(522 days)
Not Found
No
The description mentions "algorithms for spatial filtering and artifact rejection" but does not use terms like AI, ML, or deep learning, nor does it describe characteristics typically associated with AI/ML models (training/test sets, performance metrics like AUC). The algorithms described appear to be conventional signal processing techniques.
No.
The device is used for quantifying the retinal response and measuring a parameter (VEP) related to retinal response, which are diagnostic functions, not therapeutic. It tests and measures, but does not provide treatment.
Yes
The device is an "Electrophysiological Test Unit for quantifying the retinal response, measuring a parameter (VEP) related to retinal response," which directly indicates its use in assessing a physiological condition to aid in diagnosis.
No
The device description explicitly mentions hardware components like a VGA-screen, EEG electrodes, and stimulators (Ganzfeld and Miniganzfeld), indicating it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description clearly states that this device is an "Electrophysiological Test Unit for quantifying the retinal response" by presenting stimuli to the patient and recording electrical signals using electrodes. This is a direct measurement of a physiological response in the patient, not an analysis of a sample from the patient.
- The intended use is to measure a physiological parameter (VEP) related to retinal response. This is a functional assessment of the visual system, not a diagnostic test performed on a biological sample.
- The device uses conventional EEG electrodes. These are used to record electrical activity directly from the body surface, not to process biological samples.
Therefore, this device falls under the category of a medical device used for physiological measurement and assessment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RETI-Port-Scan 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 spectral and topographic maps. These functions are controlled and interpreted by trained medical professionals.
Electrophysiological Test Unit for quantifying the retinal response, measuring a parameter (VEP) related to retinal response
Product codes
GWE
Device Description
Photopic stimuli are presented to the patient on an VGA-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 are required by up to 8 recording channels using conventional EEGelectrodes. During the period of time that the system is aquiring 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 aquired, 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
Patients with ophtalmic conditions
Intended User / Care Setting
Ophtalmologists and trained medical technicians and 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 RETIscan/RETIport System has been tested for electrical safety and has received a certificate of compliance with EN60601-1 Standards.
The 21" monitor stimulator complies with IEC601-1-2.
The Ganzfeld-stimulator and the Miniganzfeld-stimulator complies with IEC 60601-1. The patients eye is exposed to a normal visual light radiation. The level of exposure was measured and represents no risk to the patient.
All Stimulators provide equivalent stimulation for the purpose of evoked potential (ERG, VEP) recording in all regards (stimulus luminance, chromaticity and size of the stimulated visual field).
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 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
MAR 2 6 2004
10. 510(k) Summary of the RETIscan/ RETIport
ROLAND CONSULT Company Name: Friedrich-Franz-Str. 19 D-14770 Brandenburg, Germany Tel.: +49 3381 382621
Contact Person: Dipl. Ing. Matthias Mai
Legally Marketed Predicate Device
The RETI-Port/RETIscan-System is substiancially equivalent to Doran Maculoscope and the Espion System (K863956) manufactured by DORAN INSTRUMENTS, INC., and the VERIS System (K003442) manufactured by Electro-Diagnostic Imaging, Inc. These are Hardware and Software products. The RETI-Port-Scan device is substantially equvalent 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 photopic stimulus and an analysis of the evoked response data collected.
Device Description
Photopic stimuli are presented to the patient on an VGA-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 are required by up to 8 recording channels using conventional EEGelectrodes. During the period of time that the system is aquiring 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 aquired, 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.
Intended Use
The RETI-Port-Scan 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 spectral and topographic maps. These functions are controlled and interpreted by trained medical professionals.
1
Substantial Equivalence
| Attribute | RETIscan
RETIport | VERIS System | Doran Maculoscope
and the Espion
System (K863956) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------|---------------------------------------------------------|
| Use: | | | |
| Intended Use: | | | |
| Generate photic
signals and measure
and display the
electrical response
signals generated by
the retina and the
visual nervous sytem | Yes | Yes | Yes |
| Intended Users: | | | |
| Ophtalmologists and
trained medical
technicians and
professionals | Yes | Yes | Yes |
| Indications for Use; | | | |
| Electrophysiological
Test Unit for
quantifying the retinal
response, measuring a
parameter (VEP)
related to retinal
response | Yes | Yes | Yes |
| Intended Population: | | | |
| Patients with
ophtalmic conditions | Yes | Yes | Yes |
| Intended use | | | |
| environment:
Hospitals, clinics and
physician offices | Yes | Yes | Yes |
| Physiological data
collected:
ERG waveforms | Yes | Yes | Yes |
| Compliance with | | | |
| Recognized standards: | | | |
| ISO/EN 60601-1-2 | Yes | Yes | Yes |
| EN 55011: 03.1991 | Yes | Yes | Yes |
:
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Performance Data
The RETIscan/RETIport System has been tested for electrical safety and has received a certificate of compliance with EN60601-1 Standards.
Safety
The 21" monitor stimulator complies with IEC601-1-2
The Ganzfeld-stimulator and the Miniganzfeld-stimulator complies with IEC 60601-1 The patients eye is exposed to a normal visual light radiation. The level of exposure was measured and represents no risk to the patient.
Effectiveness
All Stimulators provide equivalent stimulation for the purpose of evoked potential (ERG, VEP) recording in all regards (stimulus luminance, chromaticity and size of the stimulated visual field).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three horizontal lines that resemble an abstract human figure.
MAR 2 6 2004
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Matthias Mai Roland Consult Elektrophysiologische Diagnostik SY Friedrich-Franz-Strasse 19 Brandenburg Germany D 14770
Re: K023525
Trade/Device Name: RETIscan RETIport Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked response photic stimulator Regulatory Class: II Product Code: GWE Dated: February 5, 2004 Received: February 9, 2004
Dear Mr. Mai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determincd 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. 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 (PMA), 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 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 docs 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Matthias Mai
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
RETIscan RETIport
Electrophysiological Test Unit for quantifying the Electrophysiological surfing a parameter (VEP) related to retinal response
Muriam C Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)