Intuitive Surgical, Inc. received FDA approval for the 8 mm SureForm 30 Stapler on December 10, 2021 (K211997).
The 8mm SureForm 30 Stapler is a disposable, fully wristed, four-row, variable height stapler system with 120 degree articulation and SmartFire tissue compression sensors for use with the DaVinci surgical system during the resection, transection, and anastomoses of tissue. The stapler and cartridge pass through an 8 mm robotic port, with 30 mm of overlapping staples. Staggered rows of titanium alloy staples are fired prior to cutting tissue with two rows on each side of the cut line.
The 8 mm SureForm system underwent design verification (bench) as well as validation on animal models. Staple line performance, hemostasis, leak onset, and maximum torque testing were performed. Additionally, performance was assessed in lung lobectomy and wedge studies, as well as gastrectomy, small bowel anastomosis, and nephrectomy studies. All studies included comparisons to the 12 mm predicate device.
The FDA determined that the 8 mm SureForm 30 Staplers and Reloads are substantially equivalent to the predicate device SureForm 45 Staplers and Reloads (K190999), a 12 mm device.
The device is FDA approved for resection and transection of vasculature and tissue and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.
There is no data regarding staple line or tissue buttressing materials presently.
An 8mm SureForm 30 mm length stapler seen in the wild at an Intuitive local event. Notice the two rows of staples on either side of the cut line.
Comparison of the 8mm SureForm 30 and the conventional 12 mm SureForm 60 on the right.
8mm SureForm 30 staple loads as they are removed from the product packaging.
8mm SureForm 30 staple loads ready for installation and use on the DaVinci platform.