DIGITAL RETINAL CAMERA

K102013 · Canon Inc. -Medical Equipment Group · HKI · Oct 29, 2010 · Ophthalmic

Device Facts

• Record ID: K102013
• Device Name: DIGITAL RETINAL CAMERA
• Applicant: Canon Inc. -Medical Equipment Group
• Product Code: HKI · Ophthalmic
• Decision Date: Oct 29, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

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

Device Story

Digital retinal camera; captures images of human retina without mydriatic; utilizes mounted Canon EOS digital camera; enables immediate image viewing; supports applications like telemedicine and electronic filing; operated by healthcare professionals in clinical settings; facilitates clinical decision-making through high-quality retinal visualization.

Clinical Evidence

Bench testing only. Compliance with electrical safety (IEC60601-1), electromagnetic compatibility (IEC60601-1-2), and ophthalmic instrument standards (ISO15004-1:2006, ISO15004-2:2007) demonstrated equivalence to predicate.

Technological Characteristics

Ophthalmic camera; utilizes Canon EOS digital camera mount; non-mydriatic imaging principle; dimensions and weight reduced compared to predicate; complies with IEC60601-1, IEC60601-1-2, ISO15004-1:2006, and ISO15004-2:2007.

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 DIGITAL RETINAL CAMERA CR-1 MarkII (K090466)

Submission Summary (Full Text)

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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:

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## 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.

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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.

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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 [phone] or [phone] 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

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# 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<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
|-------------------------------------------------|---|

OR

| Over-The-Counter Use<br>(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)

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| (Division Sign-Off) | |
| Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices | |

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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