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An OPHTEC Enclavation Needle is a hand held, non powered, single-use ophthalmic instrument used to manipulate iris tissue during the surgical procedure to fixate an ARTISAN™ phakic or aphakic intraocular lens in a human eye.

Enclavation Needles are surgical stainless steel needles that have been dulled and molded into a configuration so as to assist in tissue manipulation during ARTISAN™ Lens implant surgery. The instrument has an acrylic handle and one needle at each end. Each end is uniquely designed to create a right-hand end and a left-hand end to aid the surgeon during the procedure.

The provided text describes a 510(k) premarket notification for the OPHTEC Enclavation Needle. It establishes substantial equivalence to a predicate device but does not contain information about acceptance criteria, a study proving device performance, or details regarding a test set, ground truth establishment, or sample sizes related to performance studies.

The document is primarily focused on the regulatory approval process (510(k)) and establishing substantial equivalence, rather than detailing clinical or performance study results. As such, I cannot extract the requested information from the provided text.

Based on the information given, the device is classified as an ophthalmic hook and is described as a surgical stainless steel needle designed to assist in tissue manipulation during ARTISAN™ Lens implant surgery. The 510(k) process typically relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different characteristics that do not raise different questions of safety and effectiveness. This often involves comparing design specifications, materials, and intended use, rather than conducting new performance studies that would require the detailed information you've requested.

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