(412 days)
The 66 Vision Tech Ophthalmoscopes (Indirect and Direct) are intended to examine the cornea, aqueous, lens and vitreous and the retina of the eye.
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This document is a 510(k) premarket notification decision letter from the FDA to Suzhou 66 Vision Tech Co., Ltd. for their ophthalmoscopes. It confirms that the device is substantially equivalent to a legally marketed predicate device.
This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter is an administrative approval based on substantial equivalence, meaning the device is considered as safe and effective as a previously cleared device. It does not typically require detailed performance studies and acceptance criteria to be submitted or reviewed in the same way a Premarket Approval (PMA) would.
Therefore, I cannot provide the requested information based solely on the provided text. The document primarily focuses on the regulatory approval process and not on the specifics of a performance study demonstrating acceptance criteria.
§ 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.