TRC-50DX RETINAL CAMERA

K123101 · Topcon Medical Systems, Inc. · HKI · Jun 5, 2013 · Ophthalmic

Device Facts

• Record ID: K123101
• Device Name: TRC-50DX RETINAL CAMERA
• Applicant: Topcon Medical Systems, Inc.
• Product Code: HKI · Ophthalmic
• Decision Date: Jun 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

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.

Device Story

The TRC-50DX is an AC-powered ophthalmic camera used by eye care professionals to observe, photograph, and record the fundus oculi and anterior segment. The device operates non-contact; it captures optical images of the eye using various digital camera attachments (Nikon D90, Allied Pike F-1100C, or Stingray F-145B) and relay lenses. Imaging modes include color, red-free, fluorescein angiography (FA), indocyanine green (ICG), and autofluorescence (AF). The system produces electronic images for subsequent clinical diagnosis. By providing high-quality retinal and anterior segment documentation, the device assists clinicians in evaluating ocular health and pathology, potentially facilitating earlier detection and management of eye diseases.

Clinical Evidence

No clinical trials were performed. Evidence consists of bench testing, including software verification and validation, optical radiation safety analysis (ISO 15004-1 and ISO 15004-2), and electrical/EMC safety testing (IEC 60601-1 and IEC 60601-1-2). Comparative image quality performance testing was conducted against the Topcon TRC-NW7SF Mark II and Canon CX-1, where a masked examiner graded images based on focus, illumination, field definition, artifacts, small pupil artifacts, and media opacity, showing the TRC-50DX performed similarly to or better than the predicates.

Technological Characteristics

AC-powered ophthalmic camera; non-contact fundus imaging. Configurations utilize various relay lenses (TL-209, TL-211, TL-238D) and digital camera bodies (Nikon D90, Allied Pike F-1100C, Stingray F-145B). Imaging modes: color, red-free, FA, ICG, AF. Complies with ISO 15004-1/2 (optical radiation safety) and IEC 60601-1/1-2 (electrical safety/EMC).

Indications for Use

Indicated for capturing images of the retina and anterior segment of the eye in patients requiring mydriasis for eye care professional examination.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*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.

Predicate Devices

• Topcon TRC-NW7SF Mark II Retinal Camera (K090115)
• Canon CX1 (K092565)

Submission Summary (Full Text)

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# 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: [phone] Facsimile: [phone] Contact Person: Michael Gusel

# Additional Correspondent:

Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Phone: [phone] Facsimile: [phone]

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

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#### 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<br>attachment | | Digital Camera Body | | | Imaging<br>Mode |
|---------------|------------------------------|----------------|---------------------|-----------------|--------------------|------------------------------|
| | | | Nikon D90 | Pike<br>F-1100C | Stingray<br>F-145B | |
| 1 | Main Body | Lower<br>mount | | √ | | Color, Red<br>Free, FA |
| 2 | Relay Lens<br>TL-211 | Port1 | √ | | | Color, Red<br>Free, FA |
| 3 | Main Body | Lower<br>mount | | √ | | Color |
| | Relay Lens<br>TL-209 | Port1 | | | √ | Red Free,<br>FA, AF |
| 4 | Relay Lens<br>TL-238D | Port1<br>Port2 | √ | | √ | Color<br>Red Free,<br>FA, AF |

#### TRC-50DX

TRC-50DX Type IA

| Configuration | Digital Camera<br>attachment | | Digital Camera Body | | | Imaging<br>Mode |
|---------------|------------------------------|----------------|---------------------|-----------------|--------------------|-----------------------------|
| | | | Nikon D90 | Pike<br>F-1100C | Stingray<br>F-145B | |
| 3 Type IA | Main Body | Lower<br>mount | | √ | | Color |
| 3 Type IA | Relay Lens<br>TL-209 | Port1 | | | √ | Red Free,<br>FA, ICG,<br>AF |
| 4 Type IA | Relay Lens<br>TL-238D | Port1<br>Port2 | √ | | | Color |
| 4 Type IA | | | | | √ | Red Free,<br>FA, ICG,<br>AF |

The fundamental technical specifications of the Relay Lenses and Digital Cameras are shown in below.

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| 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<br>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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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)

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AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

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... __________________________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, _Office_of_Device_Evaluation_(ODE) ______________________________________________________________________________________________________________________

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(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number:_ K123101

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