CVAC Aspiration System

The CVAC Aspiration System is a sterile, single-use steerable ureteral catheter paired with a reusable software-controlled image processor. It is designed to establish a conduit during endoscopic urological procedures to locate, treat, and remove urinary stones (kidney stones, fragments, and dust) using flexible ureteroscopy with dedicated irrigation and vacuum channels.

The technology of the CVAC Aspiration System subject and predicate devices is identical. There are no changes to the camera assembly, optical wiring, LED assembly, or the CVAC Image Processor. This submission involves labeling changes only, including revised Instructions for Use to incorporate recall-related updates, improve clarity, and expand troubleshooting guidance without altering device design, materials, performance specifications, or operating principles.

Not stated in this summary.

The CVAC Aspiration System is substantially equivalent to the predicate device (CVAC Aspiration System cleared under K233472) because the technology is identical, the intended use and indications for use are unchanged, and the submission involves only labeling revisions that do not change device design, materials, performance, or fundamental operating principles. These changes do not introduce new risks or raise new safety or effectiveness questions.