(18 days)
Not Found
No
The document describes a standard retinal camera for image capture and display, with no mention of AI or ML capabilities for analysis or interpretation.
No
The device is described as a retinal camera intended for capturing images of the eye for diagnostic purposes, not for treating a condition or disease.
No
The device is described as capturing images for the eye care professional, providing electronic images of the fundus oculi information for subsequent diagnosis. It explicitly states it is for “subsequent diagnosis” rather than performing diagnosis itself.
No
The device description clearly outlines hardware components such as a retinal camera, observation monitor, digital single-lens reflex camera, memory card, PC, memory devices, and a digital printer. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The NON-MYDRIATIC RETINAL CAMERA TRC-NW8F is used to capture images of the retina and anterior segment of the eye directly from the patient. It does not analyze samples taken from the patient.
- Intended Use: The intended use is to capture images and present data to an eye care professional for subsequent diagnosis. This is a form of in vivo imaging, not in vitro testing.
Therefore, the device falls under the category of an ophthalmic imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The NON-MYDRIATIC RETINAL CAMERA TRC-NW8F is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional, with the use of a mydriatic or without use of a mydriatic.
Product codes
HKI
Device Description
This product is a retinal camera designed to observe, photograph or record the fundus oculi of a patient without coming into contact with the patient's eye and provide as an electronic image the obtained fundus oculi information for subsequent diagnosis. This product can take both color photography and fluorescein angiography. This product is equipped with an observation monitor used for observation purpose and display of a photographed image. This product uses attached commercial digital single-lens reflex camera to photograph or record the fundus oculi of a patient. A photographed image may be recorded on a commercial memory card built into an commercial digital single-lens reflex camera or a personal computer (hereinafter referred to as a PC) or commercial memory devices (flash memories, hard disc, etc.). A commercial digital printer is connected and can print the observed images and the photographed images of the fundus.
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, fundus oculi
Indicated Patient Age Range
This instrument has not been designed to apply to infants. Use this instrument meticulously for infants.
Intended User / Care Setting
eye care 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)
The maximum exposure has been demonstrated to be well below the accepted threshold limits set out in ISO 15004-2:2007. The resolving power and the photographic angular field of view as defined in ISO 10940:1998 "Ophthalmic instruments -- Fundus cameras" have been measured and the result meet the requirement value set out in TOPCON self standards. In all instances, the NON-MYDRIATIC RETINAL CAMERA TRC-NW8F functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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510(k) SUMMARY
K100207
| 510(k) Owner: | TOPCON CORPORATION |
|---|---|
| 75-1 Hasunuma-cho, Itabashi-ku | |
| Tokyo, Japan 174-8580 | |
| Phone Number: +81-3-3558-2566 | |
| FAX Number: +81-3-3965-6532 |
FEB 12 2010
| U.S. Facility: | Topcon Medical Systems, Inc. |
|---|---|
| 37 West Century Road | |
| Paramus, New Jersey 07652 | |
| Phone Number: (201) 599-5153 | |
| FAX Number: (201) 599-5240 |
| Contact person: | Takao Sugawara |
|---|---|
| Manager | |
| TOPCON CORPORATION | |
| 75-1 Hasunuma-cho, Itabashi-ku | |
| Tokyo, Japan 174-8580 | |
| Phone Number: +81-3-3558-2566 | |
| FAX Number: +81-3-3965-6532 |
| Date: | November 2, 2009 |
|---|---|
| Trade Name: | NON-MYDRIATIC RETINAL CAMERA TRC-NW8F |
| Common names: | Retinal Camera |
| Classification Name: | Camera, Ophthalmic, AC-Powered |
| 21CFR886.1120 | |
| Product Code: | HKI |
1
Identification of a Legally Marketed Predicate Device
The TRC-NW8F is substantially equivalent to the TRC-NW7SF MARKII (K090115). KOWA VX-10 (K043213) and TRC-NW200 (K041367). All of those predicate have same FDA Product Code HKI.
General Description
This product is a retinal camera designed to observe, photograph or record the fundus oculi of a patient without coming into contact with the patient's eye and provide as an electronic image the obtained fundus oculi information for subsequent diagnosis. This product can take both color photography and fluorescein angiography. This product is equipped with an observation monitor used for observation purpose and display of a photographed image. This product uses attached commercial digital single-lens reflex camera to photograph or record the fundus oculi of a patient. A photographed image may be recorded on a commercial memory card built into an commercial digital single-lens reflex camera or a personal computer (hereinafter referred to as a PC) or commercial memory devices (flash memories, hard disc, etc.). A commercial digital printer is connected and can print the observed images and the photographed images of the fundus.
Intended Use / Indication for Use
The NON-MYDRIATIC RETINAL CAMERA TRC-NW8F is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional, with the use of a mydriatic or without use of a mydriatic.
Patient Profiles
This instrument has not been designed to apply to infants. Use this instrument meticulously for infants.
This instrument is contraindicated in the following patients.
- The patient who has a history of photosensitivity. .
- The patient who has just received the treatment of photodynamic therapy (PDT) (For . the prohibition period, refer to the package insert of the taken light-sensitive substance.
- . The patient who takes the medicine that can cause the photosensitivity as its side effect.
2
Use this instrument meticulously for the following patients.
- The patient who has epidemic kerato conjunctivitis, or any other infectious disease. .
- The patient who has taken the medicine that can cause the photosensitivity as its side . effect.
- The patient who is at high risk for the optical radiation hazard, such as aphakic eye, . infant, and the patient who diminishes the sensibility to light by fundus disease.
Performance Data
The maximum exposure has been demonstrated to be well below the accepted threshold limits set out in ISO 15004-2:2007. (See Attachment 3)
The resolving power and the photographic angular field of view as defined in ISO 10940:1998 "Ophthalmic instruments -- Fundus cameras" have been measured and the result meet the requirement value set out in TOPCON self standards. (See Attachment 5) In all instances, the NON-MYDRIATIC RETINAL CAMERA TRC-NW8F functioned as intended.
Basis of Substantial Equivalence
The TOPCON NON-MYDRIATIC RETINAL CAMERA TRC-NW8F is as safe and effective as TOPCON TRC-NW7SF MARKII (K090115), KOWA VX-10 (K043213) and TOPCON TRC-NW200 (K041367). The NON-MYDRIATIC RETINAL CAMERA TRC-NW8F and the predicated devices have the same intended use and similar indications, technological characteristics, and principles of operation. The minor technological differences between the NON-MYDRIATIC RETINAL CAMERA TRC-NW8F and its predicate devices raise no new issue of safety or effectiveness. Performance data demonstrate that the NON-MYDRIATIC RETINAL CAMERA TRC-NW8F is as safe and effectiveness as required in applicable international standards such as ISO 15004-2:2007 and so on. Thus, the NON-MYDRIATIC RETINAL CAMERA TRC-NW8F is substantially equivalent.
Standards for testing
TOPCON conducted several tests for the TOPCON Retinal Camera TRC-NW7SF MARK II to ascertain conformity to following standards.
- Medical Electrical Equipment Part 1: General Requirements for IEC 60601-1 Safety, 1988; Amendment 1, 1991; Amendment 2, 1995 Medical electrical equipment - Part 1-2: General requirements for IEC 60601-1-2 basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, Edition 3:2007
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3
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- ISO 15004-1:2006 Ophthalmic instruments - Fundamental requirements and test Part 1: General requirements applicable to all methods ophthalmic instruments Ophthalmic Instruments - Fundamental requirements and test ISO 15004-2:2007 methods Part 2: Light hazard protection
No deviation or adaptation is made in the use of above mentioned standards.
See Attachment 1 for IEC 60601-1 Test Reports and IEC 60601-1-2 Test Reports.
See Attachment 2 for ISO 15004-1:2006 Test Reports.
See Attachment 3 for ISO 15004-2:2007 Test Reports.
See Attachment 4 for Form FDA 3654 of each standard.
The NON-MYDRIATIC RETINAL CAMERA TRC-NW8F has no component which contacts with blood, bodily fluid or mucous membrane. Therefore, Biocompatibility tests were not performed.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Topcon Corp. c/o Mr. Stefan Preiss TUV SUD America Inc 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891
FEB 1 2 2010
Re: K100207
Trade/Device Name: Non-Mydriatic Retinal Camera TRC-NW8F Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera, AC-Powered Regulatory Class: Class II Product Code: HKI Dated: January 22, 2010 Received: January 25, 2010
Dear Mr. Preiss:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Mr. Stefan Preiss
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
.gov/MedicalDevices/ResourcesforYourIndustry/default.htm
Sincerely yours,
Kesia Alexander for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K100207 |
|---|---|
| --------------------------- | --------- |
NON-MYDRIATIC RETINAL CAMERA TRC-NW8F Device Name:
Indications for Use:
The NON-MYDRIATIC RETINAL CAMERA TRC-NW8F is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional, with the use of a mydriatic or without use of a mydriatic.
X Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE ---- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sen
(Division Sign-Off) Jivision of Ophthalmic, Neurological and Ear, Fiose and Throat Devices
Page __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
) Number K100207
510(k) Number