EIDON

K142047 · Centervue S.P.A. · MYC · Nov 12, 2014 · Ophthalmic

Device Facts

• Record ID: K142047
• Device Name: EIDON
• Applicant: Centervue S.P.A.
• Product Code: MYC · Ophthalmic
• Decision Date: Nov 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

The CenterVue EIDON is intended for taking digital images of a human retina without the use of a mydriatic agent.

Device Story

CenterVue EIDON is a standalone scanning ophthalmoscope for prescription use. It captures high-resolution color and infrared (IR) digital images of the human retina. The device uses an illumination system with IR (850nm, 940nm), white, blue, and green LEDs. An oscillating mirror scans a line of light across the retina (60° field of view). An imaging system with a focusing lens and 14-megapixel CMOS camera collects back-reflected light. An anterior segment alignment system uses two cameras and IR LEDs for stereoscopic pupil tracking. The device includes a motorized chin-rest and head-rest for patient positioning. Operated by clinicians in a clinic setting, the device provides digital retinal images to assist in ocular examination. The non-mydriatic operation benefits patients by eliminating the need for pupil-dilating drops, improving workflow and patient comfort.

Clinical Evidence

Bench testing only. The device conforms to IEC 60601-1:2005, IEC 60601-1-2:2007, ISO 10940:2009, ISO 15004-1:2006, and ISO 15004-2:2007. Performance metrics verified include 14-megapixel resolution, 60° x 55° field of view, 15-micron optical resolution, and a focus range of -12D to +15D.

Technological Characteristics

Scanning ophthalmoscope; IR (850nm, 940nm), white, blue, and green LED illumination; 14MP CMOS sensor; oscillating mirror scanning mechanism; motorized chin/head rest; standalone unit with tablet interface; conforms to IEC 60601-1, IEC 60601-1-2, ISO 10940, ISO 15004-1, and ISO 15004-2.

Indications for Use

Indicated for capturing digital retinal images in humans 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

• EasyScan (K111988)
• Digital Retinography system (DRS) (K101935)

Submission Summary (Full Text)

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

December 19, 2014

CenterVue S.p.A. Mr. Roger Gray V.P. Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania 10 00153 Rome, Italy

Re: K142047

Trade/Device Name: CenterVue EIDON Ophthalmoscope Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC Dated: September 30, 2014 Received: October 2, 2014

Dear Mr. Gray:

This letter corrects our substantially equivalent letter of November 12, 2014.

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.

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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 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/ResourcesforYou/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

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# Indications for Use

510(k) Number (if known) K142047

Device Name CenterVue EIDON

Indications for Use (Describe)

The CenterVue EIDON is intended for taking digital images of a human retina without the use of a mydriatic agent.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary in accordance with 21 CFR 807.92(c)

| Device Name: | CenterVue EIDON Ophthalmoscope |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of 510(k) submission: | Traditional |
| Date of Submission: | 24 July 2014 (summary revised on 18 September 2014) |
| Manufacturer: | CenterVue S.p.A.<br>via San Marco 9h<br>35129 Padova<br>Italy |
| 510(k) Owner: | CenterVue S.p.A.<br>via San Marco 9h<br>35129 Padova<br>Italy |
| Phone:<br>Fax: | [phone]<br>[phone] |
| 510(k) Submitter and Contact: | Mr Roger Gray<br>VP Quality and Regulatory<br>Donawa Lifescience Consulting<br>Piazza Albania 10<br>00153 Rome<br>Italy<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| FDA Product Code: | MYC |
| FDA Regulation Number: | 886.1570 |
| FDA Classification Name: | Ophthalmoscope |
| Classification Panel: | Ophthalmic |
| Common Name: | Ophthalmoscope |
| FDA Classification: | Class II |
| FDA Identification: | An ophthalmoscope is an AC-powered or battery-powered<br>device containing illumination and viewing optics intended to<br>examine the media (cornea, aqueous, lens, and vitreous) and<br>the retina of the eye. |
| Indications for Use/Intended Use: | The CenterVue EIDON is intended for taking digital images of a<br>human retina without the use of a mydriatic agent. |

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Image /page/4/Picture/0 description: The image shows the logo for Centervue. The logo consists of a stylized globe-like shape above the word "centervue" in lowercase letters. The globe is made up of several gray blocks arranged in a circular pattern, with a black circle in the center. The word "centervue" is written in a simple, sans-serif font.

#### Device Description:

The CenterVue EIDON scanning ophthalmoscope 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;
- Base, including touch-screen device (tablet with magnetic holder and USB cable), USB joystick 4. and an external power supply.

EIDON uses infrared and visible light to obtain colored confocal digital images of a human retina without a mydriatic agent.

The CenterVue EIDON device operates on the following principles:

- An illumination system consisting of infrared (IR) LEDs (850nm, 940nm), a white LED, a blue LED and a) a green 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 retina is uniformly illuminated by a line in a horizontal direction. Along the optical path there is an oscillating mirror which 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 optical axis. The LEDS are switched on during all exams in order to enable pupil tracking.
- The white and blue LEDs allow the capture of color photos. The retina is uniformly illuminated by a line in a horizontal direction. Along the optical path there is an oscillating mirror which 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 collects back-reflected light from the retina and creates a high resolution image. A focusing lens is included in the imaging path to achieve optimal retinal focusing on a CMOS camera having a resolution of 14 megapixels.
- An anterior segment alignment system is included, using two cameras and the two IR LEDs: the c) LEDs illuminate the anterior segment by diffusion, whereas allow a stereoscopic reconstruction of the pupil's position to be obtained with respect to the instrument front lens.

The EIDON device interacts with the patient by directing infrared, white, blue and green wavelength illumination into the patient's eye. The chin-rest and head-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.

### Bench tests

The CenterVue EIDON device has been tested and found to be in conformance with IEC 60601-1:2005 and IEC 60601-1-2:2007. In addition, the device meets the requirements of ISO 10940:2009, ISO 15004-1:2006, and ISO 15004-2:2007.

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Image /page/5/Picture/0 description: The image shows a stylized logo. The logo features a sphere with a dark center, surrounded by a series of gray cubes that appear to be orbiting or partially encasing the sphere. The cubes are arranged in a circular pattern, giving the impression of a three-dimensional structure. The overall design is modern and abstract.

#### Performance data:

| Performance item | Requirements | Test results |
|----------------------|-----------------------------|----------------------------|
| Sensor resolution | 14 megapixels (4608 x 3288) | 4608 x 3288 |
| Resolution on retina | 60 pixel / deg | 59.7 pixel / deg |
| Optical resolution | 15 microns at the center | 15.1 microns at the center |
| Field of view | 60° (H) × 55° (V) | 60.0° x 55.1° |
| Pixel pitch | 4.9 microns max | 4.79 microns |
| Range of focus | -12 D to +15D | -12 D to +15D |
| Minimum pupil size | 3 mm | 3 mm |

#### Comparison with predicate devices:

The predicate devices selected for comparison with the CenterVue EIDON Ophthalmoscope are:

| Predicate Device 1: | EasyScan |
|----------------------|-----------------------------------|
| 510(k) Sponsor: | i-Optics B.V. |
| 510(k) Number: | K111988 |
| Clearance Date: | 28 October 2011 |
| FDA Product Code: | MYC |
| Classification Name: | Scanning Laser Ophthalmoscope |
| Regulation No: | 886.1570 |
| Predicate Device 2: | Digital Retinography system (DRS) |
| 510(k) Sponsor: | CenterVue S.p.A. |
| 510(k) Number: | K101935 |
| Clearance Date: | 27 October 2010 |
| FDA Product Code: | HKI |
| Classification Name: | Ophthalmic Camera |
| Regulation No: | 886.1120 |

The Subject Device and the Predicate Devices share many identical or similar properties and features. Differences include:

- . Field of view
- . Imaging principle
- . Fixation target
- . Working distance
- Sensor size
- . Minimum pupil size

None of these differences have any significant effect on safety or effectiveness of the Subject Device.

#### Conclusion:

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