Da Vinci 5 Gains FDA Clearance

A new force feedback feature demonstrated up to 43 percent less force exerted on tissue, which may translate to less trauma on tissue.

Intuitive's da Vinci 5 full system.
Intuitive's da Vinci 5 full system.

Intuitive recently announced that the U.S. Food and Drug Administration (FDA) provided 510(k) clearance for da Vinci 5, the company’s next-generation multiport robotic system.

Da Vinci 5 builds on Intuitive’s da Vinci Xi’s design, which surgeons and care teams around the world have used in more than 7 million procedures to date.

The system includes more than 150 enhancements, including:

  • New surgeon controllers and powerful vibration and tremor controls, make it the smoothest and most precise system Intuitive has developed to date.
  • A high quality and natural 3D imaging system that enables surgeons to see more.
  • Force feedback technology and optional instruments that enable the system to measure, and surgeons to feel, subtle forces exerted on tissue during surgery—something no other surgical technology in any modality offers. In preclinical trials with surgeons at all experience levels, force feedback demonstrated up to 43 percent less force exerted on tissue, which may translate to less trauma on tissue. The ability to measure this force adds an important new data stream to surgical data science, which can bring future analytical insights supported through artificial intelligence.
  • Features designed to help increase surgeon autonomy and streamline surgeon and care team workflow. ​For example, da Vinci 5 has integrated key OR technologies, including insufflation and an electrosurgical unit. The system also includes an optimized user interface, with settings that are accessible by the broader surgical team and by the surgeon directly from the head-in menu. Surgeons have access to other key settings while head-in to help them stay focused on the surgical field.
  • More than 10,000 times the computing power of da Vinci Xi, which enables innovative new system capabilities and advanced digital experiences, now and in the future, including integration with Intuitive’s My Intuitive app, SimNow (virtual reality simulator), Case Insights (computational observer), and Intuitive Hub (edge computing system).
  • A redesigned console capable of customizable positioning, allowing surgeons to find their best fit for surgical viewing and comfort, including the ability to sit completely upright. The surgeon can make any necessary adjustments while their head is in the console, with options designed to fit different body types, including surgeons who are pregnant.

Da Vinci 5 will initially be available to a small number of customers in the U.S. who collaborated with Intuitive during the development period and those with mature robotic surgery programs. Intuitive will work with surgeons at these initial sites to generate additional data on the system’s use before a wider commercial introduction.

Force feedback instruments, which are optional for use with da Vinci 5, are cleared for use in the same procedures as da Vinci Xi, except pediatric and cardiac procedures, and a specific contraindication for the force feedback needle driver for use in suturing during hysterectomy and myomectomy procedures.

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