(92 days)
Not Found
No
The description focuses on optical imaging, stroboscopic light, CCD camera, and software for basic operations and data analysis. There is no mention of AI/ML terms, image processing beyond basic analysis, or any description of training or test data sets typically associated with AI/ML models. The performance studies focus on system verification and validation against design specifications and predicate devices, not on the performance of an AI/ML algorithm.
No
The device is intended for observation, capture, display, and storage of images to aid in diagnosing or monitoring diseases, and measures blood flow velocity and path. It does not provide any form of treatment or therapy.
Yes
The device is described as aiding in diagnosing or monitoring diseases of the eye. While it captures images, its explicit purpose is to assist in the diagnostic process.
No
The device description explicitly lists multiple hardware components including an optical system, a CCD camera, and an electronic unit, in addition to the software package.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples (like blood, urine, tissue) outside the body. The Retinal Functional Imager (RFI) is used to image the retina inside the patient's eye.
- The intended use is to observe, capture, display, and store images of the fundus and provide information about blood flow. This is a diagnostic imaging device, not a device that performs tests on biological specimens.
- The device description details an optical imaging system and camera. This aligns with the function of a fundus camera, not an IVD.
The device is clearly an ophthalmic imaging device used for in-vivo examination of the retina.
N/A
Intended Use / Indications for Use
The Retinal Functional Imager (RFI) is intended to observe, capture, display, and store images of patients' fundus (retina) under mydriatic conditions with the information of blood flow (velocity) and path of flow in a retinal vessel, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.
Product codes (comma separated list FDA assigned to the subject device)
HKI, HLI
Device Description
The Retinal Functional Imager (RFI) is a mydriatic fundus imaging camera intended for taking red-free images. The RFI is comprised of the following subassys:
- An optical system for illuminating and imaging the retina. The . optical imaging includes a stroboscopic light source for sequential rapid imaging of the retina.
- . A high resolution CCD camera.
- An electronic unit for driving the light source. .
- A software package for operating the system, controlling the . illumination, grabbing the images, data browsing and data analysis.
The device is also capable of using 35 mm film or using a digital camera similar to the predicate devices. Visible light is used for observation. Alignment and focusing is manual via the fundus camera controls,
Under red-free imaging, the Retinal Functional Imager (RFI) provides, through a series of multiple flashes, the ability to observe and register the blood flow velocity and path of motion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical imaging
Anatomical Site
fundus (retina)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical validation is detailed in Optical Imaging's System Verification and Validation Reports. Validation was performed on the device to establish its effectiveness and performance. The device was found to perform as well as equivalent devices on the market. Blood flow velocity measurements showed that flow velocity measurements obtained were within the design specifications of the system, were repeatable and accurate with reference to known velocity simulated data images, and that subject data measurements were both reasonable and consistent.
The main system risks addressed are electromagnetic compatibility, system electrical safety, optical radiation level and mechanical stability. These were evaluated as part of Optical Imaging's electrical safety test and verification activities.
The main software risks addressed are communication loss, power loss and out of limit conditions. These were evaluated as part of Optical Imaging's Software Test Procedure for validation of the software.
The User Interface risks addressed are functional clarity, patient data integrity and security and possible user misuse. These were also evaluated as part of Optical Imaging's Software Test Procedure for validation of the software.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K954780, K011877, K992606, K943955
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Optical Imaging Ltd.
Section 5
NOV 17 2006
510(k) Summary Retinal Functional Imager (RFI)
Date: October 10, 2006
Submitter's Name:
Optical Imaging Ltd. Openheimer St., Unit 41 Rabin Industrial Park, Rehovot Israel 76701 Tel: (972)-8-9463259 Fax: (972)-8-9463261
Contact Person:
Yoav Sella Director of QA and Regulatory Affairs Tel: (972)-8-9463259 Mobile: (972)-54-4414198 e-mail: yoav@opt-imaging.com
Trade Name:
Retinal Functional Imager (RFI)
Classification Name:
Camera, Ophthalmic, AC Powered
Classification:
| Classification | Primary | Secondary |
|---|---|---|
| Product Code: | HKI | HLI |
| Class: | II | II |
| Regulation Number | 21 CFR 886.1120 | 21 CFR 886.1570 |
| Regulation Name | Ophthalmic Camera | Ophthalmoscope |
Section 5
Page 1 of 4
1
Optical Imaging Ltd.
Substantial Equivalence:
The Retinal Functional Imager (RFI) is considered to be substantially equivalent to its predicate devices:
- · Kowa Fundus Camera FX-500 cleared under K954780;
- · Zeiss FF450 VISUPAC cleared under K011877;
- · Canon Ophthalmoscope Laser Blood Flow Meter LBFM Model 100 - cleared under K992606; and
- · Heidelberg Ophthalmoscope Retina Flow Meter cleared under K943955
without raising new safety and/or effectiveness issues.
All these devices are ophthalmic imaging management systems intended to capture, display, and store images of the retina to aid in diagnosing or monitoring diseases of the retina that may be observed and photographed.
Device Description:
The Retinal Functional Imager (RFI) is a mydriatic fundus imaging camera intended for taking red-free images. The RFI is comprised of the following subassys:
- An optical system for illuminating and imaging the retina. The . optical imaging includes a stroboscopic light source for sequential rapid imaging of the retina.
- . A high resolution CCD camera.
- An electronic unit for driving the light source. .
- A software package for operating the system, controlling the . illumination, grabbing the images, data browsing and data analysis.
The device is also capable of using 35 mm film or using a digital camera similar to the predicate devices. Visible light is used for observation. Alignment and focusing is manual via the fundus camera controls,
Under red-free imaging, the Retinal Functional Imager (RFI) provides, through a series of multiple flashes, the ability to observe and register the blood flow velocity and path of motion.
2
Optical Imaging Ltd.
Intended Use
The Retinal Functional Imager (RFI) is intended to observe, capture, display, and store images of patients' fundus (retina) under mydriatic conditions with the information of blood flow (velocity) and path of flow in a retinal vessel, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.
The Retinal Functional Imager Technology
The Retinal Functional Imager (RFI) is a mydriatic fundus camera designed to take retinal images using a standard high resolution digital camera mounted on a conventional fundus camera and a stroboscopic light source. The images can be taken at high frame rates. To facilitate this imaging frame rate, the flash illumination system of the fundus camera has been modified to permit the delivery of strobe flashes at the camera's full frame rate in a fixed train of discharges. This extension of normal fundus camera capabilities allows new information to be obtained from the retina by extracting reflectance changes due to the motion of red blood cells through the blood circulation of the retina between images. The software is able to map the blood flow through blood vessels in the eye and determine the velocity of the flow by tracking the motion of the blood cells, taking into account various control factors.
The fundus camera has a manufacturer-rated magnification specification different for each available magnification setting. The digital camera demagnification power and sensor size give a calibration of digital camera pixels to actual microns on the retina and is used in the determination of blood flow velocity.
RFI Software - The software for the RFI is comprised of a Grab and Browse module. The Grab module is responsible for acquiring and saving raw image data to a disk. The Browse module provides a user interface for entering patient data and selecting the mode in which Grab will operate; it also allows the operator to review the acquired data before continuing with data grab operations. Additional embedded software provides the Grab module with hardware state control and monitoring services.
Performance Testing
Acceptance criteria for compliance with the standards are detailed in Optical Imaging's IEC 60601-1 Technical Report, the Risk Analysis for the RFI device, and the verification and validation reports.
3
Optical Imaging Ltd.
Non-clinical validation is detailed in Optical Imaging's System Verification and Validation Reports. Validation was performed on the device to establish its effectiveness and performance. The device was found to perform as well as equivalent devices on the market. Blood flow velocity measurements showed that flow velocity measurements obtained were within the design specifications of the system, were repeatable and accurate with reference to known velocity simulated data images, and that subject data measurements were both reasonable and consistent.
The main system risks addressed are electromagnetic compatibility, system electrical safety, optical radiation level and mechanical stability. These were evaluated as part of Optical Imaging's electrical safety test and verification activities.
The main software risks addressed are communication loss, power loss and out of limit conditions. These were evaluated as part of Optical Imaging's Software Test Procedure for validation of the software.
The User Interface risks addressed are functional clarity, patient data integrity and security and possible user misuse. These were also evaluated as part of Optical Imaging's Software Test Procedure for validation of the software.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 2006
Optical Imaging Ltd. c/o Jonathan Kahan Hogan & Hartson, LI.P 555 Thirteenth Street, NW Washington, DC 20004
Re: K062416
Trade/Device Name: Retinal Functional Imager (RFI) Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI: HLI Dated: October 25, 2006 Received: October 25, 2006
Dear Mr. Kahan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
5
Page 2 - Jonathan Kahan
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eychler Si MD
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
6
iptical Imaging Ltd.
FDA Traditional 510(k)
Section 4
INDICATIONS FOR USE
510(k) Number (if known): K062416
Retinal Functional Imager (RFI) Device Name:
The Retinal Functional Imager (RFI) is intended to observe, Indications for Use: capture, display, and store images of patients' fundus (retina) under mydriatic conditions with the information of blood flow (velocity) and path of flow in a retinal vessel, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.
OR
Prescription Use X (21 C.F.R. § 801.109 subpart D) Over the Counter Use (21 C.F.R. § 801 subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dexider 11/15/2006
(Division Sign Off)
ision Sian-Off sion of Ophthalmic Ear se and Throat Devise
510(k) Number ___ K062416
Page 1 of 1