(86 days)
Not Found
No
The description mentions "algorithms for spatial filtering and artifact rejection," which are standard signal processing techniques, not necessarily indicative of AI/ML. There is no mention of AI, ML, deep learning, or any related concepts.
No
The device is described as an electrodiagnostic device used to measure and display electrical signals generated by the retina and visual nervous system for the purpose of diagnosis and management, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The device is intended for use in the diagnosis and management of retinal ischemic diseases, diabetic retinopathy, and central or branch vein occlusion."
No
The device description explicitly mentions hardware components like a CRT screen for presenting stimuli and recording channels using EEG electrodes. It is an electrodiagnostic device that relies on physical interaction with the patient and external hardware for data acquisition.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health.
- VERIS system function: The VERIS system directly interacts with the patient's body by generating photic signals and measuring electrical signals from the retina and visual nervous system. It does not analyze samples taken from the body.
The VERIS system is an in vivo diagnostic device, meaning it performs measurements and analysis directly on a living organism.
N/A
Intended Use / Indications for 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.
The device is intended for use in the diagnosis and management of retinal ischemic diseases, diabetic retinopathy, and central or branch vein occlusion.
Product codes
86 HLX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
retina and the visual nervous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical professionals / Hospital, clinics and physician offices
Description of the training set, sample size, data source, and annotation protocol
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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 VERIS System has been tested for electrical safety and has received a certificate of compliance with EN60601-1-2:1993 and EN55011:1991 Standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1630 AC-powered photostimulator.
(a)
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).(b)
Classification. Class II.
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 |
- 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.
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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
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)
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