(236 days)
The scleral plugs are intended to maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures.
Scleral plugs, 19 and 20 gauge, for use in ophthalmic surgical procedures. Both 19 and 20 gauge plugs are stainless steel. The 19 gauge plugs are gold plated.
This is a 510(k) premarket notification for a medical device (Scleral Plugs) and not an AI/ML medical device. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, is not applicable to this document.
The document primarily focuses on establishing substantial equivalence to a predicate device based on material, construction, function, and biocompatibility testing. It states:
- Basis for Substantial Equivalence (Section 6):
- No change in materials, basic components, or manufacturing methods compared to the predicate device.
- No change in basic configuration or construction.
- Biocompatibility testing by an independent lab was performed.
- The function and use are no different from the predicate device.
The document asserts that the Micro Vision Scleral Plugs are substantially equivalent to the predicate device (Storz MVS 19 & 20 Gauge Scleral Plug, K854507) and that "any differences are minor and do not raise new issues of safety and effectiveness."
Without further documentation detailing specific performance studies and acceptance criteria for this non-AI device, it is not possible to provide the requested table or additional information.
§ 886.4155 Scleral plug.
(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 These plugs prevent intraocular fluid and pressure loss when instruments are withdrawn from the eye.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.