RETISCAN, RETIPORT

K023525 · Roland Consult · GWE · Mar 26, 2004 · Neurology

Device Facts

• Record ID: K023525
• Device Name: RETISCAN, RETIPORT
• Applicant: Roland Consult
• Product Code: GWE · Neurology
• Decision Date: Mar 26, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1890
• Device Class: Class 2

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.

Device Story

RETIscan/RETIport system; electrodiagnostic device for ERG and VEP testing. Inputs: photic stimuli presented via VGA screen; electrical signals collected via up to 8 EEG electrodes. Operation: system presents stimuli to patient; acquires retinal/visual nervous system electrical responses over 1-20 minutes; software performs real-time processing including spatial filtering and artifact rejection. Outputs: raw/processed waveforms, power spectral maps, 3D topographical representations. Used in hospitals, clinics, and physician offices by ophthalmologists and trained medical professionals. Output aids clinicians in assessing retinal function and visual nervous system health; supports diagnosis of ophthalmic conditions.

Clinical Evidence

Bench testing only. Electrical safety and electromagnetic compatibility verified via compliance with EN60601-1 and IEC60601-1-2 standards. Stimulator performance (luminance, chromaticity, field size) validated as equivalent to predicate systems. No clinical study data provided.

Technological Characteristics

System includes VGA-screen stimulator, Ganzfeld/Miniganzfeld stimulators, and 8-channel EEG electrode interface. Connectivity: standard clinical workstation. Software performs signal processing (spatial filtering, artifact rejection). Electrical safety: IEC 60601-1, IEC 60601-1-2. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for patients with ophthalmic conditions requiring electrophysiological testing to quantify retinal response and measure parameters (VEP) related to retinal response.

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

• Doran Maculoscope
• Espion System (K863956)
• VERIS System (K003442)

Submission Summary (Full Text)

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K023525

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.: [phone]

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.

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## Substantial Equivalence

| Attribute | RETIscan<br>RETIport | VERIS System | Doran Maculoscope<br>and the Espion<br>System (K863956) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------|---------------------------------------------------------|
| Use: | | | |
| Intended Use: | | | |
| Generate photic<br>signals and measure<br>and display the<br>electrical response<br>signals generated by<br>the retina and the<br>visual nervous sytem | Yes | Yes | Yes |
| Intended Users: | | | |
| Ophtalmologists and<br>trained medical<br>technicians and<br>professionals | Yes | Yes | Yes |
| Indications for Use; | | | |
| Electrophysiological<br>Test Unit for<br>quantifying the retinal<br>response, measuring a<br>parameter (VEP)<br>related to retinal<br>response | Yes | Yes | Yes |
| Intended Population: | | | |
| Patients with<br>ophtalmic conditions | Yes | Yes | Yes |
| Intended use | | | |
| environment:<br>Hospitals, clinics and<br>physician offices | Yes | Yes | Yes |
| Physiological data<br>collected:<br>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).

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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 [phone]. 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 [phone] or [phone] 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):

K023525

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)