DIGITAL RETINAL CAMERA

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "Canon" in a bold, sans-serif font. The letters are black, and the background is white. The word is centered in the image and takes up most of the space. ## 5. 510(k) Summary ## K123208 ## MAR 1 9 2013 | Submitter: | Canon, Inc. - Medical Equipment Group<br>30-2 Shimomaruko, 3-chome<br>Ohta-ku, Tokyo 146-8501 Japan | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Naoyasu Asaka<br>Manager<br>TEL: 81-3-3758-2111<br>FAX: 81-3-5482-3960<br>asaka.naoyasu@canon.co.jp | | Contact/Application<br>Correspondent | Izumi Maruo<br>MIC International<br>4-1-17 Hongo, Bunkyo-ku,<br>Tokyo, 113-0033, Japan<br>TEL: 81-3-3818-8577<br>FAX: 81-3-3818-8573<br>maruo@mici.co.jp | | Date Prepared: | October 10, 2012 | | Trade Name: | Digital Retinal Camera CR-2 Plus AF | | Common Name: | Ophthalmic camera | | Classification Name: | Ophthalmic camera. (21 CFR 886.1120, Product code HKI) | | Regulation Class | II | | Predicate Device: | K111612 Canon Digital Retinal Camera CR-2 Plus | | Device Description: | The Digital Retinal Camera CR-2 Plus AF is used for taking digital<br>images of a human retina without a mydriatic. Canon EOS Digital<br>Camera is mounted to the CR-2 Plus AF. Images can be viewed<br>immediately, and procedures of imaging are more efficient with many<br>different applications such as telemedicine and electronic filing. The<br>CR-2 Plus AF is equipped with autofocus/automatic<br>shooting/automatic switching function from anterior segment image to<br>fundus image. | | Statement of<br>Intended Use: | The CR-2 Plus AF is intended to be used for taking digital images of<br>the retina of the human eye without a mydriatic. The CR-2 Plus AF has<br>the following photography modes: color, red free, cobalt digital and<br>fundus autofluorescence (FAF). | . . {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "Canon" in a bold, sans-serif font. The letters are black, and the background is white. The word is slightly curved, with the "C" being the highest point and the "n" being the lowest point. The letters are evenly spaced and easy to read. Modification from predicate device The CR-2 Plus AF is modified from the CR-2 Plus by adding following functions; - Autofocus of the fundus image . - . Automatic shooting of the fundus image - Automatic switching from anterior segment image to fundus image . In addition, the "diopter compensation knob" is removed since diopter compensation is performed using the focus ring instead of the diopter compensation knob in the CR-2 Plus AF. The CR-2 Plus AF has the same intended use and fundamental technological characteristics as the CR-2 Plus. However, the CR-2 Plus AF has some different technological characteristics compared to the CR-2 Plus as described above. In order to evaluate safety and effectiveness of the CR-2 Plus AF, non-clinical tests were performed. In conclusion, result of the testing demonstrated that the CR-2 Plus AF does not raise any new safety and effectiveness concerns compared to the CR-2 Plus. Non-clinical tests were conducted to evaluate safety and effectiveness of the CR-2 Plus AF as follows. Performance testing, Software Validation, Electrical safety, and Electromagnetic Compatibility testing have been performed. The unit complies with the US Performance Standard for ophthalmic equipment. The CR-2 Plus AF met all requirements of the standards. Canon. Inc. - Medical Equipment Group concluded that the CR-2 Plus AF is substantially equivalent to the predicate device listed above. This conclusion is based on the identical intended use and fundamental technological characteristics, and the similarities in the functional design. Although the CR-2 Plus AF has some different technological characteristics from the predicate, the non-clinical testing results indicated that the CR-2 Plus AF met all requirements of recognized or voluntary standard. Based on the test results. the CR-2 Plus AF does not raise any new safety and effectiveness concerns compared to the CR-2 Plus. Statement of Substantial Equivalence Summary of Non-Clinical/Test Data: Conclusion: {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. March 19, 2013 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Canon Inc. Medical Equipment Group % Izumi Maruo MIC International Corp. 4-1-17 Hongo Bunkyo-ku, Tokyo 113-0033 Re: K123208 Trade/Device Name: Digital Retina Camera CR-2 Plus AF Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: March 5, 2013 Received: March 7, 2013 Dear Izumi Maruo: 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 {3}------------------------------------------------ Page 2 - Izumi Maruo 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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Kesia YAlexander -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 {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K123208 Device Name: Digital Retinal Camera CR-2 Plus AF Indications For Use: The Digital Retinal Camera CR-2 Plus AF is intended to be used for taking digital images of the retina of the human eye without a mydriatic. The CR-2 Plus AF has the following photography modes: color, red free, cobalt digital and fundus autofluorescence (FAF). 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) Ka N. To 2013.03.14 08:54:22 -04'00' (Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number:________________________________________________________________________________________________________________________________________________________________ Page 1 of ____________________________________________________________________________________________________________________________________________________________________