(165 days)
K 980246, K 031629, K 014274
Not Found
No
The description focuses on the hardware and basic image capture functionality, with no mention of AI, ML, or advanced image processing beyond simple display and transfer. The predicate devices are also older models likely without AI/ML capabilities.
No
The device is described as a camera used for capturing images of the eye, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended for capturing images of the retina and anterior segment of the eye and presenting the data to an eyecare professional, which is a key part of the diagnostic process.
No
The device description clearly outlines hardware components like a camera, illumination sources (halogen, infrared filter, xenon flash bulb), joystick, and LCD display, indicating it is a physical medical device, not software-only.
Based on the provided information, the Topcon Model TRC-NW200 Non-Mydriatic Camera is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Topcon TRC-NW200 is an ophthalmic camera that captures images of the eye in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use is to capture images of the retina and anterior segment of the eye for presentation to an eyecare professional. This is a diagnostic imaging device, not an in vitro diagnostic test.
Therefore, the device falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
retina and the anterior segment of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eyecare professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 980246, K 031629, K 014274
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
NOV - 5 2004
Topcon TRC-NW200 510(k) Summary
| Name of Device: | Topcon Model TRC-NW200
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: | (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 |
1
| Description of Device: | 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. |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Substantial Equivalence: | The TRC-NW200 and the predicated devices have the same
intended use and indications. All of these devices are non-
mydriatic ophthalmic cameras that capture and display
images of the eye to aid the health care professional in
diagnosing and/or monitoring diseases of the eye that may
be observed and photographed. The NW200 and the
predicated devices acquire these images according to the
same principles of operation and technical characteristics.
The question of safety and effectiveness is the same for the
NW200 and the predicated devices. Therefore, the TRC-
NW200 is substantially equivalent to legally marketed
devices intended to capture images of the retina and the
anterior segment of the eye and presenting this data to the
eyecare professional without the use of a mydriatic. |
.
. . . . . . . .
2
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.
3
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
4
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 |
|---|---|
| --------------- | --------- |