§ 876.1050 Endoscopic transhepatic venous access needle.

(a) Identification. An endoscopic transhepatic venous access needle is inserted through the liver into the patient's portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance data must demonstrate the sterility of the patient-contacting components of the device. (3) The patient-contacting components of the device must be demonstrated to be non-pyrogenic. (4) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be tested: (i) Needle crumple testing; (ii) Tensile testing; (iii) Dimensional verification for all components; and (iv) Simulated use testing. (6) Labeling must include the following: (i) Instructions for use, including specific instructions regarding device preparation; (ii) The recommended training for safe use of the device; and (iii) A shelf life for any sterile components.