DIGITAL RETINAL CAMERA

K111612 · Canon, Inc. · HKI · Sep 14, 2011 · Ophthalmic

Device Facts

• Record ID: K111612
• Device Name: DIGITAL RETINAL CAMERA
• Applicant: Canon, Inc.
• Product Code: HKI · Ophthalmic
• Decision Date: Sep 14, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

The CR-2 Plus is intended to be used for taking digital images of the retina of the human eye without a mydriatic. The CR-2 Plus has the following photography modes: color, red free & cobalt digital filter, and fundus autofluorecence (FAF).

Device Story

Digital retinal camera for non-mydriatic imaging of human retina; utilizes Canon EOS digital camera mounted to CR-2 Plus unit. Captures color, red-free, cobalt filter, and fundus autofluorescence (FAF) images. Operated by clinicians in clinical settings; images viewed immediately for telemedicine or electronic filing. Xenon lamp light source (max 255Ws) used for photography. Software provides GUI for working dot brightness, ISO speed selection (200, 400, 800), and speed priority JPEG capture. Enables efficient retinal documentation; facilitates clinical decision-making through immediate image availability.

Clinical Evidence

Bench testing only. Performance testing conducted on optical radiation safety and fundus autofluorescence (FAF) photographing capabilities to demonstrate substantial equivalence.

Technological Characteristics

Ophthalmic camera; Xenon lamp light source (max 255Ws); Canon EOS digital camera mount; supports color, red-free, cobalt filter, and FAF modes. Software-controlled GUI for brightness, ISO (200-800), and JPEG capture speed. Connectivity for digital image output.

Indications for Use

Indicated for taking digital retinal images of human patients without a mydriatic. Modes include color, red-free, cobalt digital filter, and fundus autofluorescence (FAF).

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

• Canon Digital Retinal Camera CR-2 (K102013)
• Canon Digital Retinal Camera CX-1 (K092565)

Submission Summary (Full Text)

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Section 5: Summary

K111612

# 510(k) Summary

SEP 1 4 2011

#### Prepared:

Sept 12, 2011

Company Name: Company Address:

Contact Person: Phone Number: Fax Number:

CANON INC. 30-2 Shimomaruko 3-chome, Ohta-ku Tokyo 146-8501, Japan Naoyasu Asaka 81-3-3758-2111 81-3-5482-3960

#### Proposed Device:

Reason For 510(k): Trade Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: FDA 510(k) #:

New Model Canon Digital Retinal Camera CR-2 Plus 21 CFR 886.1120 Ophthalmic camera II HKI K11612

#### Predicate Device:

Trade Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: FDA 510(k) #:

Canon Digital Retinal Camera CR-2 21 CFR 886.1120 Ophthalmic camera II HKI K102013

Trade Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: FDA 510(k) #:

Canon Digital Retinal Camera CX-1 21 CFR 886.1120 Ophthalmic camera II HKI K092565

#### Description of Device:

The Digital Retinal Camera CR-2 Plus is used for taking digital images of a human retina without a mydriatic. Canon EOS Digital Camera is mounted to the CR-2 Plus. Images can be viewed immediately, making procedures more efficient with many different applications, such as telemedicine and electronic filing.

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### Indications for Use:

The CR-2 Plus is intended to be used for taking digital images of the retina of the human eye without a mydriatic. The CR-2 Plus has the following photography modes: color, red free & cobalt digital filter, and fundus autofluorecence (FAF).

## Summary of Modifications to the Predicate Devices

The CR-2 Plus is a modification version to CR-2. The imaging principle and intended use are similar to those of CR-2 and CX-1. The major modifications are listed in the table below:

| Table of Modifications | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Item | Modifications to CR-2 | Similar to CX-1 |
| Operation mode | Add fundus autofluorecence photography mode | Yes |
| Light Source | Use Xenon Lamp (Max 255Ws) for photography<br>( White LED is used in CR-2) | Yes |
| Software | 1. Add CR-2 Plus as a target device<br>2. Activated FAF exposure mode which had been just<br>implemented with "Rics for CX-1"<br>3. Add a GUI control of working dot brightness<br>adjustment<br>4. Add ISO 200, 400, 800 into ISO speed choices<br>5. Add a speed priority (JPEG capture) mode | Software has been<br>updated from CR-2<br>and CX-1 |

Table of Modificati

## Substantial Equivalence

The CR-2 plus has the same intended use and similar principles of operation and technological characteristics as the predicate device. Performance testing on optical radiation safety and fundus autofluorecence photographing demonstrate the minor technological differences between the CR-2 Plus and the predicate devices do not raise any new questions of safety and effectiveness. Therefore, we believe the Digital Retinal Camera CR-2 Plus is substantially equivalent to Canon's legally marketed Digital Retinal Camera CR-2 and CX-1.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The caduceus is depicted with a single snake winding around a staff.

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

Canon, Inc. c/o Mr. Koji Kubo. Manager Cosmos Corporation, Tokyo Office 6-5-3 Beaune Honkomagome 2F. Honkomagome, Bunkyo-ku, Tokyo 113-0021 JAPAN

SEP 14 2017

Re: K111612

Trade Name: Canon Digital Retinal Camera CR-2 Plus Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: II Product Code: HKI Dated: August 12, 2011 Received: August 15, 2011

Dear Mr. Kubo:

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.

ff 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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Page 2 - Mr. Koji Kubo

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/ReportalProblem/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,
Kesia Alexander

Image /page/3/Picture/6 description: The image shows a handwritten signature. The signature is written in cursive and appears to be a stylized version of the letter 'J'. The signature is in black ink on a white background. The signature is slightly tilted to the right.

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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## Indications for Use

| 510(K) Number (if known) : | K111612 |
|----------------------------|---------|
|----------------------------|---------|

CR-2 Plus Device Name:

Indications for Use:

The CR-2 Plus is intended to be used for taking digital images of the human eye without a mydriatic. The CR-2 Plus has the following photography modes: color, red free & cobalt digital filter, and fundus autofluorecence (FAF).

Prescription Use × (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

OR

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

510(k) Number K1111612