(78 days)
The Medicel MultiJect injector for intraocular lenses is intended to insert foldable intraocular lenses CeeOn JI 3A and Tecnis Z9000 made by Pharmacia when used in conjunction with the MicroGlide cartridge.
The Medicel MultiJect injector for intraocular lenses is indicated for the insertion of foldable intraocular lenses " Inc. Medicer Manason Mysetting when used in conjunction with the MicroGlide cartridge.
The Medicel MultiJect injector for intraocular lenses is intended to insert foldable intraocular Jenses CeeOn 913A and Tecnis Z9000 made by Pharmacia when used in conjunction with the MicroGlide cartridge. The injector is reusable and can be autoclaved. The cartridge is single-use and is provided sterile. Two types of injectors are provided: a syringe type and a screw type. The MultiJect is designed to be used with the Pharmacia Tecnis Z9000 lenses and the Pharmacia CeeOn 913A lenses.
The device has two components: a reusable injector and a disposable cartridge, sold sterile. The injector is made of titanium. The injector can be autoclaved. The cartridge is made of lubricated polypropylene.
The provided text describes a 510(k) submission for the Medicel MultiJect Reusable Injector for Intraocular Lenses. However, it does not contain specific acceptance criteria, performance data from clinical or non-clinical tests that show how the device meets those criteria, or details regarding study design elements such as sample sizes, ground truth establishment, or expert qualifications.
The document explicitly states: "(2) Clinical tests Not required" and presents the following conclusion: "The MultiJect injector and MicroGlide cartridge are equivalent in safety and efficacy to the legally marketed predicate devices." This indicates that the device's clearance was based on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than meeting specific, pre-defined acceptance criteria through a standalone performance study.
Therefore, I cannot provide the requested information. The document focuses on regulatory submission and substantial equivalence, not on a detailed study proving the device meets specific acceptance criteria in the manner usually associated with a performance evaluation study.
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.