(105 days)
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.
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 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.
The provided text describes a 510(k) premarket notification for the Topcon TRC-NW400 Non-Mydriatic Retinal Camera. This document is focused on demonstrating substantial equivalence to a predicate device, the TRC-NW300, rather than providing detailed acceptance criteria and a comprehensive study report for standalone device performance.
Therefore, much of the requested information regarding specific acceptance criteria, sample sizes for test/training sets, expert qualifications, and adjudication methods is not explicitly detailed in this 510(k) summary. The document focuses on regulatory compliance and a comparative analysis.
Here's an attempt to extract and infer information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from regulatory standards and comparative study) | Reported Device Performance (TRC-NW400) |
|---|---|
| Compliance with IEC60601-1:2005 (Basic Safety & Essential Performance) | Compliant |
| Compliance with IEC 60601-1-2:2007 (Electromagnetic Compatibility) | Compliant |
| Compliance with ISO 15004-1:2006 (General requirements for ophthalmic instruments) | Compliant |
| Compliance with ISO 15004-2:2007 (Light hazard protection) | Compliant |
| Compliance with ISO 10940:2009 (Fundus cameras) | Compliant |
| Image quality (sharpness, focus, resolution power) for model eye images | Equivalent to predicate device (TRC-NW300) |
| Image quality for clinical images | Equivalent to or better than predicate device (TRC-NW300) |
| Color imaging quality | Equivalent to predicate device (TRC-NW300) |
| Intended Use | Same as predicate device |
| Technological Characteristics | Similar to predicate device, minor differences do not raise new safety/effectiveness questions |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not explicitly stated. The document mentions "an analysis was performed of images captured with the TRC-NW400 and the predicate device which were formally evaluated" and "the grading of clinical images from the TRC-NW400." This implies a test set of images, but the number is not provided.
- Data provenance: Not explicitly stated. It refers to "model eye images" and "clinical images," but the country of origin or whether the study was retrospective or prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. It only states that images were "formally evaluated" and "graded."
4. Adjudication method for the test set
- This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study involving human readers and AI assistance is not mentioned. The study described compares the TRC-NW400's image quality to that of a predicate device (TRC-NW300). The device itself (TRC-NW400) is a retinal camera, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable in the context of this device. The TRC-NW400 is a retinal camera that captures images for an eye care professional to interpret; it is not an algorithm that performs standalone diagnoses. The "performance data" presented relates to the technical image capture capabilities of the camera.
7. The type of ground truth used
- For "model eye images," the ground truth implicitly would be the known ideal conditions and characteristics of the model eye.
- For "clinical images," the "grading" suggests that expert assessment was used to determine image quality, though the specific 'ground truth' criteria (e.g., presence/absence of disease, image clarity ratings) and how it was established are not detailed.
8. The sample size for the training set
- This information is not provided. The document describes a comparison study, not the development of an algorithm that would typically require a training set.
9. How the ground truth for the training set was established
- This information is not applicable as no training set for an algorithm is mentioned.
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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
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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 (800) 638-2041 or (301) 796-7100 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 (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
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)
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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: (201) 599-5553 Facsimile: (201) 599-5240 Contact Person: Michael Gusel
510(k) Submitter:
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Phone: (978) 207-1245 Facsimile: (978) 824-2541
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
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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
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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.
§ 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.