TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA

K041367 · Topcon Corp. · HKI · Nov 5, 2004 · Ophthalmic

Device Facts

• Record ID: K041367
• Device Name: TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
• Applicant: Topcon Corp.
• Product Code: HKI · Ophthalmic
• Decision Date: Nov 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

Topcon Model TRC-NW200 Non-Mydriatic Camera is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eyecare professional, without the use of a mydriatic.

Device Story

The Topcon TRC-NW200 is a non-mydriatic ophthalmic camera used by eyecare professionals to capture and display images of the retina and anterior segment of the eye. The device utilizes halogen illumination with an infrared filter for observation and a xenon flash bulb for photography. The operator aligns the camera using focusing bars and alignment dots, then triggers image capture via a joystick-mounted button. Captured images are displayed on a built-in LCD or transferred to a PC for review. By eliminating the need for mydriatic drops, the device simplifies the examination process, allowing clinicians to diagnose and monitor ocular diseases more efficiently.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Non-mydriatic ophthalmic camera; halogen illumination with infrared filter for observation; xenon flash bulb for photography; built-in LCD display; PC connectivity; joystick-controlled alignment with focusing bars and alignment dots.

Indications for Use

Indicated for capturing images of the retina and anterior segment of the eye in patients requiring eye examination without the use of a mydriatic agent. Intended for use by eyecare professionals.

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 CR6-45NM (K980246)
• Canon CR-DGi (K031629)
• Nidek NM-1000 (K014274)

Submission Summary (Full Text)

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K041367

## NOV - 5 2004

## Topcon TRC-NW200 510(k) Summary

| Name of Device: | Topcon Model TRC-NW200<br>Non-Mydriatic Retinal Camera |
|-------------------------------|--------------------------------------------------------|
| Common / Generic Device Name: | Retinal Camera |
| Classification Name: | Camera, Ophthalmic, AC-Powered |
| Regulation Number: | 886-1120 |
| Product Code: | HKI |
| Submitter: | Topcon Corporation |
| Address: | 37 West Century Road, Paramus, NJ 07652 |
| Telephone Number: | [phone] |
| Facsimile Number: | [phone] |
| Contact Person: | Donald H. Winfield |
| Date Prepared: | August 12, 2004 |

Predicated Devices:

| 1) Manufacturer: | Canon, Inc. |
|----------------------|-------------|
| Trade Name: | Canon |
| Model Name: | CR6-45NM |
| Classification Name: | 86 HKI |
| 510(k) Number: | K 980246 |

| 2) Manufacturer: | Canon, Inc. |
|----------------------|-------------|
| Trade Name: | Canon |
| Model Name: | CR-DGi |
| Classification Name: | 86 HKI |
| 510(k) Number: | K 031629 |

| 3) Manufacturer: | Nidek, Inc. |
|----------------------|-------------|
| Trade Name: | Nidek |
| Model Name: | NM-1000 |
| Classification Name: | 86 HKI |
| 510(k) Number: | K 014274 |

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| Description of Device: | The Topcon TRC-NW200 is a non-mydriatic ophthalmic<br>camera that captures and displays images of the eye. The<br>images are captured by using halogen illumination with an<br>infrared filter for observation and a xenon flash bulb for<br>photography. There is no laser illumination. Alignment<br>dots and focusing bars assist the operator in properly<br>positioning the camera. The operator presses a button on<br>the top of the joystick to capture the image. The image is<br>then displayed on the built-in LCD display or, if desired,<br>transferred to a personal computer. |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Topcon Model TRC-NW200 Non-Mydriatic Camera is<br>intended for use in capturing images of the retina and the<br>anterior segment of the eye and presenting the data to the<br>eyecare professional, without the use of a mydriatic. |
| Substantial Equivalence: | The TRC-NW200 and the predicated devices have the same<br>intended use and indications. All of these devices are non-<br>mydriatic ophthalmic cameras that capture and display<br>images of the eye to aid the health care professional in<br>diagnosing and/or monitoring diseases of the eye that may<br>be observed and photographed. The NW200 and the<br>predicated devices acquire these images according to the<br>same principles of operation and technical characteristics.<br>The question of safety and effectiveness is the same for the<br>NW200 and the predicated devices. Therefore, the TRC-<br>NW200 is substantially equivalent to legally marketed<br>devices intended to capture images of the retina and the<br>anterior segment of the eye and presenting this data to the<br>eyecare professional without the use of a mydriatic. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with three horizontal lines representing the eagle's wings and a wavy line representing the eagle's body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 2004

Topcon Medical Systems, Inc. c/o Donald Winfield Vice President 37 West Century Road Paramus. NJ 07652

Re: K041367

Trade/Device Name: Topcon Non -Mydriatic Retinal Camera, Model TRC-NW200 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: May 21, 2004 Received: May 24, 2004

Dear Mr. Winfield:

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 I ou may y are s 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 r reaso be act nove a determination that your device complies with other requirements of the Act that I Dr has Intatutes and regulations administered by other Federal agencies. You must or unr) I 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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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/dsmaldsmamain.html

Sincerely yours,

A kalgi korenthal

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 for Use

510(k) Number (if Known): K041367

Device Name: Non-Mydriatic Retinal Camera, Model TRC-NW200

Indication for Use:

The Topcon Model TRC-NW200 Non-Mydriatic Camera is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eyecare professional, without the use of a mydriatic.

Prescription Use ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺑﻘﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Dex | 11/05/2004 |
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(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

| 510(k) Number | K041367 |
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