Author: Kate Lak, MD
XACT Robotics received FDA approval for its XACT Robotic System for image guided percutaneous procedures on 10/03/2019.
The XACT Robotic system is a patient-mounted system that uses robotic technology and 5 degrees of freedom to deliver continuous targeting feedback for image-guided procedures. The system is compatible with multiple imaging modalities and cleared for use with computed tomography (CT) guided procedures.
The accuracy achieved by the system is < 3 mm and this is done while compensating for patients’ physiologic movement. This feature allows the system to improve accuracy and safety relative to static image-guided procedures.
For use, the desired target and the trajectory are confirmed by the provider prior to procedure start. The provider then advances the instrument with a foot pedal while the XACT Robotic system ensures that the target and trajectory are adhered to. If the instrument strays from its trajectory due to physiologic movement, the system detects and corrects for the deviation.
Pre-clinical animal testing was performed using a porcine model to determine safety and effectiveness1. In 40 interventional procedures, the intended target was reached in 100% of cases with an average accuracy of 1.41 mm ± 0.94 mm. Preliminary clinical data confirmed safe and effective performance2. Interventional procedures were successfully completed in 27 of 31 cases with no adverse patient events.
The FDA determined this device is substantially equivalent to two predicate devices, iSYS Medizintechnik GmbH iSYS 1 (K131433) and Perfint Healthcare Pvt. Ltd. Maxio (K132108)
The FDA approved the XACT Robotic System for the planning and advancement of an instrument during CT guided percutaneous procedures. No contraindications are specified.
References:
- Ben-David et al. Evaluation of a CT-Guided Robotic System for Precise Percutaneous Needle Insertion. J Vasc Interv Radiol. 2018 Oct;29(10):1440-1446. doi: 10.1016/j.jvir.2018.01.002. Epub 2018 Apr 6.
- 510(k) Summary: XACT Robotic System (K191332). 2019 Sept; 4. Department of Health and Human Services Food and Drug Administration.
