§ 870.5125 Laser-powered inferior vena cava filter retrieval catheter.

(a) Identification. A laser-powered inferior vena cava (IVC) filter retrieval catheter is a percutaneous catheter that uses a laser to ablate tissue and is intended to facilitate in the detachment and removal of indwelling IVC filters. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include: (i) Evaluation of major and minor complications associated with IVC filter removal; and (ii) Evaluation of success rates of IVC filter removal. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Dimensional testing must demonstrate that the device is compatible with the intended anatomy and compatible with all labeled accessories. (ii) Mechanical testing on all joints must demonstrate that the device can withstand tensile and torsional forces encountered under challenging clinical use conditions. (iii) Simulated use testing must demonstrate that the device can be inserted, tracked, activated, and removed without device damage and that the device is able to function as intended (e.g., remove IVC filter without damage) under challenging clinical use conditions. (iv) Performance testing must demonstrate that the product is visible under fluoroscopic techniques. (v) Performance testing must demonstrate that the device does not kink when subjected to clinically relevant tortuosity. (3) Compatibility testing with laser generators must include: (i) Electrical safety, electromagnetic compatibility testing, and electromagnetic interference testing must be conducted for all devices that contain electrical components. (ii) Software verification, validation, and hazard analysis must be conducted for all devices that contain software. (iii) Laser output characterization and performance testing, including verification of calibration reliability, energy output, and repetition rate, and laser lifetime testing, must be conducted. (4) All patient-contacting components must be demonstrated to be biocompatible. (5) Performance data must demonstrate the sterility and non-pyrogenicity of patient contacting components of the device that are provided sterile. (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and system functionality over the established shelf life. (7) In vivo safety testing must demonstrate that the device does not cause soft tissue damage or device damage under worst case clinical use conditions. (8) Labeling must include the following: (i) A detailed summary of the device technical parameters and materials of the device; (ii) A summary of the clinical performance testing conducted with the device; and (iii) A shelf life. (9) A training program must be provided to ensure that users can safely and reliably use the device per its instructions for use.