da Vinci SP SureForm 45 Staplers and Reloads (SP1098)

The da Vinci SP SureForm 45 Staplers and Reloads are surgical stapling instruments designed for use with the da Vinci SP robotic surgical system. They are used to resect, transect, and create anastomoses (surgical connections) in urologic, thoracic, and colorectal surgery by placing multiple staggered rows of implantable staples and cutting tissue along the staple line.

The subject device has an instrument shaft and proximal housing that allows it to mate with and be driven by the da Vinci SP Patient Side Cart instrument drives, uses SP software control parameters accounting for SP-specific mechanical characteristics (motor torque, gear ratios, friction), and utilizes the da Vinci SP Advanced Access Port system for insertion. It uses the same reloads and maintains identical tip geometry as the predicate, with SmartFire and ForceFire features, though one patient-contacting material differs from the predicate.

Not stated in this summary.

The subject and predicate devices are regulated under the same regulation, product code, and classification with identical intended use and sterility (EO sterilization). Although the subject device has design differences in its instrument shaft, housing, and software control parameters to interface with the da Vinci SP system, it maintains identical tip geometry and uses the same reloads as the predicate. Bench and animal testing (staple line performance, leak onset pressure, and design validation) demonstrated equivalent performance outcomes, and human factors evaluation confirmed safe and effective use. Because the devices share the same fundamental operating principles, achieve the same clinical performance with identical reloads, and show no new or different risks, the subject device is substantially equivalent.