8 mm Assist Cannula; 12 mm Assist Cannula

The 8 mm and 12 mm Assist Cannulas are hollow stainless steel tubes designed to establish a port of entry for surgical instruments, endoscopes, and accessories during laparoscopic procedures. They are used in medical facilities by trained professionals and may be used independently or in conjunction with da Vinci robotic surgical systems.

The subject devices are stainless steel cannulas with a seal attachment and obturator system to maintain an air-tight insufflated cavity. Key differences from the predicate include: the 8 mm cannula has a hexagonal chisel tip and ribbed tube (versus the predicate's round flat tip and smooth tube), while the 12 mm cannula has a round chisel tip and ribbed tube (versus round flat tip and smooth tube). The subject devices use 304 Full Hard stainless steel tubing rather than the predicate's 465 Carpenter Steel, and lack the predicate's magnetic fin in the funnel.

ISO 10993-1 biocompatibility evaluation was performed on all materials. The document does not cite specific mechanical, dimensional, or functional test standards by code number.

Substantial equivalence is established because both the subject devices and predicate share identical intended use (establishing surgical ports), indications for use, anatomical site of use, classification (Class II), regulatory pathway (21 CFR 876.1500), compatible accessories, and overall design intent. Although dimensional and design features differ (tip geometry, tube texture, material grade), performance testing—including bench testing, animal models, cadaver testing, and human factors evaluation with use-related risk analysis—demonstrates the subject devices perform as intended. The differences in design do not raise new questions of safety and effectiveness.