---
kind: "section"
citation: "21 C.F.R. § 876.5011"
title: "21"
number: "876.5011"
heading: "Metallic biliary stent system for benign strictures."
url: "https://uscodex.org/cfr/21/876.5011"
---

# §876.5011. Metallic biliary stent system for benign strictures.

- (a) **Identification.** A metallic biliary stent system for benign strictures is a prescription device intended for the treatment of benign biliary strictures. The biliary stents are intended to be left indwelling for a limited amount of time and subsequently removed. The device consists of a metallic stent and a delivery system intended to place the biliary stent in the bile duct. This device type is not intended for use in the vasculature.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical performance testing must demonstrate or provide the following:
    - (i) The ability to safely place and subsequently remove the stent after the maximum labeled indwell period.
    - (ii) **All adverse event data including bile duct obstruction and trauma to the bile duct.**
    - (iii) **The stent resolves strictures during the maximum labeled indwell period.**
    - (iv) **Stricture resolution is maintained post-stent removal.**
  - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:
    - (i) Corrosion testing to demonstrate that the stent maintains its integrity during indwell and does not release potentially toxic levels of leachables.
    - (ii) **Stent dimensional testing supports the intended use.**
    - (iii) Compression and expansion forces must be characterized.
    - (iv) The delivery catheter must deliver the stent to the intended location and the stent must not be adversely impacted by the delivery catheter during deployment and catheter withdrawal.
    - (v) The delivery system must withstand clinically anticipated forces.
    - (vi) **Compatibility in a magnetic resonance environment.**
  - (3) All patient contacting components of the device must be demonstrated to be biocompatible.
  - (4) Performance data must demonstrate the sterility of the device components intended to be provided sterile.
  - (5) Shelf life testing must demonstrate that the device maintains its performance characteristics and that packaging maintains sterility for the duration of the labeled shelf life.
  - (6) Labeling for the device must include:
    - (i) A detailed summary of the clinical testing including device effectiveness, and device- and procedure-related adverse events.
    - (ii) **Appropriate warning(s) to accurately ensure usage of the device for the intended patient population.**
    - (iii) **Shelf life.**
    - (iv) **Compatibility information for use in the magnetic resonance environment.**
    - (v) **Stent foreshortening information supported by dimensional testing.**

## Notes

### Amendments

[81 FR 45231, July 13, 2016]

### 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

[81 FR 45231, July 13, 2016]