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The UniVit™ HE and UniVit™ UHS are single use (disposable) products intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumatically-driven vitrectomy module.

The operation of a vitreous cutter is simple. An air pulse pushes down the diaphragm located inside the vitrectomy probe, leading the port to a closed position (the guillotine movement); at the same time, a spring is compressed and forces the diaphragm back to the open port position. In this submission VisionCare Devices is submitting two new models of vitreous cutter. The first model is the UniVit™ HE, which stands for Universal Vitcutter High Efficiency. The UniVit HE is offered in gauge sizes of 20, 23, 25, and 27). The UniVit™ HE™ operates up to 11,000 CPM depending upon vitrectorny system selection. The second model offered, in this submission, is the UniVit™ UHS™, which stands for Universal Vitcutter Ultra High Speed. The UniVit UHS is offered gauge sizes of 23, 25, and 27. The UniVit operates up to 11,000 CPM depending upon vitrectory system selection. The inner cutter has a port cut into it which allows for cutting forward and backwards; this in effect doubles the cut rate to 22,000 CPM.

The Cetus Laser System is indicated for use in phacofragmentation of the cataractous crystalline lens.

The Cetus system is a 1064nm. pulsed, Nd: YAG Q-switched laser system used together with a sterile, single use laser probe and a Phaco machine. The system console has a digital touch screen and it is used in conjunction with the Cetus probe and a Phacoemulsification machine in the operating room. The probe converts the laser light energy into acoustic energy which is used to perform the fragmentation of the the crystalline lens and has integrated aspiration and irrigation functions.

The UVE and the MID Labs Bi-Blade™ Vitrectomy Cutter labeled for use with the UVE are used to remove vitreous and intraocular tissue. The UVE can only be used with the MID Labs Bi-Blade™ Vitrectomy Cutter. The UVE is used in conjunction with ophthalmic surgical equipment as a Host system (typically phacoemulsification or vitreoretinal surgical equipment).

The Vitrectomy Cutter, one of the accessories for the Ultimate Vit Enhancer and the subject of this 510(k), is a pneumatically actuated device, which supports aspiration and guillotine-style cutting functions for the purpose of removing vitreous and/or other tissues from the eye during surgery. This 510(k) describes dimensional changes to the cutter. Specifically, a second port opening was added, and this created a second cutting edge. As the cutter moves from its retracted position to its extended position, any material in the port is cut by the first cutting edge in cooperation with the distal side of the needle port, just as in the conventional vitrectomy cutter. Unlike the conventional vitrectomy cutter, aspiration is able to continue through the opening in the side of the cutter while the cutter is in the extended position, drawing more material into the port. As the cutter moves from the extended position to the retracted position, this material is cut by the second cutting edge in cooperation with the proximal side of the needle port. Thus, there are two cuts made during a single operating cycle, as opposed to one cut for the conventional vitrectomy cutter.

The CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification, removal of cataracts, and intraocular lens injection) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. The AutoSert® IOL Injector Handpiece is intended to deliver qualified ACRYSOF® intraocular lenses into the eye following cataract removal. The AutoSert® IOL Injector Handpiece achieves the functionality of intraocular lenses. The AutoSert® is indicated for use with ACRYSOF lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySoft® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses. Flex-Tip Laser Probes · Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including: o Proliferative and nonproliferative retinopathy (including diabetic); o Choroidal neovascularization secondary to age-related macular degeneration; o Retinal tears and detachments; o Macular edema; o Retinopathy of prematurity; o Choroidal neovascularization; o Leaking microaneurysms. Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma. · Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma. · And other laser treatments including: o Internal sclerostomy; o Lattice degeneration; o Central and Branch Retinal Vein Occlusion; o Suturelysis; o Vascular and pigmented skin lesions. UltraVit Probes · Vitreous aspiration & cutting. Membrane cutting & aspiration. · Lens removal. Endoilluminator Probes · Endoillumination Valved Entry Systems Scleral incision · Canulae for posterior segment instrument access · Venting (of valved cannulae) Infusion Cannulas Posterior segment infusion (liquid or gas)

The CONSTELLATION® Vision System is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, and illumination as well as irrigation, lens emulsification and fragmentation, cautery, diathermy, and IOL Insertion.

The Synergetics VersaVit is an ophthalmic microsurgical system that is indicated for posterior segment (i.e. vitreoretinal) ophthalmic surgery. The integrated light source is intended to illuminate the eye during vitreoretinal procedures.

The VersaVit is a compact, stand-alone, portable device with a pneumatic vitrector drive, aspiration, and illumination through an imbedded solid state LED light source.

The ProCare Plus™ Vitrectomy System is a portable surgical system intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries. The PROCARE PLUS™ Vitrectomy System is indicated for use in support of the following ophthalmic surgical procedures: Removal of vitreous in cases of vitreous clouding, diabetic vitreal hemorrhaging, trauma, including contusions, penetrations, and intraocular foreign bodies; opacity, inflammation, endophthalmitis (bacterial or fungal), uvitis Removal of lens fragments after cataract surgery; Remove vitreous traction under the retina producing localized or complete retinal detachment; Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis; Treatment of vitreous loss during cataract surgery; Clean vitreous strands from the cataract wound; Provide internal illumination for vitreous surgery; Provide air pressure for maintaining intraocular pressure for retinal surgery. The VCD HSP VitCutter and Accessories is a single use (disposable) product intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumaticallydriven vitrectomy module.

The ProCare PlusTM Vitrectomy System is a portable surgical system intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries. The ProCare Plus™ Vitrectomy System is an AC powered device with an internal Li-Ion battery that provides backup power in the event that AC power is interrupted. The system is primarily run from one multifunction footswitch which gives the surgeon control over all of the surgical functions. The ProCare Plus Vitrectomy system provides many of the functions required by the ophthalmic surgeon for performing a vitrectomy including vitreous cutting and aspiration, illumination, and fluid-air exchange.

The UVE and the MID Labs Vitreous Cutter labeled for use with the UVE are used to remove vitreous and intraocular tissue. The UVE can only be used with the MID Labs Vitreous Cutter. The UVE is used in conjunction with ophthalmic surgical equipment as a Host system (typically phacoemulsification or vitreoretinal surgical equipment).

Ultimate Vit Enhancer is a standalone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine (Host system) for vitreous cutting. The UVE is used with the MID Labs Vitreous Cutter labeled for use with the UVE.

The COLIBRI Disposable Vitrectomy Cutter is intended to be used for the removal of vitreous and vitreal membranes during ophthalmic surgery.

The COLIBRI Disposable Vitrectomy Cutter is a quillotine-style pneumatic handbiece for use during ophthalmic surgery. TThe main components of the device are the handle, diaphragm, inner spring, stainless steel inner and outer cutters, and attached tubing and connectors. The device provides cutting and aspiration functions during removal of vitreous and vitreal membranes in anterior and posterior segment surgeries. It is designed to be used with 20 psi and 30 psi ophthalmic surgical systems.

An electrically powered ophthalmic device intended to remove vitreous matter from the vitreous cavity

An electrically powered ophthalmic device intended to remove vitreous matter from the vitreous cavity

The Velocity Advantage would be used by a physician in conjunction with standard vitrectomy equipment to cut and remove vitreous and other intraocular tissue.

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