(40 days)
Not Found
No
The summary describes a digital retinal camera with different imaging modes and optical/digital magnification, but there is no mention of AI or ML being used for image analysis, interpretation, or any other function. The focus is on the hardware and imaging capabilities.
No
The device is described as an imaging device for taking digital images of the retina, which is for diagnostic purposes, not therapeutic.
No
The device is described as an imaging device for taking digital images of the retina. It does not mention any analysis or interpretation of these images for diagnostic purposes.
No
The device description explicitly states that the device is a physical piece of hardware (CF-1) that is mounted with a Canon EOS Digital Camera and has optical components and mechanical structures. It is an improved model of a previous hardware device (CF-60DSi).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "tak[e] digital images of retina of human eye". This describes an imaging device used for visualization and documentation of a part of the human body.
- Device Description: The description focuses on the technical aspects of capturing images of the retina, including different imaging modes and optical properties.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples. IVDs are designed to perform tests on these types of samples to provide diagnostic information.
This device appears to be a fundus camera, which is a medical imaging device used by ophthalmologists to examine the retina. While the images captured by a fundus camera can be used to aid in diagnosis, the device itself is not performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
CF-1 is intended to be used for taking digital images of retina of human eye with a mydriatic.
The device is intended to be used for taking digital images of retina of human eye with a mydriatic.
Product codes
HKI
Device Description
CF 1 is an improved model of CF-60DSi. Canon EOS Digital Camera is mounted with CF-1, can be viewed immediately, making procedures more efficient vaniera hand different applications, such as telemedicine and electronic filing.
CF-1's intended use is the same as that of CF-60DSi. However, the differences in design are as follows:
- CF-1 can take images in three modes, such as COLOR, RED FREE, and FLOU .
- CF-60DSi can take images in four modes, such as COLOR, RED FREE, FLOU and ICG. t
- ICG digital camera cannot be attached to CF-1. .
- CF-1 has 2 variable powers (50//43 degree), where 43 degree is digital magnification. . CF-60DSi has 2 optical variable powers (60//40 degree).
CF-1 is equivalent to CF-60DSi in the following respect:
- The optical components and alignment and the mechanical structures of the CF-1 arc . almost same as the CF 60DSi. Picase refer to the CF 1 comparison table provided in this section.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
retina of human eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Ophthalmologist
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)
Not Found
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 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
Appendix G: 510(k) Summary 510(k) Summary
October 11, 200
Prepared:
October 11, 2006
Submitter:
Company Name: Company Address:
Contact Person: Phone Number Fax Number:
Proposed Device:
Reason For 510(k): Manufacturer: Trade Name: Model Name: Classification Name: Regulatory Class: FDA 510(k) #:
Canon USA, Inc. (U.S. agent for Canon Inc.) One Canon Plaza Lake Success, NY 11042 Ms. Sheila Driscoll (516) 328-5602 (516) 328-5169
- New Model Canon Inc. Canon CF-1 86HKI, Ophthalmic cameras Class II 063717 To be assigned
Predicate Device:
Manufacturer: Trade Name: Model Name: Classification Name Regulatory Class: FDA 510(k) #
Canon Inc. Canon CF-60DS! 86HKI, Ophthalmic cameras Class II K041546
Intended Use:
CF-1 is intended to be used for taking digital images of retina of human eye with a mydriatic.
Description Of Device: CF 1 is an improved model of CF-60DSi. Canon EOS Digital Camera is mounted with CF-1, can be viewed immediately, making procedures more efficient vaniera hand different applications, such as telemedicine and electronic filing.
CF-1's intended use is the same as that of CF-60DSi. However, the differences in design are as follows:
- CF-1 can take images in three modes, such as COLOR, RED FREE, and FLOU .
- CF-60DSi can take images in four modes, such as COLOR, RED FREE, FLOU and ICG. t
- ICG digital camera cannot be attached to CF-1. .
- CF-1 has 2 variable powers (50//43 degree), where 43 degree is digital magnification. . CF-60DSi has 2 optical variable powers (60//40 degree).
CF-1 is equivalent to CF-60DSi in the following respect:
- The optical components and alignment and the mechanical structures of the CF-1 arc . almost same as the CF 60DSi. Picase refer to the CF 1 comparison table provided in this section.
JAN 2 3 2007
1
Appendix G: 510(k) Summary
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ﺳ
Table of Comparison
| CF-60DSi | CF-1 | |||
|---|---|---|---|---|
| FDA 510K # | K041546 | Proposed Device | ||
| P | ||||
| R | ||||
| O | ||||
| F | ||||
| O | ||||
| R | ||||
| M | ||||
| A | ||||
| N | ||||
| C | ||||
| E | Angular field of view | 60/40 degree | 50/43 degree (digital magnification) | |
| Actual image size | φ29×22 mm (on sensor array) | |||
| φ7.5×5.7 (Type 1:on sensor array) | ||||
| Min. diameter of pupil | ||||
| required | φ5.5mm | |||
| Working distance | ||||
| (WD) | 45mm | |||
| Focusing | By aligning the split lines | |||
| Eye fixation lamp | External | |||
| Filter set | Automatic/Manual | |||
| Light source for | ||||
| photography | Max. 300WS | |||
| Image unit | EOS Digital Camera | |||
| ICG digital camera (with Adapter) | ||||
| Working range | ||||
| Vertical | ||||
| Forward and back | ||||
| Right and left | ||||
| Chin rest (vertically) | 38mm | |||
| 70mm | ||||
| 120mm | ||||
| 65mm | ||||
| Panning | 30 degree, right or left | |||
| External dimensions | ||||
| Main unit | ||||
| Power control unit | W320×D560×H565mm | |||
| W225×D380×H485mm | ||||
| Weight | Main unit | |||
| Power control unit | Approx.27kg | |||
| Approx.27kg | ||||
| Intended use | Taking digital images of retina of | |||
| human eye with a mydriatic | Same | |||
| Energy | used | 1000VA | 350VA | |
| delivered | Not Applicable | Same | ||
| Target population | Ophthalmologist | Same | ||
| Physical safety | UL60601-1 | Same | ||
| Compliance with standards | UL60601-1 | Same | ||
| Biocompatibility | Not Applicable | Same | ||
| Labeling | Printed model name and electrical ratings are changed. | |||
| "Rx Only" added | ||||
| to and EMC reference removed from CF-1 rating label. |
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle. The logo is simple, using a single color, and is designed to be easily recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2007
Canon USA, Inc. c/o Jeffrey D. Rongero Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. Melville, NY 11747
Re: K063717
Trade/Device Name: Canon Digital Retinal Camera CF-1 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: January 9, 2007 Received: January 10, 2007
Dear Mr. Rongero:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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,
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
M.B. Egelman Si MD
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 Statement
063717
510(K)Number(if known): -
Device Name: CF-1
Indications for Use:
The device is intended to be used for taking digital images of retina of human eye with a mydriatic.
. .
Prescription Use (Part 21 CFR 801 Subpart D) 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)
Dexider
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
t Devises
1/17/2007
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510(k) Number ________________________________________________________________________________________________________________________________________________________________