(229 days)
No
The summary does not mention AI, ML, or any related technologies like deep learning or neural networks. The device description focuses on standard surgical functions and comparisons to a predicate device.
Yes.
The device is used for surgical procedures such as phacoemulsification, cataract removal, and vitreoretinal treatments, as well as laser treatments for various ophthalmic conditions like diabetic retinopathy and glaucoma, all of which aim to treat or alleviate diseases.
No
The EVA NEXUS™ Ophthalmic Surgical System is described as a combined anterior and posterior procedure ophthalmic system used for surgical procedures like phacoemulsification, cataract removal, vitreoretinal procedures, and laser treatments for various eye conditions. Its functions include infusion, vitreous cutting, aspiration, illumination, irrigation, lens emulsification and fragmentation, cautery, diathermy, and photocoagulation. These are all therapeutic and surgical functions, not diagnostic ones.
No
The device description explicitly states it is a "combined anterior and posterior procedure ophthalmic system" and lists various hardware components and functions like infusion, vitreous cutting, aspiration, illumination, irrigation, lens emulsification and fragmentation, cautery, diathermy, and photocoagulation. The performance studies also detail testing of hardware components and systems.
Based on the provided information, the EVA NEXUS™ Ophthalmic Surgical System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes surgical procedures performed directly on the eye (anterior and posterior segments) for treatment purposes (phacoemulsification, cataract removal, vitreoretinal procedures, laser treatments for various eye conditions). This involves direct intervention on the patient's body.
- Device Description: The device description details a surgical system with functions like infusion, cutting, aspiration, illumination, irrigation, emulsification, fragmentation, cautery, diathermy, and photocoagulation. These are all surgical tools and techniques.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or other bodily fluids) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to perform procedures on the body itself. The EVA NEXUS™ is a surgical system used for treatment.
N/A
Intended Use / Indications for Use
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 |
Product codes (comma separated list FDA assigned to the subject device)
HQC, HQE, HQF, FMF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eye (anterior segment, posterior segment)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye surgeon, scrub nurse, circulating nurse.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 for 1364.DD:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K190875, K142877, K024061, K203264, K200325
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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)
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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 Surgical | |
| 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 |
| injection | ||
| K200325 | Orbit Subretinal Delivery System (Orbit | |
| SDS) | 1364.DD - 1 cc syringe holder for micro | |
| 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)
(9000.ANTxx/COMyy) | K190875 Predicate device
EVA
(8000.ANTxx/COMyy) | Equivalence
(same /
similar /
different) |
|-----------------------------------------|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Technical Characteristics | | | | |
| General | | | | |
| General functional
overview | Design | The EVA NEXUS console provides the following
functions:
- 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 following
functions: - Phaco-emulsification
- Vitrectomy
- Diathermy
- Irrigation / Aspiration
- Illumination
- Fluid/Air exchange
- Viscous fluid control (injection, extraction)
- Laser
- Proportional scissor | Different |
| General Product
composition | Design | Console, footswitch, power cable, accessories for
different purposes including phacoemulsification,
vitrectomy, illumination, Inspiration/Aspiration,
diathermy, and laser. Procedure packs. | Console, footswitch, power cable, accessories for
different 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 of
operation | The user selects settings for the various functions
on the Graphical User Interface by the touch
screen, or by the remote control. The user starts,
stops, and regulates the various functions with the
foot switch. | The user selects settings for the various functions
on the Graphical User Interface by the touch
screen, or by the remote control. The user starts,
stops, and regulates the various functions with the
foot switch. | Same |
| User Interfaces | Console screen | Glass Color display Touchscreen (19 inch) with
programmable Graphical User Interface | Glass Color display Touchscreen (19 inch) with
programmable Graphical User Interface | Same |
| User Interfaces | Multi-function
footswitch | Multi-function footswitch with a dual-linear pedal
and programmable function buttons to control all
functions including laser.
Wired and Wireless connection to the console.
Battery-operated with wall charger and back-up
power/connection cable. | Multi-function footswitch with a dual-linear pedal
and programmable function buttons to control all
functions including laser.
Wired and Wireless connection to the console.
Battery-operated with wall charger and back-up
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
Auto-tuning | 40kHz
Auto-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 device
EVA
(8000.ANTxx/COMyy) | Equivalence
(same /
similar /
different) |
| Vitrectomy cutting
rate | Performance
requirement | up to 10000 cpm for standard vitrectomes
up to 20000 cpm for dual cut vitrectomes | up to 8000 cpm for standard vitrectomes
up to 16000 cpm for dual cut vitrectomes | Similar |
| Diathermy | | | | |
| Diathermy | Principle of
operation | The Diathermy Module provides coagulation for
anterior and posterior eye-segment surgery | The Diathermy Module provides coagulation for
anterior and posterior eye-segment surgery | Same |
| Diathermy | Design | digitally controlled driver board to provide energy
generated by high frequency currents through a
diathermy handpiece to the tissue | driver board to provide energy generated by high
frequency currents through a diathermy handpiece
to the tissue | Similar |
| Diathermy Type | Performance
requirement | Bipolar Coagulation | Bipolar Coagulation | Same |
| Diathermy Shape of
HF-voltage | Performance
requirement | Un-modulated sinusoidal voltage | Un-modulated square voltage | Different |
| Diathermy
frequency | Performance
requirement | $1 MHz (±10%)$ | $1 MHz (±10%)$ | Same |
| Diathermy max.
output power | Performance
requirement | $10 W ±20% (at 100 Ohm)$ | $10 W ±10% (at 150 Ohm)$ | Similar |
| Diathermy Voltage
(peak-peak) | Performance
requirement | $180Vp -p max.$ | $200 Vp -p max.$ | Similar |
| Fluidics Module | | | | |
| Fluidics Module | Principle of
operation | To maintain anterior/posterior chamber stability,
the pump keeps the pressure of the fluidics in the
tubing system to the physician set value, or
alternatively keeps the inflow and outflow of the
fluidics to the physician set flow value. | To maintain anterior/posterior chamber stability,
the pump keeps the pressure of the fluidics in the
tubing system to the physician set value, or
alternatively keeps the inflow and outflow of the
fluidics to the physician set flow value. | Same |
| Irrigation (infusion) | Principle of
operation | Pressurized infusion by a plunger pump. Pressure
control by squeezing the membranes of a to the
pump connected cartridge. | Pressurized infusion by means of an height
controlled Infusion Pole (gravity) or by means of
an Air pressurized Infusion bottle. | Different |
| Irrigation (Infusion)
modes | Performance
requirement | Modes: Fixed/AIC/SMART IOP | Modes: Gravity/AIC/VGPC | Different |
| Infusion/Irrigation
pressure | Performance
requirement | 0-150 mmHg | 0-150 mmHg | Same |
| Aspiration | Principle of
operation | Plunger pump; can operate in flow control or
vacuum control by squeezing the membranes of a
to the pump connected cartridge.
The pumping system can be used in one of two
modes: pressure control or flow control. | Plunger pump; can operate in flow control or
vacuum control by squeezing the membranes of a
to the pump connected cartridge.
The pumping system can be used in one of two
modes: pressure control or flow control. | Same |
| Aspiration | Performance
requirement | 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 device
EVA
(8000.ANTxx/COMyy) | Equivalence
(same /
similar /
different) |
| Aspiration - flow
mode | Performance
requirement | 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 - vacuum
mode | Performance
requirement | 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 | Performance
requirement | 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/Irrigation
Proportional Backflush:
Pressure range 0-50 [mmHg] | Manual Backflush (Reflux):
Pressure range: see Infusion/Irrigation
Not applicable | |
| Cartridge and
Tubing Sets | Design | The cartridge consists of a collection bag to collect
aspiration fluids, tubing for irrigation and
aspiration and the tubing for the administration set
Fluid circulation is achieved by the interaction of
the membrane and the pump pistons. | The cartridge consists of a collection bag to collect
aspiration fluids, tubing for irrigation and
aspiration and the tubing for the administration set.
Fluid circulation is achieved by the interaction of
the membrane and the pump pistons. | Same |
| Endo-Illumination | Principle of
operation | The Endo-illumination module is used to
illuminate the interior of the posterior chamber of
the eye, a light source is available in the console,
controllable in output, which connects to
illumination fibers to bring the light into the eye. | The Endo-illumination module is used to
illuminate the interior of the posterior chamber of
the eye, a light source is available in the console,
controllable in output, which connects to
illumination fibers to bring the light into the eye. | Same |
| Illumination light
source | Design | LED source, 3 port connections for
endoillumination probes | LED source, 3 port connections for
endoillumination probes | Same |
| Illumination output
and accuracy | Performance
requirement | 40 lm +/-20% (with 20ga fiber) | 40 lm +/-20% (with 20ga fiber) | Same |
| Illumination
spectrum | Performance
requirement | 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 |
| Illumination
Numerical aperture | Performance
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)
(9000.ANTxx/COMyy) | K190875 Predicate device
EVA
(8000.ANTxx/COMyy) | Equivalence
(same /
similar /
different) |
| | operation | air exchange. The pressure can be set on the
screen. | air exchange. The pressure can be set on the
screen. | |
| Fluid/Air exchange | Design | Air infusion module to provide air through a
connected tubing to the eye. The air is delivered to
the tubing set through an extended 0.22µm filter. | Air infusion module to provide air through a
connected tubing to the eye. The air is delivered to
the tubing set through an extended 0.22µm filter. | Same |
| Fluid/Air exchange
pressure range | Performance
requirement | 0 - 150 mmHg | 0 - 150 mmHg | Same |
| Fluid/Air exchange
pressure accuracy | Performance
requirement |