(288 days)
A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea).
A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea).
This is a 510(k) clearance letter for a medical device (C.S.O. Tonometer) and does not contain detailed information about the acceptance criteria, study design, or performance metrics. Therefore, I cannot extract the requested information from the provided text.
The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for FDA 510(k) clearance. However, it does not provide the specific performance criteria or the results of a study to demonstrate that the device meets those criteria.
To answer your questions, I would need a detailed study report, a submission summary, or a similar technical document that describes the device's testing and performance.
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.