Device Name: Canady Flex RoboWristTM
Author(s): Nicolas Fuentes, M.D, David Pechman M.D
US Medical Innovations, LLC. received FDA approval for the Canaday Flex RobowristTM on October 20h, 2022.
The Canaday Flex RobowristTM is a hand-held motorized laparoscopic instrument that can be used for grasping, mobilization, dissection, transection, suturing and electrocautery through multiple end effectors including monopolar scissors, needle holder, and monopolar hook.
The device is designed for utilization via a 5mm laparoscopic port, enabling three degrees of freedom and a complete 360-degree rotation. Its functionality relies on a dedicated control unit for power operation and electrocautery generation, while being supported by two motorized sections.
evaluated for substantial equivalence against RealHandTM High Dexterity Instruments, from Novare Surgical Systems, Inc. and identified that the indications for use, conditions of use, design characteristics, and sterility were same or similar. Instruments deferred on principle of operation, power source, sterilization method, and reusable characteristics, as the Canaday Flex RoboWristTM is motorized with electrical energy instead of manual, requires moist heat for sterilization instead of irradiation, and can be reusable.
Non-clinical performance studies were carried out to demonstrate safety and effectiveness of the device, showing substantial equivalence to the predicate device, in regards to cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, electrical safety, electromagnetic compatibility, cleaning and sterilization validations, human factors/usability, and functionality for manipulating, cutting, and suturing. The Canaday Flex RoboWristTM passed all tests in accordance with internal requirements, national, and international standards.
FDA-approved indications for use:
- Laparoscopic grasping
- Laparoscopic mobilization
- Laparoscopic dissection
- Laparoscopic suturing
- Laparoscopic transection
- Laparoscopic electrocautery
