(105 days)
Not Found
No
The summary describes a digital retinal camera and its basic functionality, focusing on image acquisition and viewing. There is no mention of AI, ML, or advanced image processing that would typically indicate the use of such technologies. The performance studies listed are related to electrical safety and ophthalmic instrument standards, not algorithmic performance.
No
The device is described as an imaging device for taking digital images of the retina, which is a diagnostic function, not a therapeutic one. It does not mention any treatment or therapy provided by the device.
No
The device description states it is used for "taking digital images of the retina" and that "images can be viewed immediately." It doesn't mention any analysis, interpretation, or diagnosis being performed by the device itself, only imaging. There are no performance metrics related to diagnostic accuracy, nor mentions of image processing, AI, DNN, or ML, which would be typical for a diagnostic device.
No
The device description explicitly states it is a "DIGITAL RETINAL CAMERA CR-2" and mentions a "Canon EOS Digital Camera is mounted to the CR-2," indicating it is a hardware device with integrated software, not a software-only device. Performance studies also include electrical safety and electromagnetic compatibility testing, which are relevant to hardware.
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 description clearly states the device is a "DIGITAL RETINAL CAMERA" used for "taking digital images of the retina of the human eye." This is an imaging device that captures visual information directly from the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is to "tak[e] digital images of the retina," which is a direct imaging procedure, not an in vitro test.
Therefore, the device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The device is intended to be used for taking digital images of the human eye without a mydriatic.
The device is intended to be used for taking digital images of the retina of the human eye without a mydriatic.
Product codes
HKI
Device Description
The DIGITAL RETINAL CAMERA CR-2 is used for taking digital images of retina of human eye without a mydriatic.
Canon EOS Digital Camera is mounted to the CR-2. Images can be viewed immediately, making procedures more efficient with many different applications, such as telemedicine and electronic filing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital images
Anatomical Site
retina of 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)
Electrical Safety & Electromagnetic Compatibility
CR-2 was tested in accordance with IEC60601-1 and IEC60601-1-2, and was found to meet all requirements of these standards.
Requirements for Ophthalmic instruments
CR-2 was tested in accordance with ISO15004-1:2006 and ISO15004-2:2007, and was found to meet all requirements of these standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Klozoi3
Section 5: Summary
Tokyo 146-8501, Japan Naoyasu Asaka
OCT 2 9 2010
Section 5. 510(k) Summary
Prepared:
July 15, 2010
Canon Inc.
81-3-3758-2111 81-3-5482-3960
Submitter:
Company Name: Company Address:
Contact Person: . Phone Number: Fax Number:
Proposed Device:
Reason For 510(k): Trade Name: Model Name: Classification Name: FDA 510(k) #:
New Model Canon DIGITAL RETINAL CAMERA CR-2 86HKI, Ophthalmic camera To be assigned
30-2 Simomaruko 3-chome, Ohta-ku
Predicate Device:
Trade Name: . Model Name: Classification Name: FDA 510(k) #:
Canon
DIGITAL RETINAL CAMERA CR-1 MarkIl 86HKI, Ophthalmic camera K090466
Description of Device:
The DIGITAL RETINAL CAMERA CR-2 is used for taking digital images of retina of human eye without a mydriatic.
Canon EOS Digital Camera is mounted to the CR-2. Images can be viewed immediately, making procedures more efficient with many different applications, such as telemedicine and electronic filing.
Intended Use:
The device is intended to be used for taking digital images of the human eye without a mydriatic.
Comparison to Predicate:
The CR-2's imaging principle and intended use are the same as those of CR-1 Mark II. The CR-2 is reduced dimensions and weight as compared with the CR-1 Mark II. The optical components, alignment and most of the specifications are the same or better than CR-1 Mark II.
Performance testing:
The following testing was performed on the DIGITAL RETINAL CAMERA CR-2 to demonstrate that it meets all requirements and is equivalent to the predicate device:
1
Section 5: Summary
Electrical Safety & Electromagnetic Compatibility
CR-2 was tested in accordance with IEC60601-1 and IEC60601-1-2, and was found to meet all requirements of these standards.
Requirements for Ophthalmic instruments
CR-2 was tested in accordance with ISO15004-1:2006 and ISO15004-2:2007, and was found to meet all requirements of these standards.
Conclusion:
The Performance Data demonstrate that CR-2 is as safe and effective as the predicate devices. Based on the information in this submission, similarity to the predicate device (CR-1).cos. II), and the results of our design control activities, it is our opinion that the DIGITAL RETINAL CAMERA CR-2 described in this submission is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The bird is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement around the left side of the logo. The text and the bird symbol are both in black.
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 3F, 2-17-6 Akebono-cho Tachikawa-shi, Tokyo 190-0012 Japan
0CT 2 9 2010
Re: K102013
Trade/Device Name: Digital Retinal Camera, Model CR-2 Regulation Number: 21 CFR 886.1120 Regulation Name: Opthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: October 21, 2010 Received: October 22, 2010
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. 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.
3
Page 2 - Mr. Koji Kubo
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 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,
Debra Falls
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
4
Indications for Use
. .
| 510(K) Number (if known): | K102013 |
|---|---|
| Device Name: | CR-2 |
OCT 2 9 2010
Indications for Use:
The device is intended to be used for taking digital images of the retina of the human eye without a mydriatic.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
OR
| 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)
| Page 1 of 1 | |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices |
510(k) Number_________________________________________________________________________________________________________________________________________________________________
. .
.