§ 876.5015 Pancreatic drainage stent and delivery system.

(a) Identification. A pancreatic drainage stent is a prescription device that consists of a self-expanding, covered, metallic stent, intended for placement to facilitate transmural endoscopic drainage of pancreatic pseudocysts. This stent is intended to be removed upon confirmation of pseudocyst resolution. This device may also include a delivery system.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The device and elements of the delivery device that may contact the patient must be demonstrated to be biocompatible.

(2) Performance data must demonstrate the sterility of patient-contacting components of the device.

(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the requested shelf life.

(4) Non-clinical testing data must demonstrate that the stent and delivery system perform as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Deployment testing of the stent and delivery system must be conducted under simulated use conditions.

(ii) Removal force testing must be conducted. The removal force testing must demonstrate that the stent can be safely removed, and that the stent will remain in place when subjected to forces encountered during use.

(iii) Expansion force testing must be conducted. The expansion force must demonstrate that the forces exerted by the stent will not damage the tissue surrounding the stent.

(iv) Compression force testing must be conducted. The compression force must demonstrate that the stent will withstand the forces encountered during use.

(v) Dimensional verification testing must be conducted.

(vi) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.

(vii) Fatigue testing must be conducted. Material strength must demonstrate that the stent will withstand forces encountered during use.

(viii) Corrosion testing must be conducted. Corrosion resistance must demonstrate that the stent will withstand conditions encountered during use.

(5) Non-clinical testing must evaluate the compatibility of the stent in a magnetic resonance (MR) environment.

(6) Well-documented clinical experience must demonstrate safe and effective use, and capture any adverse events observed during clinical use.

(7) Labeling must include the following:

(i) Appropriate instructions, warnings, cautions, limitations, and information related to the safe use of the device, including deployment of the device, maintenance of the drainage lumen, and removal of the device.

(ii) A warning that the safety and patency of the stent has not been established beyond the duration of the documented clinical experience.

(iii) Specific instructions and the qualifications and clinical training needed for the safe use of the device, including deployment of the device, maintenance of the drainage lumen, and removal of the device.

(iv) Information on the patient population for which the device has been demonstrated to be effective.

(v) A detailed summary of the clinical experience pertinent to use of the device.

(vi) A detailed summary of the device technical parameters.

(vii) A detailed summary of the device- and procedure-related complications pertinent to use of the device.

(viii) An expiration date/shelf life.

[79 FR 30724, May 29, 2014]