TRC-NW8 NON-MYDRIATIC RETINAL CAMERA

K130289 · Topcon Corp. · HKI · May 10, 2013 · Ophthalmic

Device Facts

• Record ID: K130289
• Device Name: TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
• Applicant: Topcon Corp.
• Product Code: HKI · Ophthalmic
• Decision Date: May 10, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

The TRC-NW8 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 the use of a mydriatic.

Device Story

Non-contact retinal camera; captures color and red-free images of fundus oculi and anterior segment. Uses integrated commercial digital single-lens reflex (DSLR) camera for image acquisition. Operated by eye care professionals in clinical settings. Images displayed on observation monitor; stored on commercial memory cards, PCs, or external flash/hard drive storage. Connected to commercial digital printer for hard-copy output. Facilitates visualization of ocular structures for diagnostic review by clinicians. Modification of predicate TRC-NW8F; removes fluorescein angiography capability and associated filters.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 15004-1 (general ophthalmic requirements), and ISO 15004-2 (light hazard protection) was demonstrated. Design verification tests performed per risk analysis confirmed adherence to predetermined acceptance criteria.

Technological Characteristics

Non-mydriatic retinal camera; non-contact optical design. Integrates commercial DSLR camera for image capture. Supports color and red-free photography. Connectivity via standard memory cards, PC interfaces, and digital printers. Complies with IEC 60601-1, IEC 60601-1-2, ISO 15004-1, and ISO 15004-2. No software-based diagnostic algorithms described.

Indications for Use

Indicated for capturing retinal and anterior segment images in patients requiring ophthalmic examination, with or without mydriatics. For use by eye care professionals.

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 Medical Systems TRC-NW8F (K100207)

Submission Summary (Full Text)

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# 510(k) SUMMARY

# TOPCON TRC-NW8 Non-Mydriatic Retinal Camera

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Topcon Corporation 75-1 Hasunuma-Cho Itabashi-Ku Tokyo, Japan 174-8580 Phone: [phone] [phone] Facsimile: 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: February 4, 2013

Name of Device and Name/Address of Sponsor

Topcon TRC-NW8 Non-Mydriatic Retinal Camera Topcon Corporation 75-1 Hasunuma-Cho Itabashi-Ku Tokyo, Japan 174-8580

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 Medical Systems TRC-NW8F (K100207)

## Purpose of the Special 510(k) notice.

The TRC-NW8 is a modification to TRC-NW8F.

## Intended Use

The TRC-NW8 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 the use of a mydriatic.

#### 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. The TRC-NW8 can take both color photography and red-free photography. The TRC-NW8 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 a 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.

## Performance Data

The TRC-NW8 has been tested and found in compliance with the following recognized consensus standards:

IEC 60601-1:1988 +Amd 1: 1991 + Amd 2: 1995. Medical Electrical Equipment - Part 1: General Requirements for Safety:

IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance: Collateral Standard: Electromagnetic Capability - Requirements and Tests;

ISO 15004-1:2006 Ophthalmic Instruments-Fundamental requirements and test methods-Part 1: General requirements applicable to all ophthalmic instruments;

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ISO 15004-2:2007, Ophthalmic Instruments-Fundamental requirements and test methods-Part 2: Light hazard protection.

Design verification tests were performed as a result of the risk analysis assessment. These test results demonstrated that the TRC-NW8 met predetermined acceptance criteria.

## Substantial Equivalence

The TRC-NW8 has the same intended use, indications for use and principles of operation as the TRC-NW8F, to which it is a modification. The TRC-NW8 is identical to the TRC-NW8F with the following exceptions:

- . The TRC-NW8F performs fluorescein angiography while the TRC-NW8 does not. The TRC-NW8F uses an exciter filter and a barrier filter which are not present in the TRC-NW8.
These modifications were evaluated by Topcon to determine if they could affect the safety or effectiveness of the device and it was determined that they do not. Verification and validation was performed to ensure that the device performs as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICESPublic Health Service

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May 10, 2013

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 Regulatory Affairs and Quality Assurance Manager O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864

Re: K130289

Trade Name: TRC-NW8 Non-Mydriatic Retinal Camera Regulation Number: 21 CFR 886.1120 Regulation Name: AC-Powered Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: April 9, 2013 Received: April 10, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 [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 Statement

K130289 510(k) Number (if known):

Device Name: TRC-NW8

Indications for Use:

The TRC-NW8 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 the use of a mydriatic.

Prescription Use × (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 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)

Andrew Yang -S
2013.05.01
15:11:02 -04'00'

(Division Sign-Off) Division of Ophthalmic, and Ear, Nose, Throat Devices 510(k) Number: K130289