(83 days)
Device is intended for viewing the retinal and/or choroidal circulation patterns that are illuminated using fluorescein or indocyanine green dye, and for aiding in the:
- management of age-related macula degeneration (AMD)
- detection of choroidal neovascularization (CNV)
- assessment of diabetic retinopathy
and the comments of - assessment of diabetic maculopathy
- treatment control of diabetic maculopathy, AMD, CNV
- detection of retinal vascular disturbances
- assessment of choroidal circulation
- diagnosis of chorioditis or choroidal diseases
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Heidelberg Retina Angiograph FA/ICGA (HRA/C)". This document confirms that the device has been found substantially equivalent to a predicate device and can be marketed.
However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The letter is a regulatory approval document and does not include the technical study details that would typically be part of a submission to demonstrate performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document explicitly states:
- "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976..."
- "A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements..."
This indicates a regulatory clearance based on substantial equivalence, rather than a detailed performance study evaluation described within 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.