§876.1050. Endoscopic transhepatic venous access needle.
21 C.F.R. § 876.1050
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.
Classification. Class II (special controls). The special controls for this device are:
The patient-contacting components of the device must be demonstrated to be biocompatible.
Performance data must demonstrate the sterility of the patient-contacting components of the device.
The patient-contacting components of the device must be demonstrated to be non-pyrogenic.
Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be tested:
Needle crumple testing;
Tensile testing;
Dimensional verification for all components; and
Simulated use testing.
Labeling must include the following:
Instructions for use, including specific instructions regarding device preparation;
The recommended training for safe use of the device; and
A shelf life for any sterile components.
Notes, amendments, and revision history
Amendments
[86 FR 71145, Dec. 15, 2021]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.
Amendments
[86 FR 71145, Dec. 15, 2021]