(100 days)
The CA, an auxiliary lens adapter, when used in conjunction with RTVue, is indicated for in vivo imaging and measurement of the cornea and the other ocular structures of the anterior segment of the eve, including pachymetry and corneal power.
The already cleared (K071250) RTVue CA Module (CAM) is an instrument based on Fourier-Domain Optical Coherence Tomography (OCT) for in vivo imaging and measurement of the cornea and other ocular structures of the anterior segment of the eye with US FDA 510(k) clearance (K071250) in 2007. The RTVue CAM has been used in clinical practice for imaging the cornea, measuring corneal thickness, and visualizing the anterior segment angle. The RTVue CAM device uses the same Optical Coherence Tomography (OCT) technology that was previously cleared by FDA (K101505). The CAM adapter gives the user an option to use the RTVue device as previously approved for retina scans, or to use it for cornea and anterior eye scans. Aside from the CAM auxiliary attachment, the RTVue is virtually unchanged for the CAM use except the CAM software module provides for menu selections in the graphical user interface, which are selected by the operator to label corresponding corneal landmarks instead of those of the retina. The system scans a beam into patient's eye and uses a low coherence interferometer to measure the reflectivity of the ocular tissue. The cross-sectional ocular tissue structure is composed of sequence of A-scans. The RTVue has a traditional patient and instrumentinterface like most ophthalmic devices. The device is mounted on a motorized patient table. The patient will rest their head on the forehead and chin rest. The operator uses joystick to align the device to patient's eye. The computer has a graphic user interface for acquiring, and displaying the acquired image. The RTVue image acquisition speed and image resolution remain the same when used in conjunction with CAM.
The provided document describes the RTVue CAM with Corneal Power Measurement device and its performance data to support substantial equivalence. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Calibration Accuracy | Accuracy of ±0.25D for corneal power measurement. | Implicitly met by the bench test results showing error |
§ 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.