(163 days)
No
The summary does not mention AI, ML, or any related concepts like image processing or algorithms that would typically indicate the presence of AI/ML. The performance studies focus on standard medical device testing (biocompatibility, electrical safety, software verification, and bench testing) rather than AI/ML specific validation.
Yes
The device is used for ophthalmic surgery, including the treatment of conditions like cataracts, diabetic retinopathy, retinal tears, and glaucoma, which directly address diseases or abnormal conditions in the body.
No
The EVA Ophthalmic Surgical System is described as a combined anterior and posterior procedure ophthalmic system used for surgical procedures like phacoemulsification, cataract removal, vitreoretinal surgery, and laser treatments for various conditions. It performs functions such as infusion, vitrectomy, aspiration, illumination, irrigation, lens emulsification, fragmentation, cautery, diathermy, and photocoagulation. These are all therapeutic or surgical interventions, not diagnostic functions.
No
The device description explicitly states it is a "combined anterior and posterior procedure ophthalmic system" designed for use in procedures requiring infusion, cutting, aspiration, illumination, irrigation, emulsification, fragmentation, cautery, diathermy, and photocoagulation. This indicates the presence of significant hardware components beyond just software. The performance studies also include testing for biocompatibility, electrical safety, EMC, and various bench performance tests related to physical components like cutters, pumps, light probes, and waste bags.
Based on the provided information, the EVA Ophthalmic Surgical System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for performing surgical procedures on the eye (anterior and posterior segments). This involves direct intervention on the patient's body.
- Device Description: The description details a surgical system with components for procedures like phacoemulsification, vitreous cutting, aspiration, illumination, etc. These are all surgical functions.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or other bodily fluids) outside of the body to provide diagnostic information. IVDs are designed for testing samples in a laboratory or similar setting.
The EVA Ophthalmic Surgical System is a surgical device used for treatment, not for diagnosing conditions by analyzing samples in vitro.
N/A
Intended Use / 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 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
HOC, HOE, HOF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ophthalmic (anterior segment, posterior segment, vitreoretinal)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance data provided in support of substantial equivalence determination include:
- Biocompatibility testing: Conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. The device console materials are common and widely used. For accessories potentially contacting the patient (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 and electromagnetic compatibility (EMC): Testing conducted on the EVA Ophthalmic Surgical System. The system complies with IEC 60601-1, EN 60601-2-2, EN 80601-2-58 for safety, and EN 60601-1-2 and 47 CFR Part 15 Subpart B for EMC.
- Software Verification and Validation Testing: Conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software was considered a "major" level of concern.
- Performance Testing: Although animal and clinical performance testing were not required, various laboratory (bench) performance tests were conducted. These include:
- Testing for compliance to IEC 80601-2-58 (Medical electrical equipment requirements for lens removal and vitrectomy devices).
- Testing for compliance to IEC 60601-2-2 (Medical electrical equipment requirements for high frequency surgical equipment).
- Testing for compliance to ISO 15004-2:2007 (Ophthalmic instruments - light hazard protection).
- Testing to confirm vitrectomy cutters will not fail at normal working pressure (41PSI).
- Testing to determine the durability of the EVA Pump module.
- Testing to confirm light probe tips will not melt at maximum LED illumination output.
- Testing to confirm waste bags will not rupture when full.
- Testing to confirm vitrectomy cutters will not generate particulate matter at the highest cut speed.
- Testing to confirm reusable accessories can withstand repeat sterilization without impact to device characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081877, K101285, K101325, K102222, K121675, K062624
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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
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 (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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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 | |
| 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 |
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: +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
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 | |
| ● | 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.
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
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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 |
| Testing | |
| ISO 10993-5: 2009 | Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro |
| Cytotoxicity | |
| ISO 10993-7: 2008 | Biological Evaluation Of Medical Devices - Part 7: Ethylene Oxide |
| Sterilization Residuals | |
| ISO 10993-10: 2010 | Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation |
| And Sensitization | |
| ISO 10993-12: 2012 | Biological Evaluation Of Medical Devices - Part 12: Sample Preparation |
| and Reference Materials | |
| ISO 11135:2007 | Sterilization Of Health-Care Products - Ethylene Oxide – Part 1: |
| Requirements for the Development, Validation and Routine Control of a | |
| 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: |
| Requirements For Materials, Sterile Barrier Systems And Packaging | |
| Systems | |
| ISO 11607-2:2007 | Packaging For Terminally Sterilized Medical Devices - Part 2: Validation |
| Requirements 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 Continued | |
| Compliance 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: General |
| Requirements 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: Particular
Requirements For The Basic Safety And Essential
Performance Of High Frequency Surgical Equipment And
High Frequency Surgical Accessories. Clause 202. |
| EN 80601-2-58: 2008 | Medical Electrical Equipment – Part 2-58: Particular Requirements For The
Basic Safety And Essential Performance Of Lens Removal Devices And
Vitrectomy Devices For Ophthalmic Surgery |
| EN 60601-1-6:2007/
AC: 2010 | Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability |
| IEC 60825-1 Edition
2.0 2007-03 | Safety Of Laser Products - Part 1: Equipment Classification, And
Requirements [Including: Technical Corrigendum 1 (2008), Interpretation
Sheet 1 (2007), Interpretation Sheet 2 (2007)] |
| EN 60601-2-22:1996 | Medical Electrical Equipment. Particular Requirements For Safety
Specification For Diagnostic And Therapeutic Laser Equipment |
| EN ISO 17664:2004 | Information To Be Provided By The Manufacturer For The Processing Of
Resterilizable Medical Devices |
| Standard # | Title |
| EN 1707:1996 | Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And
Certain Other Medical Equipment |
| ISO 594-1:1986 | Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And
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
Against Autoclaving, Corrosion And Thermal Exposure |
| ISO 15883-2:2009 | Washer-Disinfectors - Part 2: Requirements And Tests For Washer
Disinfectors 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- Pressure
Regulators Intended For Incorporation Into Medical Equipment |
| EN ISO 10079-3: 2009 | Medical Suction Equipment - Part 3: Suction Equipment Powered From A
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
Output Characteristics |
| EN 62366:2008 | Medical Devices - Application Of Usability Engineering To Medical
Devices |
| EN 556-1: 2001/ C1 | Sterilization Of Medical Devices- Requirements For Medical Devices To
Be Designated 'Sterile'- Part 1: Requirements For Terminally Sterilized
Medical Devices |
| ISO 11137-1: 2006/
C1 | Sterilization Of Health Care Products - Radiation - Part 1: Requirements
For Development, Validation And Routine Control Of A Sterilization
Process For Medical Devices |
| ISO 11137-2: 2012 | Sterilization Of Health Care Products - Radiation - Part 2: Establishing The
Sterilization 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: Requirements
For The Development, Validation And Routine Control Of A Sterilization
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 |
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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.
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.