(165 days)
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.
The Topcon TRC-NW200 is a non-mydriatic ophthalmic camera that captures and displays images of the eye. The images are captured by using halogen illumination with an infrared filter for observation and a xenon flash bulb for photography. There is no laser illumination. Alignment dots and focusing bars assist the operator in properly positioning the camera. The operator presses a button on the top of the joystick to capture the image. The image is then displayed on the built-in LCD display or, if desired, transferred to a personal computer.
The provided text {0} to {4} describes a 510(k) submission for the Topcon TRC-NW200 Non-Mydriatic Retinal Camera. However, this document does not contain information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about ground truth, sample sizes for testing/training, or expert involvement.
The 510(k) summary focuses on establishing substantial equivalence to predicate devices rather than providing performance metrics against predefined acceptance criteria.
Therefore, I cannot fulfill your request for the tables and detailed information you’ve asked for based on the provided text. The document primarily covers:
- Device Name, Classification, and Submitter Information
- Identification of Predicate Devices
- Description of the Device and its Intended Use
- A statement of Substantial Equivalence outlining that the device has the same intended use, indications, principles of operation, and technical characteristics as the predicates.
- FDA's response letter confirming the substantial equivalence determination and allowing the device to be marketed.
- Indications for Use Statement
There is no mention of specific performance metrics, clinical studies, or data analysis concerning the device's accuracy or effectiveness in capturing images of the retina. The focus is on demonstrating that it functions similarly to previously cleared devices.
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NOV - 5 2004
Topcon TRC-NW200 510(k) Summary
| Name of Device: | Topcon Model TRC-NW200Non-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: | (201) 261-9450 |
| Facsimile Number: | (201) 387-2710 |
| 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 ophthalmiccamera that captures and displays images of the eye. Theimages are captured by using halogen illumination with aninfrared filter for observation and a xenon flash bulb forphotography. There is no laser illumination. Alignmentdots and focusing bars assist the operator in properlypositioning the camera. The operator presses a button onthe top of the joystick to capture the image. The image isthen displayed on the built-in LCD display or, if desired,transferred to a personal computer. |
|---|---|
| Intended Use: | Topcon Model TRC-NW200 Non-Mydriatic Camera isintended for use in capturing images of the retina and theanterior segment of the eye and presenting the data to theeyecare professional, without the use of a mydriatic. |
| Substantial Equivalence: | The TRC-NW200 and the predicated devices have the sameintended use and indications. All of these devices are non-mydriatic ophthalmic cameras that capture and displayimages of the eye to aid the health care professional indiagnosing and/or monitoring diseases of the eye that maybe observed and photographed. The NW200 and thepredicated devices acquire these images according to thesame principles of operation and technical characteristics.The question of safety and effectiveness is the same for theNW200 and the predicated devices. Therefore, the TRC-NW200 is substantially equivalent to legally marketeddevices intended to capture images of the retina and theanterior segment of the eye and presenting this data to theeyecare 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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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 | |
|---|---|---|
| -- | ----- | ------------ |
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K041367 |
|---|---|
| --------------- | --------- |
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
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.