(158 days)
Not Found
No
The summary describes automated functions like autofocus and automatic shooting, but these are standard features in digital cameras and do not inherently indicate the use of AI or ML. There is no mention of AI, ML, or related concepts like deep learning or neural networks.
No
The device is described as a camera intended for taking digital images of the retina, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.
No
The device is described as a camera intended for "taking digital images of the retina" and making "procedures of imaging more efficient." It does not mention analyzing images or providing diagnoses based on the images. Its function is image acquisition, not diagnostic interpretation.
No
The device description explicitly states it is a "Digital Retinal Camera CR-2 Plus AF" and mentions a "Canon EOS Digital Camera is mounted to the CR-2 Plus AF," indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Digital Retinal Camera CR-2 Plus AF is used to take images of the retina of the human eye. This is a non-invasive imaging procedure performed directly on the patient's body.
- No Sample Analysis: The description does not mention the analysis of any biological samples. The device captures images, which are then viewed and potentially used for diagnosis, but the device itself is not performing a diagnostic test on a sample.
Therefore, the CR-2 Plus AF falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
The Digital Retinal Camera CR-2 Plus AF is used for taking digital images of a human retina without a mydriatic. Canon EOS Digital Camera is mounted to the CR-2 Plus AF. Images can be viewed immediately, and procedures of imaging are more efficient with many different applications such as telemedicine and electronic filing. The CR-2 Plus AF is equipped with autofocus/automatic shooting/automatic switching function from anterior segment image to fundus image.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
retina of the human eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K111612 Canon Digital Retinal Camera CR-2 Plus
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
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.
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
30-2 Shimomaruko, 3-chome
Ohta-ku, Tokyo 146-8501 Japan |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Naoyasu Asaka
Manager
TEL: 81-3-3758-2111
FAX: 81-3-5482-3960
asaka.naoyasu@canon.co.jp |
| Contact/Application
Correspondent | Izumi Maruo
MIC International
4-1-17 Hongo, Bunkyo-ku,
Tokyo, 113-0033, Japan
TEL: 81-3-3818-8577
FAX: 81-3-3818-8573
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
images of a human retina without a mydriatic. Canon EOS Digital
Camera is mounted to the CR-2 Plus AF. Images can be viewed
immediately, and procedures of imaging are more efficient with many
different applications such as telemedicine and electronic filing. The
CR-2 Plus AF is equipped with autofocus/automatic
shooting/automatic switching function from anterior segment image to
fundus image. |
| Statement of
Intended Use: | The 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). |
. .
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:________________________________________________________________________________________________________________________________________________________________
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