(12 days)
No
The summary mentions "computer analysis of these images" but provides no details suggesting the use of AI/ML algorithms, training data, or performance metrics typically associated with such technologies. The description aligns with standard image processing techniques.
No.
The document states that the device is intended to "determine the thickness and the inner structure of the retina" and is "indicated for assessing the area and location of retinal thickness abnormalities," which are diagnostic functions, not therapeutic ones.
Yes
The device is described as a computerized slitlamp biomicroscope that determines the thickness and inner structure of the retina and is indicated for assessing retinal thickness abnormalities and visualizing retinal pathologies. This falls under the definition of a diagnostic device as it helps identify and characterize diseases.
No
The device description explicitly states it is a computerized electro-optical system comprised of an optical head and a computer system, with the optical head containing hardware components like laser and conventional light sources, optics, a scanner, and a digital camera.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body). The RTA Model D, as described, is a device that directly examines the retina in vivo (within the living body) using optical imaging.
- The intended use and device description clearly state that the RTA is a computerized slitlamp biomicroscope that performs tomography of the retina in vivo. It scans the fundus and analyzes images of the retina within the eye.
Therefore, the RTA Model D falls under the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RTA Model D Retinal Thickness Analyzer ("RTA") is a computerized slitlamp biomicroscope that is intended to provide manual and computerized tomography of the retina in vivo. The RTA scans successive slit images on the fundus, without the need for a contact lens, to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. It is indicated for assessing the area and location of retinal thickness abnormalities, such as thickening due to macular edema and atrophy associated with degenerative diseases, and for visualizing other retinal pathologies.
Product codes
HLI
Device Description
The RTA is a modification of the previously cleared CRTA Clinical Retinal Thickness Analyzer ("CRTA"). As with the CRTA, the RTA is a computerized electro-optical system comprised of two primary components, namely the optical head and the computer system. The main elements of the optical head include laser and conventional light sources, optics, a scanner, and a digital camera. The RTA is a computerized slitlamp biomicroscope that provides manual and computerized tomography of the retina in vivo. The RTA scans successive slit images of the fundus to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. The RTA uses a helium neon laser source that emits green light at a wavelength of 543.3 nm. The beam is focused into a thin slit and, by means of a mirror, is directed toward the eye. The scanner and optics then detect the image of the illuminated portion of the retina and transmit the image to the digital camera. The digital camera then captures the image, where it can then be stored and analyzed by the computer system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical, slit images
Anatomical Site
retina, fundus
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
K031312
510(k) SUMMARY
Talia Technology, Ltd's RTA Model D Retinal Thickness Analyzer
Contact Information:
| Submitter: | Talia Technology, Ltd.
Communication Center
Neve-Ilan 90850, Israel
Phone: 011-972-2-534-4023
Facsimile: 011-972-2-534-4486
Email: eamoyal@talia.com |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Efi Amoyal, QA Manager |
| Name of The Device: | RTA Model D Retinal Thickness Analyzer |
| Common or Usual Name: | Retinal Thickness Analyzer |
| Classification Name: | Ophtalmoscope, AC-Powered (Product Code HLI) |
| Predicate Devices: | Talia Technology Ltd. CRTA Retinal Thickness
Analyzer
(K000731) |
Intended Use:
The RTA Model D Retinal Thickness Analyzer ("RTA") is a computerized slitlamp biomicroscope that is intended to provide manual and computerized tomography of the retina in vivo. The RTA scans successive slit images on the fundus, without the need for a contact lens, to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. It is indicated for assessing the area and location of retinal thickness abnormalities, such as thickening due to macular edema and atrophy associated with degenerative diseases, and for visualizing other retinal pathologies.
Device Description, Principles of Operation, and Technological Characteristics:
The RTA is a modification of the previously cleared CRTA Clinical Retinal Thickness Analyzer ("CRTA"). As with the CRTA, the RTA is a computerized electro-optical system comprised of two primary components, namely the optical head and the computer system. The main elements of the optical head include laser and conventional light sources, optics, a scanner, and a digital camera.
1
510(K) SUMMARY RTA Model D Retinal Thickness Analyzer Page 2 of 2
The RTA is a computerized slitlamp biomicroscope that provides manual and computerized tomography of the retina in vivo. The RTA scans successive slit images of the fundus to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. The RTA uses a helium neon laser source that emits green light at a wavelength of 543.3 nm. The beam is focused into a thin slit and, by means of a mirror, is directed toward the eye. The scanner and optics then detect the image of the illuminated portion of the retina and transmit the image to the digital camera. The digital camera then captures the image, where it can then be stored and analyzed by the computer system.
Substantial Equivalence:
The RTA is a modification to the previously cleared CRTA Retinal Thickness Analyzer. The only differences between the previously cleared CRTA and the modified RTA device are:
-
- The diameter of the aperture opening has been reduced from 5.2 mm to 3 mm:
-
- The angle between outgoing and incoming beam (Stereo-base) has been modified:
- The analog fundus imaging camera has been replaced by a CCD digital 3. camera;
- An, additional, non-mydriatic (flash) operating mode has been added: 4. and
- The user interface has been updated to account for the above 5. modifications and to increase overall ease of use.
Through design control assessment, including verification and validation testing, Talia has demonstrated that the modifications to the RTA do not alter the device's intended use or indications, nor have the principles of operation or technological characteristics been altered. Although there are minor differences between the RTA and the CRTA, these differences do not raise new issues of safety and effectiveness. Accordingly, the RTA is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 6 2003
Talia Technology Ltd. c/o Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street N.W. Washington, DC 20004-1109
Re: K031312
Trade/Device Name: RTA Model D Retinal Thickness Analyzer Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLI Dated: April 23, 2003 Received: April 24, 2003
Dear Mr. Amoyal:
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.
3
Page 2 - Jonathan S. Kahan, Esq.
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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A helyi Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use Statement
510(K) Number (if known):
Device Name:
RTA Model D Retinal Thickness Analyzer
Indications for Use:
The RTA Model D Retinal Thickness Analyzer ("RTA") is a computerized slitlamp biomicroscope that is intended to provide manual and computerized tomography of the retina in vivo. The RTA scans successive slit images on the fundus, without the need for a contact lens, to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. It is indicated for assessing the area and location of retinal thickness abnormalities, such as thickening due to macular edema and atrophy associated with degenerative diseases, and for visualizing other retinal pathologies.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number
(Division Sign-off)
Division of Ophthalmic Devices
510(k) Number
Prescription Use _ V (Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________