CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI

K031629 · Canon USA, Inc. · HKI · Jun 6, 2003 · Ophthalmic

Device Facts

• Record ID: K031629
• Device Name: CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
• Applicant: Canon USA, Inc.
• Product Code: HKI · Ophthalmic
• Decision Date: Jun 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Canon Non-Mydriatic Retinal Camera CR-DGi is intended to be used for taking pictures of retina of human eye without a mydriatic.

Device Story

Canon CR-DGi is an ophthalmic camera designed for capturing retinal images without mydriasis. Device utilizes internal and external fixation lamps to guide patient eye positioning. Operates by aligning split lines for focus; captures images using an EOS Digital Camera unit. Used in clinical settings by optometrists and ophthalmologists. Provides digital retinal images to assist clinicians in ocular examination and documentation. Benefits include non-invasive retinal imaging without requiring pupil dilation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics.

Technological Characteristics

Ophthalmic camera; 45° angle of view; 45mm working distance; internal and external fixation lamps; EOS Digital Camera image unit; 300VA energy consumption; UL544 safety compliance.

Indications for Use

Indicated for use by optometrists and ophthalmologists for capturing retinal images of human eyes 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 45 NM (K980246)

Submission Summary (Full Text)

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K031629

Section 7: Summary

## 510(k) Summary

Prepared:

April 16, 2003

Submitter:

Company Name: Canon USA, Inc. (U.S. agent for Canon Inc.) One Canon Plaza Company Address: Lake Success, NY 11042 Ms. Sheila Driscoll Contact Person: Phone Number: [phone] Fax Number: [phone]

Proposed Device:

Reason For 510(k): Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k) #:

New Model Canon Inc. Canon CR-DGi HKI, Ophthalmic cameras To be assigned

Predicate Device: Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k) #:

Canon Inc. Canon CR 45 NM 86HKI, , Ophthalmic cameras K980246

Description Of Device: CR-DGi is an improved model of CR5-45NM.

CR-DGi is intended to be used for taking pictures of retina of human eye Intended Use: without a mydriatic.

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K031629

## Appendix D: Substantial Equivalence Comparison D-2 Table of comparison

| | | CR6-45NM | CR-DGi |
|-----------------------------------------------------|------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| | Angle of view | 45° (37° when S.P switch is ON) | Same |
| | Actual image size | $\phi$ 22mm (on 35mm film)<br>$\phi$ 74mm (on Polaroid film) | Same |
| | Min. diameter of pupil<br>required | 4.0mm -<br>(3.7mm when S.P switch is ON) | Same |
| P<br>E<br>R<br>F<br>O<br>R<br>M<br>A<br>N<br>C<br>E | Working distance (WD) | 45mm | Same |
| | Focusing | By aligning the split lines | Same |
| | Data to be printed | Hand-written data | None |
| | Eye fixation lamp | Internal (during observation of eye front<br>image and retinal image) | Internal (during observation of eye<br>front image and retinal image)<br>External |
| | Light source for<br>photography | Max. 300WS | Same |
| | Image unit | EOS Digital Camera (with Adapter)<br>35mm film unit<br>Polaroid film unit<br>3CCD TV Camera (with Adapter) | EOS Digital Camera |
| | Working range | | |
| | Vertical | 37mm | Same |
| | Forward & back | 40mm | Same |
| | Right & left | 100mm | Same |
| | Chin rest (vertically) | 70mm | Same |
| | External dimension | W325xL496xH570mm | Same |
| | Weight | Approx. 24kg | Approx. 23kg |
| Intended use | | Taking picture of retina of human eye | Same |
| | Energy used | 300VA | Same |
| | Energy delivered | NA | Same |
| Target population | | Optometrist and Ophthalmologist | Same |
| Physical safety | | UL544 | Same |
| Compliance with standards | | UL544 | Same |
| Biocompatibility | | NA | Same |
| Labeling Packaging | | Printed model name is changed | |

・

. •••

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, featuring three human profiles facing to the right, with flowing lines beneath them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2003

Canon U.S.A., Inc. c/o Mr. Joseph Murnane Senior Staff Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road Melville, NY 11747

Re: K031629

Trade/Device Name: Canon Non-Mydriatic Retinal Camera, Model CR-DGI Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: May 27, 2003 Received: May 27, 2003

Dear Mr. Murnane:

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.

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Page 2 - Mr. Joseph Murnane

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A Kalipi Rosenthal

A. Ralph Rosenthal, 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): | K031629 |
|-------------------------|---------|
|-------------------------|---------|

Page 1 of 1

| Device Name: | CANON Non-Mydriatic RETINAL CAMERA CR-DGi |
|--------------|-------------------------------------------|
|--------------|-------------------------------------------|

Indications for Use:

.

Canon Non-Mydriatic Retinal Camera CR-DGi is intended to be used for taking pictures of retina of human eye without a mydriatic.

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Concurrence of CDRH, Office of Device Evaluation(ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="display:inline-block; width:30px;"></div> OR <div style="display:inline-block; width:30px;"></div> Over-The-Counter Use |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|

(Optional Format 1-2-96)

(Division Sign-Off)

Division of Ophthalmic Ear,
Nose and Throat Devises

| 510(k) Number | K031629 |
|---------------|---------|
|---------------|---------|

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