(74 days)
The QuiteTip™ I/A handpiece and tips are used in ophthalmic surgery to provide controlled aspiration of lens tissue while maintaining anterior chamber shape by replacing aspirated fluids with BSS.
I/A Handpiece and Tips
The provided text is a 510(k) premarket notification letter from the FDA to Paradigm Medical Industries, Inc., regarding their QuiteTip™ I/A Handpiece and Tips. This document indicates the device has been found substantially equivalent to a predicate device and can be marketed.
However, the letter does not contain any information about acceptance criteria, performance data, or studies that prove the device meets specific acceptance criteria. It is a regulatory approval letter based on substantial equivalence, not a detailed report of a device performance study.
Therefore, I cannot provide the requested information as it is not present in the given text.
To answer your request, I would need a document that describes the specific performance studies, their methodology, results, and acceptance criteria for the QuiteTip™ I/A Handpiece and Tips.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.