(41 days)
To fold and deliver AMO® Acrylic OptiEdge intraocular lenses into the eye for the replacement of the human crystalline lens.
Not Found
The provided text is a 510(k) summary for a medical device (Lens Delivery System) and does not contain any information about acceptance criteria or a study proving device performance against such criteria.
The document is a regulatory letter from the FDA stating that the device has been found substantially equivalent to a predicate device and can be marketed. It discusses:
- Device Name: Duckworth & Kent Ltd, Lens Delivery System, Model DK7788
- Regulation Number/Name: 21 CFR 886.4300, Intraocular Lens Guide
- Regulatory Class: Class I
- Product Code: MSS
- Indications for Use: To fold and deliver AMO® Acrylic OptiEdge intraocular lenses into the eye for the replacement of the human crystalline lens.
Therefore, I cannot provide the requested information based on the input text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.
§ 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.