21 CFR §876.1050

1. (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.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)The patient-contacting components of the device must be demonstrated to be biocompatible.
   2. (2)Performance data must demonstrate the sterility of the patient-contacting components of the device.
   3. (3)The patient-contacting components of the device must be demonstrated to be non-pyrogenic.
   4. (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. (5)Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be tested:
      1. (i)Needle crumple testing;
      2. (ii)Tensile testing;
      3. (iii)Dimensional verification for all components; and
      4. (iv)Simulated use testing.
   6. (6)Labeling must include the following:
      1. (i)Instructions for use, including specific instructions regarding device preparation;
      2. (ii)The recommended training for safe use of the device; and
      3. (iii)A shelf life for any sterile components.