(97 days)
Not Found
No
The summary describes a digital retinal camera with different imaging modes and mentions image viewing and filing applications. There is no mention of AI, ML, or any algorithms that would process images for diagnostic or analytical purposes beyond basic viewing and storage. The performance studies focus on safety and effectiveness related to optical radiation and photography, not algorithmic performance.
No
The device is used for taking digital images of the retina, which is a diagnostic function rather than a therapeutic one. It captures images but does not treat any condition.
Yes
Explanation: The device is used to take digital images of the retina, which are then used by a healthcare professional to identify and monitor conditions, making it a diagnostic tool.
No
The device description explicitly states that a Canon EOS Digital Camera is mounted to the CR-2 Plus, indicating it includes hardware components beyond just software.
Based on the provided information, the CR-2 Plus 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.
- CR-2 Plus Function: The CR-2 Plus is a device used to take digital images of the retina of the human eye. This is a form of in vivo imaging, meaning it's performed directly on the living body, not on a sample taken from the body.
The device description and intended use clearly indicate its purpose is to capture images of the retina, which is an internal part of the eye. This falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human eye, retina
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)
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.
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.
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
Section 5: Summary
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.
1
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 | |
| ( White LED is used in CR-2) | Yes | |
| Software | 1. Add CR-2 Plus as a target device |
- Activated FAF exposure mode which had been just
implemented with "Rics for CX-1" - Add a GUI control of working dot brightness
adjustment - Add ISO 200, 400, 800 into ISO speed choices
- Add a speed priority (JPEG capture) mode | Software has been
updated from CR-2
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
3
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 (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 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
4
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
Page 1 of 1
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K1111612