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.

AI/ML Overview

The provided text does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity, or accuracy), or a study that evaluates the device's clinical performance against such criteria.

The document is a 510(k) summary for the Topcon TRC-NW8 Non-Mydriatic Retinal Camera. It primarily focuses on demonstrating substantial equivalence to a predicate device (TRC-NW8F) and compliance with general safety and performance standards.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of clinical performance (e.g., image quality metrics or diagnostic accuracy). The acceptance criteria mentioned are related to compliance with recognized consensus standards (IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2) and the results of a risk analysis assessment.
Reported Device Performance: The document states that "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." However, no specific performance metrics or data (e.g., image resolution, diagnostic accuracy) are reported.

2. Sample Size Used for the Test Set and Data Provenance:

Not provided. The document does not describe any clinical test set or data used to evaluate the device's performance in a diagnostic context. The testing mentioned appears to be engineering design verification for safety and fundamental requirements.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable/Not provided. Since no clinical test set is described, there's no mention of experts or ground truth establishment for diagnostic performance.

4. Adjudication Method:

Not applicable/Not provided. No clinical performance study requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document does not mention any MRMC study or a comparison of human reader performance with or without AI assistance. The device is a retinal camera, not an AI-powered diagnostic tool in this context.

6. Standalone (Algorithm Only) Performance Study:

No. The device is a retinal camera for capturing images, not an algorithm for standalone diagnostic performance.

7. Type of Ground Truth Used:

Not applicable/Not provided. No clinical study for diagnostic accuracy is described that would require a ground truth.

8. Sample Size for the Training Set:

Not applicable/Not provided. The device is not an AI algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established:

Not applicable/Not provided. As above, no AI training set is mentioned.

Summary of available "Performance Data" from the document:

The "Performance Data" section solely refers to the device's compliance with electrical safety, EMC, and ophthalmic instrument-specific fundamental requirements and light hazard protection standards. It also states that design verification tests were performed as a result of risk analysis and that the results met predetermined acceptance criteria, but it does not detail those criteria or results in a clinical or diagnostic performance context.

This 510(k) summary focuses on the safety and fundamental performance characteristics of the hardware device (retinal camera) and its substantial equivalence to an existing device, rather than on the diagnostic or clinical accuracy of images or any integrated AI component.

Summary

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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: (201) 599-5553 (201) 599-5240 Facsimile: 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: 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

Device Description

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

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.

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 (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

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Indications for Use Statement

K130289 510(k) Number (if known):

Device Name: TRC-NW8

Indications for Use:

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

Regulation Number and Section

§ 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.