EVA NEXUS Ophthalmic Surgical System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. June 14, 2022 D.O.R.C. Dutch Ophthalmic Research Center (International) Linda Leeuwen Regulatory Affairs Officer B.V. Scheiidelveweg 2 Zuidland, Zuid Holland 3214 VN Netherlands Re: K213467 Trade/Device Name: EVA NEXUS Ophthalmic Surgical System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC, HQE, HQF, FMF Dated: April 28, 2022 Received: May 6, 2022 Dear Linda Leeuwen: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Anjana Jain, PhD Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213467 Device Name EVA NEXUS™ Ophthalmic Surgical System ### Indications for Use (Describe) 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 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 | Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) SUMMARY This summary is in accordance with 21 CFR 807.92. ### 1. Submitter The submitter of the 510(k) is: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. Scheijdelveweg 2 3214 VN Zuidland The Netherlands Contact person: Linda Van Leeuwen, Regulatory Affairs Officer Tel: +31 181 45 8080 Fax: +31 181 458090 Mail: 1.vanleeuwen@dorcglobal.com Date Prepared: June 14, 2022 ### 2. Device Device Subject to this 510(k): EVA NEXUS™ Ophthalmic Surgical System Trade Name: Phacoemulsification/Vitrectomy System Common Name: Classification Name: ClassII The following regulations are applicable for this 510(k): - 21 CFR 886.4670 Phacofragmentation System (Product Code: HQC) - 21 CFR 886.4150 Vitreous Aspirating and Cutting Device (Product Code: HQE) ● - 21 CFR 886.4390 Ophthalmic Laser (Product Code: HQF) ● - 21 CFR 886.5860 Piston Syringe (Product Code FMF) | 510(k) number | Device | Predicate for | |---------------|-------------------------------------------------|------------------------------------------------------| | K190875 | EVA Ophthalmic Surgical System<br>(DORC) | EVA NEXUSTM Ophthalmic Surgical<br>System | | K142877 | 8267 and 8268.series vitrectomes | 9268.series vitrectomes | | K142877 | 8110.series tubing | 9110.series tubing | | K024061 | 7525.series stepped laser probes | 7227.series directional laser probes | | K203264 | MicroDose™ Injector (MedOne) | 1364.DD - 1 cc syringe holder for micro<br>injection | | K200325 | Orbit Subretinal Delivery System (Orbit<br>SDS) | 1364.DD - 1 cc syringe holder for micro<br>injection | #### 3. Predicate Device(s) {4}------------------------------------------------ ### Indications for Use 4. 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 surgery, including 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 | ### ર. Device Features The purpose of this 510(k) is to obtain clearance for improvements to the cleared device. These changes include: - . Infusion pole: The adjustable infusion pole has been replaced with a bottle holder at fixed height. - Second infusion/irrigation port: A second infusion/irrigation port is introduced so that the surgeon can connect and prime vitrectome and phaco-handpiece at the start of the surgery to ensure smooth transition between anterior and posterior procedures. It has been ensured in EVA NEXUS software that the two infusion/irrigation ports cannot be used simultaneously. - Smart IOP: A setting called Smart IOP is introduced, that allows the surgeon to use an automatic infusion/irrigation based on a preset desired Intra Ocular Pressure (IOP). EVA NEXUS uses predefined instruments characteristics and the set aspiration to determine the required infusion/irrigation pressure. - Microinjection capability: Currently the Viscous Fluid Injection is suitable for injection of ● approximately 10 ml of fluid. The Microinjection capability uses exactly the same functionality, but is suitable for injection of volumes as small as 50 µl. The injection is controlled by means of the footswitch which allows the surgeon to hold the delivery device in a stable position without the need to push a syringe plunger manually. This capability is intended for subretinal {5}------------------------------------------------ microinjection of gases or aqueous fluids. In order to use a surgical system to aid with the injection an adaptor kit to the surgical system should be used. For this purpose, 1364.DD is available: a 1 cc syringe holder for micro injection. - . Phaco board: Is now a digitally controlled board instead of the previous board being based on analog technology. - Increased cutter speed: The cutter speed of the vitrectomes is increased to maximally 10,000 cuts per minute, based on a regular vitrectome. For the TDC (Two Dimensional Cutter) vitrectomes that cut both on the forward and backward motion, the cutting speed is effectively doubled to maximally 20,000 cuts per minute. At this moment 9268.series TDC vitrectomes are introduced to support the maximum drive of 10,000 cycles per minute (which equals 20,000 cuts per minute). - Video overlay device: The possibility to connect a video-overlay device is introduced, ● that allows the surgeon to show EVA NEXUS settings on the surgical video. - Software: To support these changes the EVA NEXUS software was upgraded as well as anomaly/bug fixes. - Accessory Changes: - Surgical packs (combinations of accessories): New configurations are added specifically ● for use on EVA NEXUS - Change of 1364.DD: 1 cc syringe holder for micro injection. An updated version of o 1364.DD that was included in K142877 with documentation. The syringe supplier changed, as well as the product name. - Tubing sets: Tubing sets specifically for EVA NEXUS have been developed O to accommodate for the two infusion/irrigation ports. - Addition of new vitrectomes: To support the increased cutting speed and to update look o and feel. - Changed phaco needles and sleeves: The design of the phaco needles was optimized to o improve holdability of lens fragments; sleeves were re-designed to maximize irrigation flow and optimize sleeve positioning. - Addition of directional laser probes: Apart from the existing directional laser probes, o currently marketed OUS by DORC, DORC has introduced directional laserprobes in 27 gauge size. {6}------------------------------------------------ A comparison between EVA NEXUS under evaluation and the predicate EVA system can be found in Table 5. | Item compared | sub category | K213467 EVA NEXUS (Subject Device)<br>(9000.ANTxx/COMyy) | K190875 Predicate device<br>EVA<br>(8000.ANTxx/COMyy) | Equivalence<br>(same /<br>similar /<br>different) | |-----------------------------------------|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------| | Technical Characteristics | | | | | | General | | | | | | General functional<br>overview | Design | The EVA NEXUS console provides the following<br>functions:<br>- Phaco-emulsification<br>- Vitrectomy<br>- Diathermy<br>- Irrigation / Aspiration<br>- Illumination<br>- Fluid/Air exchange<br>- Viscous fluid control (injection, extraction,<br>Micro Injection)<br>- Laser<br>- Visualization (Digital overlay) | The EVA console provides the following<br>functions:<br>- Phaco-emulsification<br>- Vitrectomy<br>- Diathermy<br>- Irrigation / Aspiration<br>- Illumination<br>- Fluid/Air exchange<br>- Viscous fluid control (injection, extraction)<br>- Laser<br>- Proportional scissor | Different | | General Product<br>composition | Design | Console, footswitch, power cable, accessories for<br>different purposes including phacoemulsification,<br>vitrectomy, illumination, Inspiration/Aspiration,<br>diathermy, and laser. Procedure packs. | Console, footswitch, power cable, accessories for<br>different purposes including phacoemulsification,<br>vitrectomy, illumination, Inspiration/Aspiration,<br>diathermy, and laser. Procedure packs. | Similar | | | Dimensions | 70x185x60 cm | 72x167x60 cm | Similar | | | Weight | 128 kg | 142 kg | Similar | | User Interfaces | | | | | | User Interfaces | Principle of<br>operation | The user selects settings for the various functions<br>on the Graphical User Interface by the touch<br>screen, or by the remote control. The user starts,<br>stops, and regulates the various functions with the<br>foot switch. | The user selects settings for the various functions<br>on the Graphical User Interface by the touch<br>screen, or by the remote control. The user starts,<br>stops, and regulates the various functions with the<br>foot switch. | Same | | User Interfaces | Console screen | Glass Color display Touchscreen (19 inch) with<br>programmable Graphical User Interface | Glass Color display Touchscreen (19 inch) with<br>programmable Graphical User Interface | Same | | User Interfaces | Multi-function<br>footswitch | Multi-function footswitch with a dual-linear pedal<br>and programmable function buttons to control all<br>functions including laser.<br>Wired and Wireless connection to the console.<br>Battery-operated with wall charger and back-up<br>power/connection cable. | Multi-function footswitch with a dual-linear pedal<br>and programmable function buttons to control all<br>functions including laser.<br>Wired and Wireless connection to the console.<br>Battery-operated with wall charger and back-up<br>power/connection cable. | Same | | User Interfaces | Remote | a remote control provides a navigational interface | a remote control provides a navigational interface | Same | | Item compared | sub category | K213467 EVA NEXUS (Subject Device)(9000.ANTxx/COMyy) | K190875 Predicate device EVA(8000.ANTxx/COMyy) | Equivalence(same /similar /different) | | | controller | to the system's GUI, remotely through the IR receiver in the screen | to the system's GUI, remotely through the IR receiver in the screen | | | User Interfaces | Digital Overlay | An (optional) Digital Overlay module is available which outputs information from the surgical system for visualization on an external screen. The visualization function may be used to overlay parameters from the surgical system on top of the microscope image for the surgeon or the audience. | Not applicable | Different | | Phaco-emulsification | | | | | | Phaco-emulsification | Principle of operation | The Phaco Module can be used for Phaco emulsification and fragmentation. The module provides ultrasound power with continuous auto-tuning. The module drives a connected Phaco handpiece. The handpiece contains piezo-electric elements which transforms the electrical drive energy into an ultrasonic output at the distal end of the handpiece needle. | The Phaco Module can be used for Phaco emulsification and fragmentation. The module provides ultrasound power with continuous auto-tuning. The module drives a connected Phaco handpiece. The handpiece contains piezo-electric elements which transforms the electrical drive energy into an ultrasonic output at the distal end of the handpiece needle. | Same | | Phaco Module | Design | digitally controlled driver board to drive Ultrasound power Phaco handpiece, for emulsification or fragmentation of lens | driver board to drive Ultrasound power Phaco handpiece, for emulsification or fragmentation of lens | Similar | | Power output | Performance requirement | $50 \pm 20\% [W]$ | $50 [W]$ | Same | | Phaco frequency | Performance requirement | 40kHz<br>Auto-tuning | 40kHz<br>Auto-tuning | Same | | Phaco stroke length | Performance requirement | 80 μm +/-20 μm (for 3002.M handpiece)<br>100 μm +/-20 μm (for 3002.P handpiece) | 80 μm +/-20 μm (for 3002.M handpiece)<br>100 μm +/-20 μm (for 3002.P handpiece) | Same | | Maximum U/S velocity of tip output | Performance requirement | Velocity of tip max. 13.2 m/s(at maximum U/S power, measured in water) | Velocity of tip max. 13.2 m/s(at maximum U/S power, measured in water) | Same | | Vitrectomy | | | | | | Vitrectomy | Principle of operation | The Vitrectomy module provides pulsed pressurized air to drive a Vitreous cutter (vitrectome) in order to remove some or all of the vitreous humor from the eye to provide better access to the retina for a variety of surgical repairs. | The vitrectomy module provides pulsed pressurized air to drive a Vitreous cutter (vitrectome) in order to remove some or all of the vitreous humor from the eye to provide better access to the retina for a variety of surgical repairs. | Same | | Vitrectomy | Design | Driver for pneumatically operated vitreous cutters | Driver for pneumatically operated vitreous cutters | Same | | Vitrectomy pulse rate | Performance requirement | single and 20-10000 ppm;<br>tolerance +/- 20%<br>Single cut function | single and 20-8000 ppm;<br>tolerance +/- 20%<br>Single cut function | Similar | | Item compared | sub category | K213467 EVA NEXUS (Subject Device)<br>(9000.ANTxx/COMyy) | K190875 Predicate device<br>EVA<br>(8000.ANTxx/COMyy) | Equivalence<br>(same /<br>similar /<br>different) | | Vitrectomy cutting<br>rate | Performance<br>requirement | up to 10000 cpm for standard vitrectomes<br>up to 20000 cpm for dual cut vitrectomes | up to 8000 cpm for standard vitrectomes<br>up to 16000 cpm for dual cut vitrectomes | Similar | | Diathermy | | | | | | Diathermy | Principle of<br>operation | The Diathermy Module provides coagulation for<br>anterior and posterior eye-segment surgery | The Diathermy Module provides coagulation for<br>anterior and posterior eye-segment surgery | Same | | Diathermy | Design | digitally controlled driver board to provide energy<br>generated by high frequency currents through a<br>diathermy handpiece to the tissue | driver board to provide energy generated by high<br>frequency currents through a diathermy handpiece<br>to the tissue | Similar | | Diathermy Type | Performance<br>requirement | Bipolar Coagulation | Bipolar Coagulation | Same | | Diathermy Shape of<br>HF-voltage | Performance<br>requirement | Un-modulated sinusoidal voltage | Un-modulated square voltage | Different | | Diathermy<br>frequency | Performance<br>requirement | $1 MHz (±10%)$ | $1 MHz (±10%)$ | Same | | Diathermy max.<br>output power | Performance<br>requirement | $10 W ±20% (at 100 Ohm)$ | $10 W ±10% (at 150 Ohm)$ | Similar | | Diathermy Voltage<br>(peak-peak) | Performance<br>requirement | $180Vp -p max.$ | $200 Vp -p max.$ | Similar | | Fluidics Module | | | | | | Fluidics Module | Principle of<br>operation | To maintain anterior/posterior chamber stability,<br>the pump keeps the pressure of the fluidics in the<br>tubing system to the physician set value, or<br>alternatively keeps the inflow and outflow of the<br>fluidics to the physician set flow value. | To maintain anterior/posterior chamber stability,<br>the pump keeps the pressure of the fluidics in the<br>tubing system to the physician set value, or<br>alternatively keeps the inflow and outflow of the<br>fluidics to the physician set flow value. | Same | | Irrigation (infusion) | Principle of<br>operation | Pressurized infusion by a plunger pump. Pressure<br>control by squeezing the membranes of a to the<br>pump connected cartridge. | Pressurized infusion by means of an height<br>controlled Infusion Pole (gravity) or by means of<br>an Air pressurized Infusion bottle. | Different | | Irrigation (Infusion)<br>modes | Performance<br>requirement | Modes: Fixed/AIC/SMART IOP | Modes: Gravity/AIC/VGPC | Different | | Infusion/Irrigation<br>pressure | Performance<br>requirement | 0-150 mmHg | 0-150 mmHg | Same | | Aspiration | Principle of<br>operation | Plunger pump; can operate in flow control or<br>vacuum control by squeezing the membranes of a<br>to the pump connected cartridge.<br>The pumping system can be used in one of two<br>modes: pressure control or flow control. | Plunger pump; can operate in flow control or<br>vacuum control by squeezing the membranes of a<br>to the pump connected cartridge.<br>The pumping system can be used in one of two<br>modes: pressure control or flow control. | Same | | Aspiration | Performance<br>requirement | Flow mode or vacuum mode | Flow mode or vacuum mode | Same | | Item compared | sub category | K213467 EVA NEXUS (Subject Device)<br>(9000.ANTxx/COMyy) | K190875 Predicate device<br>EVA<br>(8000.ANTxx/COMyy) | Equivalence<br>(same /<br>similar /<br>different) | | Aspiration - flow<br>mode | Performance<br>requirement | Flow mode:<br>Nominal flow 0-90 [ml/min]<br>Vacuum limit 0 to -680 [mmHg@sea level] | Flow mode:<br>Nominal flow 0-90 [ml/min]<br>Vacuum limit 0 to -680 [mmHg@sea level] | Same | | Aspiration - vacuum<br>mode | Performance<br>requirement | Vacuum mode:<br>Vacuum 0 to -680 [mmHg@sea level}<br>Rise time 300 [ms] (measured step 0 to 650mm Hg<br>@ 0 cc/min) | Vacuum mode:<br>Vacuum 0 to -680 [mmHg@sea level}<br>Rise time 300 [ms] (measured step 0 to 650mm Hg<br>@ 0 cc/min) | Same | | Aspiration -<br>Backflush | Performance<br>requirement | Micro Backflush (Reflux):<br>Pressure range 0-50 [mmHg]<br>Time of activation 0-250 [ms]<br>Auto Backflush (Reflux):<br>no user selectable parameters | Micro Backflush (Reflux):<br>Pressure range 0-50 [mmHg]<br>Time of activation 0-250 [ms]<br>Auto Backflush (Reflux):<br>Pressure range 0 to 50 [mmHg]<br>Time of Activation 0-250 [ms] | Similar | | | | Manual Backflush (Reflux):<br>Pressure range: see Infusion/Irrigation<br>Proportional Backflush:<br>Pressure range 0-50 [mmHg] | Manual Backflush (Reflux):<br>Pressure range: see Infusion/Irrigation<br>Not applicable | | | Cartridge and<br>Tubing Sets | Design | The cartridge consists of a collection bag to collect<br>aspiration fluids, tubing for irrigation and<br>aspiration and the tubing for the administration set<br>Fluid circulation is achieved by the interaction of<br>the membrane and the pump pistons. | The cartridge consists of a collection bag to collect<br>aspiration fluids, tubing for irrigation and<br>aspiration and the tubing for the administration set.<br>Fluid circulation is achieved by the interaction of<br>the membrane and the pump pistons. | Same | | Endo-Illumination | Principle of<br>operation | The Endo-illumination module is used to<br>illuminate the interior of the posterior chamber of<br>the eye, a light source is available in the console,<br>controllable in output, which connects to<br>illumination fibers to bring the light into the eye. | The Endo-illumination module is used to<br>illuminate the interior of the posterior chamber of<br>the eye, a light source is available in the console,<br>controllable in output, which connects to<br>illumination fibers to bring the light into the eye. | Same | | Illumination light<br>source | Design | LED source, 3 port connections for<br>endoillumination probes | LED source, 3 port connections for<br>endoillumination probes | Same | | Illumination output<br>and accuracy | Performance<br>requirement | 40 lm +/-20% (with 20ga fiber) | 40 lm +/-20% (with 20ga fiber) | Same | | Illumination<br>spectrum | Performance<br>requirement | 425 to 680 [nm]<br>UV filter (up to 425 nm), IR filter (above 680 nm) | 425 to 680 [nm]<br>UV filter (up to 425 nm), IR filter (above 680 nm) | Same | | Illumination<br>Numerical aperture | Performance<br>requirement | up to NA = 0.6 | up to NA = 0.6 | Same | | Fluid/Air exchange | Principle of | The Air Module provides pressurized air for fluid | The Air Module provides pressurized air for fluid | Same | | Item compared | sub category | K213467 EVA NEXUS (Subject Device)<br>(9000.ANTxx/COMyy) | K190875 Predicate device<br>EVA<br>(8000.ANTxx/COMyy) | Equivalence<br>(same /<br>similar /<br>different) | | | operation | air exchange. The pressure can be set on the<br>screen. | air exchange. The pressure can be set on the<br>screen. | | | Fluid/Air exchange | Design | Air infusion module to provide air through a<br>connected tubing to the eye. The air is delivered to<br>the tubing set through an extended 0.22µm filter. | Air infusion module to provide air through a<br>connected tubing to the eye. The air is delivered to<br>the tubing set through an extended 0.22µm filter. | Same | | Fluid/Air exchange<br>pressure range | Performance<br>requirement | 0 - 150 mmHg | 0 - 150 mmHg | Same | | Fluid/Air exchange<br>pressure accuracy | Performance<br>requirement | <3 mmHg | <3 mmHg | Same | | Fluid/Air exchange<br>flow rate | Performance<br>requirement | 1200 [ml/min] | 1200 [ml/min] | Same | | VFC Module | | | | | | Viscous Fluid<br>Extraction | Principle of<br>operation | VFE (Viscous Fluid Extraction) is used to extract<br>intraocular<br>viscous fluid from the eye into a syringe. It is done<br>with vacuum. | VFE (Viscous Fluid Extraction) is used to extract<br>intraocular<br>viscous fluid from the eye into a syringe. It is done<br>with vacuum. | Same | | Viscous Fluid<br>Extraction pressure | Performance<br>requirement | 0 to -660 mmHg | 0 to -660 mmHg | Same | | Viscous Fluid<br>Injection | Principle of<br>operation | VFI (Viscous Fluid Injection) is used to inject<br>viscous fluid from a syringe into the eye. It can be<br>done with pressurizing a pre-filled syringe. | VFI (Viscous Fluid Injection) is used to inject<br>viscous fluid from a syringe into the eye. It can be<br>done with pressurizing a pre-filled syringe. | Same | | Viscous Fluid<br>Injection pressure | Performance<br>requirement | 0 - 6 bar | 0 - 6 bar | Same | | Micro Injection | Principle of<br>operation | MI (Micro Injection) is used to inject a small<br>amount of aqueous fluid though a high gauge<br>delivery device into the eye. It is done by<br>pressurizing a pre-filled syringe. | n/a | Different | | Micro Injection | Performance<br>requirement | 0 - 2 bar | n/a | Different | | Laser | | | | | | Laser | Principle of<br>operation | The (optional) Laser Module provides a<br>therapeutic eye Laser device indicated for photo<br>coagulation of both anterior and posterior<br>segments of the eye | The (optional) Laser Module provides a<br>therapeutic eye Laser device indicated for photo<br>coagulation of both anterior and posterior<br>segments of the eye | Same | | Treatment laser type | Design | Diode pumped frequency doubled Nd:YAG Laser<br>for photogoagulation, wavelength 532nm | Diode pumped frequency doubled Nd:YAG Laser<br>for photogoagulation, wavelength 532nm | Same | | Laser Class | Performance<br>requirement | Class IV | Class IV | Same | | Item compared | sub category | K213467 EVA NEXUS (Subject Device)(9000.ANTxx/COMyy) | K190875 Predicate device EVA(8000.ANTxx/COMyy) | Equivalence(same /similar /different) | | Laser Modes | Performance requirement | Single shot, pulsed or continuous mode | Single shot, pulsed or continuous mode | Same | | Laser wavelenght | Performance requirement | Green - 532 nm ±5 nm | Green - 532 nm ±5 nm | Same | | Laser power | Performance requirement | 0.05-1.2 W ±20% | 0.05-1.2 W ±20% | Same | | Laser pulse duration | Performance requirement | 50-5000 ms | 50-5000 ms…