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MAIA is intended for taking digital images of a human retina without the use of a mydriatic agent.

MAIA is intended for taking digital images of a human retina without the use of a mydriatic agent. The device works with a dedicated software application, operates as a standalone unit, integrates a multitouch display, a push-button and is provided with an external power supply. MAIA operates in non-mydriatic conditions, i.e. without the need of pharmacological dilation and is intended for prescription use only The key functional elements of the device are: - the device base, - the device optical head, - the headrest, - the chinrest, - the multi-touch display, - the embedded software, - patient push-button, - the power supply and its power cable. The device acquires confocal retinal images illuminating the retina of the patient's eye, with visible light for imaging purposes and with infrared light for imaging purposes, focusing and retinal tracking. A specific feature of MAIA is the pupil tracking. The patient's pupils are illuminated and viewed by a different optical system; two cameras track the pupil's movements and allow for automatic alignment of the optical head with the eye position. From an imaging point of view, an important characteristic of MAIA is that it is a confocal instrument: this means that the illumination of the retina is focused on the same plane of the acquisition (same focus). Compared to traditional imaging, where the entire specimen is flooded evenly in light, a confocal illumination system is able to focus the illuminating light on the same focus plane (conjugate plane) of the acquisition optics. Another important characteristic of MAIA is the use of white light to illuminate the retina. The result of the combination of confocal imaging and white light obtained in MAIA is the acquisition of sharp, detailed, naturally colored retinal images. This medical device product has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this application, the product has also functions that are not subject to FDA premarket review; FDA assesses those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review. The "other function" of the device is the automatic perimetry (Product Code HPT, 510(K) Exempt), that allows the measurement of retinal threshold sensitivity and the analysis of fixation. This function consists in projecting light stimuli at different intensities together with a uniform light background; the device records the pressures of the pushbutton by the tested patient when he detects such stimuli, as in Standard Automated Perimetry test. With its retinal tracking, for all the duration of the exam, MAIA acquires infrared images of the retina and detects its movement, to correct the position for the stimuli, reducing the positioning error that might occur if the patient has poor fixation stability.

iCare ALTIUS CW is a Medical Device Software indicated for the review, processing and analysis of ophthalmic medical images, for the review of video, clinical and diagnostic data, measurements and reports, generated by ophthalmic medical devices or documentation system through computerized networks, to support trained healthcare professionals in the diagnosis and monitoring of several eye pathologies.

iCare ALTIUS CW is a cloud-based software application with a web-based interface able to: - review medical ophthalmic images, including videos, - digitally process images, - review diagnostic data, clinical information and reports, from ophthalmic diagnostic instruments. CW does not perform automated image analysis but provides advanced imaging manipulation tools. CW allows to review and process diagnostic data and multiple images with different formats (e.g. PDFS, JPEG, ...) and provides the following features: - image manipulation filters such as zooming, changing brightness and contrast and gamma, RGB filtering, - side-by-side image comparison (detached or synchronized mode) with different layouts, - advanced imaging tools, such as flicker between different pictures and mosaics of several images, - review and print reports generated by ophthalmic devices. CW integrates with PACS software systems, which provide the medical images and reports, to be analysed by the CW. The patient data and medical images exchange between CW and PACS is done through computerized networks using secured network communication. The web-based interface of CW is designed to be used through a desktop PC or a laptop using keyboard and mouse (further details in the technical requirements section). The User Interface is available in the languages required by the applicable regulatory requirement of the country where the device is placed on the market.

The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color and infrared imaging of a human retina without the use of a mydriatic agent.

The CenterVue DRSplus with Software version 2.0 is a modification of the CenterVue DRSplus (K192113). The DRSplus (K192113) is a scanning ophthalmoscope which uses infrared and white light to obtain confocal images of the retina, without pharmacological dilation. With respect to the previous cleared device, DRSplus with software version 2.0 (subject of this submission) provides one additional software feature that enable to acquire, store and review infrared retinal images, in addition to color and red-free photos which were the only imaging modalities of the previously cleared device. This feature does not require any hardware modification, because the infrared illumination is already present in the previously cleared device: in fact, the infrared retinal pictures were automatically taken by the device for alignment and focusing purposes, but they were not presented in the patient's image collection. In the proposed device modification, the user can decide to acquire also infrared pictures that are stored and displayed amongst the other, color and red-free images. The modified device uses the same base technology and maintains the same Intended Use of the previously cleared device; the Indications for Use of the modified device are amended to add the infrared imaging modality. The fundamental scientific technology of the device is unchanged from the previously cleared device and remains confocal, line scanning, LED-based, imaging.

The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared and autofluorescence imaging and fluorescein angiography of a human retina with or without the use of a mydriatic agent.

The CenterVue EIDON FA with Software version 4.0 and Ultra Widefield Lens is a modification of the CenterVue EIDON FA (K180526). The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared and autofluorescence imaging and fluorescein angiography of a human retina with or without the use of a mydriatic agent. CenterVue EIDON FA (K180526) is a scanning ophthalmoscope white light to obtain color images of the retina, infrared light to obtain infrared-reflectance images of the retina, and blue light to obtain autofluorescence and fluorescence images. The CenterVue EIDON FA is part of a family of devices, which includes three models: EIDON FA, EIDON AF, and EIDON. EIDON is the base model, which features the following imaging modalities: infrared reflectance, color and red-free. EIDON AF adds autofluorescence imaging to the base model. EIDON FA is the fully featured device, which adds fluorescein angiography to the capabilities of the EIDON AF and encompasses the features and functionality of the other models. With respect to the CenterVue EIDON FA, EIDON FA with software version 4.0 provides additional features to acquire retinal images with the Ultra Widefield Lens. The optional Ultra Widefield Lens increases the field of view of the devices from 60° to 80°. All the features related to the acquisition without the Ultra Widefield Lens are unchanged. The modified devices use the same base technology and maintains the same Intended Use and Indications for Use of the predicate device. The fundamental scientific technology of the subject device is unchanged from the predicate and remains confocal, line scanning, LED-based, imaging. The functional differences between EIDON FA and EIDON FA with software version 4.0 are as follows: EIDON FA with software version 4.0 allows to capture retinal picture with an increased field of view, from 60° to 80° to allow the user to view a greater proportion of the posterior eye in one view. EIDON FA with software version 4.0 allows to capture Ultra Widefield images with the same modalities of the unmodified device, namely: color images, infrared-reflectance images, autofluorescence images and fluorescence images. No technological differences between EIDON FA and EIDON FA with SW version 4.0 exist. The modified device can be used with or without the Ultra Widefield Lens. The technological principle of retinal acquisitions remains the same in the modified device. The device software has been modified to implement the acquisition and management of images taken with the Ultra Widefield Lens. The EIDON UWFL – Ultra Widefield Lens accessory is composed of a lens doublet, assembled in a custom lens holder, which can be mounted on the standard objective of the parent device by means of an incorporated threaded ring to increase the field of view of the parent device from 60° (standard objective) to 80° (with UWFL). The CenterVue EIDON UWFL – Ultra Widefield Lens is an optional accessory to extend the field of view of the CenterVue EIDON, EIDON AF and EIDON FA from 60° to 80°. It is indicated for color, infrared and autofluorescence imaging and fluorescein angiography of a human retina with or without the use of a mydriatic agent. The principle of operation of the EIDON UWFL is an increase of the standard objective to achieve a greater field of view. The mechanism of action and the conditions for use are the same of the predicate device. Other than the above, no differences exist between the EIDON FA with Ultra Widefield Lens, in particular the principle of operation, mechanism of action and interaction with the patient are unchanged.

The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color imaging of a human retina without the use of a mydriatic agent.

The DRSplus is a scanning ophthalmoscope which uses infrared and white light to obtain confocal images of the retina, without pharmacological dilation. The DRSplus operates as a standalone unit, running a dedicated software application, is intended for prescription use only, and includes: 1. an optical head; 2. a patient forehead rest; 3. a display; 4. a base; 5. a stand. The CenterVue DRSplus operates based on the following principles: a) An illumination system consisting of infrared (IR) LEDs, white LEDs and a green LED illuminates the patient eye with the following functions: · the IR LED allows the capture of IR photos, which are used for alignment and focusing purposes. The patient's retina is uniformly illuminated by a line in the horizontal direction. Along the optical path there is an oscillating mirror which scans the line in order to illuminate the retina. · Two IR LEDs are seen from the eye in a free viewing system. The two LEDs are equally shifted with respect to the machine's optical axis. The LEDS are switched on during all exams in order to enable pupil tracking. · The white LEDs allow the capture of color photos. The retina is uniformly illuminated by a line in the horizontal direction. Along the optical path an oscillating mirror scans the line in order to illuminate the retina. · The green LED is used as fixation target. b) An imaging system collects back-reflected light from the retina and creates a high-resolution image. A focusing lens is included in the imaging path to achieve optimal retinal focusing on a CMOS camera. c) An anterior segment alignment system is included, using two cameras and the two IR LEDs. The LEDs illuminate the anterior segment by diffusion, whereas the cameras allow a stereoscopic reconstruction of the pupil's position to be obtained with respect to the instrument's frontlens. The DRSplus interacts with the patient by directing infrared, white (for imaging) and green (for fixation) illumination into the patient's eye. The only part of the only part of the device that contacts the patient.

The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared and autofluorescence imaging and fluorescein angiography of a human retina with or without the use of a mydriatic agent.

The CenterVue EIDON FA has been derived from the CenterVue EIDON, a retinal imaging device cleared under K142047. EIDON FA is a scanning ophthalmoscope which uses LED light to capture confocal images of the retina. In particular, EIDON FA uses infrared light to obtain infraredreflectance images, white light to obtain color images and blue light to obtain auto-fluorescence and fluorescence images. EIDON FA can be used with or without pharmacological dilation. The CenterVue EIDON FA is part of a family of devices, which includes three models: EIDON FA, EIDON AF, and EIDON. EIDON is the base model, which features the following imaging modalities: infrared reflectance, color and red-free. EIDON AF adds autofluorescence imaging to the base model. The EIDON FA is the fully featured device, which adds fluorescein angiography to the capabilities of the EIDON AF and encompasses the features and functionality of the other models. EIDON FA operates as a standalone unit, running a dedicated software application, is intended for prescription use only, and includes: 1. an optical head, including a removable lens cap; 2. a patient head-rest, including a removable front-rest; 3. a patient chin rest; 4. a base, including a touch-screen device (tablet with magnetic holder and USB cable), USB joystick and an external power supply. EIDON FA operates based on the following principles: a) An illumination system consisting of an infrared (IR) LED (825-875 nm and 940 nm), a white LED (440-650 nm), a blue LED (440-475 nm) and a green LED, illuminates the patient eye with the following functions: - the IR LED with central wavelength at 850 nm allows the capture of IR photos. The patient's retina is uniformly illuminated by a line in a horizontal direction. Along the optical path there is an oscillating mirror which scans the line in order to illuminate the retina with a field of view of 60°. - Two IR LEDs with central wavelength at 940 nm are seen from the eye in a free viewing system. The two LEDs are equally shifted with respect to the machine's optical axis. The LEDS are switched on during all exams in order to enable pupil tracking. - The white and blue LEDs allow the capture of color photos. The retina is uniformly illuminated by a line in the horizontal direction. Along the optical path an oscillating mirror scans the line in order to illuminate the retina with a field of view of 60°. - The blue LED is also used to capture auto-fluorescence and fluorescence retinal images; - The green LED is used as fixation target. b) An imaging system including a barrier filter (high-pass with a cutoff at 500 nm) stops back reflected light from the retina and allows fluorescent light to be detected for imaging. A focusing lens is included in the imaging path to achieve optimal focusing on a CMOS camera. c) An anterior segment alignment system is included, using two cameras and the two IR LEDs. The LEDs illuminate the anterior segment by diffusion, whereas allow a stereoscopic reconstruction of the pupil's position to be obtained with respect to the instrument's front lens. EIDON FA interacts with the patient by directing infrared, white, blue (for imaging) and green (for fixation) illumination into the patient's eye. The chin-rest and head-rest are the only parts of the device that contact the patient. The chin-rest includes a patient proximity sensor and is motorized for height adjustment.

The CenterVue RETIA 2 is a confocal scanning ophthalmoscope indicated for infrared and auto-fluorescence imaging of a human retina with or without the use of a mydriatic agent.

The CenterVue RETIA 2 is a modification of the CenterVue EIDON (K142047). RETIA 2 is a scanning ophthalmoscope which uses infrared light to obtain infrared-reflectance images of the retina and blue light to obtain auto-fluorescence images of the retina. RETIA 2 operates as a standalone unit, running a dedicated software application, intended for prescription use only, and includes: 1. Optical head, including a removable lens cap; 2. Patient head-rest, including removable front-rest; 3. Patient chin rest; 4. Base, including touch-screen device (tablet with magnetic holder and USB cable), USB joystick and an external power supply. RETIA 2 operates based on the following principles: a) An illumination system consisting of infrared LEDs (850nm, 940nm), a blue LED (450nm) and a green LED illuminates the patient eye with the following functionality: - The IR LED with a centroid wavelength of 850 nm allows the capture of IR photos. The patient's retina is uniformly illuminated by a line in a horizontal direction. An oscillating mirror scans the line in order to illuminate the retina with a field of view of 60°. - Two IR LEDs with a centroid wavelength of 940 nm are seen from the eye in a free viewing system. The two LEDs are equally shifted with respect to the machine's optical axis. The LEDS are switched on during all exams in order to enable pupil tracking. - . The blue LED (450 nm) is used to illuminate the retina and capture fluorescence retinal images. The retina is uniformly illuminated by a line in a horizontal direction. An oscillating mirror scans the line in order to illuminate the retina with a field of view of 60°. - The green LED is used as fixation target. b) An imaging system including a barrier filter (high-pass with a cutoff at 500 nm) stops back-reflected light from the retina and only allows fluorescent light to be detected for imaging. A focusing lens is included in the imaging path to achieve optimal retinal focusing on a CMOS camera having a resolution of 5 megapixels. c) An anterior segment alignment system is included, using two cameras and the two IR LEDs. The LEDs illuminate the anterior segment by diffusion, whereas the cameras allow a stereoscopic reconstruction of the pupil's position to be obtained with respect to the instrument's front lens. RETIA 2 interacts with the patient by directing infrared- and blue-wavelength illumination for imaging purposes and green illumination for fixation purposes into the patient's eye. The chin-rest are the only parts of the device that contact the patient. The chin-rest includes a patient proximity sensor and is motorized for height adjustment.

The Centervue MAIA is intended for: • measuring macular sensitivity, • measuring fixation stability and the locus of fixation, • providing infrared retinal imaging, and • aiding visual rehabilitation. It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.

A previous version of the CenterVue MAIA, a device for macular integrity assessment, has been cleared by FDA under K133758 on 23 April 2014. The present submission relates to a revised version of the MAIA device in which the only difference between the subject device and the MAIA device cleared under K133758 is in the software, where a new function called "Fixation Training" (FT) has been introduced to aid visual rehabilitation of patients with unstable fixation. The FT is independent from the functions available in the device cleared under K133758 and it does not interfere or modify the original functions in any way. No other design changes are being introduced by this revision to the MAIA device. The FT is intended for visual rehabilitation, to help Vision Rehabilitation Specialists train patients with unstable fixation to improve their fixation stability. A FT session consists of asking the patient to move his/her gaze according to the trainer's instructions and to an audible signal, so to attempt fixation of the internal visual target using a specific retinal area, which is identified by the trainer ahead of the training session. The center of such area is called Fixation Training Target (FTT). During the FT session, the MAIA retinal tracker continuously determines the position of the fixation point and provides an audible feedback to the patient in the form of pulses of a certain repetition frequency. The number of pulses / sec (i.e. the repetition frequency) is inversely proportional to the distance between the patient's fixation point at that time and the FTT; when such distance falls below one degree, the sound becomes continuous. Optionally, before starting the FT session, operators are able to replace the continuous sound with an MP3 audio file. The MAIA device interacts with the patient by directing illumination into the patient's eye. The chin-rest and head-rest are the only parts of the device that contact the patient. The chin-rest includes a patient proximity sensor and is motorized for height adjustment. The biocompatibility of the patient-contacting materials, which are the same as used in the previous version of the subject device (K133758) has been established. The MAIA device operates as a 'stand-alone' device and does not need to interface with other medical devices.

The CenterVue COMPASS is intended for taking digital images of a human retina without the use of a mydriatic agent and for measuring retinal sensitivity, fixation stability and the locus of fixation. It contains a reference database that is a quantitative tool for the comparison of retinal sensitivity to a database of known normal subjects.

The CenterVue COMPASS is a scanning ophthalmoscope combined with an automatic perimeter that allows the acquisition of images of the retina, as well as the measurement of retinal threshold sensitivity and the analysis of fixation. The device works with a dedicated software application, operates as a standalone unit, integrates a dedicated tablet, a joystick, a push-button and is provided with an external power supply. COMPASS operates in non-mydriatic conditions, i.e. without the need of pharmacological dilation and is intended for prescription use only. The Centervue COMPASS device operates on the following principles: - An anterior segment alignment system is included, which uses two infrared LEDs with a centroid wavelength of 940 nm and two cameras, whereas the former illuminate the external eye by diffusion and the latter allow a stereoscopic reconstruction of the pupil's position, used for automated alignment purposes via pupil tracking; - An infrared imaging system captures live monochromatic images of the central retina over a circular field of view of 60° in diameter, by an horizontal line from an infrared LED with a centroid wavelength of 850 nm and by an oscillating mirror which scans the line to uniformly illuminate the retina; such images are in turn used for auto-focusing purposes and to track eye movements, providing a measure of a patient's fixation characteristics and allowing active compensation of the position of perimetric stimuli; - A concurrent color imaging system allows the capture of color images of the central retina over a circular field of view of 60° in diameter, using a white LED and a blue LED combined to obtain a white light illuminating the retina by the same scan mechanism; - A fixation target projecting onto the retina a fixation target obtained from a green LED; - A stimuli projector, projecting onto the retina white light Goldmann stimuli at variable intensity and allowing measurements of threshold sensitivity at multiple locations, according to a patient's subjective response to the light stimulus projected at a certain location. The COMPASS device interacts with the patient by directing infrared, white, blue and green wavelength illumination into the patient's eye and by recording a patient's confirmation that a certain light stimulus has been perceived or not.

The CenterVue EIDON is intended for taking digital images of a human retina without the use of a mydriatic agent.

The CenterVue EIDON scanning ophthalmoscope operates as a standalone unit, running a dedicated software application, intended for prescription use only, and includes: 1. Optical head, including a removable lens cap; 2. Patient head-rest, including removable front-rest; 3. Patient chin rest; Base, including touch-screen device (tablet with magnetic holder and USB cable), USB joystick 4. and an external power supply. EIDON uses infrared and visible light to obtain colored confocal digital images of a human retina without a mydriatic agent. The CenterVue EIDON device operates on the following principles: a) An illumination system consisting of infrared (IR) LEDs (850nm, 940nm), a white LED, a blue LED and a green LED illuminates the patient eye with the following functionality: - The IR LED with a centroid wavelength of 850 nm allows the capture of IR photos. The patient retina is uniformly illuminated by a line in a horizontal direction. Along the optical path there is an oscillating mirror which scans the line in order to illuminate the retina with a field of view of 60°. - Two IR Leds with a centroid wavelength of 940 nm are seen from the eye in a free viewing system. The two LEDs are equally shifted with respect to the machine optical axis. The LEDS are switched on during all exams in order to enable pupil tracking. - The white and blue LEDs allow the capture of color photos. The retina is uniformly illuminated by a line in a horizontal direction. Along the optical path there is an oscillating mirror which scans the line in order to illuminate the retina with a field of view of 60°. - The green LED is used as fixation target. b) An imaging system collects back-reflected light from the retina and creates a high resolution image. A focusing lens is included in the imaging path to achieve optimal retinal focusing on a CMOS camera having a resolution of 14 megapixels. c) An anterior segment alignment system is included, using two cameras and the two IR LEDs: the LEDs illuminate the anterior segment by diffusion, whereas allow a stereoscopic reconstruction of the pupil's position to be obtained with respect to the instrument front lens. The EIDON device interacts with the patient by directing infrared, white, blue and green wavelength illumination into the patient's eye. The chin-rest and head-rest are the only parts of the device that contact the patient. The chin-rest includes a patient proximity sensor and is motorized for height adjustment.