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The EVA NEXUS™ Ophthalmic Surgical System is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic subretinal microinjection of gases or aqueous fluids. In addition, the optional laser is indicated for the following: | Condition | Treatment | |-------------------------------------------------------------------------------|----------------------------------| | Diabetic Retinopathy | | | • Proliferative Diabetic Retinopathy | • Panretinal Photocoagulation | | • Clinically Significant Macular Edema | • Focal or Grid Laser | | Retinal Tear and Detachments | Laser Retinopathy | | Lattice Degeneration | Retinal Photocoagulation | | Sub-retinal (choroidal) Neovascularization | Focal Laser | | Retinal Vascular Occlusion | | | • Neovascularization secondary to Brand or Central retinal vein occlusion | • Scatter Laser Photocoagulation | | • Chronic macular edema secondary to Branch or Central retinal vein occlusion | • Focal or Grid Laser | | Glaucoma | | | • Primary Open-angle | • Trabeculoplasty | | • Closed Angle | • Iridotomy or Iridoplasty |

The EVA NEXUS™ Ophthalmic Surgical System (EVA NEXUS) is a combined anterior and posterior procedure ophthalmic system that is modular in design and is identical in most respects to the recently cleared predicate EVA Ophthalmic Surgical System (K190875). EVA NEXUS (see Figures 1, and 2 for external views) is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, illumination, irrigation, lens emulsification and fragmentation, cautery, diathermy as well as photocoagulation.

The EVA Ophthalmic surgical system is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In addition, the optional laser is indicated for the following: | Condition: | Treatment: | |-------------------------------------------------------------------------------|--------------------------------| | Diabetic Retinopathy | | | * Proliferative Diabetic Retinopathy | Panretinal Photocoagulation | | * Clinically Significant Macular Edema | Focal or Grid Laser | | Retinal Tear and Detachments | Laser Retinopathy | | Lattics Degeneration | Retinal Photocoagulation | | Sub-retinal (choroidal) Neovascularization | Focal laser | | Retinal Vascular Occlusion | | | * Neovascularization secondary to Branch or Central retinal vein occlusion | Scatter Laser Photocoagulation | | * Chronic macular edema secondary to Branch or Central retinal vein occlusion | Focal or Grid Laser | | Glaucoma | | | * Primary Open-angle | Trabeculoplasty | | * Closed Angle | Iridotomy or Iridoplasty |

The EVA Ophthalmic Surgical System (EVA) is a combined anterior and posterior procedure ophthalmic system that was cleared by FDA in March, 2015 (K142877). The EVA is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, illumination, irrigation, lens emulsification and fragmentation, cautery, diathermy as well as photocoagulation. The purpose of this 510(k) is to obtain clearance for minor improvements to the cleared device. These changes include: - Footswitch: The footswitch of the EVA has been modified to improve ergonomics and simultaneously integrate the laser pedal functionality. An optional separate laser footswitch will remain available if surgeons prefer. - Illumination: Due to quality improvements in the LED output, the light output has been increased to improve illumination with small gauge fibers. However, the system controls the absolute output of the module to 40 lumens as previously cleared. As an example, the illumination output for a 27 gauge fiber has been improved from 5 lumens as cleared to 7 lumens in the proposed system. However, the maximum output, and maximum exposure to patient, remains at 40 lumens for any fiber as previously cleared. Thus there are no risks introduced with this change. - The Posterior Module (Air Functionality): To support use of EVA for fluid/air exchanges (F-AX), independent of the compressed air / gas supply available, the hardware design of the Posterior (VFIE, Air, Proportional Scissors) module has been modified to provide air through two independent circuits, instead of one as previously cleared. As a result, the air for F-AX is provided by a separate circuit that draws air from the environment (with appropriate filtration), whilst the compressed gas drive for other EVA functions is provided from the pneumatic input (supplied by the surgical setting - typically compressed air or Nitrogen) as per the current design. With this improved design, the compressed gas input of the system will only be used for internal system operation while air needed for surgical use will be derived from filtered, ambient air. Thus, the consumption of compressed gas used to operate the EVA is reduced. - Software: To support these changes the EVA software was upgraded as well as anomaly/bug fixes. A complete detail of these minor improvements can be found in the Software portion of this 510(k) (Section 16 and Annex 5). - Sterilization of Reusable Accessories: Minor changes to the conditions recommended in the labeling have been made and are supported by validation and performance testing included in this 510(k). - Shelf life of Disposable Accessories: The shelf-life of peel pouch packed disposable accessories has been extended to 5-years and is supported by validation and performance testing included in this 510(k). - Accessory Changes: Some packs (combinations of accessories) were discontinued and new configurations added. No new accessories that were not previously cleared were added.