NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM

K980246 · Canon USA, Inc. · HKI · May 6, 1998 · Ophthalmic

Device Facts

• Record ID: K980246
• Device Name: NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM
• Applicant: Canon USA, Inc.
• Product Code: HKI · Ophthalmic
• Decision Date: May 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

Taking pictures of retina of human eye without a mydriatic.

Device Story

The Canon CR6-45NM is an AC-powered, non-mydriatic retinal camera used to capture images of the human retina. It functions by aligning the device with the patient's eye using split-line focusing and an internal fixation lamp. The device features an auto-flash adjustment system and an advanced internal fixation lamp to facilitate easier operation compared to its predecessor. It is operated by a clinician in a clinical setting. The captured retinal images are used by healthcare providers to assist in clinical decision-making regarding ocular health. The device benefits patients by allowing for retinal imaging without the need for pupil dilation (mydriasis).

Clinical Evidence

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

Technological Characteristics

AC-powered non-mydriatic retinal camera. Materials include ABS resin, Aluminum die cast (ADC10), NBR rubber, PC resin, and Stainless steel (SUS303BG). Features 45-degree angle of view, 45mm working distance, and split-line focusing. Complies with UL544 safety standards. Includes exclusive pre-installed software for device operation.

Indications for Use

Indicated for taking retinal images of the human eye in the general population 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 CR5-45NM (K941234)

Submission Summary (Full Text)

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K980246

## MAY 6 1098

## 510(K)Summary

1.Date Prepared: January 29, 1998 2.Applicant's Name: Canon USA, Inc. One Canon Plaza. Lake Success, NY 11042 Mr. Glenn Impal/Mr. Ken Shadoff Phone: [phone] Fax. [phone] Canon CR6-45NM 3.Model Name: 86HKI, Non-Mydriatic Retinal Camera, AC Powered Document Control Number. 4.Predicate Model: Canon CR5-45NM 86HKI, Non-Mydriatic Retinal Camera, AC Powered Document Control Number. K941234 CR6-45NM is an improved model of CR5-45NM. CR6-45NM has employed 5.Device Description: Auto Flash Adjustment and Advanced Internal Fixation Lamp, making operation easier. CR6-45NM is intended to be used for taking pictures of retina of human eye 5.Intended Use: without a mydriatic. 7.Summary of Technological

Characteristics:

See the attached comparison chart.

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K980246

## COMPARISON CHART

| | | | CR5-45NM | CR6-45NM |
|---------------------------|---------------------------------|------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------|
| P | Angle of view | | 45°<br>(37° when S.P switch is ON) | Same |
| | Actual image size | | $\phi$ 22mm (on 35mm film)<br>$\phi$ 74mm (on Polaroid film) | Same |
| R | Min. diameter of pupil required | | 4.0mm<br>(3.7mm when S.P switch is ON) | Same |
| F | Working distance(WD) | | 45mm | Same |
| | Focusing | | By aligning the split lines | Same |
| O | Data to be printed | | Hand-written data | Same |
| R | Eye fixation lamp | | Internal(during observation of retinal image) | Internal(during observation of eye front image and retinal image) |
| M | | Light source for photography | Max. 300WS | Same |
| A | Working range | Vertical | 37mm | Same |
| N | | Forward & back | 40mm | |
| | | Right & left | 100mm | |
| | | Chin rest(vertically) | 70mm | |
| E | External dimension | | W325xL480xH585mm | W325xL496xH570mm |
| | Weight | | Approx. 24kg | Same |
| Intended use | | | Taking picture of retina of human eye | Same |
| | Design | | See Attachment | See Attachment |
| | Energy | used | 300VA | Same |
| | | delivered | NA | Same |
| | Materials | | See Attachment | |
| Target population | | | General Population | Same |
| Physical safety | | | UL544 | Same |
| Compliance with standards | | | UL544 | Same |
| Biocompatibility | | | NA | Same |
| | Labeling | Packaging | See Attachment | See Attachment |
| | | Inserts | See Attachment | See Attachment |
| | | Prompts | See Attachment | See Attachment |
| | | Software | Exclusive pre-installed software | Same |

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K980246

:

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## Materials

:

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

| | CR5-45NM | CR6-45NM |
|---|-----------------------------------|----------------------------|
| 1 | ABS resin | Same |
| 2 | Aluminum die cast<br>ADC10 | Same |
| 3 | robber<br>NBR | Same |
| 4 | ABS resin | Same |
| 5 | Aluminum casting<br>AC2A | Aluminum die cast<br>ADC10 |
| 6 | PBT resin | PC resin |
| 7 | Stainless steel stick<br>SUS303BG | Same |
| 8 | PBT resin | Same |
| 9 | ABS resin | Same |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circular seal. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the perimeter of the circle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 6 1898

Mr. Ken Shadoff Product Safety Engineer Quality Management Department Cannon, USA One Canon Plaza Lake Success, NY 11042-1198

Re: K980246

> Trade Name: Non-Mydriatic Retinal Camera, Model CR6-45NM Regulatory Class: II Product Code: 86 HKI Dated: March 11, 1998 Received: April 28, 1998

Dear Mr. Shadoff:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. * Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Ken Shadoff

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph L. Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (IF Known): K980246 Device Name: CAMERA, OPHTHALMIC, AC-POWERED_ Indications For Use:

Taking pictures of retina of human eye.

Evelyn R. Bera

(Division Sign-Off)
Division of Ophthalmic Devices

Division of Ophthalmic Devices 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use -(Per 21 CFR 201.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)