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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 Bioptigen EnFocusTM device is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT). The EnFocusTM is indicated for use as an aid in the visualization of physiologic conditions of the eye through non-contact optical imaging. It is indicated for use on patient promotions from premature and neonant lintants to adult. The system is indicated for use in supine imaging, mounted to a superiod microscope, with coperative patients or patients under anesthesia.

The EnFocus™ is a non-contact, noninvasive ophthalmic imaging device that includes an OCT Engine, a scan head, a System Computer, an Uninterruptible Power Supply (UPS), a mobile Security Cart and the System Software. The EnFocus™ uses Spectral Domain Optical Coherence Tomography (SD-OCT) and a near infrared light source to image ocular tissue microstructures. The EnFocus is coupled to a surgical micrsoscope for OCT imaging during ophthalmic surgical procedures. The EnFocus has been validated and found to be compatible for use with the Leica M844 Surgical Microscope and the Insight Instruments Super View™ Wide Angle Viewing System™ for retina visualization. The software, InVivoVue™ Version 2.6, works with the hardware and the hardware controller to offer intuitive, flexible system control for high-speed volume data acquisition and imaging. The EnFocus™ system includes two OCT-compatible objective lenses for use with the surgical microscope: a 175mm lens and 200mm lens. The system also offers a choice of accessory masks that may be deployed in the Leica M844 filter port to manage illumination glare artifacts when necessary. Using the EnFocus™, OCT imaging may be acquired during the surgical procedure, without stopping a procedure or repositioning the surgical microscope. The surgical microscope position is stationary relative to the surgical procedure, and the surgical view is unaltered by the scanning of the OCT beam.

OptoMedical Technologies OCT-Camera is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT). The OCT-Camera is indicated for the use as an aid in the diagnosis of physiologic conditions of the eye through non-contact optical imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on patient populations from premature and neonatal infants to adult, and is suitable for patients ambulatory or confined. The system is indicated for use in supine imaging, mounted to a surgical microscope HS Hi-R NEO 900A NIR (Haag-Streit), and is suited for imaging patients under anesthesia.

The OCT-Camera can be attached to the camera port of surgical microscopes. The OCT-Camera is completely integrated into the surgical procedure by enabling the OCT imaging before, during, and after microsurgery without disrupting the microscopic view. The individual steps and the outcome of the surgical procedures, such as transplantation of the thin membranes or micro implants, are visualized in real time. The OCT-Camera by OptoMedical Technologies GmbH facilitates the intraoperative use of OCT (iOCT). It is called OCT-Camera because it can be attached to the camera port of an operating microscope like any common camera that are used for the purpose of providing live view images of the surgical field.

Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-adapter powered or rechargeable battery powered device for medical professionals containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye

The Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-powered or rechargeable battery-powered indirect ophthalmoscope that complies with standard ISO 10943:2012, Ophthalmic Instruments - Indirect Ophthalmoscopes. The Propper Insight 100 is a Binocular Indirect Ophthalmoscope (abbreviated - BIO), worn on the medical professional's head containing illumination and viewing optics intended to examine the media and the retina of the eye when used in conjunction with an ophthalmic lens. The illumination part of the Propper Insight™ Binocular Indirect Ophthalmoscope consists of a LED (Light Emitting Diode) source, lenses, a selection of red-free, amber and cobalt blue filters, three sizes of light apertures, diffuser and illumination mirror. The device has optomechanical system for adjustment of illumination level, which is based on the relative positions of two polarizer filters. The viewing part consists of viewing lenses, and mirrors that are adjustable to obtain views of the patient eye fundus. The illumination part and the viewing part are combined in the metal housing (BIO Module) which is attached to the headband with the pivot bracket mechanism. The attachment mechanism allows the BIO Module to be pivoted between in-use (down) and out-of-use positions (up). The attachment mechanism also allows adjustment of the BIO Module relative to the user's eyes for the most optimal viewing path. The attachment mechanism includes a magnetic securement of the BIO Module in both in-use and out-of-use positions. Part of the magnetic securement operates an electric contact to automatically provide power to the illumination source in the in-use position. The BIO Module and the power cable connector (AC-powered version), or the BIO Module and the rechargeable battery are attached to the adjustable headband.

The Macular Integrity Assessment (MAIA™) is intended for measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing infrared retinal imaging. It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.

MAIA™ integrates in one device an automated perimeter and an ophthalmoscope, providing: - images of the central retina over a field of view of 36° x 36°, acquired under infrared illumination and a confocal imaging set-up; - . recordings of eye movements obtained by "tracking" retinal details in the live retinal video, acquired at 25 fps, providing a measure of a patient's fixation capabilities; - . measurements of differential light sensitivity (or threshold sensitivity) at multiple locations in the macula, obtained as in fundus perimetry by recording a patient's subjective response (see / do not see) to a light stimulus projected at a certain location on the retina; MAIA™ works with no pupil dilation (non-mydriatic). MAIA™ integrates a computer for control and data processing and a touch-screen display and it is provided with a power cord and a push-button. MAIA™ works with a dedicated software application running on a custom Linux O.S. MAIA is composed of: - 1. An optical head; - 2. A chin-rest and head-rest; - 3. A base, including a touch-screen display. The optical head comprises: - An infrared source at 845 nm (SLD) 1. - 2. A line-scanning confocal imaging system of the retina. The line, generated by means of an anamorphic lens, is scanned on the retina while the back-reflected light is de-scanned and revealed by a linear CCD sensor; - 3. A projection system comprising visible LEDs to generate Goldmann stimuli and background at controlled luminance values; - A fixation target in the shape of a red circle (two different dimensions available); 4. - 5. An auto-focus system. The base of the MAIA includes: - 1. A 3-axis robot that moves the optical head; - 2. An embedded PC that hosts the control software and related interface ports; - 3. The power supply.

An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.

The ophthalmoscope is an AC powered hand-held device containing illumination and viewing optics to examine the cornea, aqueous, lens, vitreous, and the retina of the eye.

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 indirect ophthalmoscope HEINE OMEGA® 500 is an AC-powered or battery powered device for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.

The HEINE OMEGA® 500 is an indirect ophthalmoscope, worn on the user's head to provide illumination and viewing optics in order to examine the retina of a patient's eve. The ophthalmoscope can be operated either by rechargeable battery or directly by mains power supply. The HEINE OMEGA® 500 allows wireless comfortable movement for the user and mobile charging (depending on chosen power source).

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.

Bioptigen Envisu™ Spectral Domain Ophthalmic Imaging System (SDOIS) is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT). The Envisu SDOIS is indicated for use as an aid in the diagnosis of physiologic and pathologic conditions of the eye through non-contact optical imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on patient populations from premature and neonatal infants to adult, and is suitable for patients ambulatory or confined. The system is indicated for use in upright or supine imaging, handheld or mounted, and is suited for imaģing patients under anesthesia.

The Envisu™ SDOIS is a non-contact, non-invasive and mobile ophthalmic imaging device that can be used to view ocular tissue physiology and pathology through the interaction of light with the optical scattering properties of structures of the eye. Like its predicate, the Envisu™ Spectral Domain Ophthalmic Imaging System (SDOIS) is a nearinfrared scanning imaging medical device designed to capture depth-resolved images of ocular tissue microstructure. It is available in "high (HR)" and "very-high (VHR)" resolution based on the SLED light source chosen. Each option includes an optical engine, a scanning head, an interchangeable lens set, a computer and the InVivoVue™ Clinic software for imaging of ocular tissue microstructures. The smaller system footprint and mobile security cart easily accommodate any clinical environment. The optical engine includes a low power broadband LED light source with bandwidths of 40 - 100 nm operating in the wavelength range between 760 - 930 nm and a spectrometer that detects backscattered radiation. The scanning head is flexibly designed to be used mounted or handheld for the mutual convenience and comfort of patient and ciinician. Handheld use of the light-weight (< 3.5 lbs), compact handheld scanner makes it possible to image pediatric patients, supine patients, or any patient that finds it difficult to sit upright or where it is clinically preferable to image without the constraint of a chin rest. Tabletop, chin-rest mediated imaging is enabled though a mounting accessory.