Device Name: MIRA Surgical System
Author(s): Andrew Luhrs, MD
Virtual Incision received FDA authorization for MIRA Surgical System on February 23, 2022.
MIRA is a table mounted miniaturized robotic-assisted surgery (RAS) platform. Its form factor is designed to offer the benefits of RAS during colectomy while seeking to minimize the logistical inefficiencies of traditional RAS platforms. The device weighs approximately 2 pounds and is designed to offer internal triangulation of the two wristed arms which can grasp, retract, and dissect tissue. MIRA can be used in any operating room and does not require conventional drapes or docking procedures. MIRA can be used standalone or as a complimentary tool to existing RAS platforms. This table mounted miniaturized electromechanical surgical system is software controlled and operated via a surgeon console.
Clinical testing was conducted to verify that the MIRA Surgical System performs as intended.
The FDA authorized this device through the de novo pathway as no substantially equivalent device exists.
MIRA Surgical System is intended for use in the intra-abdominal space during colon resection.
