The EVA Ophthalmic Surgical System is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

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 retinalvein occlusion	Scatter LaserPhotocoagulation
• Chronic macular edema secondary to Branch or Centralretinal vein occlusion	Focal or Grid Laser
Glaucoma
• Primary Open-angle	Trabeculoplasty
• Closed Angle	Iridotomy or Iridoplasty

Device Description

The EVA Ophthalmic Surgical System (EVA) is a combined anterior and posterior procedure ophthalmic system that is modular in design and serves as an enhanced version of the currently cleared Associate (K081877). The EVA 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.

AI/ML Overview

The provided text describes the "EVA Ophthalmic Surgical System." It discusses various performance data, including biocompatibility, electrical safety, electromagnetic compatibility (EMC), and software verification and validation. However, the document does not contain information about specific clinical performance studies where the device's efficacy is measured against defined acceptance criteria using patient data. Instead, it focuses on demonstrating the device's safety and equivalence to predicate devices through engineering and laboratory tests.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) cannot be sourced from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative format for device performance in clinical use, nor does it report patient-centric performance in such a table. It states that "animal and clinical performance testing was not required for the EVA to demonstrate efficacy, safety and substantial equivalence to predicate devices."

Instead, it lists various engineering and laboratory tests and states that the device "complies" or "will not fail."

Acceptance Criteria (Implied from tests)	Reported Device Performance
Biocompatibility: No cytotoxicity, irritation, or sensitization for patient-contacting components (cartridges and vitrectomy handpieces).	Biocompatibility was evaluated 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: Compliance with applicable standards.	The system complies with IEC 60601-1, EN 60601-2-2, and EN 80601-2-58 standards for safety.
EMC: Compliance with applicable standards.	The system complies with EN 60601-1-2 and 47 CFR Part 15 Subpart B for EMC.
Software: Software verification and validation ensure safety and intended performance (categorized as "major" level of concern).	Software verification and validation testing were conducted and documentation provided as recommended by FDA guidance. The device's software was considered to be of "major" level of concern.
Vitrectomy cutters: Will not fail at normal working pressure (41 PSI).	Testing confirmed that vitrectomy cutters will not fail at the normal working pressure (41 PSI).
EVA Pump module: Durability.	Testing determined the durability of the EVA Pump module. (Specific metrics not provided).
Light probe tips: Will not melt at maximum output of LED illumination module.	Testing confirmed that the light probe tips will not melt at the maximum output of the LED illumination module.
Waste bags: Will not rupture when full.	Testing confirmed that the waste bags will not rupture when full.
Vitrectomy cutters: Will not generate particulate matter at highest cut speed.	Testing confirmed that the vitrectomy cutters will not generate particulate matter at the highest cut speed.
Reusable accessories: Withstand repeat sterilization without impact to device characteristics.	Testing confirmed that reusable accessories can withstand repeat sterilization without impact to device characteristics.
Compliance with specific standards for lens removal/vitrectomy, high-frequency surgical equipment, and light hazard protection (e.g., IEC 80601-2-58).	Testing ensured 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," IEC 60601-2-2, and ISO 15004-2: 2007 "Illuminator Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not applicable. The document states that "animal and clinical performance testing was not required." The performance data provided are from laboratory/bench testing on device components and the system itself, not from a clinical test set with patient data.
Data provenance: Not explicitly stated, but the testing appears to be internal lab/bench testing for device compliance.

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)

Not applicable, as no clinical test set with human-established ground truth was used for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set requiring adjudication was used.

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 device is an ophthalmic surgical system, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a surgical system, not an algorithm. The software verification and validation are for the embedded software controlling the surgical system, not for a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The ground truth for the "performance testing" described is based on engineering specifications, physical properties, and compliance with recognized standards (e.g., whether a pump is durable, if a tip melts, if a waste bag ruptures, if a cutter generates particulates, compliance with electrical safety standards).

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning product for performance evaluation.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized graphic. The graphic depicts three human profiles facing to the right, layered on top of each other, symbolizing health and human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 13, 2015

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. Ms. Daniëlle Sleegers MSc. QA/RA Manager Scheijdelveweg 2. 3214 VN Zuidland, Netherlands

Re: K142877

Trade/Device Name: EVA Ophthalmic Surgical System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HOC, HOE, HOF Dated: February 6, 2015 Received: February 9, 2015

Dear Ms. Sleegers:

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. 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 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); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"

(21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K142877

Device Name: EVA Ophthalmic Surgical System

Indications for Use:

The EVA Ophthalmic Surgical System is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

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 retinalvein occlusion	Scatter LaserPhotocoagulation
• Chronic macular edema secondary to Branch or Centralretinal vein occlusion	Focal or Grid Laser
Glaucoma
• Primary Open-angle	Trabeculoplasty
• Closed Angle	Iridotomy or Iridoplasty

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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5. 510(K) SUMMARY

This summary is in accordance with 21 CFR 807.92.

Submitter 5.1

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: Mrs. D.F.J. Sleegers, QA/RA Manager Phone: +31 181 458080 Email: d.sleegers@dorc.eu

Date Prepared: January 15, 2015

5.2 Device

Device Subject to this 510(k):

Trade Name: EVA Ophthalmic Surgical System Common Name: Phacoemulsification/Vitrectomy System Classification Name: Class II

The following regulations are applicable for this 510(k):

o 21 CFR 886.4670 Phacofragmentation System
21 CFR 886.4150 Vitreous Aspirating and Cutting Device
21 CFR 886.4390 Ophthalmic Laser

5.3. Predicate Devices

510(k) Number Device

K081877	Associate 2500 dual and compact systems (DORC)
K101285	Constellation Vision System (Alcon)
K101325	Stellaris PC Vision Enhancement System (Bausch & Lomb)
K102222	Ultimate Vit Enhancer (MID Labs)
K121675	VersaVit (Synergetics)
K062624	Next Generation Laser (PurePoint; Alcon)

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5.4. Device Description

5.5. Indications for Use

The EVA Ophthalmic Surgical System is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

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●	Scatter Laser
vein occlusion	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

5.6. Comparison of Technological Characteristics with the Predicate Devices

As described in Section 12 of this 510(k) there are no technological characteristics (including operating specifications) or features of the EVA Ophthalmic Surgical System that have not been previously cleared in predicate devices.

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5.7 Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation of the EVA Ophthalmic Surgical System was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993. 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.'' May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

The EVA Ophthalmic Surgical System is not intended to come into contact with the patient. The materials used for the device console are common and widely used for ophthalmic and similar applications without reported health concerns.

With the exception of the cartridges and vitrectomy handpieces all accessories used with the EVA Ophthalmic Surgical System that potentially come into contact with the patient or patient fluid path have been previously cleared.

The biocompatibility of the cartridges and vitrectomy handpieces has been evaluated 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 Ophthalmic Surgical System. The system complies with the IEC 60601-1, EN 60601-2-2 and EN 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 Submissions for Software Contained in Medical Devices." The software for this

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DORC

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 Testing

Although animal and clinical performance testing was not required for the EVA to demonstrate efficacy, safety and substantial equivalence to predicate devices, a variety of laboratory (bench) performance tests have been conducted including:

o 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"
o 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"
Testing to ensure compliance to ISO 15004-2: 2007 "Illuminator Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection"
Testing to confirm that vitrectomy cutters will not fail at the normal working pressure ● (41PSI).
Testing to determine the durability of the EVA Pump module
Testing to confirm that the light probe tips will not melt at the maximum output of the ● LED illumination module.
Testing to confirm that the waste bags will not rupture when full. ●
Testing to confirm that the vitrectomy cutters will not generate particulate matter at ● the highest cut speed.
Testing to confirm that reusable accessories can withstand repeat sterilization without ● impact to device characteristics

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Standard #	Title
ISO 10993-1: 2009	Biological Evaluation Of Medical Devices -- Part 1: Evaluation AndTesting
ISO 10993-5: 2009	Biological Evaluation Of Medical Devices -- Part 5: Tests For In VitroCytotoxicity
ISO 10993-7: 2008	Biological Evaluation Of Medical Devices - Part 7: Ethylene OxideSterilization Residuals
ISO 10993-10: 2010	Biological Evaluation Of Medical Devices - Part 10: Tests For IrritationAnd Sensitization
ISO 10993-12: 2012	Biological Evaluation Of Medical Devices - Part 12: Sample Preparationand Reference Materials
ISO 11135:2007	Sterilization Of Health-Care Products - Ethylene Oxide – Part 1:Requirements for the Development, Validation and Routine Control of aSterilization Process for Medical Devices
ISO 14971:2007	Medical Devices: Application Of Risk Management To Medical Devices
ISO 11607-1:2006	Packaging For Terminally Sterilized Medical Devices - Part 1:Requirements For Materials, Sterile Barrier Systems And PackagingSystems
ISO 11607-2:2007	Packaging For Terminally Sterilized Medical Devices - Part 2: ValidationRequirements For Forming, Sealing And Assembly Processes
ISO 15004-2:2007	Ophthalmic Instruments - Fundamental Requirements And Test Methods -Part 2: Light Hazard Protection
ISO 14644-2:2000	Cleanrooms And Associated Controlled Environments - Part 2:Specifications For Testing And Monitoring To Prove ContinuedCompliance With ISO 14644-1
ISO 15223-1:2012	Medical Devices - Symbols To Be Used With Medical Device Labels,Labelling And Information To Be Supplied - Part 1: General Requirements
IEC 60601-1: 2005 +CORR. 1 (2006) +CORR. 2 (2007)	Medical Electrical Equipment, Part 1 – General Requirements For Safety
EN 60601-1-2 :2007	Medical Electrical Equipment – Part 1-2: GeneralRequirements For Basic Safety And Essential Performance- Collateral Standard: Electromagnetic Compatibility –Requirements And Tests.
EN 60601-2-2: 2009:+A11: 2011	Medical Electrical Equipment – Part 2-2: ParticularRequirements For The Basic Safety And EssentialPerformance Of High Frequency Surgical Equipment AndHigh Frequency Surgical Accessories. Clause 202.
EN 80601-2-58: 2008	Medical Electrical Equipment – Part 2-58: Particular Requirements For TheBasic Safety And Essential Performance Of Lens Removal Devices AndVitrectomy Devices For Ophthalmic Surgery
EN 60601-1-6:2007/AC: 2010	Medical electrical equipment - Part 1-6: General requirements for basicsafety and essential performance - Collateral standard: Usability
IEC 60825-1 Edition2.0 2007-03	Safety Of Laser Products - Part 1: Equipment Classification, AndRequirements [Including: Technical Corrigendum 1 (2008), InterpretationSheet 1 (2007), Interpretation Sheet 2 (2007)]
EN 60601-2-22:1996	Medical Electrical Equipment. Particular Requirements For SafetySpecification For Diagnostic And Therapeutic Laser Equipment
EN ISO 17664:2004	Information To Be Provided By The Manufacturer For The Processing OfResterilizable Medical Devices
Standard #	Title
EN 1707:1996	Conical Fittings With A 6% (Luer) Taper For Syringes, Needles AndCertain Other Medical Equipment
ISO 594-1:1986	Conical Fittings With A 6% (Luer) Taper For Syringes, Needles AndCertain Other Medical Equipment- Part 1: General Requirements
ISO 9626:1991	Stainless Steel Needle Tubing For Manufacture Of Medical Devices
ISO 13402:1995	Surgical And Dental Hand Instruments - Determination Of ResistanceAgainst Autoclaving, Corrosion And Thermal Exposure
ISO 15883-2:2009	Washer-Disinfectors - Part 2: Requirements And Tests For WasherDisinfectors Employing Thermal Disinfection For Surgical Instruments,Anaesthetic Equipment, Bowls, Dishes, Receivers, Utensils, Glassware,Etc. (ISO 15883-2:2006,IDT)
EN ISO 10524-4: 2008	Pressure Regulators For Use With Medical Gases- Part 4: Low- PressureRegulators Intended For Incorporation Into Medical Equipment
EN ISO 10079-3: 2009	Medical Suction Equipment - Part 3: Suction Equipment Powered From AVacuum Or Pressure Source
EN ISO 5359:2008	Low-Pressure Hose Assemblies For Use With Medical Gases
IEC 61847:1998	Ultrasonics Surgical Systems Measurement And Declaration Of The BasicOutput Characteristics
EN 62366:2008	Medical Devices - Application Of Usability Engineering To MedicalDevices
EN 556-1: 2001/ C1	Sterilization Of Medical Devices- Requirements For Medical Devices ToBe Designated 'Sterile'- Part 1: Requirements For Terminally SterilizedMedical Devices
ISO 11137-1: 2006/C1	Sterilization Of Health Care Products - Radiation - Part 1: RequirementsFor Development, Validation And Routine Control Of A SterilizationProcess For Medical Devices
ISO 11137-2: 2012	Sterilization Of Health Care Products - Radiation - Part 2: Establishing TheSterilization Dose
EN ISO 11140-1: 2009	Sterilization Of Health Care Products - Chemical Indicators - Part 1:General Requirements
EN ISO 11737-1:2006/ AC: 2009	Sterilization Of Medical Devices - Microbiological Methods - Part 1:Determination Of A Population Of Microorganisms On Products
ISO 17665-1:2006	Sterilization Of Health Care Products - Moist Heat - Part 1: RequirementsFor The Development, Validation And Routine Control Of A SterilizationProcess For Medical Devices
ANSI Z136.1:2007	American National Standard for Safe Use of Lasers
EN 62304:2006	Medical device software - Software life-cycle processes

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Image /page/8/Picture/1 description: The image shows the logo for DORC. The logo consists of the letters "DORC" in a sans-serif font. The letters "D" and "RC" are blue, while the "O" is a red circle with a blue semicircle inside. The logo is simple and modern.

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Image /page/9/Picture/1 description: The image shows the logo for DORC, which is a medical company. The logo is made up of the letters "DORC" in blue, with the "O" being a red circle with a blue dot in the middle. The logo is simple and modern, and it is likely used on the company's website, marketing materials, and products.

5.8 Conclusion

The performance data described herein support the safety of the device and the hardware and software verification and validation demonstrate that the EVA Ophthalmic Surgical System is substantially equivalent to the predicate devices and should perform as intended in the specified use conditions.

Regulation Number and Section

§ 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.