C-Lant Port

The C-Lant Port is a sterile, single-use access system comprising a trocar and port with a self-fixating element, designed to provide secure entry into abdominal and thoracic cavities during endoscopic procedures. It features a retractable blade trocar that automatically re-sheaths after cavity access, an internal fixation element that expands to anchor the device, and a rotatable iris sealing mechanism that maintains a hermetic seal around instruments or catheters up to 28 French.

The C-Lant Port uses a retractable blade trocar (rather than balloon inflation like SoftFix or blunt separator like Fixation trocar) and incorporates a self-expanding internal fixation element with external foam-padded disk for prevention of over-insertion. It includes an iris sealing mechanism for maintaining instrument passage without leakage, with compatibility up to 28 French and a length of 64.5 mm.

ISO 11137-1, ISO 11137-2, ISO 13004:2022 (sterilization); ISO 10993 (biocompatibility including cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity); MRI safety testing; usability testing; penetration, gas leakage, and visibility comparison testing.

The C-Lant Port demonstrates substantial equivalence by sharing the same intended use (endoscopic access to abdominal and thoracic cavities), similar principles of operation (trocar-based access with port fixation and sealing), and core technological features with three predicate devices (SoftFix Balloon Trocar K211577, Fixation Trocar K083638, Reactor Trocar K150549). Although technological differences exist (self-expanding fixation element and iris sealing mechanism), comprehensive bench and performance testing confirm these features do not raise new safety or effectiveness concerns.