Explant Express

The Explant Express is a single-use suction device designed to assist surgeons in removing ruptured silicone breast implants. It consists of a rigid plastic container with a nozzle and vacuum port, connected to operating room suction, and is not intended for en bloc removal or removal of residual silicone.

Both the subject device and predicate (BIRD) feature a rigid plastic container with a nozzle and vacuum port, two separable parts for material retrieval, and connection to OR suction without creating or transforming energy. The minor difference is that Explant Express uses an O-ring seal between container halves, whereas the predicate relies on interference fit between rigid plastic components.

ISO 10993-1 (biocompatibility), ISO 11135 (EO sterilization validation), ISO 10993-7 (sterilant residuals), FDA Design Control Guidance (March 1997), and FDA Applying Human Factors and Usability Engineering Guidance (February 2016).

Explant Express is substantially equivalent because it has identical indications and contraindications as the predicate device, shares the same technological characteristics and principle of operation, and comprehensive bench testing, biocompatibility, sterilization validation, design verification, human factors, and animal testing all demonstrate safety and effectiveness at least equivalent to the predicate.