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SOLIX™ is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and the threedimensional imaging and measurement of anterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelium, corneal stroma, pachymetry, and anterior chamber of the eye. With the integrated reference database. SOLIX™ is also a quantitative tool for the comparison of the retinal nerve fiber layer, and optic disc measurements in the human eye to a database of known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases. The SOLIX™ with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects with glaucoma and retinal diseases. The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects with glaucoma and retinal diseases. The non-mydriatic color fundus camera of SOLIX™ is an integrated non-contact. high resolution digital imaging component which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The SOLIX™ fundus camera component is indicated for in-vivo viewing of the posterior and external area of the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.

SOLIX is a computer-controlled, ophthalmic imaging system with combined spectral-domain optical coherence tomography (SD-OCT) and non-mydriatic, digital fundus camera. The SD-OCT employs non-invasive, non-contact, low coherence interferometry to acquire crosssectional tomograms of the anterior and posterior segment of the eye and motion-contrast images of the retinal microvasculature (i.e., OCT "angiography" [OCTA]). The fundus camera produces color internal and external ocular images.

The Avanti is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and threedimensional imaging and measurement of anterior ocular structures, including retina, retinal netve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelia, corneal stroma, pachymetry, corneal power, and anterior chamber of the eye. With the integrated normative database, Avantitative tool for the comparison of retinal nerve fiber layer, and optic disc measurements in the human eye to a database of a known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases. The Avanti with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects with glaucoma and retinal diseases. The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects with glaucoma and retinal diseases.

The Avanti is a computer-controlled ophthalmic imaging system that acquires cross-sectional tomograms of the anterior and posterior ocular structures (including cornea, anterior chamber angle, retina, ganglion cell complex, retinal nerve fiber layer, and optic disc). It employs noninvasive, non-contact, low-coherence interferometry to obtain these high-resolution reflectance images and, by rapidly repeating the cross-sectional image at same location, to produce high resolution motion-contrast images of the retina microvasculature. Using this non-invasive optical technique, the Avanti produces high-resolution cross-sectional tomograms of the eye without contacting the eye. It also produces images of the retina and layers of the retina from an en face perspective (i.e., as if looking directly in the eye) and non-invasive angiographic imaging of the retinal microvasculature based on OCT angiography (OCTA). Qualitative analyses are provided for the cornea and layers of the cornea, the retina and layers of the retina, the optic disc and the nerve fiber layer, and the retinal microvasculature.

The iVue is a non-contact, high resolution tomographic imaging device. It is intended for in-vivo imaging, axial crosssectional, and three-dimensional imaging and measurement of anterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelia, corneal stroma and anterior chamber of the eye. With the integrated normative database, the iVue is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

The iVue is used to capture, store, display and print spectral domain-optical coherence tomography (SD-OCT) images of the posterior and anterior structure of the eye. The device software includes a Normative Database (NDB), consisting of OCT data from a range of known normal subjects that can be used to compare a new patient's measurements in relation to the normal distribution. iVue is a computer-controlled ophthalmic imaging system using either a laptop computer or "All-in-One" computer. For laptop systems there are two control box options of 120 or 230 volts. The control box interfaces between the motorized table column and the medical-grade power supply for the computer. iVue System Key Functional Components: - Scanner Head - Computer - Control Box - Joystick and Chinrest Assembly - Footswitch (optional) - Motorized Table (optional) - Cornea Adapter Module

The RTVue XR OCT Avanti with Normative Database is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disc as a tool and aid in the diagnosis and management of retinal diseases by a clinician. The RTVue XR OCT Avanti with Normative Database is also a quantitative tool for the comparison of retinal nerve fiber layer, and optic disk measurements in the human eve to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases. The RTVue XR OCT Avanti with AngioVue Software is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The RTVue XR OCT Avanti is a non-invasive diagnostic device for imaging the cornea, anterior chamber, and measurement of the retinal nerve fiber layer and optic disc with micrometer range resolution as a tool and aid in the diagnosis and management of retinal disease. Imaging and measurements include but are not limited to the internal limiting membrane (ILM), the retinal nerve fiber layer (RNFL), the ganglion cell complex (GCC), the retinal pigment epithelium (RPE), the outer retinal thickness, the total retinal thickness and optic disc structures including the cup and neuroretinal rim as an aid in the diagnosis and management of retinal disease. The measurements for the ILM and RPE are height measurements relative to the RPE reference plane. The RNFL, GCC and outer retinal thickness and total retinal thickness are thickness measurements where RNFL is the thickness of the RNFL layer, the GCC is the thickness from the ILM to the inner plexiform layer (IPL), the outer retinal thickness is the thickness from the IPL to the RPE, and total retinal thickness is the thickness from the ILM to the RPE. The RTVue XR OCT Avanti is a computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The computer has a graphic user interface for acquiring and analyzing the image. The line-scan camera operates at approximately 70,000 A-lines per second. The RTVue XR OCT Avanti offers three scan types: Retina, Glaucoma, and Cornea. For the cornea and anterior eye scans, a lens must be attached to the front of the device for proper scanning. This lens is called the CAM auxiliary attachment (Cornea Anterior Module). The CAM software module provides for menu selections in the graphical user interface, which are selected by the operator to label corresponding corneal landmarks instead of those of the retina. With the normative database (NDB), the RTVue XR OCT Avanti can compare the measured data from the GCC, the RNFL, the full retinal thickness, optic disc cup and optic disc rim measurements to the normative database. The device will provide the analysis information to he used as a clinical reference to aid in the diagnosis and management of ocular diseases. The RTVue XR OCT with AngioVue™ has an additional software module to aid in the visualization of vascular structures of the retina and choroid using a motion-contrast techniques without the need for intravenous dyes.

The iVue 500 with normative database is an optical coherence tomography system intended for in vivo imaging, axial crosssectional, three-dimensional imaging and measurement of anterior and posterior ocular structures. The iVue 500 with normative database is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population. (identical to predicate device)

The iVue 500 is a modification of its predicate device iVue with Normative Database (NDB) (K121739). The intended use, system performance, sub-assemblies, and key components of the iVue with NDB are all the same as the iVue with NDB. The intent of this redesign was to make the iVue a more compact desktop device, so it is more convenient to use and set-up in a typical office. Additionally operation via touchscreen or mouse driven technology, makes it simpler for a technician to use. The iVue 500 is a non-invasive device for imaging the cornea, anterior chamber, and retinal tissue structure with micrometer range resolution.

The iFusion connects the iCam (K122572) and iVue (K121739) devices via a sliding bracket mechanism (iShuttle), to facilitate switching between the two devices. The iShuttle provides position adjustment ability of the iCam or iVue device during use. The iFusion interfaces with the iCam and iVue devices to enable the operation of the iCam and iVue devices from one computer unit.

iFusion is a combination of the cleared iVue with NDB (K121739)("iVue") and the cleared iCam Fundus Camera (K122572)("iCam") on a shuttle platform, called the iShuttle. The iShuttle mounts to a joystick assembly using a central nut and bolt and four adjustable set screws. The iShuttle consists of a sliding metal plate supporting the iVue and the iCam. The iShuttle travels on tracks fitted to the X-Y-Z joystick assembly which helps position the iVue and the iCam devices. A release button is located at the front of the iShuttle to lock the iShuttle in position for the iVue and the iCam device. The iCam can be switched in position by pressing on the release button to unlock the iShuttle platform, then the iVue or the iCam can be pushed to slide to an opposite end until it is locked into position. In addition, the software of the iFusion system is created to allow the user to switch between the iVue and the iCam programs with the same computer. The iVue and the iCam programs use the same data communication and programming storage with a single shared database.

The iVue with Normative Database is an optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior ocular structures. The iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The i Vue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

iVue with Normative Database (NDB) is a modification of its predicate device iVue (K091404) through the inclusion of the database collected with the iVue. The intent of use, system performance, majority of sub-assemblies, and key components of the iVue with NDB are all the same as iVue and RTVue with NDB. iVue with NDB, based on the same Optical Coherence Tomography (OCT) technology that is used in the predicate device iVue (K091404) and RTVue with NDB (K101505), is a noninvasive diagnostic device for viewing the ocular tissue structure with micrometer range resolution. Both iVue and RTVue with NDB are designed and manufactured by Optovue, Inc. The device is currently cleared for in vivo imaging and measurement of the various retinal layers (K091404). The current submission is for a software modification through the addition of a normative database feature, similar to the NDB feature on the cleared predicate device RTV ue with NDB (K101505). With the addition of the normative database (NDB), the iVue can compare the measured data from the Retina Map scan, the Nerve Fiber scan, and the iWellness scan, to the normative database. The iVue/RTVue with Normative Database provide a comparison of the scanned measurements to a database of known normal subjects to provide a reference of where the patient's measurement stands in relation to the normative distribution. The iVue with normative database provides analysis information to be used as a clinical reference to aid in the diagnosis and management of ocular health and diseases. There is no hardware change from the 510(k) cleared iVue System (K091404). Additional scan patterns and acquisition of 3-D disc scan as ONH scan reference, optic disc analysis, and modification of the blood vessel extraction for the retina map scan are other software changes implemented in the current submission. These software changes are similar to features in the predicate RTVue device (K101505) and do not impact the safety and effectiveness of the system. The device scans a patient's eye and uses a low coherence interferometer to measure the reflectivity of the retinal and corneal tissue. The cross sectional B-scan of the retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The patient will rest their head on the forehead and chin rest while the operator uses a joystick to align the device to the patient's eve. The computer has a graphic user interface for acquiring and analyzing the image. iVue with NDB has similar scan patterns and analysis functions as the predicate device RTVue with NDB.

The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. iCam is indicated for in-vivo viewing of the posterior and external area of the eye and the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease.

The iCam is a non-mydriatic fundus camera for capturing, storing and displaying color fundus images with 1.3 MP @ 12 bits per color channel up to 45 degree (axial arc) field of view. It was designed to provide an acceptable area for broad range, high resolution viewing of most retinalbased and optic nerve pathologies. The design allows for the acquisition of high quality images that are of comparable quality to other predicate ocular cameras. The design incorporates the use of an LED light sources providing two advantages over the flash lamp light source of other cameras: 1) longer life expectancy of the LED compared to the typical Xenon flash lamp, and 2) reliability of solid state devices that allow for more reproducible light characteristics over time. The LED light source provides lower voltage operation, a higher efficiency overall and allows for smaller design of the system based on the relatively small size of the LEDs compared to the Xenon bulb. LED light source has a considerably longer lifespan than a Xenon light source, while emitting minimal heat compared to the heat generating Xenon source. The LED light source also reliability of solid state devices that allow for more reproducible image quality over time. Solid state devices that function via an on-or-off state are known to maintain light characteristics such as color temperature, lumens of output, and distribution of light. This characteristic of no demonstrable degradation results in more reproducible images over time.

The RTVue XR with Normative Database is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disc as a tool and aid in the diagnosis and management of retinal diseases by a clinician. The RTVue XR with Normative Database is also a quantitative tool for the comparison of retina, retinal nerve fiber laver, and optic disk measurements in the human eye to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases.

The RTVue XR is a non-invasive diagnostic device for imaging the cornea, anterior chamber, and retinal tissue structure with micrometer range resolution. The RTVue XR OCT is based on the same Optical Coherence Tomography (OCT) technology used in its predicate device, RTVue with NDB OCT. The RTVue XR is a computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of Ascans. It has a traditional patient and instrument interface like most ophthalmic devices. The computer has a graphic user interface for acquiring and analyzing the image. RTVue XR offers three scan types: Retina, Glaucoma, and Cornea. For the Cornea scan, a lens must be attached to the front of the device for proper scanning. This lens is called the CAM (Cornea Anterior Module-cleared under K111505). The upgrade of the line scan camera is designed to provide faster image acquisition. The RTVue XR is an updated version of RTVue with NDB that operates at ~70,000 A-lines per second while the RTVue-100 operates at ~27,000 A-lines per second. The RTVue XR machines will be equipped with new line-scan cameras capable of operating at ~70,000 Alines per second while delivering equivalent imaging results as the older generation RTVue line-scan cameras operating at ~27,000 A-lines per second.

The CA, an auxiliary lens adapter, when used in conjunction with RTVue, is indicated for in vivo imaging and measurement of the cornea and the other ocular structures of the anterior segment of the eve, including pachymetry and corneal power.

The already cleared (K071250) RTVue CA Module (CAM) is an instrument based on Fourier-Domain Optical Coherence Tomography (OCT) for in vivo imaging and measurement of the cornea and other ocular structures of the anterior segment of the eye with US FDA 510(k) clearance (K071250) in 2007. The RTVue CAM has been used in clinical practice for imaging the cornea, measuring corneal thickness, and visualizing the anterior segment angle. The RTVue CAM device uses the same Optical Coherence Tomography (OCT) technology that was previously cleared by FDA (K101505). The CAM adapter gives the user an option to use the RTVue device as previously approved for retina scans, or to use it for cornea and anterior eye scans. Aside from the CAM auxiliary attachment, the RTVue is virtually unchanged for the CAM use except the CAM software module provides for menu selections in the graphical user interface, which are selected by the operator to label corresponding corneal landmarks instead of those of the retina. The system scans a beam into patient's eye and uses a low coherence interferometer to measure the reflectivity of the ocular tissue. The cross-sectional ocular tissue structure is composed of sequence of A-scans. The RTVue has a traditional patient and instrumentinterface like most ophthalmic devices. The device is mounted on a motorized patient table. The patient will rest their head on the forehead and chin rest. The operator uses joystick to align the device to patient's eye. The computer has a graphic user interface for acquiring, and displaying the acquired image. The RTVue image acquisition speed and image resolution remain the same when used in conjunction with CAM.