(169 days)
The Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX is intended to capture, display, store and manipulate images of the retina and the anterior segment of the eye, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.
The Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NA VIS-EX ("AFC-330 with NA VIS-EX") is a conventional non-mydriatic auto fundus camera. The AFC-330 with NAVIS-EX captures fundus images using a built-in colour CCD camera without the use of mydriatic agents. With this single device, registration of patient information, image capture, and viewing of captured images are possible. By connecting a personal computer (PC) to the device via a LAN and installing the NA VIS-EX image filing system software, images captured by this device can be transferred to the PC and viewed and managed on the PC.
The provided text is a 510(k) summary for the Nidek Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX. It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically found in clinical performance studies of AI/CADe devices.
The document states:
- Testing in support of substantial equivalence determination: "All necessary bench testing was conducted on the AFC-330 with NA VIS-EX to support a determination of substantial equivalence to the predicate devices. The performance testing included the following tests:
- Electrical and mechanical safety testing
- Electromagnetic compatibility testing
- Light burden testing
- Verification and validation testing"
- Summary: "The collective performance testing results demonstrate that AFC-330 with NA VIS-EX is substantially equivalent to the predicate devices."
This indicates that the submission relied on bench testing to demonstrate performance characteristics related to safety and fundamental functionality, rather than a clinical study evaluating diagnostic accuracy against specific performance metrics and acceptance criteria for an AI or CADe component. The device appears to be a traditional fundus camera with image filing software, not a product that performs automated diagnostic interpretations requiring acceptance criteria like sensitivity, specificity, or AUC based on expert reads.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving the device meets them because such information is not present in the provided text. The submission focuses on demonstrating substantial equivalence through standard device testing (safety, EMC, light burden, verification/validation) for a medical imaging acquisition and management system.
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MAY - 8 2012
NIDEK CO., LTD
Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX TRADITIONAL 510(K) PREMARKET NOTIFICATION
Section 05
510(k) Summary (Cont.)
510(k) Notification K_1/345/
GENERAL INFORMATION
Applicant: Nidek Co., Ltd 34-14, Maehama, Hiroishi-cho Gamagori. Aichi 443-0038 Japan Phone: +81-533-67-8901 Fax: +81-533-67-6628
Contact Person:
Enrico Bisson Quality and Regulatory Affairs Manager Nidek Technologies srl Via dell'Artigianato. 6/A 1 - 35020 Albignasego (Padova) tel. +39 049 8629200 fax +39 049 8626824 E-mail: enricobisson@nidektechnologies.it
Date Prepared: October 31, 2011
DEVICE INFORMATION
The Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NA VIS-EX ("AFC-330 with NAVIS-EX") is a conventional non-mydriatic auto fundus camera. The AFC-330 with NAVIS-EX captures fundus images using a built-in colour CCD camera without the use of mydriatic agents. With this single device, registration of patient information, image capture, and viewing of captured images are possible.
By connecting a personal computer (PC) to the device via a LAN and installing the NA VIS-EX image filing system software, images captured by this device can be transferred to the PC and viewed and managed on the PC.
Classification:
21 CFR §886.1120, Class 11
Product Code: HKI
Subsequent Classification: 21 CFR 892.2010 class I; 21 CFR 892.2020 class I
Subsequent product codes: NFF, NFG .
Trade Name: Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NA VIS-EX
Generic/Common Name:
Camera, Ophthalmic, Ac-Powered
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Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX TRADITIONAL 510(K) PREMARKET NOTIFICATION
Section 05 510(k) Summary (Cont.)
PREDICATE DEVICES
Nidek NM-1000 (K014274) Carl Zeiss Meditec FF450 with Fundus Camera and VISUPAC System (K011877) Nidek Technologies Orion (K070231)
INDICATIONS FOR USE
The Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX is intended to capture, display, store and manipulate images of the retina and the anterior segment of the eye. to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.
PRODUCT DESCRIPTION
The Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NA VIS-EX ("AFC-330 with NA VIS-EX") is a conventional fundus camera.
Regarding the alignment, an observation light irradiates the patient's fundus. The light reflected from the patient's fundus is received by the CCD camera for observation.
Regarding the image capturing, the light emitted from a xenon flash lamp is guided to the main body and the light is made coaxial with the observation light. The light then irradiates the patient's fundus . The light reflected from the patient's fundus is received by the CCD camera for capturing .
AFC-330 with NAVIS-EX allows the operator to conduct the observation of the retina with reduced time, an increased usability, thanks to some improved features.
SUBSTANTIAL EQUIVALENCE
AFC-330 with NAVIS-EX represents a modification to a cleared device, the Nidek NM 1000. The principle modification is the introduction of some functions:
- Anterior eye image capturing mode .
- Stereo image capturing mode .
- Panorama Photography Mode ●
- Evelid and required pupil diameter detection ♥
- . linage filing software
The image filing software NAVIS-EX represents a motification to another cleared devices, the Carl Zeiss Meditec FF450 with Fundus Camera and VISUPAC System and the Nidek Technologies Orion with NAVIS software, allowing the user to export, manage and process the images acquired by the Non-Mydriatic Auto Fundus Camera AFC-330.
AFC-330 with NAVIS-EX is substantially equivalent to the predicate devices with regard to design, function, safety and technological and performance characteristic, intended use.
Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the proposed AFC-330 with NA VIS-EX is substantially equivalent to the predicate devices.
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Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX TRADITIONAL 510(K) PREMARKET NOTIFICATION
113451
Section 05 510(k) Summary (Cont.)
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary bench testing was conducted on the AFC-330 with NA VIS-EX to support a determination of substantial equivalence to the predicate devices. The performance testing included the following tests:
- Electrical and mechanical safety testing .
- . Electromagnetic compatibility testing
- . Light burden testing
- Verification and validation testing •
SUMMARY
The collective performance testing results demonstrate that AFC-330 with NA VIS-EX is substantially equivalent to the predicate devices.
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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 stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nidek Technologies Srl c/o Mr. Enrico Bisson Quality and Regulatory Affairs Manager Via dell'Artigianato, 6/A Albignasego (Padova) IT 35020
MAY - 8 2012
Re: K113451
Trade/Device Name: Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX
Regulation Number: 21 CFR 886.1120
Regulation Name: Ophthalmic Camera
Regulatory Class: II Product Code: HKI, NFF, NFG Dated: April 24, 2012 Received: April 25, 2012
Dear Mr. Bisson:
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
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Page 2 - Mr. Enrico Bisson
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 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.
Sincerely vours.
Kesia Alexander
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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NIDEK CO., LTD
Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX TRADITIONAL 510(K) PREMARKET NOTIFICATION
Section 04 Indications for Use Statements
INDICATIONS FOR USE
510(k) Number (if known):
K113451
Device Name:
Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX
Indications for Use:
The Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX is intended to capture, display, store and manipulate images of the retina and the anterior segment of the eye, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
CLCC
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Rev. I
pag. 004-01
510(k) Number 15113451
§ 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.