EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)

K142877 · Dutch Ophthalmic Research Center International BV · HQC · Mar 13, 2015 · Ophthalmic

Device Facts

• Record ID: K142877
• Device Name: EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)
• Applicant: Dutch Ophthalmic Research Center International BV
• Product Code: HQC · Ophthalmic
• Decision Date: Mar 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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

Device Story

Modular ophthalmic surgical system for anterior and posterior segment procedures; performs infusion, vitreous cutting, aspiration, illumination, irrigation, lens emulsification/fragmentation, cautery, diathermy, and photocoagulation. Used in clinical settings by ophthalmic surgeons. System integrates pump modules, vitrectomy handpieces, and optional laser module. Provides real-time control of surgical parameters; output allows surgeon to perform precise tissue removal and laser therapy. Benefits include enhanced surgical capability for complex eye conditions. Device console is non-patient contacting; accessories (cartridges, handpieces) contact patient/fluid path.

Clinical Evidence

No clinical or animal performance testing was required. Substantial equivalence supported by bench testing, including compliance with IEC 80601-2-58 (lens removal/vitrectomy safety), IEC 60601-2-2 (high-frequency surgical equipment), and ISO 15004-2 (light hazard protection). Additional bench tests confirmed vitrectomy cutter pressure integrity, pump durability, LED light probe thermal safety, waste bag rupture resistance, and sterilization durability for reusable accessories.

Technological Characteristics

Modular console for ophthalmic surgery. Features include pump module, LED illumination, and optional laser. Materials: biocompatible per ISO 10993-1. Standards: IEC 60601-1 (safety), EN 60601-2-2 (HF surgery), EN 80601-2-58 (lens removal/vitrectomy), EN 60601-1-2 (EMC). Sterilization: Ethylene Oxide (ISO 11135) and moist heat (ISO 17665-1). Connectivity: Standalone surgical system.

Indications for Use

Indicated for patients undergoing anterior segment (phacoemulsification/cataract removal) or posterior segment (vitreoretinal) ophthalmic surgery. Optional laser indicated for diabetic retinopathy, retinal tears/detachments, lattice degeneration, sub-retinal neovascularization, retinal vascular occlusion, and glaucoma.

Regulatory Classification

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.

Predicate Devices

• Associate 2500 dual and compact systems (K081877)
• Constellation Vision System (K101285)
• Stellaris PC Vision Enhancement System (K101325)
• Ultimate Vit Enhancer (K102222)
• VersaVit (K121675)
• Next Generation Laser (PurePoint) (K062624)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for DORC. The logo consists of the letters "DORC" in blue, with the "O" being a stylized eye. The left half of the "O" is blue, and the right half is red. The letters are all in uppercase and are a sans-serif font.

#### 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 retinal<br>vein occlusion | Scatter Laser<br>Photocoagulation |
| • Chronic macular edema secondary to Branch or Central<br>retinal 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)

{3}------------------------------------------------

#### 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: [phone] Email: [e-mail]

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) |

{4}------------------------------------------------

#### 5.4. 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.

#### 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<br>● | Panretinal Photocoagulation |
| Clinically Significant Macular Edema<br>● | 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<br>● | Scatter Laser |
| vein occlusion | Photocoagulation |
| Chronic macular edema secondary to Branch or Central<br>●<br>retinal vein occlusion | Focal or Grid Laser |
| Glaucoma | |
| ●<br>Primary Open-angle | Trabeculoplasty |
| ●<br>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.

{5}------------------------------------------------

### 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

{6}------------------------------------------------

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

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for DORC. The logo consists of the letters "DORC" in a sans-serif font. The "D" and "C" are blue, while the "O" is a red circle with a blue dot inside. The logo is simple and modern.

| Standard # | Title |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-1: 2009 | Biological Evaluation Of Medical Devices -- Part 1: Evaluation And<br>Testing |
| ISO 10993-5: 2009 | Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro<br>Cytotoxicity |
| ISO 10993-7: 2008 | Biological Evaluation Of Medical Devices - Part 7: Ethylene Oxide<br>Sterilization Residuals |
| ISO 10993-10: 2010 | Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation<br>And Sensitization |
| ISO 10993-12: 2012 | Biological Evaluation Of Medical Devices - Part 12: Sample Preparation<br>and Reference Materials |
| ISO 11135:2007 | Sterilization Of Health-Care Products - Ethylene Oxide – Part 1:<br>Requirements for the Development, Validation and Routine Control of a<br>Sterilization 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:<br>Requirements For Materials, Sterile Barrier Systems And Packaging<br>Systems |
| ISO 11607-2:2007 | Packaging For Terminally Sterilized Medical Devices - Part 2: Validation<br>Requirements For Forming, Sealing And Assembly Processes |
| ISO 15004-2:2007 | Ophthalmic Instruments - Fundamental Requirements And Test Methods -<br>Part 2: Light Hazard Protection |
| ISO 14644-2:2000 | Cleanrooms And Associated Controlled Environments - Part 2:<br>Specifications For Testing And Monitoring To Prove Continued<br>Compliance With ISO 14644-1 |
| ISO 15223-1:2012 | Medical Devices - Symbols To Be Used With Medical Device Labels,<br>Labelling And Information To Be Supplied - Part 1: General Requirements |
| IEC 60601-1: 2005 +<br>CORR. 1 (2006) +<br>CORR. 2 (2007) | Medical Electrical Equipment, Part 1 – General Requirements For Safety |
| EN 60601-1-2 :2007 | Medical Electrical Equipment – Part 1-2: General<br>Requirements For Basic Safety And Essential Performance<br>- Collateral Standard: Electromagnetic Compatibility –<br>Requirements And Tests. |
| EN 60601-2-2: 2009:<br>+A11: 2011 | Medical Electrical Equipment – Part 2-2: Particular<br>Requirements For The Basic Safety And Essential<br>Performance Of High Frequency Surgical Equipment And<br>High Frequency Surgical Accessories. Clause 202. |
| EN 80601-2-58: 2008 | Medical Electrical Equipment – Part 2-58: Particular Requirements For The<br>Basic Safety And Essential Performance Of Lens Removal Devices And<br>Vitrectomy Devices For Ophthalmic Surgery |
| EN 60601-1-6:2007/<br>AC: 2010 | Medical electrical equipment - Part 1-6: General requirements for basic<br>safety and essential performance - Collateral standard: Usability |
| IEC 60825-1 Edition<br>2.0 2007-03 | Safety Of Laser Products - Part 1: Equipment Classification, And<br>Requirements [Including: Technical Corrigendum 1 (2008), Interpretation<br>Sheet 1 (2007), Interpretation Sheet 2 (2007)] |
| EN 60601-2-22:1996 | Medical Electrical Equipment. Particular Requirements For Safety<br>Specification For Diagnostic And Therapeutic Laser Equipment |
| EN ISO 17664:2004 | Information To Be Provided By The Manufacturer For The Processing Of<br>Resterilizable Medical Devices |
| Standard # | Title |
| EN 1707:1996 | Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And<br>Certain Other Medical Equipment |
| ISO 594-1:1986 | Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And<br>Certain 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 Resistance<br>Against Autoclaving, Corrosion And Thermal Exposure |
| ISO 15883-2:2009 | Washer-Disinfectors - Part 2: Requirements And Tests For Washer<br>Disinfectors Employing Thermal Disinfection For Surgical Instruments,<br>Anaesthetic Equipment, Bowls, Dishes, Receivers, Utensils, Glassware,<br>Etc. (ISO 15883-2:2006,IDT) |
| EN ISO 10524-4: 2008 | Pressure Regulators For Use With Medical Gases- Part 4: Low- Pressure<br>Regulators Intended For Incorporation Into Medical Equipment |
| EN ISO 10079-3: 2009 | Medical Suction Equipment - Part 3: Suction Equipment Powered From A<br>Vacuum 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 Basic<br>Output Characteristics |
| EN 62366:2008 | Medical Devices - Application Of Usability Engineering To Medical<br>Devices |
| EN 556-1: 2001/ C1 | Sterilization Of Medical Devices- Requirements For Medical Devices To<br>Be Designated 'Sterile'- Part 1: Requirements For Terminally Sterilized<br>Medical Devices |
| ISO 11137-1: 2006/<br>C1 | Sterilization Of Health Care Products - Radiation - Part 1: Requirements<br>For Development, Validation And Routine Control Of A Sterilization<br>Process For Medical Devices |
| ISO 11137-2: 2012 | Sterilization Of Health Care Products - Radiation - Part 2: Establishing The<br>Sterilization Dose |
| EN ISO 11140-1: 2009 | Sterilization Of Health Care Products - Chemical Indicators - Part 1:<br>General Requirements |
| EN ISO 11737-1:<br>2006/ AC: 2009 | Sterilization Of Medical Devices - Microbiological Methods - Part 1:<br>Determination Of A Population Of Microorganisms On Products |
| ISO 17665-1:2006 | Sterilization Of Health Care Products - Moist Heat - Part 1: Requirements<br>For The Development, Validation And Routine Control Of A Sterilization<br>Process 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 |

{8}------------------------------------------------

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.

{9}------------------------------------------------

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.