(229 days)
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.
This document describes the EVA NEXUS™ Ophthalmic Surgical System, a combined anterior and posterior procedure ophthalmic system. The submission (K213467) seeks to demonstrate substantial equivalence to its predicate device, the EVA Ophthalmic Surgical System (K190875), and other components cleared under different K numbers.
The device includes several modifications and new components compared to its predicate, such as a redesigned infusion pole, a second infusion/irrigation port, "Smart IOP" functionality, microinjection capability, a digitally controlled phaco board, increased cutter speed, and a video overlay device.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative thresholds for efficacy or safety endpoints. Instead, it relies on demonstrating substantial equivalence to predicate devices through a combination of bench testing, compliance with international standards, and verification/validation testing. The performance aspects are primarily evaluated by comparison to the predicate device and relevant standards.
However, based on the "Comparison of Technological Characteristics with the Predicate Devices" (Table 5 and subsequent detailed comparisons for individual components like vitrectomy probes, tubing, and laser probes) and "Performance (Bench) Testing" sections, we can infer some performance requirements and reported outcomes:
| Feature/Parameter | Acceptance Criteria (Inferred from Predicate/Standard) | Reported Device Performance (EVA NEXUS) |
|---|---|---|
| General | Similar functional overview to predicate, with added features (e.g., Micro Injection, Digital Overlay). | Provides Phaco-emulsification, Vitrectomy, Diathermy, Irrigation/Aspiration, Illumination, Fluid/Air exchange, Viscous fluid control (injection, extraction, Micro Injection), Laser, Visualization (Digital overlay). (Different) |
| Dimensions | Similar to predicate (72x167x60 cm) | 70x185x60 cm (Similar) |
| Weight | Similar to predicate (142 kg) | 128 kg (Similar) |
| User Interfaces | Same principle of operation, console screen, multifunction footswitch, remote. | Same principle of operation, 19-inch glass color display touchscreen, multifunction footswitch, remote. (Same for core interfaces, Digital Overlay is Different/New) |
| Phaco-emulsification | Same principle of operation as predicate. | Same principle of operation. (Same) |
| Phaco Module (Design) | To drive Ultrasound power Phaco handpiece. | Digitally controlled driver board. (Similar - change from analog to digital) |
| Power Output | 50 ± 20% [W] (predicate: 50 [W]) | 50 ± 20% [W] (Same) |
| Phaco Frequency | 40kHz, Auto-tuning. | 40kHz, Auto-tuning. (Same) |
| Phaco Stroke Length | 80 µm +/-20 µm (3002.M), 100 µm +/-20 µm (3002.P). | 80 µm +/-20 µm (3002.M), 100 µm +/-20 µm (3002.P). (Same) |
| Max U/S Velocity of Tip Output | Velocity of tip max. 13.2 m/s. | Velocity of tip max. 13.2 m/s. (Same) |
| Vitrectomy | Same principle of operation. | Same principle of operation. (Same) |
| Vitrectomy Pulse Rate | 20-8000 ppm, tolerance +/- 20% (predicate). | Single and 20-10000 ppm, tolerance +/- 20%. (Similar - increased max rate) |
| Vitrectomy Cutting Rate | Up to 8000 cpm (standard), up to 16000 cpm (dual cut) (predicate). | Up to 10000 cpm (standard), up to 20000 cpm (dual cut). (Similar - increased max rate) |
| Vitrectome Durability (New) | Withstand overpressure of 4.5 bar, function throughout lifetime (5 min at 5000 CPM, 5 min at max cut rate), ≥ 150,000 cutting cycles. | Successfully met in Disposable Pneumatic Vitrectomes Product Verification Report (RPRT 30612000). (Met) |
| Diathermy | Same principle of operation. | Same principle of operation. (Same) |
| Diathermy Type | Bipolar Coagulation. | Bipolar Coagulation. (Same) |
| Diathermy Shape of HF-voltage | Un-modulated square voltage (predicate). | Un-modulated sinusoidal voltage. (Different) |
| Diathermy Frequency | 1 MHz (±10%). | 1 MHz (±10%). (Same) |
| Diathermy Max. Output Power | 10 W ±10% (at 150 Ohm) (predicate). | 10 W ±20% (at 100 Ohm). (Similar - different impedance, wider tolerance) |
| Diathermy Voltage (peak-peak) | 200 Vp-p max. (predicate). | 180Vp-p max. (Similar - lower max voltage) |
| Fluidics Module | To maintain anterior/posterior chamber stability. | Same principle of operation. (Same) |
| Irrigation (Infusion) Principle | Gravity or Air pressurized Infusion bottle (predicate). | Pressurized infusion by plunger pump, pressure control by squeezing membranes of cartridge. (Different - from gravity to pumped) |
| Irrigation (Infusion) Modes | Gravity/AIC/VGPC (predicate). | Fixed/AIC/SMART IOP. (Different - new Smart IOP mode) |
| Infusion/Irrigation Pressure | 0-150 mmHg. | 0-150 mmHg. (Same) |
| Aspiration Mode | Flow mode or vacuum mode. | Flow mode or vacuum mode. (Same) |
| Aspiration - Flow Mode | Nominal flow 0-90 [ml/min], Vacuum limit 0 to -680 [mmHg]. | Nominal flow 0-90 [ml/min], Vacuum limit 0 to -680 [mmHg]. (Same) |
| Aspiration - Vacuum Mode | Vacuum 0 to -680 [mmHg], Rise time 300 [ms]. | Vacuum 0 to -680 [mmHg], Rise time 300 [ms]. (Same) |
| Aspiration - Backflush | Micro Backflush (Pressure 0-50 mmHg, Time 0-250 ms), Auto Backflush (Pressure 0-50 mmHg, Time 0-250 ms), Manual Backflush (Pressure as Infusion/Irrigation). | Micro Backflush (Pressure 0-50 mmHg, Time 0-250 ms), Auto Backflush (no user selectable parameters), Manual Backflush (Pressure as Infusion/Irrigation), Proportional Backflush (Pressure 0-50mmHg). (Similar - Auto Backflush parameters changed, Proportional Backflush added) |
| Cartridge and Tubing Sets | Same design principle as predicate. | Same design principle (collection bag, tubing for irrigation/aspiration, administration set). (Same - with modifications to tubing design for new infusion mechanisms) |
| Endo-Illumination | Same principle of operation, LED source, 3 port connections, 40 lm ±20% output, 425-680 nm spectrum, NA=0.6. | Same principle of operation, LED source, 3 port connections, 40 lm ±20% output, 425-680 nm spectrum, NA=0.6. (Same) |
| Fluid/Air Exchange | Same principle of operation and design. | Same principle of operation and design. (Same) |
| Pressure Range | 0 - 150 mmHg. | 0 - 150 mmHg. (Same) |
| Pressure Accuracy |
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.