(12 days)
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.
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.
This 510(k) summary does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.
The document is a submission for the RTA Model D Retinal Thickness Analyzer, asserting its substantial equivalence to a previously cleared device (CRTA Retinal Thickness Analyzer). The primary focus is on highlighting the modifications made to the RTA from the CRTA and arguing that these changes do not alter its intended use or raise new issues of safety and effectiveness.
Therefore, I cannot extract the requested information from the provided text.
§ 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.