Section 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;(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.86 FR 71145, Dec. 15, 2021