion | Diagnosis and management of retinal ischemic diseases, diabetic retinopathy, central or branch vein occlusion | Diagnosis and management of retinal ischemic diseases, diabetic retinopathy, central or branch vein occlusion | | Intended Population | Patients with ophthalmic conditions | Patients with ophthalmic conditions | Patients with ophthalmic conditions | Patients with ophthalmic conditions | | Site of Use | Hospital, clinics and physician offices | Hospital, clinics and physician offices | Hospital, clinics and physician offices | Hospital, clinics and physician offices | | Data Collected | ERG waveforms | ERG waveforms | ERG waveforms | ERG waveforms | ## E. Performance Data The VERIS System has been tested for electrical safety and has received a certificate of compliance with EN60601-1-2:1993 and EN55011:1991 Standards. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines emanating from a central point. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 3 1999 FEB Sheila W. Pickering Ph.D. Electro- Diagnostic Imaging, Inc. 2081 Longden Circle Los Altos, California 94024 Re: K983983 Trade Name: EDI Veris System Regulatory Class: II Product Code: 86 HLX Dated: November 5, 1998 Received: November 9, 1998 Dear Dr. Pickering: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations . {3}------------------------------------------------ Page 2 - Sheila W. Pickering Ph.D. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, A Roerl forential A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K983983 #### FDA Submission Cover Sheet 510(k) Number (if known): Device Name: VERIS System Indications For Use: The VERIS system is an electodiagnostic 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) and visual evoked potential (VEP) signals, power spectra, and topographic maps. These functions are controlled and interpreted by trained medical professionals. The device is intended for use in the diagnosis and management of retinal ischemic diseases, diabetic retinopathy, and central or branch vein occlusion. Evenette Bean 510(k) Number (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence Of CDRH, Office Of Device Evaluation (ODE) Prescription Use_ 1 OR Over-The-Counter Use _ (Per 21CFR 801) i