CENTERVUE DIGITAL RETINOGRAPHY SYSTEM

K101935 · Centervue S.P.A. · HKI · Oct 27, 2010 · Ophthalmic

Device Facts

• Record ID: K101935
• Device Name: CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
• Applicant: Centervue S.P.A.
• Product Code: HKI · Ophthalmic
• Decision Date: Oct 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

The CenterVue Digital Retinography System DRS is intended for taking digital images of a human retina without the use of a mydriatic agent.

Device Story

The Digital Retinography System (DRS) is an ophthalmic camera designed to capture colored digital images of the human retina. The device operates without the need for mydriatic agents (pupil dilation). It consists of an optical head, head-rest, chin rest, and base, integrating a dedicated computer and touch-screen display as a standalone unit. The system features automated alignment to the center of the pupil, auto-focusing, and image capture capabilities. It is operated by healthcare personnel in a clinical setting. The captured images are displayed on the integrated screen for clinician review, facilitating retinal assessment and clinical decision-making. The device benefits patients by providing a non-mydriatic, efficient method for retinal imaging.

Clinical Evidence

Bench testing only. Performance testing verified sensor resolution (48.15 pixels/degree), field of view (42.95° x 40.3°), focus range (-15D to +15D), minimum pupil size (4.0mm), and accuracy of internal fixation targets. Automated alignment and OD/OS detection were validated on multiple subjects.

Technological Characteristics

Standalone ophthalmic camera; integrated computer and touch-screen. Complies with IEC 60601-1:2005, IEC 60601-1-2:2007, ISO 10940-2:2009, and ISO 15004-2:2007. Features auto-alignment and auto-focusing algorithms. Focus range -15D to +15D; 4.0mm minimum pupil size requirement.

Indications for Use

Indicated for capturing digital images of the human retina in patients without the use of a mydriatic agent.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• EyeScan (K092374)
• Orion (K070231)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image is a logo for "centerview at the center of vision". The logo features the word "centerview" in a sans-serif font, with the tagline "at the center of vision" in a smaller font below it. Above the text is a stylized eye symbol, which is composed of a circle and a series of curved lines that create a sense of depth and dimension.

# APPENDIX B

OCT 2 7 2010

# 510(k) Summary of safety and effectiveness

#### 510(k) OWNER INFORMATION

| A. Company name: | CenterVue SpA |
|--------------------------|---------------------------------------|
| B. Company address: | via Tommaseo 77, 35131, Padova, ITALY |
| C. Company phone: | [phone] |
| C. Company fax: | [phone] |
| D. Contact person: | Giuliano Barbaro, Managing Director |
| E. Revised summary date: | September 21st 2010 |

## SUBMITTER INFORMATION

| | A. Company name: | Donawa Lifescience Consulting Srl |
|--|---------------------|---------------------------------------|
| | B. Company address: | Piazza Albania, 10, 00153 Rome, ITALY |
| | C. Company phone: | [phone] |
| | D. Company fax: | [phone] |
| | E. Contact person: | Roger Gray, VP Quality and Regulatory |

## DEVICE IDENTIFICATION

- Camera, ophthalmic, ac-powered Generic Device name: A.
- B. Trade/proprietary name: Digital Retinography System DRS
- Classification: ll C.
- HKI Product code: D.

## DEVICE DESCRIPTION

The DRS is an ophthalmic camera used to take colored digital images of a human retina without use of a mydriatic agent. The instrument body includes: optical head, head-rest, chin rest and a base. The device integrates a dedicated computer and a touch-screen display and operates as a standalone unit, running a dedicated software application. The device is provided with a front lens cap, a power cord and spare fuses.

tel. [phone] fax [phone] e-mail: [e-mail]

REA: 378243 CCIAA PD C.F./P. IVA: 04296580287

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Image /page/1/Picture/0 description: The image shows a logo for "centerview at the center of vision". The logo features a stylized eye design above the word "centerview", with the tagline "at the center of vision" written in a smaller font below. The eye design is abstract and appears to be made up of several geometric shapes.

#### INTENDED USE

The CenterVue Digital Retinography System DRS is intended for taking digital images of a human retina without the use of a mydriatic agent.

## SUBSTANTIAL EQUIVALENCE

The DRS device is substantially equivalent to the following predicate devices with regard to intended use, operating principle, and function:

| Predicate Device | 510(k) Holder | 510(k) No. | Date cleared |
|------------------|----------------------------|------------|------------------|
| EyeScan | Ophthalmic Imaging Systems | K092374 | 17 November 2009 |
| Orion | Nidek Technologies Srl | K070231 | 24 April 2007 |

## TEST DATA

The DRS has undergone extensive performance testing before release to ensure that the device and its software meet the functional requirements and to demonstrate equivalence to the predicate devices.

A summary of the results of performance testing vs. the device requirements follows:

| Performance item | Requirements | Test results |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Sensor resolution | 48 pixels / degree | 48.15 pixels / degree |
| Resolution on retina | ≥ 60 line pairs/mm at the center of the field<br>≥ 40 line pairs/mm at the mid field (r/2)<br>≥ 25line pairs/mm at the periphery of the field (r) | Yes<br>Yes<br>Yes |
| Field of view | 45° horizontal x 40° vertical | 42.95° horizontal x<br>40.3° vertical |
| Pixel pitch | 6 μm | 6.39 μm |
| Range of focus | -15 D to + 15 D | -15 D to + 15 D |
| Minimum pupil size | 4.0 mm | 4.0 mm |
| Position of internal<br>fixation targets for<br>central and peripheral<br>fields | CENTRAL: field centered on the foveal pit<br>NASAL: field centered 17° nasally to the fovea<br>TEMPORAL: field centered 17° temporally to the fovea<br>SUPERO-TEMPORAL: field centered 12° superiorly and 12°<br>temporally to the fovea<br>PERI-CENTRAL: field centered 5° nasally to the fovea<br>SUPERIOR: field centered 17° superiorly to the fovea<br>INFERIOR: field centered 17° inferiorly to the fovea | Actual position (for<br>normally fixating<br>subjects) within ±1°<br>from expected<br>position |
| OD/OS detection | Device captures OD or OS or both based on operator's<br>selection | Yes (tested on<br>multiple subjects) |
| Auto-alignment | Device automatically aligns to the center of the pupil prior<br>to auto-focusing and capture | Yes (tested on<br>multiple subjects) |

via Tommaseo, 77 35131 Padova, Italy www.centervue.com tel. [phone] fax [phone] e-mail: [e-mail]

REA: 378243 CCIAA PD C.F./P. IVA: 04296580287

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Image /page/2/Picture/0 description: The image shows a logo for "centerview at the center of vision". The logo features a stylized eye design above the text. The eye is composed of geometric shapes, with a dark circle representing the pupil. The text is in a sans-serif font and is stacked, with "centerview" on top and "at the center of vision" below.

## PERFORMANCE STANDARDS

The DRS complies with the following standards: IEC 60601-1:2005; IEC 60601-1-2:2007; ISO 10940-2:2009; ISO 15004-2 2007.

#### CONCLUSION

As described in this 510(k) Summary, all testing deemed necessary was conducted on the DRS to ensure that the device is safe and effective for its intended use, when used in accordance with its Instructions for Use, and equivalence with the identified predicate devices has been demonstrated.

tel. [phone] fax [phone] e-mail: [e-mail] REA: 378243 CCIAA PD C.F./P. IVA: 04296580287

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

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

CENTERVUE SpA c/o Mr. Roger Gray Vice President, Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania, 10 00153 Rome, Italy

Re: K101935

Trade/Device Name: Digital Retinography System (DRS) Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: II Product Code: HKI Dated: September 29, 2010 Received: October 4, 2010

OCT 2 7 2010

Dear Mr. Gray:

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.

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Debra Falls

Malvina B. Eydelman, M.D. Director

Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Appendix A

#### Indications for Use Statement

510(k) Number (if known): K101935

Device Name: CenterVue Digital Retinography System DRS .

Indications for Use: The CenterVue Digital Retinography System DRS is intended for taking digital images of a human retina without the use of a mydriatic agent.

Prescription Use (Part 21 CFR 801 Subpart D)

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AND/OR

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

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(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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(Division Sigh-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

> Page 1 of 1 Rev.2 Apr 4, 2008

510(k) Number_k101935