(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]
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