da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)

The da Vinci Xi (IS4000) and X (IS4200) Surgical Systems are robotic-assisted surgical platforms that assist surgeons in controlling endoscopic instruments for minimally invasive procedures. They enable precise manipulation of tissue through grasping, cutting, dissection, ligation, electrocautery, and ablation across urologic, general, gynecologic, and thoracoscopic surgical procedures, including the newly labeled tracheobronchoplasty for symptomatic severe tracheobronchomalacia.

There are no changes to the technological characteristics of the subject devices compared to the cleared predicate devices. The systems consist of a Surgeon Console, Patient Side Cart, Vision Side Cart, endoscope, EndoWrist instruments, and accessories. This submission is a labeling modification only, adding tracheobronchoplasty as a specific representative procedure under the previously cleared General Thoracoscopic Surgical Procedures indication.

Not stated in this summary.

Substantial equivalence is established through real-world evidence from the Premier Health Database showing 124 robotic-assisted tracheobronchoplasty procedures performed at six U.S. hospitals from 2013–2023, compared to 278 open tracheobronchoplasty procedures from literature review. The analysis demonstrated equivalent outcomes across nine measures: operative time, conversion rate, bleeding/transfusion, hospital and ICU length of stay, complication rates, mortality, 30-day readmission, and 30-day reoperation rates. Since tracheobronchoplasty falls within the previously cleared General Thoracoscopic Surgical Procedures indication and uses the same hardware with no technological changes, the device poses no new safety or effectiveness concerns.