MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer

These are temporary breast implant sizers used intraoperatively to help surgeons evaluate the appropriate size and shape of breast implants before permanent implantation. Three variants are cleared: MemoryShape Resterilizable (reusable up to 10 times), MemoryGel Resterilizable (reusable up to 10 times), and MemoryGel Enhance Single Use (single-use only). All are silicone elastomer devices filled with silicone gel.

The only technological change from the predicate device is the dip coat material applied to the outside surface: changing from Krayden/Dow DC 92-009 to NuSil MED6-6605. All other materials, sterilization parameters (dry heat at 236–251°F for 34–52 hours depending on type), indications for use, and device design remain unchanged.

Not stated in this summary. The document references biocompatibility testing (cytotoxicity, sensitization, irritation, pyrogenicity, acute systemic toxicity) and performance qualification testing, but does not cite specific ISO, IEC, or ASTM standards.

The predicate device used the same sizer design, materials (except dip coat), and sterilization method. The new dip coat material (MED6-6605) is already successfully used in other cleared MENTOR saline-filled and adjustable breast implants approved since 2000 with no significant safety issues. Biocompatibility testing of MED6-6605 and sizer reprocessing lifetime testing both passed acceptance criteria, demonstrating the new dip coat performs identically to the original. Since indications for use, intended use, technological characteristics, and safety profile are unchanged, substantial equivalence is supported.