(262 days)
CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior ocular structures. The device is indicated for visualizing and measuring and posterior ocular structures, including corneal epithelium, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head.
CIRRUS' AngioPlex OCT Angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.
CIRRUS HD-OCT is indicated as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.
This device is Prescription Use (Rx) only.
The CIRRUS™ HD-OCT Model 6000 is indicated for in-vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of anterior and posterior ocular structures. The clinical purpose of this device has not been modified as compared to the predicate.
CIRRUS 6000 uses the same optical system, architecture, and principle of operation as the previously cleared CIRRUS 5000 (K181534). CIRRUS 6000 has a 100 kHz scan rate for all structural and angiography scans. The primary impact of the higher acquisition speed is its impact on signal-to-noise ratio. The signal-to-noise ratio m the subject device is calibrated to match the specifications of the CIRRUS 6000 uses the same segmentation algorithms as the predicate device and therefore the segmentation results will be equivalent.
In addition to the acquisition speed change, CIRRUS 6000 also has a wider field of view (FOV) and has increased the number of fixation points to 21.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the reported precision summaries (Repeatability %CV and Reproducibility %CV and Limits) for various measurements on the CIRRUS HD-OCT 6000 (C6000) and the qualitative image quality results. The studies aim to demonstrate that the C6000 performs comparably to the predicate device, the CIRRUS HD-OCT 5000 (C5000), and that its image quality is clinically acceptable.
Since explicit numerical acceptance criteria (e.g., "Repeatability %CV must be
§ 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.