Product Classification

• Device: electromechanical system for open microsurgery
• Definition: An electromechanical system for open microsurgery is a software-controlled electromechanical system with bedside human/device interfaces and without an integrated visualization system which allows a qualified user to perform surgical techniques during open mircosurgical procedures using surgical instruments attached to an electromechanical arm.
• Physical State: The device may contain a bedside control console, robotic arms, and associated accessories.
• Technical Method: The device utilizes two electromechanical arms with instruments that are controlled by a qualified surgeon to manipulate small structures. The device utilizes a 3rd party microscope to visualize the anatomy.
• Target Area: head, neck, breast, trunk, upper limbs, and lower limbs
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: SAQ
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); General Surgery Devices (DHT4A)
• Submission Type: 510(k)
• Regulation Number: 878.4963
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 6-510 IEC 80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION
  Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT

Third Party Review

Not Third Party Eligible