DIGITAL RETINAL CAMERA, CR-1 MARK II

K090466 · Canon, Inc. · HKI · Mar 23, 2009 · Ophthalmic

Device Facts

• Record ID: K090466
• Device Name: DIGITAL RETINAL CAMERA, CR-1 MARK II
• Applicant: Canon, Inc.
• Product Code: HKI · Ophthalmic
• Decision Date: Mar 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The device is intended to be used for taking digital images of retina of human eye without a mydriatic.

Device Story

Digital retinal camera CR-1 Mark II captures digital images of human retina without mydriatic. Device utilizes mounted Canon EOS Digital Camera. Operation involves non-mydriatic imaging; images viewed immediately for clinical applications including telemedicine and electronic filing. Differences from predicate include modified flash intensity settings (Standard, LOW1, LOW2 modes). Used in clinical settings by healthcare professionals to facilitate retinal examination and documentation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological comparison and bench testing of flash intensity modifications.

Technological Characteristics

Ophthalmic camera; non-mydriatic imaging; utilizes mounted Canon EOS Digital Camera; adjustable flash intensity modes (Standard, LOW1, LOW2).

Indications for Use

Indicated for capturing digital retinal images of the human eye without the use of a mydriatic agent.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*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.

Predicate Devices

• Canon CR-1 (K080883)

Submission Summary (Full Text)

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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 [phone] [phone]

#### 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 intensity<br>mode(LOW1) | 1/2 | 1/4 | |
| | Low flash intensity<br>mode(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 [phone]. 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 [phone] or [phone] 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