(129 days)
Not Found
No
The description focuses on standard signal processing and comparison to a reference dataset, with no mention of AI/ML terms or techniques.
No.
The device is used for quantifying the response to visual stimulation by measuring the Visual Evoked Potential and displaying electrical responses, which indicates a diagnostic rather than therapeutic purpose.
Yes
The device is described as an "Electrophysiological Test Unit" that measures "Visual Evoked Potential" and displays the "electrical response from each segment of the retina." It also allows comparison of response times and individual measurements to a reference set, all of which are functions associated with diagnostic testing to assess physiological function.
No
The device description explicitly states the system consists of "specialist software and the supporting computer and peripherals" and utilizes "specific, validated third party EEG electrodes and biological amplifier." This indicates the system includes hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this system measures the electrophysiological response to visual stimulation by detecting electrical signals (Visual Evoked Potentials) from the visual cortex using EEG electrodes. This is a measurement of a physiological response within the living body, not an analysis of a specimen taken from the body.
- The device interacts directly with the patient. It displays visual patterns to the patient and uses electrodes placed on the patient's head to detect signals. IVDs typically involve analyzing samples in a laboratory setting.
Therefore, this device falls under the category of a medical device that performs a physiological measurement, but it is not an IVD.
N/A
Intended Use / Indications for Use
Electrophysiological Test Unit for quantifying the response to visual stimulation by measuring the Visual Evoked Potential.
Product codes
GWE
Device Description
The Visionsearch1 System consists of specialist software and the supporting computer and peripherals. The System displays multifocal visual patterns to evoke response in the retina which are transmitted to the visual cortex. The System then detects responses in the visual cortex using specific, validated third party EEG electrodes and biological amplifier. After analyzing the EEG, the System displays the electrical response from each segment of the retina. It also allows the user to compare the response time between eyes and compare an individual's measurements to those from a set of data that the user has compiled as reference.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Retina, visual cortex
Indicated Patient Age Range
Patients with ophthalmic conditions (implied)
Intended User / Care Setting
Ophthalmologists 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)
Effectiveness: Stimulus provided is essentially identical (in terms of luminance, chromaticity and size of the stimulated visual field) to that of the predicate. The effectiveness of data capture and analysis is validated through development under IEC 62304 software life cycle controls and independent laboratory verification of software functionality.
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
§ 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).
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510(k) Summary : Visionsearch1 System
MAY 2 1 2012 Contact Person: Dr. Arthur Brandwood Brandwood Biomedical Pty. Ltd. Suite 408, 460 Pacific Highway St Leonards, NSW 2065, AUSTRALIA Tel: +61 2 9906 2984 Fax: +61 2 8580 4613 arthur@brandwoodbiomedical.com Brand Name: Visionsearch1 System Common Name: Multi focal visual evoked potential (mfVEP) device Classification Name: (21CFR 882.1890) Evoked Response Photic Stimulator Product Code: GWE Predicate Device: RETIScan/RETIPort (K023525). Date Prepared: 11 May 2012 Device Description: The Visionsearch1 System consists of specialist software and the supporting computer and peripherals. The System displays multifocal visual patterns to evoke response in the retina which are transmitted to the visual cortex. The System then detects responses in the visual cortex using specific, validated third party EEG electrodes and biological amplifier. After analyzing the EEG, the System displays the electrical response from each segment of the retina. It also allows the user to compare the response time between eyes and compare an individual's measurements to those from a set of data that the user has compiled as reference. Indications for Use: Electrophysiological Test Unit for quantifying the response to visual stimulation by measuring the Visual Evoked Potential.
Summary of Basis for Substantial Equivalence:
The Visionsearch1 is substantially equivalent to the RETIScan/RETIPort (K023525) for mfVEP measurement. Equivalence is based on both devices having the same intended use and technological characteristics as summarized in the following Comparison Table.
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| Feature | Predicate RETiscan (K023525) | Visionsearch1 |
|---|---|---|
| Intended use | Generate photic signals and measure | |
| and display the electrical response | ||
| signals generated by the retina and the | ||
| visual nervous system. | Same as predicate | |
| Intended users | Ophthalmologists and trained medical | |
| technicians and professionals | Same as predicate | |
| Indications for use | Electrophysiological Test Unit for | |
| quantifying the retinal response and | ||
| measuring parameters (VEP and ERG) | ||
| related to retinal response. | Same as predicate for mfVEP | |
| functionality subset | ||
| Intended | ||
| Population | Patients with ophthalmic conditions | Same as predicate |
| Intended Use | ||
| environment | Hospitals, clinics and physician offices | Same as predicate |
| Physiological data | ||
| collected | Electroretinogram and Visual Evoked | |
| Potential (VEP) waveforms | VEP waveforms | |
| Principle of | ||
| operation | Display multi-focal, light/dark patterns , | |
| read resultant waveforms, filter and | ||
| correlate against stimulus patterns to | ||
| produce response measurements. | ||
| Key features: | ||
| Dartboard layout with 58 | ||
| segments for mfVEP (1 | ||
| innermost ring with 8 segments, | ||
| 4 rings with 12 segments, 2 extra | ||
| segments in nasal field. Displayed on standard LCD | ||
| monitor (60:000 to 1 contrast, | ||
| 1.5 or greater LUX) at 24 degree | ||
| field of view when patient is | ||
| correctly positioned. Uses m-sequence for temporal | ||
| sequence generation. Supports 60Hz stimulation rate. Pattern reversal stimulation with | ||
| 4*4 checkerboard in each | ||
| segment. Patient fixates on fixed icon or | ||
| changing pattern (where they | ||
| count the number of events and | ||
| verbally inform the operator at | Same as predicate, except: | |
| Only 56 segments are used | ||
| (nasal field segments are not | ||
| included). More advanced patient fixation | ||
| – a wireless device is used for | ||
| patient feedback instead of | ||
| verbal communication, and a | ||
| 'multi response' /' multi button' | ||
| fixation system is supported. | ||
| Feature | Predicate RETIscan (K023525) | Visionsearch1 |
| the end). | ||
| Materials of | ||
| construction | Enterprise grade PC with stimulus quality | |
| monitor and/or Ganzfeld-stimulator | ||
| and/or Miniganzfeld-stimulator and | ||
| integrated bio amplifier (2-8 channels). | Enterprise grade PC with stimulus quality | |
| monitor attached to 3rd party | ||
| (independently certified) clinical bio | ||
| amplifier (4 channels). | ||
| Functions offered | ||
| by the software | Provision of stimulus patterns via | |
| computer monitor. | ||
| Acquisition of evoked response through | ||
| a bio amplifier. | ||
| Display of waveforms captured by the | ||
| amplifier during recording. | ||
| Detection of noise and artifacts in the | ||
| acquired response. | ||
| Scaling and correlation of the response | ||
| to the stimulus to produce amplitude | ||
| and latency measurements. | ||
| Resulting measurements are displayed in | ||
| numerical and 2d/3d graphical formats. | ||
| Comparisons between measurements | ||
| and against user supplied reference sets | ||
| are possible. | ||
| Recordings can be exported and | ||
| imported between systems. | ||
| Measurements and graphs can be | ||
| printed. | Same as predicate |
Comments of the country
: : : : :
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Safety:
The Visionsearch1 device complies with applicable standards for electrical and biological safety. It was developed in accordance with design control requirements of 15013485:2003 and 21 CFR- 820.30. Software development was conducted in accordance with requirements of IEC 62304:2006 "Medical device software – Software lifecycle processes" and software validation was performed by an independent laboratory accredited by the Australian National Association of Testing Authorities (NATA) for testing and validation of medical device software. Electrical components in contact with the patient conform to IEC60601-1-2:2007. The isolation transformer powering all other electrical components complies with IEC 60601-1.
Effectiveness: Stimulus provided is essentially identical (in terms of luminance, chromaticity and size of the stimulated visual field) to that of the predicate. The effectiveness of data capture and analysis is validated
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through development under IEC 62304 software life cycle controls and independent laboratory verification of software functionality.
Substantial equivalence conclusion
The new device, the Visionsearch1 System, is considered to be substantially equivalent to the predicate device based on:
- . equivalent technological characteristics
- identical intended use .
- . identical indications for use
- identical users ●
- identical patient population .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 1 2012
Brandwood Biomedical Pty. Ltd. c/o Mr. Norbert Stuiber TÜV SÜD America 1775 Old Hwy. 8 NW, Ste. 104 New Brighton, MN 55112-18914
Re: K120104
Trade/Device Name: Visionsearch1 System Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked Response Photic Stimulator Regulatory Class: Class II Product Code: GWE Dated: May 15, 2012 Received: May 17, 2012
Dear Mr. Stuiber:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becases of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered prior to rialy 20, sire) in accordance with the provisions of the Federal Food, DNA de necs that have been roomsonied in assire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, merciolo, manel the act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and uevices, good manufacturing practices and evaluate information related to contract liability adulteration. Trease note: ODFET assement 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 If your device is classified (600 above). Existing major regulations affecting your device can be finay of subject to additional controls. Inc. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
5
Page 2 - Mr. Norbert Stuiber
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Quk. Kum m fa
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat 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: _
Visionsearch1 System
Electrophysiological Test Unit for quantifying the response Indications For Use: to visual stimulation by measuring the Visual Evoked Potential.
Prescription Use _
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
. (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quynt Hoang
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, 1 Nose and Throat Devices
Page 1 of 1
510(k) Number KL20104