(30 days)
The device is intended to be used for taking digital images of retina of human eye without a mydriatic.
The DIGITAL RETINAL CAMERA CR-1 Mark II is used for taking digital images of a human retina without a mydriatic. Canon EOS Digital Camera is mounted to the CR-1 Mark II. Images can be viewed immediately, making procedures more efficient with many different applications, such as telemedicine and electronic filing.
The provided text is a 510(k) summary for the DIGITAL RETINAL CAMERA CR-1 Mark II. This document focuses on establishing substantial equivalence to a predicate device (Canon CR-1) and does not contain detailed information about a study proving device acceptance criteria in the way a clinical trial report would.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study proving the device meets acceptance criteria from the provided text.
The document primarily describes:
- Device Identification: Manufacturer, trade name, model name, classification, and 510(k) number of the proposed device (CR-1 Mark II) and its predicate (CR-1).
- Description of Device: The CR-1 Mark II is an ophthalmic camera used for taking digital images of the human retina without mydriatics. It uses a Canon EOS Digital Camera.
- Differences from Predicate: The primary difference highlighted is the flash intensity settings, with the CR-1 Mark II offering an additional "Low flash intensity mode (LOW2)" at 1/8 flash intensity compared to the CR-1.
- Intended Use/Indications for Use: To take digital images of the retina of the human eye without a mydriatic.
- FDA Determination: The FDA found the device substantially equivalent to the predicate device.
Key Missing Information for your Request:
The 510(k) summary is a regulatory document to demonstrate substantial equivalence, not a detailed scientific study report. It does not typically include:
- Specific, quantified acceptance criteria for performance (e.g., minimum resolution, image quality metrics).
- Results from a formal study that tests against these acceptance criteria.
- Clinical data with sample sizes, expert ground truth, or MRMC analyses.
Without a detailed clinical or performance study report, which is not part of this 510(k) summary, I cannot fulfill your request for specific study details.
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Section F: Summary
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510(k) Summary
Prepared:
December 10. 2008
MAR 2 3 2009
Submitter:
Company Name: Company Address:
Contact Person: Phone Number: Fax Number:
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
Proposed Device:
| Reason For 510(k): |
|---|
| Manufacturer: |
| Trade Name: |
| Model Name: |
| Classification Name: |
| FDA 510(k) #: |
New Model Canon Inc. Canon CR-1 Mark II 86HKI, ophthalmic cameras To be assigned
Predicate Device:
Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k) #:
Canon Inc. Canon CR-1 86HKI. ophthalmic cameras K080883
Description of Device: The DIGITAL RETINAL CAMERA CR-1 Mark II is used for taking digital images of a human retina without a mydriatic. Canon EOS Digital Camera is mounted to the CR-1 Mark II. Images can be viewed immediately, making procedures more efficient with many different applications, such as telemedicine and electronic filing.
| The differences between CR-1 and CR-1 Mark II are as follows; | ||||
|---|---|---|---|---|
| CR-1 | CR-1 Mark II | |||
| Flash intensity | Standard mode | 1 | 1/2 | |
| Low flash intensitymode(LOW1) | 1/2 | 1/4 | ||
| Low flash intensitymode(LOW2) | 1/8 |
1 CD 4 M-14 U ﻋﺘﺮﺍﻧ
*In comparison with CR-1 standard mode.
Intended Use: The device's intended use is for taking digital images of a human retina without a mydriatic.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
MAR 2 3 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD. 20850
Canon, Inc. c/o Casey Conry Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. Melville, NY 11747
K090466 Re: Trade/Device Name: DIGITAL RETINAL CAMERA CR-1 MARK II Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: March 13, 2009 Received: March 17, 2009
Dear Mr. Conry:
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 for association 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 Crici 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.
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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. Egleston, m.d.
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
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Indications Statement
510(K)Number(if known):
Kogo466
Device Name: CR-1 Mark II
Indications for Use:
The device is intended to be used for taking digital images of retina of human eye without a mydriatic.
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)
OR
Concurrence of CDRH, Office of Device Evaluation(ODE)
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(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K090466
§ 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.