---
kind: "section"
citation: "21 C.F.R. § 876.1050"
title: "21"
number: "876.1050"
heading: "Endoscopic transhepatic venous access needle."
url: "https://uscodex.org/cfr/21/876.1050"
---

# §876.1050. Endoscopic transhepatic venous access needle.

- (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.**

## Notes

### 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]