(244 days)
Not Found
No
The summary describes a standard retinal camera and its performance testing, with no mention of AI, ML, or advanced image processing beyond basic capture and presentation.
No
The device is described as a retinal camera intended for capturing images for diagnosis, not for treating any condition.
No
Explanation: The device description states its purpose is to "provide an electronic image of the fundus oculi information for subsequent diagnosis," indicating it provides data for diagnosis rather than performing the diagnosis itself.
No
The device description explicitly states it is a "Retinal Camera" and describes hardware components and functions like observing, photographing, and recording the fundus oculi, which are physical actions performed by a hardware device. The performance studies also include optical radiation safety, electrical safety, and EMC testing, which are relevant to hardware devices.
Based on the provided information, this device 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 TRC-50DX Retinal Camera is an imaging device 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 for presentation to an eye care professional for diagnosis. This is a direct imaging and visualization tool, not a laboratory test.
- Device Description: The description reinforces that it observes, photographs, and records the fundus oculi without coming into contact with the patient's eye. This further confirms it's an external imaging device.
Therefore, the TRC-50DX Retinal Camera falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The TRC-50DX Retinal Camera 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.
Product codes
HKI
Device Description
The Topcon TRC-50DX Retinal Camera is designed to observe, photograph and record the fundus oculi of a patient without coming into contact with the patient's eye and provide an electronic image of the fundus oculi information for subsequent diagnosis. The TRC-50DX is provided in several configurations based on the photography needs of the user. The configurations are shown in following table.
| Configuration | Digital Camera attachment | Digital Camera Body | Imaging Mode | |||
|---|---|---|---|---|---|---|
| Nikon D90 | Pike F-1100C | Stingray F-145B | ||||
| 1 | Main Body | Lower mount | √ | Color, Red Free, FA | ||
| 2 | Relay Lens TL-211 | Port1 | √ | Color, Red Free, FA | ||
| 3 | Main Body | Lower mount | √ | Color | ||
| Relay Lens TL-209 | Port1 | √ | Red Free, FA, AF | |||
| 4 | Relay Lens TL-238D | Port1 Port2 | √ | √ | Color Red Free, FA, AF |
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
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)
Software verification and validation, system performance testing, optical radiation safety hazard analysis (ISO 15004-1 and ISO 15004-2) and electrical safety and EMC testing (IEC 60601-1 and IEC 60601-1-2) have been performed to support the substantial equivalence of the TRC-50DX. Additionally performance testing which compares image quality with the TRC-50DX to the Topcon TRC-NWSF MARK II and Canon CX-1 was performed. Images were evaluated and graded by a masked examiner based on the following image quality factors: focus, illumination, field definition, artifact, small pupil artifact and media opacity. The study found the scores from the TRC-50DX images were similar to or better than the scores of the images from the predicate devices.
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.
0
K123101
510(k) SUMMARY Topcon Medical Systems, Inc. TRC-50DX Retinal Camera
JUN 5 2013
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Topcon Medical Systems, Inc. 111 Bauer Drive Oakland, NJ 07436 Phone: (201) 599-5553 Facsimile: (201) 599-5240 Contact Person: Michael Gusel
Additional Correspondent:
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Phone: (978) 207-1245 Facsimile: (978) 824-2541
Date Prepared: May 29, 2013
Name of Device and Name/Address of Sponsor
Topcon TRC-50DX Retinal Camera Topcon Medical Systems, Inc. 111 Bauer Drive Oakland, NJ 07436
Common or Usual Name
Retinal Camera
Classification Name
Camera, Ophthalmic, AC-Powered 21 C.F.R. 886.1120 Product Code: HKI
1
Predicate Devices
Topcon TRC-NW7SF Mark II Retinal Camera (K090115) Canon CX1 (K092565)
Intended Use / Indications for Use
The TRC-50DX Retinal Camera 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.
Technological Characteristics
The Topcon TRC-50DX Retinal Camera is designed to observe, photograph and record the fundus oculi of a patient without coming into contact with the patient's eye and provide an electronic image of the fundus oculi information for subsequent diagnosis. The TRC-50DX is provided in several configurations based on the photography needs of the user. The configurations are shown in following table.
| Configuration | Digital Camera
attachment | | Digital Camera Body | | | Imaging
Mode |
|---------------|------------------------------|----------------|---------------------|-----------------|--------------------|------------------------------|
| | | | Nikon D90 | Pike
F-1100C | Stingray
F-145B | |
| 1 | Main Body | Lower
mount | | √ | | Color, Red
Free, FA |
| 2 | Relay Lens
TL-211 | Port1 | √ | | | Color, Red
Free, FA |
| 3 | Main Body | Lower
mount | | √ | | Color |
| | Relay Lens
TL-209 | Port1 | | | √ | Red Free,
FA, AF |
| 4 | Relay Lens
TL-238D | Port1
Port2 | √ | | √ | Color
Red Free,
FA, AF |
TRC-50DX
TRC-50DX Type IA
| Configuration | Digital Camera
attachment | | Digital Camera Body | | | Imaging
Mode |
|---------------|------------------------------|----------------|---------------------|-----------------|--------------------|-----------------------------|
| | | | Nikon D90 | Pike
F-1100C | Stingray
F-145B | |
| 3 Type IA | Main Body | Lower
mount | | √ | | Color |
| 3 Type IA | Relay Lens
TL-209 | Port1 | | | √ | Red Free,
FA, ICG,
AF |
| 4 Type IA | Relay Lens
TL-238D | Port1
Port2 | √ | | | Color |
| 4 Type IA | | | | | √ | Red Free,
FA, ICG,
AF |
The fundamental technical specifications of the Relay Lenses and Digital Cameras are shown in below.
2
| Model | Type | Port and Mount | Size | |
|---|---|---|---|---|
| TL-209 | 1 Port | Port 1 | C Mount | 85×140×236 |
| TL-211 | 1 Port | Port 1 | F Mount | 85×140×236 |
| TL-238D | 2 Port | Port 1 | F Mount | 85×189×236 |
| Port 2 | C Mount |
| Digital Camera
| Body | Specification |
|---|---|
| Nikon D90 | APS-C size CMOS single-lens reflex digital camera (Color) 12.3M pixels |
| Allied | 35mm CCD and single-plate digital camera (Color) 11M pixels |
| Pike F-100C | |
| Allied | 2/3 inch CCD single-plate digital camera (B/W) 1.4M pixels |
| Stingray F-145B |
Performance Testing
Software verification and validation, system performance testing, optical radiation safety hazard analysis (ISO 15004-1 and ISO 15004-2) and electrical safety and EMC testing (IEC 60601-1 and IEC 60601-1-2) have been performed to support the substantial equivalence of the TRC-50DX. Additionally performance testing which compares image quality with the TRC-50DX to the Topcon TRC-NWSF MARK II and Canon CX-1 was performed. Images were evaluated and graded by a masked examiner based on the following image quality factors: focus, illumination, field definition, artifact, small pupil artifact and media opacity. The study found the scores from the TRC-50DX images were similar to or better than the scores of the images from the predicate devices.
Substantial Equivalence
The Topcon TRC-50DX Retinal Camera is as safe and effective as the identified predicate devices including the Topcon TRC-NW7SF Mark II Retinal Camera (K090115) and the Canon CX-1 (K092565). The Topcon TRC-50DX Retinal Camera has the same intended use and similar indications for use, technological characteristics, and principles of operation as the previously cleared predicates. The Topcon TRC-50DX Retinal Camera is as safe and effective as its predicate devices, and thus, substantially equivalent.
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 consists of a stylized graphic of three overlapping human figures, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the graphic.
June 5, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Topcon Medical Systems, Inc. % Ms. Maureen O'Connell O'Connell Regulatory Consultants. Inc. 5 Timber Lane North Reading, MA 01864
Re: K123101
Trade/Device Name: TRC-50DX Retinal Camera Regulation Number: 21 CFR 886.1120 Regulation Name: AC-Powered Ophthalmic Camera · Regulatory Class: Class II Product Code: HKI Dated: May 29, 2013 Received: May 30, 2013
Dear Ms. O'Connell:
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
4
Page 2 -- Ms. Maureen O'Connell
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y Alexander -S
for Malvina B. Eydelman, M.D. Director
Division of Ophthalmic 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): K123101
Device Name: Topcon TRC-50DX Retinal Camera
Indications For Use:
The TRC-50DX Retinal Camera is intended for use in capturing images of the retina and anterior segment of the eye and presenting the data to the eye care professional, with the use of a mydriatic.
Prescription Use X (part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
... __________________________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office_of_Device_Evaluation(ODE) ______________________________________________________________________________________________________________________
Image /page/5/Picture/10 description: The image shows the text "Ka N. To" on the top line. The second line of text reads "2013.06.05 10:33:06 -04'00'". There is a graphic in the middle of the two lines of text.
(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number:_ K123101
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