(160 days)
Not Found
No
The document describes a standard retinal camera for image capture and presentation, with no mention of AI/ML capabilities or related performance metrics.
No
The device is described as a retinal camera intended for capturing images of the eye for diagnosis, observation, and recording the fundus oculi, not for treating or providing therapy.
Yes
The device is intended for "capturing images... and presenting the data to the eye care professional" and "provide as an electronic image the obtained fundus oculi information for subsequent diagnosis." This indicates its role in providing information for diagnostic purposes.
No
The device description clearly outlines hardware components such as a retinal camera, observation monitor, digital photography unit, TV camera, and digital single-lens reflex camera. It is a physical medical device that captures images.
Based on the provided information, the TOPCON Retinal Camera TRC-NW7SF MARK II 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 Retinal Camera TRC-NW7SF MARK II is a medical device used to capture images of the retina and anterior segment 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 and present the data to an eye care professional for subsequent diagnosis. This is an imaging device, not a diagnostic test performed on a sample.
Therefore, the device falls under the category of an ophthalmic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TOPCON Retinal Camera TRC-NW7SF MARK II 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. For details of Patient Profiles, please refer Attachment 16.
Retina Camera TRC-NW7SF MARK II system 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 or without the use of mydriatic.
Product codes (comma separated list FDA assigned to the subject device)
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 comes in two types: a type that capable of both color photography and fluorescein angiography (hereinafter referred to as FA photography); and "Type IA" capable of color photography, FA photography and indocyanine green angiography (hereinafter referred to as IA photography).
This product is either equipped with or without an observation monitor used for observation purpose and display of a photographed image. This product comes in three types: a type that houses a digital photography unit for photographing an image; a type to which a commercial TV camera is attached; and a type to which a commercial digital single-lens reflex camera. A digital photography unit, a TV camera and a digital single-lens reflex camera are hereinafter generally referred to as an electronic photography device. A photographed image may be recorded on a commercial memory card built into an electronic photography device, or a connected commercial printer, or a personal computer (hereinafter referred to as a PC).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fundus photography, Fluorescein angiography, Indocyanine green angiography
Anatomical Site
Retina, anterior segment of the eye, fundus oculi
Indicated Patient Age Range
Not Found
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. (See Attachment 1)
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 Attachmet 2) In all instances, the TOPCON Retinal Camera TRC-NW7SF MARK II functioned as intended.
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.
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.
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Page 15 of 81
5. 510(k) SUMMARY
510(k) Owner:
JUN 30 2009
Topcon Corporation. 75-1 Hasunuma-cho, Itabashi-ku Tokyo, Japan 174-8580 Phone Number: +81-3-3558-2566 FAX Number: +81-3-3965-6532
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 +81-3-3965-6532 FAX Number:
Date:
ﺳ ﮧ
October 3, 2008
Trade Name:
Retinal Camera TRC-NW7SF MARK II
Retinal Camera Common names:
Camera, Ophthalmic, AC-Powered Classification Name: 21CFR886.1120
HKI
Product Code:
TOPCON CORPORATION Proprietary and Confidential Information
1
Intended Use / Indication for Use
The TOPCON Retinal Camera TRC-NW7SF MARK II 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. For details of Patient Profiles, please refer Attachment 16.
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 comes in two types: a type that capable of both color photography and fluorescein angiography (hereinafter referred to as FA photography); and "Type IA" capable of color photography, FA photography and indocyanine green angiography (hereinafter referred to as IA photography).
This product is either equipped with or without an observation monitor used for observation purpose and display of a photographed image. This product comes in three types: a type that houses a digital photography unit for photographing an image; a type to which a commercial TV camera is attached; and a type to which a commercial digital single-lens reflex camera. A digital photography unit, a TV camera and a digital single-lens reflex camera are hereinafter generally referred to as an electronic photography device. A photographed image may be recorded on a commercial memory card built into an electronic photography device, or a connected commercial printer, or a personal computer (hereinafter referred to as a PC).
*Type IA is used as a catalog symbol.
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 1)
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 Attachmet 2) In all instances, the TOPCON Retinal Camera TRC-NW7SF MARK II functioned as intended.
TOPCON CORPORATION Proprietary and Confidential Information
2
Basis of Substantial Equivalence
The TOPCON Retinal Camera TRC-NW7SF MARK II is as safe and effective as Canon Inc. Fundus Camera CF-60UVi (K946058), TOPCON CORPORATION Non-Mydriatic Retinal Camera TRC-NW200 (K041367) and Kowa Company, Ltd. KOWA VX-10 (K043213). The TOPCON Retinal Camera TRC-NW7SF MARK II and the predicated devices have the same intended use and similar indications, technological characteristics, and principles of operation. The minor technological differences between the Retinal Camera TRC-NW7SF MARK II and its predicate devices raise no new issue of safety or effectiveness. Performance data demonstrate that the Retinal Camera TRC-NW7SF MARK II is as safe and effectiveness as required in applicable international standards such as ISO 15004-2:2007 and so on. Thus, the Retinal Camera TRC-NW7SF MARK II 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.
| IEC 60601-1 | Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991; Amendment 2, 1995 |
|---|---|
| IEC 60601-1-2 | Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)) |
| ISO 15004-1:2006 | Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments |
| ISO 15004-2:2007 | Ophthalmic Instruments - Fundamental requirements and test methods Part 2: Light hazard protection |
No deviation or adaptation is made in the use of above mentioned standards.
See Attachment 3 for IEC 60601-1 Test Reports and IEC 60601-1-2 Test Reports.
See Attachment 4 for ISO 15004-2:2007 Test Reports.
See Attachment 1 for ISO 15004-2:2007 Test Reports.
See Attachment14 for Form FDA 3654 of each standard.
The TOPCON Retinal Camera TRC-NW7SF MARK II has no component which contacts with blood, bodily fluid or mucous membrane. Therefore, Biocompatibility tests were not performed.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
JUN 30 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Topcon Corp. c/o Tamas Borsai TÜV Rheinland of North America, Inc. 12 Commerce Rd. Newton, Connecticut 06470 United States
Re: K090115
Trade/Device Name: Retina Camera TRC-NW.7SF MARK II
Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: II Product Code: HKI Dated: June 16, 2009 Received: June 17, 2009
Dear Mr. Borsai:
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.
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 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.
4
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/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Kesia Alexander Jr
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
5
Indications for Use
510(k) Number (if known):_K090115
Device Name: Retina Camera TRC-NW7SF MARK II
Indications For Use:
Retina Camera TRC-NW7SF MARK II system 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 or without the use of mydriatic.
X Prescription Use (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)
Aen
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K090115