TRC-NW400 NON-MYDRIATIC RETINAL CAMERA

K141481 · Topcon Corporation · HKI · Sep 17, 2014 · Ophthalmic

Device Facts

• Record ID: K141481
• Device Name: TRC-NW400 NON-MYDRIATIC RETINAL CAMERA
• Applicant: Topcon Corporation
• Product Code: HKI · Ophthalmic
• Decision Date: Sep 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

The TRC-NW400 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, without use of a mydriatic.

Device Story

TRC-NW400 is a non-mydriatic fundus camera; captures digital images of retina and anterior eye segment; non-contact operation. Device features color LCD monitor for observation; digital photography unit for recording. Images stored on PC or external storage (flash memory, hard disk, card reader); output to digital printer. Operated by eye care professionals in clinical settings. Provides electronic image data for professional analysis; facilitates diagnosis and documentation of ocular conditions. Benefits include non-invasive imaging without pupil dilation.

Clinical Evidence

Bench testing and clinical image evaluation performed. Compliance with IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2, and ISO 10940 standards confirmed. Comparative analysis of model eye images demonstrated equivalence in sharpness, focus, and resolution. Clinical image grading study showed TRC-NW400 performance was equivalent or superior to the predicate device for color imaging.

Technological Characteristics

Non-mydriatic fundus camera; non-contact; AC-powered. Features color LCD monitor, digital photography unit, and connectivity for PC/storage/printers. Data input via control panel, barcode reader, or magnetic card reader. Complies with IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2, and ISO 10940.

Indications for Use

Indicated for capturing images of the retina and anterior segment of the eye in patients without the use of a mydriatic, for presentation to an eye care professional.

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

• TRC-NW300 (K123460)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a stylized emblem. The emblem features three human profiles facing right, layered to create a sense of depth and unity. The profiles are rendered in a simple, elegant style.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 17, 2014

Topcon Corporation % Ms. Maureen O'Connell O'Connell Regulatory Consultants 5 Timber Lane North Reading, MA 01864

Re: K141481

Trade/Device Name: TRC-NW400 Non-Mydriatic Retinal Camera Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: August 12, 2014 Received: August 13, 2014

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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 toll-free 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K141481

Device Name

TRC-NW400 Non-Mydriatic Retinal Camera

#### Indications for Use (Describe)

The TRC-NW400 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, without use of a mydriatic.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(k) SUMMARY

## Non-Mydriatic Retinal Camera TRC-NW400

#### 510(k) Owner

Topcon Corporation 75-1 Hasunuma-cho, Itabashi-ku Tokyo. Japan 174-8580 Phone: [phone] Facsimile: [phone] Contact Person: Michael Gusel

#### 510(k) Submitter:

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

May 29, 2014 Date Prepared:

# Name of Device and Name/Address of Sponsor

Non-Mydriatic Retinal Camera TRC-NW400

Common or Usual Name Retinal Camera

#### Classification Name

Camera, Ophthalmic, AC-Powered 21 C.F.R. 886.1120 Product Code: HKI

## Predicate Devices Non-Mydriatic Retinal Camera TRC-NW300 (K123460)

#### Indications for Use

The TRC-NW400 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, without use of a mydriatic.

#### Technological Characteristics

The Topcon TRC-NW400 is a fundus camera designed to observe, photograph and record the fundus oculi of a patient's eye with or without the use of a mydriatic. The TRC-NW400

{4}------------------------------------------------

does not come into contact with the patient's eye and provides the fundus oculi image information as an electronic image for later analysis.

The TRC-NW400 houses a color LCD monitor used for observation and display of a photographed image and a digital photography unit used for recording images. A photographed image may be recorded on a personal computer (hereinafter referred to as a PC), or on a commercially available storage device (such as a flash memory, a hard disk or a card reader/writer) connected to the TRC-NW400. A photographed image may also be printed on a commercially available digital printer connected to the TRC-NW400 or PC.

Patient information may be input on the control panel of the main unit or by using a commercially available data input device (for example: a bar code reader or a magnetic card reader) or PC.

# Performance Data

The TRC-NW400 has been tested and found in compliance with the following recognized consensus standards:

TEC60601-1:2005 + CORR.1: 2006+CORR.2: 2007 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance:

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;

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

ISO 10940: 2009 Ophthalmic instruments - Fundus cameras

An analysis was performed of images captured with the TRC-NW400 and the predicate device which were formally evaluated and it was found that model eye images from the TRC-NW400 and from the predicate device were equivalent in terms of sharpness, image focus and resolution power. The results from the grading of clinical images from the TRC-NW400 were either equivalent or better than the predicate device. This study demonstrated that the TRC-NW400 is substantially equivalent to the predicate device.

# Substantial Equivalence

The TRC-NW400 has the same intended use and similar indications, principles of operation, and technological characteristics as the TRC-NW300. The minor differences in the TRC-NW400's technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the TRC-NW400 is as safe and effective

{5}------------------------------------------------

as the TRC-NW300. And also, the image grading result of color image shows that the TRC-NW400 is equivalent to the TRC-NW300 for color imaging. Thus, the TRC-NW400 is substantially equivalent to its predicate devices.