Search Results

The MVS 1011A is intended to be used as an accessory to the Storz PREMIERE® and Storz DAISY™ Microsurgical Systems, as a light source to facilitate viewing of the posterior segment of the eye during ophthalmic surgical procedures.

The device consists of an optical fiber encased in plastic tubing; a molded nylon proximal end which connects the device to the microsurgical unit; and a molded acetal distal end, from which protrudes the fiberoptic enclosed within a stainless steel housing. The stainless steel tip, which is the point of light emission, is covered by a plastic protective sleeve that attaches to the molded distal end, and which is removed prior to use of the endoilluminator.

This document describes a premarket notification for a fiberoptic endoilluminator. It compares a new device (Storz MVS 1011A) to a predicate device (Storz MVS 1011).

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. It is a 510(k) summary for a medical device (Storz MVS 1011A Fiberoptic Endoilluminator) and focuses on demonstrating substantial equivalence to a predicate device (Storz MVS 1011).

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance studies, as that information is not present in the provided text. The document primarily describes the device, its intended use, and a comparison to a predicate device.

Ask a specific question about this device