(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 | <3 mmHg. | <3 mmHg. (Same) |
| Flow Rate | 1200 [ml/min]. | 1200 [ml/min]. (Same) |
| VFC Module | ||
| Viscous Fluid Extraction | Same principle of operation, 0 to -660 mmHg pressure. | Same principle of operation, 0 to -660 mmHg pressure. (Same) |
| Viscous Fluid Injection | Same principle of operation, 0 - 6 bar pressure. | Same principle of operation, 0 - 6 bar pressure. (Same) |
| Micro Injection (New Feature) | Not applicable for predicate. Required to inject small amounts of fluid (min 50 µl) through high gauge delivery device. | Inject small amount of aqueous fluid through high gauge delivery device, 0 - 2 bar pressure, footswitch controlled. (New Capability) |
| Laser | Same principle of operation. | Same principle of operation. (Same) |
| Treatment Laser Type | Diode pumped frequency doubled Nd:YAG Laser, 532nm wavelength. | Diode pumped frequency doubled Nd:YAG Laser, 532nm wavelength. (Same) |
| Laser Class | Class IV. | Class IV. (Same) |
| Laser Modes | Single shot, pulsed or continuous. | Single shot, pulsed or continuous mode. (Same) |
| Laser Wavelength | Green - 532 nm ±5 nm. | Green - 532 nm ±5 nm. (Same) |
| Laser Power | 0.05-1.2 W ±20%. | 0.05-1.2 W ±20%. (Same) |
| Laser Pulse Duration | 50-5000 ms. | 50-5000 ms. (Same) |
| Laser Interpulse Time | 50-5000 ms. | 50-5000 ms. (Same) |
| Aiming Beam Wavelength | Red - 630 - 645 nm. | Red - 630 - 645 nm. (Same) |
| Aiming Beam Power | Less than 1 mW. | Less than 1 mW. (Same) |
| Software | Windows embedded OS, GUI for parameter setting and control. | Windows embedded OS, EVA NEXUS GUI for parameter setting, interfaces for operator to control different modules, and service purpose. (Similar - upgraded software with new features) |
| Biocompatibility | Compliance with ISO 10993-1, 10993-5, 10993-10, 10993-12 for patient contact components. | Confirmed acceptable by cytotoxicity, Kligman maximization, and intracutaneous irritation testing. (Met) |
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-2-2, IEC 80601-2-58, EN 60601-1-2, 47 CFR Part 15 Subpart B. | System complies with these standards. (Met) |
| Software V&V | Compliance with FDA Guidance for Software in Medical Devices ("Major" level of concern). | Verification and validation testing conducted, documentation provided as recommended. (Met) |
| Performance (Bench) Testing | Compliance with ISO 15004-2 (illuminator), IEC 60601-2-22 (laser), IEC 80601-2-58 (lens removal/vitrectomy). | Testing to ensure compliance reported as performed. (Met) |
| EVA/EVA NEXUS Performance Comparison (Irrigation, Aspiration, Micro Injection) | Functions "similar" to predicate, in relation to IEC 80601-2-58:2016. | Report RPRT 30609300 concludes functions are "very similar", substantiating substantial equivalence. (Met) |
| Pneumatic Compatibility | Compatible with compressed nitrogen (N2). | Reports (RPRT 30554100) conclude no changes impact N2 compatibility, substantially equivalent to predicate. (Met) |
| Cartridge Verification | Designed for EVA NEXUS is substantially equivalent to EVA cartridge. | Report RPRT 30518300 shows substantial equivalence. (Met) |
| 1364.DD Biocompatibility | ISO 10993-1 (cytotoxicity) for new components, with prior 510(k) for syringe. | Cytotoxicity testing (RPRT 30527100) and adoption of prior 510(k) (K063280) for syringe satisfied requirement. (Met) |
| 1364.DD Sterilization | ISO 11135 validation, adequate for product. | Sterilization validation (chapter 14.1.3, adoption 2020031 STER) concludes product is less worst case and adopted. (Met) |
| 1364.DD Shelf Life | Adequate packaging system for storage throughout specified shelf life. | Shelf life testing (chapter 14, adoption 2015052 SLAD) concludes 1364.DD is less worst case, studies adopted. (Met) |
| 1364.DD Performance Tests | All tests performed successfully (RPRT 30492800, section 7.14). | All tests performed successfully. (Met) |
| 1364.DD Package & Performance Post Shipping | Package integrity and functionality post shipping. | Testing (chapter 14, adoption 2015052 PIAD) concludes 1364.DD is not worst case, studies adopted. (Met) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing and compliance with international standards, rather than clinical studies with human participants. Therefore, concepts like "test set sample size" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable in the way they would be for a clinical trial or AI model validation with patient data.
- Sample Size for Bench Tests: Specific sample sizes for individual bench tests (e.g., number of vitrectomy probes tested for durability, units for electrical safety) are generally not explicitly stated in this high-level summary but would be detailed in the individual RPRT reports (e.g., RPRT 30612000 for vitrectomes). For example, vitrectome durability tests refer to "≥ 150,000 cutting cycles," indicating a performance threshold rather than a sample size of devices.
- Data Provenance: All testing appears to be laboratory/bench data, performed by the manufacturer, D.O.R.C. Dutch Ophthalmic Research Center (International) B.V., located in the Netherlands.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a surgical system, not a diagnostic AI device that requires expert-annotated ground truth from medical images or similar data. The "ground truth" for its performance is established through adherence to engineering specifications, international medical device standards (e.g., IEC, ISO), and performance equivalence to a legally marketed predicate device.
Therefore, the concept of "experts establishing ground truth for a test set" with specific qualifications (like radiologists) is not applicable here. The "experts" involved would be the engineers, quality control personnel, and regulatory affairs specialists who designed the tests, interpreted the results, and compiled the submission, ensuring compliance with established norms and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this is not a diagnostic device requiring human adjudication of results from a test set. The evaluation is based on objective measurements against engineering specifications and international standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic or interpretation device that would involve human readers or MRMC studies. The device is a surgical system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The EVA NEXUS is a surgical system operated by a human surgeon ("human-in-the-loop" by definition for a surgical tool). It does not function as a standalone algorithm for diagnosis or decision-making.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the EVA NEXUS Ophthalmic Surgical System is:
- Compliance with established international medical device standards (e.g., IEC 60601 series, ISO 10993 series, ISO 15004-2).
- Engineering specifications and performance metrics derived from device design and functionality.
- Substantial equivalence to legally marketed predicate devices, implying that the predicate's established safety and effectiveness forms the basis for the new device's acceptable performance.
- Successful completion of verification and validation testing against these standards and specifications.
8. The sample size for the training set
Not applicable. The EVA NEXUS is a hardware-based surgical system with embedded software for control; it is not an AI/ML model that undergoes "training" on a "training set" of data in the conventional sense. The software verification and validation activities are for ensuring its functional requirements and safety, not for machine learning model training.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" or "ground truth" for such a set in the context of this device.
{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. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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(DORC) | EVA NEXUSTM Ophthalmic SurgicalSystem |
| 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 microinjection |
| K200325 | Orbit Subretinal Delivery System (OrbitSDS) | 1364.DD - 1 cc syringe holder for microinjection |
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)(9000.ANTxx/COMyy) | K190875 Predicate deviceEVA(8000.ANTxx/COMyy) | Equivalence(same /similar /different) |
|---|---|---|---|---|
| Technical Characteristics | ||||
| General | ||||
| General functionaloverview | Design | The EVA NEXUS console provides the followingfunctions:- Phaco-emulsification- Vitrectomy- Diathermy- Irrigation / Aspiration- Illumination- Fluid/Air exchange- Viscous fluid control (injection, extraction,Micro Injection)- Laser- Visualization (Digital overlay) | The EVA console provides the followingfunctions:- Phaco-emulsification- Vitrectomy- Diathermy- Irrigation / Aspiration- Illumination- Fluid/Air exchange- Viscous fluid control (injection, extraction)- Laser- Proportional scissor | Different |
| General Productcomposition | Design | Console, footswitch, power cable, accessories fordifferent purposes including phacoemulsification,vitrectomy, illumination, Inspiration/Aspiration,diathermy, and laser. Procedure packs. | Console, footswitch, power cable, accessories fordifferent purposes including phacoemulsification,vitrectomy, illumination, Inspiration/Aspiration,diathermy, and laser. Procedure packs. | Similar |
| Dimensions | 70x185x60 cm | 72x167x60 cm | Similar | |
| Weight | 128 kg | 142 kg | Similar | |
| User Interfaces | ||||
| User Interfaces | Principle ofoperation | The user selects settings for the various functionson the Graphical User Interface by the touchscreen, or by the remote control. The user starts,stops, and regulates the various functions with thefoot switch. | The user selects settings for the various functionson the Graphical User Interface by the touchscreen, or by the remote control. The user starts,stops, and regulates the various functions with thefoot switch. | Same |
| User Interfaces | Console screen | Glass Color display Touchscreen (19 inch) withprogrammable Graphical User Interface | Glass Color display Touchscreen (19 inch) withprogrammable Graphical User Interface | Same |
| User Interfaces | Multi-functionfootswitch | Multi-function footswitch with a dual-linear pedaland programmable function buttons to control allfunctions including laser.Wired and Wireless connection to the console.Battery-operated with wall charger and back-uppower/connection cable. | Multi-function footswitch with a dual-linear pedaland programmable function buttons to control allfunctions including laser.Wired and Wireless connection to the console.Battery-operated with wall charger and back-uppower/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 | 40kHzAuto-tuning | 40kHzAuto-tuning | Same |
| Phaco stroke length | Performance requirement | 80 μm +/-20 μm (for 3002.M handpiece)100 μm +/-20 μm (for 3002.P handpiece) | 80 μm +/-20 μm (for 3002.M handpiece)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;tolerance +/- 20%Single cut function | single and 20-8000 ppm;tolerance +/- 20%Single cut function | Similar |
| Item compared | sub category | K213467 EVA NEXUS (Subject Device)(9000.ANTxx/COMyy) | K190875 Predicate deviceEVA(8000.ANTxx/COMyy) | Equivalence(same /similar /different) |
| Vitrectomy cuttingrate | Performancerequirement | up to 10000 cpm for standard vitrectomesup to 20000 cpm for dual cut vitrectomes | up to 8000 cpm for standard vitrectomesup to 16000 cpm for dual cut vitrectomes | Similar |
| Diathermy | ||||
| Diathermy | Principle ofoperation | The Diathermy Module provides coagulation foranterior and posterior eye-segment surgery | The Diathermy Module provides coagulation foranterior and posterior eye-segment surgery | Same |
| Diathermy | Design | digitally controlled driver board to provide energygenerated by high frequency currents through adiathermy handpiece to the tissue | driver board to provide energy generated by highfrequency currents through a diathermy handpieceto the tissue | Similar |
| Diathermy Type | Performancerequirement | Bipolar Coagulation | Bipolar Coagulation | Same |
| Diathermy Shape ofHF-voltage | Performancerequirement | Un-modulated sinusoidal voltage | Un-modulated square voltage | Different |
| Diathermyfrequency | Performancerequirement | $1 MHz (±10%)$ | $1 MHz (±10%)$ | Same |
| Diathermy max.output power | Performancerequirement | $10 W ±20% (at 100 Ohm)$ | $10 W ±10% (at 150 Ohm)$ | Similar |
| Diathermy Voltage(peak-peak) | Performancerequirement | $180Vp -p max.$ | $200 Vp -p max.$ | Similar |
| Fluidics Module | ||||
| Fluidics Module | Principle ofoperation | To maintain anterior/posterior chamber stability,the pump keeps the pressure of the fluidics in thetubing system to the physician set value, oralternatively keeps the inflow and outflow of thefluidics to the physician set flow value. | To maintain anterior/posterior chamber stability,the pump keeps the pressure of the fluidics in thetubing system to the physician set value, oralternatively keeps the inflow and outflow of thefluidics to the physician set flow value. | Same |
| Irrigation (infusion) | Principle ofoperation | Pressurized infusion by a plunger pump. Pressurecontrol by squeezing the membranes of a to thepump connected cartridge. | Pressurized infusion by means of an heightcontrolled Infusion Pole (gravity) or by means ofan Air pressurized Infusion bottle. | Different |
| Irrigation (Infusion)modes | Performancerequirement | Modes: Fixed/AIC/SMART IOP | Modes: Gravity/AIC/VGPC | Different |
| Infusion/Irrigationpressure | Performancerequirement | 0-150 mmHg | 0-150 mmHg | Same |
| Aspiration | Principle ofoperation | Plunger pump; can operate in flow control orvacuum control by squeezing the membranes of ato the pump connected cartridge.The pumping system can be used in one of twomodes: pressure control or flow control. | Plunger pump; can operate in flow control orvacuum control by squeezing the membranes of ato the pump connected cartridge.The pumping system can be used in one of twomodes: pressure control or flow control. | Same |
| Aspiration | Performancerequirement | Flow mode or vacuum mode | Flow mode or vacuum mode | Same |
| Item compared | sub category | K213467 EVA NEXUS (Subject Device)(9000.ANTxx/COMyy) | K190875 Predicate deviceEVA(8000.ANTxx/COMyy) | Equivalence(same /similar /different) |
| Aspiration - flowmode | Performancerequirement | Flow mode:Nominal flow 0-90 [ml/min]Vacuum limit 0 to -680 [mmHg@sea level] | Flow mode:Nominal flow 0-90 [ml/min]Vacuum limit 0 to -680 [mmHg@sea level] | Same |
| Aspiration - vacuummode | Performancerequirement | Vacuum mode:Vacuum 0 to -680 [mmHg@sea level}Rise time 300 [ms] (measured step 0 to 650mm Hg@ 0 cc/min) | Vacuum mode:Vacuum 0 to -680 [mmHg@sea level}Rise time 300 [ms] (measured step 0 to 650mm Hg@ 0 cc/min) | Same |
| Aspiration -Backflush | Performancerequirement | Micro Backflush (Reflux):Pressure range 0-50 [mmHg]Time of activation 0-250 [ms]Auto Backflush (Reflux):no user selectable parameters | Micro Backflush (Reflux):Pressure range 0-50 [mmHg]Time of activation 0-250 [ms]Auto Backflush (Reflux):Pressure range 0 to 50 [mmHg]Time of Activation 0-250 [ms] | Similar |
| Manual Backflush (Reflux):Pressure range: see Infusion/IrrigationProportional Backflush:Pressure range 0-50 [mmHg] | Manual Backflush (Reflux):Pressure range: see Infusion/IrrigationNot applicable | |||
| Cartridge andTubing Sets | Design | The cartridge consists of a collection bag to collectaspiration fluids, tubing for irrigation andaspiration and the tubing for the administration setFluid circulation is achieved by the interaction ofthe membrane and the pump pistons. | The cartridge consists of a collection bag to collectaspiration fluids, tubing for irrigation andaspiration and the tubing for the administration set.Fluid circulation is achieved by the interaction ofthe membrane and the pump pistons. | Same |
| Endo-Illumination | Principle ofoperation | The Endo-illumination module is used toilluminate the interior of the posterior chamber ofthe eye, a light source is available in the console,controllable in output, which connects toillumination fibers to bring the light into the eye. | The Endo-illumination module is used toilluminate the interior of the posterior chamber ofthe eye, a light source is available in the console,controllable in output, which connects toillumination fibers to bring the light into the eye. | Same |
| Illumination lightsource | Design | LED source, 3 port connections forendoillumination probes | LED source, 3 port connections forendoillumination probes | Same |
| Illumination outputand accuracy | Performancerequirement | 40 lm +/-20% (with 20ga fiber) | 40 lm +/-20% (with 20ga fiber) | Same |
| Illuminationspectrum | Performancerequirement | 425 to 680 [nm]UV filter (up to 425 nm), IR filter (above 680 nm) | 425 to 680 [nm]UV filter (up to 425 nm), IR filter (above 680 nm) | Same |
| IlluminationNumerical aperture | Performancerequirement | 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)(9000.ANTxx/COMyy) | K190875 Predicate deviceEVA(8000.ANTxx/COMyy) | Equivalence(same /similar /different) |
| operation | air exchange. The pressure can be set on thescreen. | air exchange. The pressure can be set on thescreen. | ||
| Fluid/Air exchange | Design | Air infusion module to provide air through aconnected tubing to the eye. The air is delivered tothe tubing set through an extended 0.22µm filter. | Air infusion module to provide air through aconnected tubing to the eye. The air is delivered tothe tubing set through an extended 0.22µm filter. | Same |
| Fluid/Air exchangepressure range | Performancerequirement | 0 - 150 mmHg | 0 - 150 mmHg | Same |
| Fluid/Air exchangepressure accuracy | Performancerequirement | <3 mmHg | <3 mmHg | Same |
| Fluid/Air exchangeflow rate | Performancerequirement | 1200 [ml/min] | 1200 [ml/min] | Same |
| VFC Module | ||||
| Viscous FluidExtraction | Principle ofoperation | VFE (Viscous Fluid Extraction) is used to extractintraocularviscous fluid from the eye into a syringe. It is donewith vacuum. | VFE (Viscous Fluid Extraction) is used to extractintraocularviscous fluid from the eye into a syringe. It is donewith vacuum. | Same |
| Viscous FluidExtraction pressure | Performancerequirement | 0 to -660 mmHg | 0 to -660 mmHg | Same |
| Viscous FluidInjection | Principle ofoperation | VFI (Viscous Fluid Injection) is used to injectviscous fluid from a syringe into the eye. It can bedone with pressurizing a pre-filled syringe. | VFI (Viscous Fluid Injection) is used to injectviscous fluid from a syringe into the eye. It can bedone with pressurizing a pre-filled syringe. | Same |
| Viscous FluidInjection pressure | Performancerequirement | 0 - 6 bar | 0 - 6 bar | Same |
| Micro Injection | Principle ofoperation | MI (Micro Injection) is used to inject a smallamount of aqueous fluid though a high gaugedelivery device into the eye. It is done bypressurizing a pre-filled syringe. | n/a | Different |
| Micro Injection | Performancerequirement | 0 - 2 bar | n/a | Different |
| Laser | ||||
| Laser | Principle ofoperation | The (optional) Laser Module provides atherapeutic eye Laser device indicated for photocoagulation of both anterior and posteriorsegments of the eye | The (optional) Laser Module provides atherapeutic eye Laser device indicated for photocoagulation of both anterior and posteriorsegments of the eye | Same |
| Treatment laser type | Design | Diode pumped frequency doubled Nd:YAG Laserfor photogoagulation, wavelength 532nm | Diode pumped frequency doubled Nd:YAG Laserfor photogoagulation, wavelength 532nm | Same |
| Laser Class | Performancerequirement | 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 | Same |
| Laser interpulse time | Performance requirement | 50-5000 ms | 50-5000 ms | Same |
| Aiming beam wavelength | Performance requirement | red - 630 - 645 nm | red - 630 - 645 nm | Same |
| Aiming beam power | Performance requirement | less than 1 mW | less than 1 mW | Same |
| Other | ||||
| Software | Operating system | Windows embedded OS | Windows embedded OS | Same |
| Application | EVA NEXUS GUI for parameter setting, interfaces for operator to control different modules, and service purpose. | EVA GUI for parameter setting, interfaces for operator to control different modules, and service purpose. | Similar | |
| Preventive measures and warnings | Device/GUI/IFU | Relevant safety signs and warnings are included on the device, in the EVA NEXUS Graphical user interface and the User Manual | Relevant safety signs and warnings are included on the device, in the EVA Graphical user interface and the User Manual | Similar |
| Packaging | Console | Plastic dust cover and protective flight case or carton | Plastic dust cover and protective flight case or carton | Similar |
| Accessories | Disposable - Primary EO sterilization package and protective box Reusable - Protective packaging | Disposable - Primary EO sterilization package and protective box Reusable - Protective packaging | Same | |
| Labelling | Labels | Labels according to international standards including safety signs for both console and accessories | Labelling according to international standards including safety signs for both console and accessories | Same |
| User manual | Full user manual available and delivered with the system | Full user manual available and delivered with the system | Similar |
Table 5 Comparison of EVA NEXUS (under evaluation) and the EVA system.
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
6. Device Description
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 vitrectomy probes to be used with the EVA NEXUS™ Ophthalmic Surgical System are identical in function to those cleared with the EVA Ophthalmic Surgical System (K142877). Specifically, for EVA NEXUS a new TDC (Two directional cutter) vitrectome was developed to support the maximum cutting frequency of 10,000 cycles per minute. A comparison between the cleared vitrectome and the vitrectome under evaluation is given in table 1.
{13}------------------------------------------------
| Items | Predicate vitrectomy probe (K142877) | Subject Device |
|---|---|---|
| Device name | Disposable High Speed TDC Cutter | Two Dimensional Cutter |
| Model | 23G: 8268.VIT2325G: 8268.VIT2527G: 8268.VIT27 | 23G: 9268.VIT2325G: 9268.VIT2527G: 9268.VIT27 |
| Construction | Image: Predicate vitrectomy probe construction diagram10 – Extension handle20 – Vitrectome body30, 30a – Outer & innerknives40 – Pressure tubing50 – Aspiration tubing60, 70, 80, 90 –Connectors10a - Outer knife10b - Inner knife | Image: Subject device construction diagram10 - Vitrectome10c - Hub (colour indicatesgauge size)10d - Body, 10e - Cap20 – Extension handle30 - Pressure tubing40 - Aspiration tubing50, 60, 70, 80, connectors10a - Outer knife10b - Inner knife |
| Packaging | Supportive packaging: tray, tapeSterile packaging: peel pouch | Supportive packaging: elastic tubular net & extensionhandle |
| Items | Predicate vitrectomy probe (K142877) | Subject Device |
| Outer packaging: carton box | Sterile packaging: peel pouchOuter packaging: carton box | |
| Basicprinciples(operationprinciples/mechanism) | To remove vitreous from the posterior chamber of the eye via a cutting and aspiration function; Cutting action is performed via forward motion and backward motion of the inner knife via pneumatic pressure from surgical system and a spring. | To remove vitreous from the posterior chamber of the eye via a cutting and aspiration function; Cutting action is performed via forward motion and backward motion of the inner knife via pneumatic pressure from surgical system and a spring. |
| Structuralcomposition | The device consists of following main components: body with pneumatic pressure chamber and spring, inner & outer knife, tubing with connectors for pneumatic air from surgical system and aspiration of eye fluids to the cartridge of the surgical system and an extension handle. | The device consists of following main components: body with pneumatic pressure chamber and spring, inner & outer knife, tubing with connectors for pneumatic air from surgical system and aspiration of eye fluids to the cartridge of the surgical system and an extension handle. |
| This product does not contain electrical connection or electrical components and the product is disposable. | This product does not contain electrical connection or electrical components and the product is disposable. | |
| Materials | Body, extension handle: PC;Knives: AISI 304, phynox;Tubing: PVCConnectors: Nylon and PVC | Body, hub, cap, extension handle: PC;Knives: AISI 304, phynox;Tubing: PVCConnectors: Nylon and PVC |
| Compatibility with surgical system: EVA and EVANEXUS, when taking into account the maximumdriving frequency. | Compatibility with surgical system: EVA NEXUS | |
| Driving frequency: 20-8000 CPM, ±20% | Driving frequency: 20-10,000 CPM, ±20% | |
| 8268.VIT23 | 9268.VIT23 | |
| Shaft diameter: 23G / 0.64 mm | Shaft diameter: 23G / 0.64 mm | |
| Performance | Shaft length: 33.0 mm | Shaft length (L1 in drawing above): 33.0 mm |
| 8268.VIT25 | 9268.VIT25 | |
| Shaft diameter: 25G / 0.53 mm | Shaft diameter: 25G / 0.53 mm | |
| Shaft length: 28.5 mm | Shaft length: 27 mm | |
| 8268.VIT27 | 9268.VIT27 | |
| Shaft diameter: 0.43 mm | Shaft diameter: 0.43 mm | |
| Shaft length:8268.VIT27: 28.5 mm | Shaft length:9268.VIT27: 27 mm | |
| Items | Predicate vitrectomy probe (K142877) | Subject Device |
| Sterilizationmethod | EO | EO |
| Indication | It is used for ophthalmic vitrectomy and is usedtogether with an ophthalmic surgical system. | It is used for ophthalmic vitrectomy and is used togetherwith an ophthalmic surgical system. |
| method ofapplication | Handled by scrub nurse, circulating nurse, used by eyesurgeon;1) connected to surgical system via pilot tube andaspiration tube2) cutting frequency and aspiration level set via GUI onsurgical machine3) control of cutting speed and aspiration level bysurgeon via footswitch | Handled by scrub nurse, circulating nurse, used by eyesurgeon;1) connected to surgical system via pilot tube andaspiration tube2) cutting frequency and aspiration level set via GUI onsurgical machine3) control of cutting speed and aspiration level by surgeonvia footswitch |
Table 1 Comparison of predicate vitrectomy probes and vitrectomy probes under evaluation.
{14}------------------------------------------------
{15}------------------------------------------------
{16}------------------------------------------------
The tubing sets and luer connectors utilized for the EVA NEXUS are similar to those cleared with the EVA Ophthalmic Surgical System (K142877). However, since EVA NEXUS no longer has a height adjustable infusion pole and it now includes an additional infusion / irrigation port, tubing adjusted to that has been developed. The additional tubing has the existing tubing and same connector types, however the connector has a different colour in order to clearly distinguish it and make it unique for connection. The infusion line was changed by removing the dripchamber. Table 2 below shows a comparison between previously cleared (right) and new (left) tubing. In the figure, the following connectors are present: White for influsion giving, from BSS container to cartridge. Blue for infusion of BSS from cartridge to the eye. Green for irrigation e.g. to a phaco handpiece. Red for aspiration from vitrectorny cutter to the cartridge collection bag. Orange for auxilliary aspiration e.g. from a phaco handpiece to the cartridge collection bag. Air tubing is used in certain surgical procedures to transport air to the surgical site, commonly done through separate tubing. In these cases the BSS is replaced by air from the surgical system, and the intraccular pressure will be controlled by the air pressure. All tubing is sterilized by means of ethylene oxide.
| Table 2 Comparison of predicate tubing and tubing under evaluation. | ||
|---|---|---|
| Items | EVA NEXUS tubing (new) | EVA tubing (K142877) |
| PictureProduct codeProduct name | 9110.INP01: EVA NEXUS™ Infusion Giving set | 8110.INP01: Disposable EVA Gravity Input set |
| Sterile packaging | Peel pouch | Peel pouch |
| Operating principle | The Infusion Giving set is connected between the container with BSS and the cartridge to provide BSS to the surgical system | The gravity input set is connected between the container with BSS and the cartridge to provide BSS to the surgical system |
| Materials | Connector and tubing: PVC | Connector and tubing: PVC |
Table 2 Comparison of predicate tubing and tubing under evaluation
{17}------------------------------------------------
| Spike, cap, filter: ABS, PE, ACP, PPClamp: PP | Dripchamber incl. Spike, cap, filter: PVC, ABS, PE,ACP, PP, VersaporClamp: PP | |
|---|---|---|
| Size | Length: 1200 mmInner Diameter: 4 mm | Length: 1900 mmInner Diameter: 4 mm |
| PictureProduct codeProduct name | Image: 9110.IAD01: EVA NEXUSTM Irrigation and Aux. Aspiration Tubing | Image: 8110.IAD01: Disposable EVA Irrigation and Aspiration Tubing |
| Sterile packaging | Peel pouch | Peel pouch |
| Operatingprinciple | The irrigation tubing is used to provide BSS to thesurgical site. The auxiliary aspiration tubing is used totransport fluids from the surgical site to the surgicalsystem. | The irrigation tubing is used to provide BSS to thesurgical site and the aspiration tubing is used to removefluids from the surgical site. |
| Materials | Connector and tubing: PVCClamp: PP | Connector and tubing: PVC |
| Size | Length: 1900 mmInner Diameter irrigation: 4 mmInner diameter aspiration: 1.5 mm | Length: 1900 mmInner Diameter irrigation: 4 mmInner diameter aspiration: 1.5 mmSee 8110.IAD01 |
| PictureProduct codeProduct name | Image: 9110.IAD02: EVA NEXUS™ Infusion and Aux. Aspiration Tubing | |
| Sterile packaging | Peel pouch | Peel pouch |
| Operating | The infusion tubing is used to transport BSS from the | The irrigation tubing is used to provide BSS to the |
| principle | surgical system to the surgical site. The auxiliaryaspiration tubing is used to transport fluids from thesurgical site to the surgical system. | surgical site and the aspiration tubing is used to removefluids from the surgical site. |
| Materials | Connector and tubing: PVCClamp: PP | Connector and tubing: PVC |
| Size | Length: 1900 mmInner Diameter infusion: 4 mmInner diameter aspiration: 1.5 mm | Length: 1900 mmInner Diameter irrigation: 4 mmInner diameter aspiration: 1.5 mm |
| PictureProduct codeProduct name | 9110.AAS01: EVA NEXUS™ Aux. Aspiration Tubing | This is the same tubing as the Auxilliary aspirationtubing in 9110.IAD01 and 9110.IAD02 |
| PictureProduct codeProduct name | 9110.IRR01: EVA NEXUS™ Irrigation Tubing | This is the same tubing as the irrigation tubing in9110.IAD01 |
| PictureProduct codeProduct name | 9110.INF01: EVA NEXUS™ Infusion Tubing | This is the same tubing as the infusion tubing in9110.IAD02 |
{18}------------------------------------------------
In order to use a surgical system to aid with the injection an adaptor kit to the surgical system should be used.
When the surgeon has to inject fluids into the eye the injected fluid could vary. Therefore, the surgeon requires a system to inject fluid with a 1 cc syringe.
{19}------------------------------------------------
Pictures of the injection and extraction kits can be found between 1364.DD (to be used with the Micro Injection capability) and the equivalent 1363.DD which was cleared in K142877 is shown in table 3.
Image /page/19/Figure/2 description: The image shows several medical devices, including syringes, tubes, and connectors. There is a syringe labeled "1362.D" with a needle attached. Other items include "1362.VFE2", "1363.DD", "1362.VFE", "1279.VFI", and "1364.DD (changed)", each appearing to be different types of connectors or tubing setups used in medical procedures.
{20}------------------------------------------------
| Device under evaluation | MicroDose™ Injector (MedOne) | Orbit Subretinal Delivery System (Orbit SDS) |
|---|---|---|
| 1364.DD - 1 cc syringe holder forinjection | ||
| K1115-67 | K203264 | K200325 |
| Class II FMF, Syringe, Piston | Class II FMF, Syringe, Piston | Class II FMF, Syringe, Piston |
| Feature | Device under evaluation1364.DD - 1 cc syringe holder formicro injection | MicroDose™ Injector (MedOne) | Orbit Subretinal Delivery System(Orbit SDS) |
|---|---|---|---|
| K# | K213467 | K203264 | K200325 |
| Device classification /Code | Class II FMF, Syringe, Piston21 CFR 880.5860 | Class II FMF, Syringe, Piston21 CFR 880.5860 | Class II FMF, Syringe, Piston21 CFR 880.5860 |
| Secondary productclassification / code | N/A | N/A | Class I HMX, Ophthalmic Cannula21 CFR 886.4350 |
| Indication for Use | The 1364.DD is indicated for micro-injection into the subretinal space. | The MicroDose is indicated for lowvolume ophthalmic injection into thesubretinal space. | The Orbit Subretinal Delivery Systemis indicated for micro injection intothe subretinal space. |
| How Supplied | Sterile, single use only | Sterile, single use only | Sterile, single use only |
| Configuration | 1 mL syringe (syringe barrel andpiston, plunger separated from barrel),Tubing with snap collars on syringeend and connector on surgical systemend | 1 mL Syringe (syringe barrel andpiston – plunger removed) andConnector | 1 mL Syringe (syringe barrel, plungerand piston), Cannula, Tubing set,connector for surgical system,Magnetic pad, Ophthalmic marker |
| Mode of Operation | Pneumatic | Pneumatic | Pneumatic or Manual |
| Volume | 1 mL | 1 mL | 1 mL |
| Fluid delivery | Cannula sold separately | Cannula sold separately | Cannula supplied with the device |
| Biocompatibility | Meets ISO 10993-1 | Meets ISO 10993-1 | Meets ISO 10993-1 |
The laser probes to be used with EVA NEXUS will be available with various tip shapes. The laser probes are the same as used for the predicate EVA Ophthalmic Surgical System (K190875), are purchased from Peregrine and were cleared in K024061, K031023, and
{21}------------------------------------------------
K 132614. In addition, DORC wishes to include directional laser probes; examples are shown below (7225.DORC). These laser probes are similar in materials to the cleared laserprobes, but have a sliding mechanism, which allows the surgeon to retract the laser fiber when inserting it through a trocar cannula and extending it inside the eye, allowing it to reach the retina.
Image /page/21/Figure/2 description: The image shows two different types of laser probes. The first one is labeled "7525.DORC Stepped laser probe 25 gauge / 0.5 mm". The second one is labeled "7225.DORC Directional laser probe (25 gauge / 0.5 mm)". Both probes are white with a blue laser beam coming out of the tip.
Table 4 gives a comparison between the cleared laserprobe and the directional laser probe under evaluation.
Table 4 Comparison of predicate laser probes and laser probes under evaluation.
{22}------------------------------------------------
| Items | Predicate laser probe (K024061) | Device under evaluation |
|---|---|---|
| Device name | Stepped laser probe 25 gauge / 0.5 mm | Directional laser probe (25 gauge / 0.5 mm) |
| Model | 7525.ALC and 7525.DORC | 7225.ALC and 7225.DORC |
| Construction | 10 – SMA Connector20 - Connector bushing30 – Strain relief boot40 - Jacket50 – Optical fiber60 – Handpiece70 – O-ring80 - Needle | 10 – SMA Connector20 - Connector bushing30 – Strain relief boot40 - Jacket50 - Optical fiber60 – O-ring70 – Handpiece80 – Slide knob90 – Needle100 - Tip110 - Cap |
| Packaging | Peel pouch | Peel pouch |
| Basic principles (operation principles/ mechanism) | A laser probe that transfers laser light (energy) from laser energy source in surgical system via the tip of the device to the retina to locally reattach retinal detachments. The shaft can be straight, curved or directional to facilitate easy access to all locations on the retina (including the periphery). | A laser probe that transfers laser light (energy) from laser energy source in surgical system via the tip of the device to the retina to locally reattach retinal detachments. The shaft can be straight, curved or directional to facilitate easy access to all locations on the retina (including the periphery). |
| Structural composition | The product is composed of laser connector, handpiece and probe protector. | The product is composed of laser connector, handpiece with sliding mechanism and probe protector. |
| Items | Predicate laser probe (K024061) | Device under evaluation |
| Materials | Nickel plated Brass / CuNiZn, Neoprene, Acrylated Olefin,Glass, Hard Clad Silica, ETFE, POM, Silicone, StainlessSteel, Nitinol, PMMA | Nickel plated Brass / CuNiZn, Neoprene, Acrylated Olefin,Glass, Hard Clad Silica, ETFE, POM, Silicone, Stainless Steel,Nitinol, PMMA, PC, PP |
| Performanceand | Compatibility with surgical system: EVA and EVA NEXUS | Compatibility with surgical system: EVA and EVA NEXUS |
| .ALC is meant for use on machines with SMA connector | .ALC is meant for use on machines with SMA connector | |
| .DORC is meant for use on machines with a DORC connector | .DORC is meant for use on machines with a DORC connector | |
| and | 7025.ALC and 7025.DORC | 7225.ALC and 7225.DORC |
| mechanicalproperties | Total length: 256 cm ± 10 cm | Total length: 256 cm ± 10 cm |
| Core diameter: 200 µm | Core diameter: 200 µm | |
| Beam divergence angle: 210 mrad | Beam divergence angle: 210 mrad | |
| Fiber tensile strength: at least 5N | Fiber tensile strength: at least 5N | |
| Sterilizationmethod | EO | EO |
| Indication | The product is used in conjunction with 532nm laser for laser | The product is used in conjunction with 532nm laser for laser |
| light transmission | light transmission | |
| method ofapplication | Handled by scrub nurse, circulating nurse, used by eyesurgeon; | Handled by scrub nurse, circulating nurse, used by eye surgeon; |
| 1) connected to surgical system via connector | 1) connected to surgical system via connector | |
| 2) laser power output set via GUI on surgical machine | 2) laser power output set via GUI on surgical machine | |
| 3) activation of laser function by surgeon via footswitch | 3) activation of laser function by surgeon via footswitch |
{23}------------------------------------------------
{24}------------------------------------------------
Image /page/24/Figure/1 description: The image shows a medical device with several labeled parts. The device has a screen at the top, labeled as '1', displaying various graphs and data. Below the screen, there are several buttons and ports, labeled as '3', '4', and '5', which likely control different functions of the device. The base of the device has wheels, labeled as '8', allowing it to be easily moved.
Figure 1: EVA NEXUS™ (Front)
- Display with touch screen ●
- . Infrared receiver (remote control)
- Holder for touch screen pen
- . Instrument connections and buttons
- . Cartridge (Irrigation/Infusion/Aspiration)
- Mayo arm and tray
- Footswitch holder
- Brake lever
{25}------------------------------------------------
Figure 2: EVA NEXUS™ (Back)
Image /page/25/Picture/2 description: The image shows a medical device with several parts labeled with numbers. The numbers range from 9 to 17, each pointing to a specific component of the device. These components include parts of the frame, the display, and the base of the device.
- Bottle holder ●
- Monitor arm ●
- USB port ª
- Push bar ●
- Cooling outlet
- Laser connections
- Storage Compartment (documentation, hoses,
tubes and power cord)
- . Brake lever
- · Supply connections, Fuse, Mains switch, Ethernet port and Footswitch.
a.Note: The USB port is restricted to use of an USB storage device only.
{26}------------------------------------------------
Comparison of Technological Characteristics with the Predicate Devices 7.
There are no indications for use, features or technological of the EVA NEXUS™ Ophthalmic Surgical System that have not been previously cleared in the predicate devices.
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
BIOCOMPATIBILITY TESTING
The biocompatibility evaluation of the EVA NEXUS™ Ophthalmic Surgical System was conducted in accordance with FDA Guidance "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process", issued on September 4, 2020.
The EVA NEXUS ™ Ophthalmic Surgical System is not intended to come into contact with the patient.
Surgical System that potentially come into contact with the patient fluid path have been previously cleared. Since new vitrectomes, tubing, phaco needles and sleeves and directional laser probes are introduced in this 510(k), the most recent biocompatibility testing is provided in Annex 4.
Biocompatibility testing of accessories has been conducted and confirmed acceptable by cytotoxicity, Kligman maximization and intracutaneous irritation testing, in compliance with ISO 10993-1, 10993-5, 10993-10 and 10993-12.
ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY (EMC)
Electrical safety and EMC testing were conducted on the EVA NEXUS™ Ophthalmic Surgical System. The system complies with the IEC 60601-1, IEC 60601-2-2 and IEC 80601-2-58 standards for safety and EN 60601-1-2 and 47 CFR Part 15 Subpart B for EMC.
SOFTWARE VERIFICATION AND VALIDATION TESTING
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket
{27}------------------------------------------------
Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
PERFORMANCE (BENCH) TESTING
Although animal and clinical performance testing were not required for the EVA NEXUS to demonstrate efficacy, safety and substantial equivalence to predicate devices, a variety of laboratory (bench) performance tests have been conducted including:
- Testing to ensure compliance to ISO 15004-2: 2007 "Illuminator Ophthalmic instruments -. Fundamental requirements and test methods - Part 2: Light hazard protection"
- Testing to ensure compliance to IEC 60601-2-22:2007. A1:2012. Medical electrical equipment -. Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment is reported in 2230157.50D.
- EVA pneumatic compatibility test which concludes that no changes that might impact Nitrogen-. compatibility are introduced in EVA NEXUS when compared to the predicate EVA. Therefore EVA NEXUS is compatible with compressed nitrogen (N2) and is in that sense substantially equivalent to the predicate EVA.
- EVA pneumatic compatibility test: RPRT 30554100 which concludes that no changes that might . impact Nitrogen-compatibility are introduced in EVA NEXUS when compared to the predicate EVA. Therefore EVA NEXUS is compatible with compressed nitrogen (N2) and is in that sense substantially equivalent to the predicate EVA.
- EVA / EVA NEXUS Performance comparison test report: RPRT 30609300. This report includes . a comparison between EVA NEXUS and the predicate EVA, regarding the functions: irrigation, aspiration, and micro injection in relation to IEC 80601-2-58:2016. The report concludes that the functions are very similar, substantiating the substantial equivalence between EVA NEXUS and the predicate EVA.
- RPRT 30572000 EVA Reliability Prediction report gives a prediction on the system and . subsystem failure rate using the Telcordia Issue 3 model.
- Disposable Pneumatic Vitrectomes Product Verification Report: RPRT 30612000 shows that the . vitrectomes can withstand an overpressure of 4.5 bar (65psi). The same report is used to show that the vitretomes function as intended throughout the life time of the device, by means of
{28}------------------------------------------------
lifetime (5 minutes at 5000 CPM and 5 minutes at maximum cut rate) and durability tests (≥ 150,000 cutting cycles).
- EVA NEXUS Cartridge Verification Report: RPRT 30518300 shows that the cartridge designed ● for EVA NEXUS is substantially equivalent to the EVA cartridge.
- Testing to ensure compliance to IEC 80601-2-58 " Medical electrical equipment, Part 2: ● Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery"
- Testing to ensure compliance to IEC 60601-2-2 " Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories"
Performance data:
The following tests were successfully performed with DORCs 1364.DD to establish substantial
equivalence to the predicate devices:
- Biocompatibility testing in accordance with ISO 10993-1 including cytotoxicity (ISO 10993-5) . as reported in RPRT 30527100 which was included in VOL024 of the original submission of K213467. Since the syringe used in the 1364.DD has a 510(k) (K063280) additional biocompatibility testing is deemed not required.
- Sterilization validation in accordance with ISO 11135 as reported in chapter 14.1.3 of the ● original submission of K213467. An adoption (see 2020031 STER) is prepared to record the rationale for adopting the validation criteria and validation test results, which concluded that the product is less worst case as defined in the current validated sterilization process and therefore the mentioned product is adopted.
- Shelf life testing was conducted as reported in chapter 14 of the original submission of K213467. . An adoption (see attached 2015052 SLAD) was prepared to provide a rationale to demonstrate that the selected packaging system is considered adequate in protecting the device during storage throughout the specified shelf life. The adoption concluded that the 1364.DD is less worst case than the products included in the shelf life study as referred to in Chapter 14 of the original submission. Therefore revalidation is considered not necessary and the conclusion from the reports is adopted for the 1364.DD.
- Performance tests on sterilized products are performed as reported in RPRT 30492800, section ● 7.14 (see attached). The tests were all performed successfully.
- Package and performance testing was performed post shipping to ensure package integrity and functionality of the device as reported in chapter 14 of the original submission of K213467. An adoption (see attached 2015052 PIAD) was prepared to demonstrate that the selected packaging system is considered adequate in protecting the device during transport and distribution of shipping units. The adoption concludes that the 1364.DD is not worst case when compared to the products included in earlier packaging studies. Therefore the studies are deemed to be applicable for 1364.DD.
{29}------------------------------------------------
9. Conclusion
As described in this 510(k) Summary, all testing deemed necessary was conducted on the EVA NEXUS™ Ophthalmic Surgical System to ensure that the device is substantially equivalent to the predicate device for its intended use when used in accordance with its Instructions for Use. The 1364.DD "1 cc syringe holder for micro injection" shares the same intended use, the same or similar device operation, and overall technical and functional capabilities to the predicate devices and meets applicable standards. Any difference between the 1364.DD and the predicate devices has no significant influence on safety or effectiveness of the 1364.DD. Therefore the 1364.DD "1 cc syringe holder for micro injection" is substantially equivalent to the predicate devices.
§ 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.