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The CLARUS 700 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structures of the retina and the choroid.

The CLARUS 700 is an active, software controlled, high resolution ophthalmic imaging device for In-vivo imaging of the human eye. Imaging modes include True color, Fundus Auto-fluorescence with green excitation, Fundus Auto-fluorescence with blue excitation, Fluorescein Angiography, Stereo External eye and Fluorescein Angiography- Indocyanine green angiography (FA-ICGA). All true color images can be separated into red, green and blue channel images to help enhance visual contrast of details in certain layers of the retina. The CLARUS 700 angiography imaging aids in the visualization of the vascular structures of the retina and the choroid. With a single capture, CLARUS 700 produces a 90º high definition widefield image. Widefield images are automatically merged to achieve a 135º ultra-widefield of view. The CLARUS 700 makes use of a deep learning algorithm for Optic Nerve Head (ONH) detection. The ultra-widefield montage on CLARUS 700 is no longer dependent just on the patient accurately fixating their gaze on the internal fixation. With the ONH detection, the software will find the optic nerve and determine based on the image(s) captured where the patient was gazing at the point of capture. The CLARUS 700 device allows clinicians to easily review and compare high-quality images captured during a single exam while providing annotation and caliper measurement tools that allow in-depth analysis of eye health. CLARUS 700 is designed to optimize each patient's experience by providing a simple head and chin rest that allows the patient to maintain a stable, neutral position while the operator brings the optics to the patient, facilitating a more comfortable imaging experience. The ability to swivel the device between the right and left eye helps technicians capture an image without realigning the patient. Live IR Preview allows the technician to confirm image quality and screen for lid and lash obstructions, prior to imaging, ensuring fewer image recaptures. The CLARUS 700 device's principle of operation is Slit Scanning Ophthalmic Camera also referred to as Broad Line Fundus Imaging (BLFI). During image capture, a line of illumination passes through the slit and scans across the retina. A 2D monochromatic camera captures the returned light to image the retina. A single sweep of the illumination is used to illuminate the retina for image capture. Repeated sweeps of near infrared light are used for a live retina view for alignment. Red, green and blue LEDs sequentially illuminate to generate true color images. Blue and green LED illumination enables Fundus Autofluorescence (FAF) imaging. Fluorescein Angiography images are captured with green LED illumination at a wavelength that stimulates fluorescence of the injected sodium fluorescein dye. The principle of operation of CLARUS 700 has not changed since the previous clearance, K191194. The CLARUS 700 system is mainly comprised of an acquisition device, all-in-one PC, keyboard, mouse, instrument lift table and external power supply. The device hardware is based on the predicate CLARUS 700 (K191194) hardware. The new ICGA imaging mode on the device required the following hardware changes as stated in the summary above: - Lightbox for Infrared (IR) Laser - Modified Slit filter – FA/ICG Slit Excitation Filter – new coating, no change to FA - Modified Turret Filter 1- FA/ICG Dual Band barrier filter – new coating, no change to FA. - Added Turret Filter 2 – Added second filter. Same coating as Turret Filter 1 to eliminate cornea reflex band in ICG images with a different shape. - Added Large Alignment Tool (LAT) - Added ICG Power Meter Tool The CLARUS software provides the user the capability to align, capture, review and annotate images. The software has two installation configurations: Software installed on the Instrument (Acquisition & Review) as well as Software installed on a separate 'Review Station' (Laptop or Computer) (only Review). The DEVICE software version 1.2 is based on the predicate CLARUS 700 software version 1.0 (K191194). Added capability for DEVICE software version 1.2 include: - **Simultaneous capture of Fluorescein Angiography (FA) + Indocyanine Green Angiography (ICGA)** - **Angiography Movie:** Capture of multiple pictures in sequence, after a single press of a button. Available for FA, ICGA and Simultaneous FA+ICGA. - **Early Treatment Diabetic Retinopathy Study (ETDRS)** – Manual placement of ETDRS grids (7 field ETDRS and Macula ETDRS) over the pictures: - The ETDRS 7-fields grid in CLARUS is a display of the standard 7-fields in Color Fundus Photography used to determine an ETDRS (Early Treatment Diabetic Retinopathy Study) level for patients with Diabetic Retinopathy. These 7-fields in and around the macular region are displayed in one single widefield image according to definitions followed by the gold-standard 7-field images using narrow-field fundus cameras. - The Macular ETDRS grids display assists in the identification of an ETDRS level in nine subfields centered around the fovea. - **ICGA Boost Mode:** user-selectable option for ICGA capture that increase used light to obtain better picture at later phase. - **8 up view:** addition of the possibility to view eight pictures side by side (currently it is only possible to see 1, 2, 4, 16) The CLARUS 700 device meets the requirements of ISO 10940:2009 standard. The device technical specifications are identical to the predicate device.

CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for invivo viewing, axial cross-sectional, and three-dimensional imaging of anterior ocular structures. The device is indicated for visualizing and measuring and posterior ocular structures, including corneal epithelium, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The CIRRUS normative databases are quantitative tools indicated for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of normal subjects. CIRRUS' AngioPlex OCT Angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid. (Model 5000 only.) CIRRUS HD-OCT is indicated as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

The CIRRUSTM HD-OCT is a computerized instrument that acquires and analyses crosssectional tomograms of anterior and posterior ocular structures (including cornea, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this non-invasive optical technique, CIRRUS HD-OCT 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). The CIRRUS HD-OCT is offered in two models, Model 5000 and 500. In the CIRRUS HD-OCT Model 5000, the fundus camera is a line scanning ophthalmoscope. The CIRRUS HD-OCT Model 500 is similar to the Model 5000 except that it provides the fundus image using the OCT scanner only. The acquired imaging data can be analyzed to provide thickness and area measurements of regions of interest to the clinician. The system uses acquired data to determine the fovea location or the optic disc location. Measurements can then be oriented using the fovea and/or optic disc locations. The patient's results can be compared to subjects without disease for measurements of RNFL thickness, neuroretinal rim area, average and vertical cup-to-disc area ratio, cup volume, macular thickness and ganglion cell plus inner plexiform layer thickness. In addition to macular and optic disc cube scans, the CIRRUS HD-OCT 5000 also offers scans for OCT angiography imaging, a non-invasive approach with depth sectioning capability to visualize microvascular structures of the eye. Anterior segment scans enable analysis of the anterior segment including Anterior Chamber Depth, Angle-to-Angle and automated measurement of the thickness of the cornea with the Pachymetry scan.

The CLARUS 500 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view.

The CLARUS™ 500 is an active, software controlled, high-resolution ophthalmic imaging device for In-vivo imaging of the human eye. Imaging modes include True color, Fundus Autofluorescence with green excitation, Fundus Auto-fluorescence with blue excitation, Stereo and External eye. All true color images can be separated into red, green and blue channel images to help enhance visual contrast of details in certain layers of the retina. With a single capture, CLARUS 500 produces a 90° high definition widefield image. Widefield images are automatically merged to achieve a 135° ultra-widefield view. The technology allows clinicians to easily review and compare high-quality images captured during a single exam while providing annotation and caliper measurement tools that allow analysis of eye health. CLARUS 500 is designed to optimize each patient's experience by providing a simple head and chin rest that allows the patient to maintain a stable, neutral position while the operator brings the optics to the patient, facilitating a more comfortable imaging experience. The ability to swivel the device between the right and left eye helps technicians capture an image without realigning the patient. Live Infrared Preview allows the technician to confirm image quality and screen for lid and lash obstructions, prior to imaging, ensuring fewer image recaptures. The CLARUS 500 device's principle of operation is based on Slit Scanning Ophthalmoscope also referred to as Broad Line Fundus Imaging (BLFI). During image capture, a broad line of illumination is scanned across the retina. A monochromatic camera captures the returned light to image the retina. A single sweep of the illumination is used to illuminate the retina for image capture. Repeated sweeps of near infrared light are used for a live retina view for alignment. Red, green and blue LEDs sequentially illuminate to generate true color images. Blue and green LED illumination enables Fundus Autofluorescence (FAF) imaging. The CLARUS 500 system is mainly comprised of an acquisition device, all-in-one PC, keyboard, mouse, instrument lift table and external power supply. The CLARUS software provides the user the capability to align, capture, review and annotate images. The software has two installation configurations: Software installed on the Instrument (Acquisition & Review) as well as Software installed on a separate 'Review Station' (Laptop or Computer) (only Review). The CLARUS 500 technical features relevant to the user are: Field of View (FoV), Image Resolution, Pixel Pitch and Focusing Range. The device meets the requirements of ISO 10940:2009 standard. The performance specifications are summarized in the Table 1 below.

The VisuMax Femtosecond Laser is cleared for the following indications for use: · In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; · In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; · In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty; · In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting; · In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.

The VisuMax Femtosecond Laser is an ophthalmic surgical femtosecond laser intended for use in patients requiring corneal incisions. The cutting action of the VisuMax laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.

The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid. The PLEX™ Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The PLEX™ Elite 9000 SS-OCT is a computerized instrument that acquires cross-sectional tomograms of the posterior ocular structures (including cornea, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this non-invasive optical technique, the PLEX Elite SS-OCT 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-contrast angiographic imaging of the retinal microvasculature. The PLEX Elite 9000 SS-OCT is offered in one model, the Elite 9000 in a new compact desktop system. The PLEX Elite SS-OCT contains a swept source, Class 1 Laser system operating at 1060 nm and includes a new system computer and archive with up to 24 TB storage capacity. The PLEX Elite also contains an iris viewer, fixation system and the fundus camera is a similar line-scanning ophthalmoscope (LSO) as used on the CIRRUS HD-OCT system, model 4000.

The IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures: - Lens thickness - Corneal curvature and thickness - Axial length - Anterior chamber depth - Pupil diameter - White-to-white distance (WTW) For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain two-dimensional images of ocular structures of the anterior and posterior segments of the eye. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.

The IOLMaster 700 device is a computerized biometry device consisting of an OCT system, a Keratometer system, and a camera for the purposes of: - measuring distances within the human eye along the visual axis (e.g. axial length, lens thickness, anterior chamber depth), - measuring the corneal surface with a keratometer, - measuring distances at the front of the eye with a camera (e.g. white-to-white distance). The IOLMaster 700 is used for visualization and measurement of ocular structures mainly required for the preparation of cataract surgeries to calculate the refractive power of the intraocular lens (IOL) to be implanted. The IOLMaster 700 device includes a swept source frequency domain optical coherence tomography (OCT) module capable of acquiring tomograms of the eye. The axial measurements are based on those tomograms. The IOLMaster 700 device is operated via multi touch monitor and alternatively with computer mouse and keyboard. A joystick on the measuring head is used for manual alignment of the device to the patient's eye.

The INTRABEAM® System is indicated for radiation therapy treatments. The INTRABEAM® Spherical Applicators are indicated for use with the INTRABEAM® System to deliver a prescribed dose of radiation to the treatment margin or turnor bed during intracavity and intraoperative radiotherapy treatments. The INTRABEAM® Spherical Applicators used with the INTRABEAM System are able to deliver a prescribed dose of intraoperative radiation in conjunction with whole breast irradiation, based upon the medical judgment of the physician. The safety and effectiveness of the INTRABEAM System as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.

The INTRABEAM System is a miniature, high-dose rate, low energy X-ray source that emits Xray radiation intraoperatively for the treatment of cancer at the tumor cavity. The INTRABEAM Spherical applicators are accessories to the INTRABEAM System. The INTRABEAM Spherical Applicators received 510(k) clearance in K992577. There are eight sizes of applicators in a set ranging from 1.5 cm to 5.0 cm in diameter. The INTRABEAM Spherical Applicators have not changed in design or technological characteristics as described in K992577.

FORUM is a software system application intended for use in storing, managing, and displaying patient data, diagnostic data, videos and images from computerized diagnostic instruments or video documentation systems through networks.

FORUM is a personal computer software system designed for storage, retrieval, and review of DICOM images, videos and reports originating from ophthalmic instruments and surgical microscopy. FORUM consists of two components: the FORUM Archive and the FORUM Viewer. The FORUM Archive, which contains both a server and client application, provides an archive for storage and administration of medical documents and patient data. The FORUM Viewer is an additional module to the client application which allows images, reports and videos stored in the archive to be reviewed. The FORUM Viewer also includes a modality worklist scheduling function. When utilized together, the FORUM Archive and Viewer provide a complete workflow cycle from administering patient information via scheduling patients for examinations on connected instruments, through archiving the results of the examinations to retrieval and review of examination data.