(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.

[86 FR 71145, Dec. 15, 2021]