(a) Identification. A scleral plug is a prescription device intended to provide temporary closure of a scleral incision during an ophthalmic surgical procedure. These plugs prevent intraocular fluid and pressure loss when instruments are withdrawn from the eye. Scleral plugs include a head portion remaining above the sclera, which can be gripped for insertion and removal, and a shaft that fits inside the scleral incision. Scleral plugs are removed before completing the surgery.

(b) Classification. Class II (special controls). The special controls for the scleral plug are as follows:

(1) 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 if the material is a surgical grade stainless steel with or without a gold, silver, or titanium coating. The special controls for the surgical grade stainless steel scleral plug (with or without a gold, silver, or titanium coating) are:

(i) The device must be demonstrated to be sterile during the labeled shelf life;

(ii) The device must be demonstrated to be biocompatible; and

(iii) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device.

(2) The device is not exempt from premarket notification procedures if it is composed of a material other than surgical grade stainless steel (with or without a gold, silver, or titanium coating). The special controls for scleral plugs made of other materials are:

(i) The device must be demonstrated to be sterile during the labeled shelf life;

(ii) The device must be demonstrated to be biocompatible;

(iii) Characterization of the device materials must be performed;

(iv) Performance data must demonstrate acceptable mechanical properties under simulated clinical use conditions including insertion and removal of the device;

(v) Performance data must demonstrate adequately low levels of the extractables or residues from manufacturing (or processing) of the device; and

(vi) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device.