TransEnterix, a US-based medical device company, has completed a pre-submission filing with the US Food and Drug Administration (FDA) to request additional feedback from the agency regarding its planned 510(k) filing for the SurgiBot system, pursuant to the FDA's Pre-Submission Program.
The SurgiBot is a minimally invasive, patient-side robotic surgery system. It allows the surgeon to remain patient-side within the sterile field, representing a new approach in surgical robotics.
TransEnterix president and CEO Todd Pope said, "Completing this pre-submission with the FDA on schedule demonstrates that our SurgiBot system development program continues to progress along our anticipated timeline."
Earlier in January 2014, multiple surgeons had used SurgiBot to successfully complete general surgery procedures in the porcine model. The procedures performed in the pre-clinical testing included cholecystectomy and sleeve gastrectomy.
According to the company, the pre-submission is consistent with FDA’s ‘Guidance for Industry and Food and Drug Administration Staff,’ dated February 18, 2014.