(36 days)
The Corneal Light Shield is a sterile sponge that is not absorbable by the body. It is intended for short-term transient use by a physician to be placed on the surface of the cornea and shield the retina from illumination during ophthalmic procedures. The Corneal Light Shield is to be used once and discarded.
The M-Pact Corneal Light Shield is designed to be placed on the surface of the cornea during ophthalmic procedures to shield the retina from excessive illumination. The Corneal Light Shield is transient to minimal short-term use only. The Shield is nonabrasive, and is formulated to resist tearing or shedding of fibers.
This document does not contain an acceptance criteria table or a study proving that the device meets specific acceptance criteria.
Instead, this is a 510(k) summary notification for a medical device called the "M-Pact Corneal Light Shield." The document focuses on demonstrating substantial equivalence to a predicate device (Merocel Corneal Sponge), rather than proving performance against defined acceptance criteria through a specific study.
The "Substantial Equivalence Table" in the document lists features of the M-Pact Corneal Light Shield and the predicate device, showing that they share similar technological characteristics. This is a comparison of design and material properties, not a performance study against acceptance criteria.
Therefore, I cannot provide the requested information as it is not present in the provided text.
§ 886.4790 Ophthalmic sponge.
(a)
Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.