MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)

The MitraClip G5 and TriClip G5 Steerable Guide Catheters are handheld catheter systems designed to introduce cardiovascular catheters into the heart. The MitraClip G5 accesses the left side of the heart through the interatrial septum, while the TriClip G5 accesses the right side. Both devices consist of a distal and proximal catheter shaft, steering mechanism, hemostasis valve, and dilator, and are provided sterile for single use only.

The devices are substantially similar to predicate devices in design, materials, principle of operation, and sterilization method. Key differences include a new Guide Attach feature that secures the device to the updated G5 Stabilizer, and an alternate luer component with different material and dimensions. Both devices use ethylene oxide sterilization to achieve a Sterility Assurance Level of 10⁻⁶.

Biocompatibility testing was conducted per ISO 10993-1 (cytotoxicity, hemocompatibility, sensitization, irritation, acute systemic toxicity, and materials-mediated pyrogenicity). Sterilization validation followed ISO 11135, residuals assessment per ISO 10993-7, and packaging verification per ISO 11607-1 and ISO 11607-2.

The subject devices have identical intended use and technological characteristics to the predicate TriClip Steerable Guide Catheter (K241538) and reference MitraClip G4 Steerable Guide Catheter (K221397). The new Guide Attach feature and alternate luer component represent minor design variations to facilitate compatibility with updated accessory devices, but do not introduce new functional or safety concerns. Design verification testing confirms all performance specifications are met, and biocompatibility and sterilization validation demonstrate the devices are as safe and effective as their predicates.