§ 876.1050. Endoscopic transhepatic venous access needle.
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/us/cfr/t21/s§ 876.1050·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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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§ 876.1050
Endoscopic transhepatic venous access needle.
Fed. Reg.×1
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