(158 days)
The Bio-eye Hydroxyapatite Ocular Implant is intended to be implanted in the eyeball to occupy space following removal of the contents of the eyeball. The Ophthalmic Conformer is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity during the healing process following surgery.
The Bio-eye Hydroxyapatite Ocular Implant is indicated as a primary implant in cases of enucleation and evisceration, and as a secondary implant in cases of poor performance of a primary implant, such as in cases of poor motility, migration, extrusion, chronic infection, enophthalmos, and lid sag. The device is indicated in any situation where silicone, acrylic, polyethylene, glass, or other traditional ocular implants are used.
The Conformer is indicated in all cases in which an orbital implant is used.
Both the Motility Orbital Implant and the Bio-eye Hydroxyapatite Ocular Implant are eye sphere implants manufactured of hydroxyapatite. The Bio-eve Hydroxyapatite Ocular Implant will now be provided sterile. The Ophthalmic Conformer is used in conjunction with the Ocular Implant for ocular prosthesis and will also be supplied sterile.
The technological characteristics of the Ocular Implant are the same as the predicate: Both Implants are manufactured of porous hydroxyapatite. It is a synthetic hydroxyapatite which is similar in composition to the mineral content of human bone. The implant material has a unique interconnected porous matrix derived from specific marine corals. A patented manufacturing process preserves the porous structure of the coral while the calcium carbonate skeleton undergoes a hydrothermal chemical conversion to hydroxyapatite. The Bio-eye Hydroxyapatite Ocular Implant will now be supplied sterile.
The Interpore 200 Porous Hydroxyapatite is identical to the Motility Orbital Implant described above. Interpore is the manufacturer and supplier of the Motility Orbital Implant. The Interpore 200 Porous Hydroxyapatite is sterilized by gamma radiation and is supplied sterile.
The Ophthalmic Conformer, which is now 510(k) exempt (Federal Register 1-21-98), will now be supplied sterile.
The provided document is a 510(k) premarket notification for the Bio-eye® Hydroxyapatite Ocular Implant and Conformer. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through comprehensive studies as one might find for a novel device.
Therefore, the document explicitly states:
- SUMMARY OF PERFORMANCE DATA: Not applicable.
- CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS: Not applicable.
This means the 510(k) submission does not include performance data or studies that would allow for the completion of the requested table and detailed information about acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The basis for clearance is the demonstration of substantial equivalence to existing predicate devices (Motility Orbital Implant K891137, Ophthalmic Conformer K945110, and Interpore 200 Porous Hydroxyapatite K860983), primarily based on technological characteristics (both are manufactured of porous hydroxyapatite, similar in composition to human bone, derived from marine corals with a patented manufacturing process preserving porous structure, and converting to hydroxyapatite). The primary "change" noted is that the Bio-eye Hydroxyapatite Ocular Implant will now be supplied sterile.
§ 886.3320 Eye sphere implant.
(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.