The NON-MYDRIATIC RETINAL CAMERA TRC-NW8F 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 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. This product can take both color photography and fluorescein angiography. This product 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 an 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

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them:

Acceptance Criteria and Device Performance Study for NON-MYDRIATIC RETINAL CAMERA TRC-NW8F

Based on the provided 510(k) summary (K100207), the device is a retinal camera intended for capturing images of the retina and the anterior segment of the eye. The acceptance criteria and the studies that demonstrate the device meets these criteria are focused on safety and functional performance, primarily by adherence to established international standards and demonstrating substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance and Method of Assessment
Safety	Light Hazard Protection: Maximum exposure must be below accepted threshold limits.	"The maximum exposure has been demonstrated to be well below the accepted threshold limits set out in ISO 15004-2:2007." (See Attachment 3 for Test Reports).
	General Electrical Safety: Conformity to IEC 60601-1 standards.	"Conformity to following standards: Medical Electrical Equipment Part 1: General Requirements for IEC 60601-1 Safety, 1988; Amendment 1, 1991; Amendment 2, 1995" (See Attachment 1 for Test Reports).
	Electromagnetic Compatibility (EMC): Conformity to IEC 60601-1-2 standards.	"Conformity to following standards: IEC 60601-1-2 basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, Edition 3:2007" (See Attachment 1 for Test Reports).
	Fundamental Requirements (General Ophthalmic Instruments): Conformity to ISO 15004-1 standards.	"Conformity to following standards: ISO 15004-1:2006 Ophthalmic instruments - Fundamental requirements and test Part 1: General requirements applicable to all methods ophthalmic instruments" (See Attachment 2 for Test Reports).
Functional Performance	Resolving Power: Meets requirement values set out in TOPCON self-standards based on ISO 10940:1998.	"The resolving power... as defined in ISO 10940:1998 'Ophthalmic instruments -- Fundus cameras' have been measured and the result meet the requirement value set out in TOPCON self standards."
	Photographic Angular Field of View: Meets requirement values set out in TOPCON self-standards based on ISO 10940:1998.	"...the photographic angular field of view as defined in ISO 10940:1998 'Ophthalmic instruments -- Fundus cameras' have been measured and the result meet the requirement value set out in TOPCON self standards."
Overall Functionality	The device functions as intended.	"In all instances, the NON-MYDRIATIC RETINAL CAMERA TRC-NW8F functioned as intended." (Implied by successful completion of other tests and substantial equivalence claim).

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

The provided document does not specify a sample size or data provenance (e.g., country of origin, retrospective or prospective) for a clinical test set in the traditional sense of evaluating diagnostic accuracy.

The performance evaluation is based on engineering and performance testing against international standards (ISO, IEC) and internal TOPCON standards, which typically involve testing units of the device in a controlled environment, not on human subjects or clinical data in the context of diagnostic accuracy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable in the context of the provided performance data. The device's performance is not being evaluated for diagnostic accuracy against a ground truth established by medical experts. Instead, it is being evaluated for compliance with technical standards related to safety and imaging capabilities by engineers and testing facilities.

4. Adjudication Method for the Test Set

The concept of an adjudication method (e.g., 2+1, 3+1) is not applicable here. Adjudication is used to resolve disagreements among experts when establishing ground truth for diagnostic accuracy studies. The studies described are technical compliance tests, not diagnostic performance evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on device safety and technical performance through compliance with standards, and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance. This device is a camera, not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance study was not done. This device is a retinal camera, a hardware device for image capture, not an algorithm. Therefore, an algorithm-only performance study is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance, in this context, is defined by:

International Standards: e.g., ISO 15004-2:2007 (light hazard), ISO 10940:1998 (resolving power, field of view), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC).
TOPCON Self Standards: For resolving power and photographic angular field of view, these internal standards serve as the performance benchmarks.

There is no "expert consensus," "pathology," or "outcomes data" ground truth utilized for the acceptance criteria described.

8. The Sample Size for the Training Set

Not applicable. This submission describes a medical imaging device (a camera), not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As this is not an AI algorithm, there is no training set or ground truth establishment related to AI.

Summary

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510(k) SUMMARY

K100207

510(k) Owner:	TOPCON CORPORATION
	75-1 Hasunuma-cho, Itabashi-ku
	Tokyo, Japan 174-8580
	Phone Number: +81-3-3558-2566
	FAX Number: +81-3-3965-6532

FEB 12 2010

U.S. Facility:	Topcon Medical Systems, Inc.
	37 West Century Road
	Paramus, New Jersey 07652
	Phone Number: (201) 599-5153
	FAX Number: (201) 599-5240

Contact person:	Takao Sugawara
	Manager
	TOPCON CORPORATION
	75-1 Hasunuma-cho, Itabashi-ku
	Tokyo, Japan 174-8580
	Phone Number: +81-3-3558-2566
	FAX Number: +81-3-3965-6532

Date:	November 2, 2009
Trade Name:	NON-MYDRIATIC RETINAL CAMERA TRC-NW8F
Common names:	Retinal Camera
Classification Name:	Camera, Ophthalmic, AC-Powered
	21CFR886.1120
Product Code:	HKI

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Identification of a Legally Marketed Predicate Device

The TRC-NW8F is substantially equivalent to the TRC-NW7SF MARKII (K090115). KOWA VX-10 (K043213) and TRC-NW200 (K041367). All of those predicate have same FDA Product Code HKI.

General Description

Intended Use / Indication for Use

Patient Profiles

This instrument has not been designed to apply to infants. Use this instrument meticulously for infants.

This instrument is contraindicated in the following patients.

The patient who has a history of photosensitivity. .
The patient who has just received the treatment of photodynamic therapy (PDT) (For . the prohibition period, refer to the package insert of the taken light-sensitive substance.
. The patient who takes the medicine that can cause the photosensitivity as its side effect.

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K106207

Use this instrument meticulously for the following patients.

The patient who has epidemic kerato conjunctivitis, or any other infectious disease. .
The patient who has taken the medicine that can cause the photosensitivity as its side . effect.
The patient who is at high risk for the optical radiation hazard, such as aphakic eye, . infant, and the patient who diminishes the sensibility to light by fundus disease.

Performance Data

The maximum exposure has been demonstrated to be well below the accepted threshold limits set out in ISO 15004-2:2007. (See Attachment 3)

The resolving power and the photographic angular field of view as defined in ISO 10940:1998 "Ophthalmic instruments -- Fundus cameras" have been measured and the result meet the requirement value set out in TOPCON self standards. (See Attachment 5) In all instances, the NON-MYDRIATIC RETINAL CAMERA TRC-NW8F functioned as intended.

Basis of Substantial Equivalence

The TOPCON NON-MYDRIATIC RETINAL CAMERA TRC-NW8F is as safe and effective as TOPCON TRC-NW7SF MARKII (K090115), KOWA VX-10 (K043213) and TOPCON TRC-NW200 (K041367). The NON-MYDRIATIC RETINAL CAMERA TRC-NW8F and the predicated devices have the same intended use and similar indications, technological characteristics, and principles of operation. The minor technological differences between the NON-MYDRIATIC RETINAL CAMERA TRC-NW8F and its predicate devices raise no new issue of safety or effectiveness. Performance data demonstrate that the NON-MYDRIATIC RETINAL CAMERA TRC-NW8F is as safe and effectiveness as required in applicable international standards such as ISO 15004-2:2007 and so on. Thus, the NON-MYDRIATIC RETINAL CAMERA TRC-NW8F is substantially equivalent.

Standards for testing

TOPCON conducted several tests for the TOPCON Retinal Camera TRC-NW7SF MARK II to ascertain conformity to following standards.

Medical Electrical Equipment Part 1: General Requirements for IEC 60601-1 Safety, 1988; Amendment 1, 1991; Amendment 2, 1995 Medical electrical equipment - Part 1-2: General requirements for IEC 60601-1-2 basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, Edition 3:2007
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K100207

ISO 15004-1:2006 Ophthalmic instruments - Fundamental requirements and test Part 1: General requirements applicable to all methods ophthalmic instruments Ophthalmic Instruments - Fundamental requirements and test ISO 15004-2:2007 methods Part 2: Light hazard protection
No deviation or adaptation is made in the use of above mentioned standards.

See Attachment 1 for IEC 60601-1 Test Reports and IEC 60601-1-2 Test Reports.

See Attachment 2 for ISO 15004-1:2006 Test Reports.

See Attachment 3 for ISO 15004-2:2007 Test Reports.

See Attachment 4 for Form FDA 3654 of each standard.

The NON-MYDRIATIC RETINAL CAMERA TRC-NW8F has no component which contacts with blood, bodily fluid or mucous membrane. Therefore, Biocompatibility tests were not performed.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

Topcon Corp. c/o Mr. Stefan Preiss TUV SUD America Inc 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891

FEB 1 2 2010

Re: K100207

Trade/Device Name: Non-Mydriatic Retinal Camera TRC-NW8F Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera, AC-Powered Regulatory Class: Class II Product Code: HKI Dated: January 22, 2010 Received: January 25, 2010

Dear Mr. Preiss:

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

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Page 2 - Mr. Stefan Preiss

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 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/Resourcesfor You/Industry/default.htm.

.gov/MedicalDevices/ResourcesforYourIndustry/default.htm

Sincerely yours,

Kesia Alexander for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, 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

510(k) Number (if known):	K100207
---------------------------	---------

NON-MYDRIATIC RETINAL CAMERA TRC-NW8F Device Name:

Indications for Use:

X Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use __ (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)

Sen

(Division Sign-Off) Jivision of Ophthalmic, Neurological and Ear, Fiose and Throat Devices

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) Number K100207

510(k) Number

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.