Retia 2

K180293 · Centervue S.P.A. · MYC · May 30, 2018 · Ophthalmic

Device Facts

• Record ID: K180293
• Device Name: Retia 2
• Applicant: Centervue S.P.A.
• Product Code: MYC · Ophthalmic
• Decision Date: May 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

The CenterVue RETIA 2 is a confocal scanning ophthalmoscope indicated for infrared and auto-fluorescence imaging of a human retina with or without the use of a mydriatic agent.

Device Story

RETIA 2 is a confocal scanning ophthalmoscope for retinal imaging. It uses infrared (850nm, 940nm) and blue (450nm) LEDs to illuminate the retina via a horizontal scanning line; an oscillating mirror provides a 60° field of view. A 5-megapixel monochrome CMOS sensor captures reflected infrared or fluorescent light (via a 500nm high-pass barrier filter). The device includes an anterior segment alignment system using two cameras and IR LEDs for stereoscopic pupil tracking. Operated via a tablet interface, it performs automated alignment, focus, exposure, and capture. Used in clinical settings by eye care professionals, it provides high-resolution retinal images to assist in diagnosing and monitoring retinal conditions. The device is a modification of the EIDON (K142047), optimized for auto-fluorescence imaging.

Clinical Evidence

Bench testing and clinical image comparison. Clinical assessment compared RETIA 2 infrared images against EIDON (K142047) and auto-fluorescence images against SPECTRALIS (K172649). Images from eyes with and without pathology were evaluated. Results demonstrated that RETIA 2 provides infrared and auto-fluorescence images similar to those of the predicate and reference devices.

Technological Characteristics

Confocal scanning ophthalmoscope; LED-based illumination (IR 850/940nm, Blue 450nm, Green fixation). 5MP monochrome CMOS sensor. 60° field of view. 28mm working distance. 17-micron retinal resolution. Connectivity: Ethernet, SSD storage. Tablet-based interface. Complies with ISO 15004-1/2, ISO 10940, IEC 60601-1, IEC 60601-1-2, and IEC 62304.

Indications for Use

Indicated for infrared and auto-fluorescence imaging of the human retina in patients, with or without mydriatic agents.

Regulatory Classification

Identification

An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

Special Controls

*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, 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

• EIDON (K142047)

Reference Devices

• SPECTRALIS (K172649)

Submission Summary (Full Text)

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May 30, 2018

CenterVue S.p.A Roberto Gabriotti Quality and Regulatory Affairs Manager via San Marco 9h 35219 Padova. ITALY

Re: K180293

Trade/Device Name: Retia 2 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC Dated: March 27, 2018 Received: April 2, 2018

Dear Roberto Gabriotti:

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. Iisting 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 (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.

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

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

Denise L. Hampton -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/202 See PRA Statement below.

510(k) Number (if known)

K180293

Device Name

RETIA 2

Indications for Use (Describe)

The CenterVue RETIA 2 is a confocal scanning ophthalmoscope indicated for infrared and auto-fluorescence imaging of a human retina with or without the use of a mydriatic agent.

Type of Use (Select one or both, as applicable)

7 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FORM FDA 3881 (7/17)

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Image /page/3/Picture/0 description: The image contains the logo for Centervue. The logo features a stylized globe made of yellow squares, with a black circle in the center resembling an eye. Below the globe is the word "centervue" in a lowercase, sans-serif font, with the "vue" portion in yellow.

# 510(k) Summary

| Proprietary Name: | RETIA 2 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of submission: | Traditional |
| Date of submission: | January 29th, 2018 |
| Last revised on: | May 25th, 2018 |
| Manufacturer: | CENTERVUE S.p.A.<br>Via San Marco 9H<br>35129 Padova - ITALY |
| Applicant and contact | Mr. Roberto Gabriotti<br>Centervue S.p.A.<br>Manager of Quality and Regulatory Affairs<br>Via San Marco 9H, 35129 Padova - ITALY<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Product Code: | MYC |
| Regulation Number: | 886.1570 |
| Common Name: | Ophthalmoscope |
| Panel: | Ophthalmic |
| Class: | Class II |
| Indications for Use: | The CenterVue RETIA 2 is a confocal scanning ophthalmoscope<br>indicated for infrared and auto-fluorescence imaging of a human retina<br>with or without the use of a mydriatic agent. |

K180293

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Image /page/4/Picture/0 description: The image shows the logo for Centervue. The logo features a stylized eye made of yellow and gray squares, with a black circle in the center representing the pupil. Below the eye is the word "centervue" in lowercase letters.

# Device description

The CenterVue RETIA 2 is a modification of the CenterVue EIDON (K142047).

RETIA 2 is a scanning ophthalmoscope which uses infrared light to obtain infrared-reflectance images of the retina and blue light to obtain auto-fluorescence images of the retina.

RETIA 2 operates as a standalone unit, running a dedicated software application, intended for prescription use only, and includes:

- 1. Optical head, including a removable lens cap;
- 2. Patient head-rest, including removable front-rest;
- 3. Patient chin rest;
- 4. Base, including touch-screen device (tablet with magnetic holder and USB cable), USB joystick and an external power supply.

RETIA 2 operates based on the following principles:

- An illumination system consisting of infrared LEDs (850nm, 940nm), a blue LED (450nm) and a green a) LED illuminates the patient eye with the following functionality:
- The IR LED with a centroid wavelength of 850 nm allows the capture of IR photos. The patient's retina is uniformly illuminated by a line in a horizontal direction. An oscillating mirror scans the line in order to illuminate the retina with a field of view of 60°.
- Two IR LEDs with a centroid wavelength of 940 nm are seen from the eye in a free viewing system. The two LEDs are equally shifted with respect to the machine's optical axis. The LEDS are switched on during all exams in order to enable pupil tracking.
- . The blue LED (450 nm) is used to illuminate the retina and capture fluorescence retinal images. The retina is uniformly illuminated by a line in a horizontal direction. An oscillating mirror scans the line in order to illuminate the retina with a field of view of 60°.
- The green LED is used as fixation target.
- b) An imaging system including a barrier filter (high-pass with a cutoff at 500 nm) stops back-reflected light from the retina and only allows fluorescent light to be detected for imaging. A focusing lens is included in the imaging path to achieve optimal retinal focusing on a CMOS camera having a resolution of 5 megapixels.
- c) An anterior segment alignment system is included, using two cameras and the two IR LEDs. The LEDs illuminate the anterior segment by diffusion, whereas the cameras allow a stereoscopic reconstruction of the pupil's position to be obtained with respect to the instrument's front lens.

RETIA 2 interacts with the patient by directing infrared- and blue-wavelength illumination for imaging purposes and green illumination for fixation purposes into the patient's eye. The chin-rest are the only parts of the device that contact the patient. The chin-rest includes a patient proximity sensor and is motorized for height adjustment.

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Image /page/5/Picture/0 description: The image contains the logo for Centervue. The logo features a stylized globe made of yellow and gray blocks, with a black circle in the center resembling an eye. Below the globe, the word "centervue" is written in lowercase letters.

## TECHNICAL SPECIFICATIONS

## Class and type of applied part

- . Class I, Type B (according to IEC 60601-1)
## IP classification:

- . IPX0 (according to the degree of protection provided by the enclosure with respect to harmful penetration of particulate matter or water).
## Image acquisition:

- Non-mydriatic (minimum pupil size 2.5 mm)
- . Field of view: 60° (H) x 55° (V) captured in a single exposure
- Sensor size: 5 Mpixel (2592 x 1944)
- Light source: near infrared (825-870 nm) and blue LED (440-475 nm)
- Working distance: 28 mm
- Resolution: 30 pixels/deg
- Resolution on retina: 17 microns
- Pixel pitch: 9.3 µm

## Other features:

- Imaging modalities: IR, auto-fluorescence
- Automatic operation: auto-alignment, auto-focus, auto-exposure, auto-capture
- . Auto-focusing adjustment range: -12D to +15D
- Dynamic, programmable internal fixation target, in every position of the field
- . Tablet operated, with multi-touch, color display
- Ethernet connection through device
- . Embedded hard disc (SSD)

#### Dimensions:

- . Weight: 25 Kg
- Size: 620 X 590 X 360 mm

#### Power supply:

- Voltage: 12 V DC
- Power consumption: 60 W

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Image /page/6/Picture/0 description: The image shows the logo for Centervue. The logo features a stylized eye made up of yellow squares arranged in a spherical shape, with a black pupil in the center. Below the eye is the word "centervue" in a lowercase, sans-serif font.

## Comparison with predicate device

The predicate device selected for comparison with the CenterVue RETIA 2 is identified as follows:

| Proprietary Name: | EIDON |
|----------------------|---------------------------------|
| Manufacturer: | CenterVue S.p.A. |
| 510(k) Number: | K142047 |
| Clearance Date: | 12 November 2014 |
| FDA Product Code: | MYC |
| Classification Name: | Ophthalmoscope, Laser, Scanning |
| Regulation Number: | 886.1570 |

The following device was used as reference:

| Proprietary Name: | SPECTRALIS |
|----------------------|---------------------------------|
| Manufacturer: | Heidelberg Engineering Gmbh |
| 510(k) Number: | K172649 |
| FDA Product Code: | MYC |
| Classification Name: | Ophthalmoscope, Laser, Scanning |
| Regulation Number: | 886.1570 |

The Subject Device and the Predicate Device share many identical or similar properties and features. In particular, the fundamental scientific technology of the subject device is unchanged from the predicate and remains confocal, line scanning, LED-based, ophthalmoscopy. Also, the principle of operation, mechanism of action and interaction with the patient are unchanged.

With respect to EIDON, the RETIA 2 includes some modifications which enable it to capture fundus autofluorescence images, using the same base technology and maintaining the same Intended Use and Indications for Use.

Specifically, functional differences between RETIA 2 and EIDON are as follows:

- . RETIA 2 does not allow the capture of color images, using white light;
- RETIA 2 allows the capture of auto-fluorescence images, using blue LED light.

Technological differences between RETIA 2 and EIDON include:

| Characteristic | CenterVue EIDON | CenterVue RETIA 2 |
|----------------------------------|--------------------------------------|--------------------------------------------------------------------------------------|
| Imaging system | Scanning LED imaged to CMOS sensor | Scanning LED imaged to CMOS sensor with barrier filter for auto-fluorescence imaging |
| Imaging sensor | Color CMOS, 4608x3288 pixels (14 MP) | Monochrome CMOS, 2592x1944 pixels (5 MP) |
| Visible light source for imaging | Blue LED and white LEDs | Blue LED (more powerful) |
| Imaging modalities | Infrared, color, red-free | Infrared, auto-fluorescence |

⁴ Neither the CenterVue EIDON nor the RETIA 2 contain lasers but rather use LEDs for confocal imaging

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Image /page/7/Picture/0 description: The image is a logo for a company called "centerview". The logo features a stylized eye made up of yellow squares and a black circle. The eye is positioned above the company name, which is written in a lowercase sans-serif font. The overall design is modern and minimalist.

| Characteristic | CenterVue EIDON | CenterVue RETIA 2 |
|-----------------------------------|-----------------|----------------------------------------------------------------------------------------------------------------------|
| Flash control<br>electronic board | | The board contains some modifications needed to drive<br>the modified blue LED |
| Software | | The device software is modified to implement fundus<br>auto-fluorescence imaging and remove color retinal<br>imaging |

None of these differences have any significant effect on safety or effectiveness of the Subject Device. Notably, with respect to the impact of these design modifications on a key part of the product's risk analysis (i.e. optical radiation safety), Centervue has confirmed conformance with the applicable recognized standard, ISO 15004-2, making these modifications eligible for a Special 510(k) notification.

## Performance data - Bench

Continued conformance with the following standards has been confirmed in support of the substantial equivalence determination:

## ISO 15004-2 (light Hazard Protection)

RETIA 2 fulfills the requirements for a group 1 determination according to ISO 15004-2:2007, i.e. ophthalmic instruments for which no potential light hazard exists.

## ISO 15004-1

The subject device complies with the ISO 15004-1:2006 standard for ophthalmic instruments.

Electrical safety and electromagnetic compatibility The device complies with IEC 60601-1:2005 and IEC 60601-1-2:2007.

IEC 62304

The device software complies with IEC 62304.

#### ISO 10940

RETIA 2 complies with the applicable requirements of ISO 10940 - Ophthalmic instruments — Fundus Cameras.

## Performance data - Clinical

The imaging properties of the RETIA 2 were assessed by comparing infrared images taken with the RETIA 2 with infrared images taken using the predicate device (CenterVue EIDON, K142047) and by comparing autofluorescence images taken with the RETIA 2 with auto-fluorescence images taken with the reference device (Heidelberg SPECTRALIS, K172649). Images of eyes with and without diagnosed pathology were included in the comparison.

The comparison showed that RETIA 2 provides infrared and autofluorescence images that are similar to those of the mentioned devices.

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Image /page/8/Picture/0 description: The image shows the logo for Centervue. The logo features a stylized globe made of yellow and gray blocks, with a black circle in the center resembling an eye. Below the globe, the word "centervue" is written in lowercase letters, with the "vue" portion in yellow.

K180293

# Conclusion

Based on the information contained within this submission, it is concluded that the CenterVue RETIA 2 is substantially equivalent to the identified predicate devices already in interstate commerce within the USA.