21 CFR §876.5011

1. (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.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)Clinical performance testing must demonstrate or provide the following:
      1. (i)The ability to safely place and subsequently remove the stent after the maximum labeled indwell period.
      2. (ii)All adverse event data including bile duct obstruction and trauma to the bile duct.
      3. (iii)The stent resolves strictures during the maximum labeled indwell period.
      4. (iv)Stricture resolution is maintained post-stent removal.
   2. (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:
      1. (i)Corrosion testing to demonstrate that the stent maintains its integrity during indwell and does not release potentially toxic levels of leachables.
      2. (ii)Stent dimensional testing supports the intended use.
      3. (iii)Compression and expansion forces must be characterized.
      4. (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.
      5. (v)The delivery system must withstand clinically anticipated forces.
      6. (vi)Compatibility in a magnetic resonance environment.
   3. (3)All patient contacting components of the device must be demonstrated to be biocompatible.
   4. (4)Performance data must demonstrate the sterility of the device components intended to be provided sterile.
   5. (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. (6)Labeling for the device must include:
      1. (i)A detailed summary of the clinical testing including device effectiveness, and device- and procedure-related adverse events.
      2. (ii)Appropriate warning(s) to accurately ensure usage of the device for the intended patient population.
      3. (iii)Shelf life.
      4. (iv)Compatibility information for use in the magnetic resonance environment.
      5. (v)Stent foreshortening information supported by dimensional testing.