da Vinci SP Advanced Access Port Kit (432701)

The da Vinci SP Advanced Access Port Kit is a sterile, single-use, disposable accessory that provides surgical access for the da Vinci SP robotic surgical system during minimally invasive endoscopic procedures. It allows da Vinci SP instruments, an endoscope, and manual assist instruments to pass through a single incision while maintaining insufflation.

The subject device adds new compatibility with 12mm da Vinci SP instruments (versus 6mm only in the predicate), features an integrated entry guide with a larger 32mm lumen diameter (versus 25mm), includes a removable 12-6mm reducer, adds two additional chamber seals (three total versus one), introduces a new magnet configuration, and reduces the number and length of insufflation tubes.

ISO 10993-1 was cited for biocompatibility testing of patient-contacting materials. No other specific consensus standards (ISO, IEC, ASTM) are explicitly cited in the performance data or testing sections.

The device maintains the same intended use (providing single-port surgical access), indications for use, principles of operation (master-slave servomechanism), sterilization method (ethylene oxide), and clinical function as the predicate. Although it adds 12mm instrument compatibility and modifies the entry guide lumen configuration and sealing design, these changes are design enhancements that do not alter the fundamental safety or effectiveness profile. Bench testing, cadaver and animal validations, and human factors analysis all demonstrated that design outputs meet design inputs and performance is substantially equivalent to the predicate device.