(257 days)
The ARCHIMEDES biodegradable pancreatic stent is intended to drain pancreatic ducts in patients indicated for pancreatic duct stenting.
The ARCHIMEDES Biodegradable Pancreatic Stent is intended to be delivered through the working channel of a therapeutic endoscope using a guidewire with a maximum outer diameter of 0.035 inches and a pushing catheter of between 5 to 10 French.
The ARCHIMEDES™ Biodegradable Pancreatic Stent is a single use, sterile, biodegradable stent implant intended for use in the pancreatic duct. The device is intended to be delivered endoscopically through the working channel of a duodenoscope.
The ARCHIMEDES™ has a fluted cross-sectional profile and provides three drainage channels, two of which spiral in a double helical pattern down the length of the stent and one of which is the hollow inner lumen of the device tube. This unique design permits fluids to flow both around and through the stent. It has a curved form design to fit the natural curvature of the pancreatic duct, and contains flap and split-end features to minimize spontaneous migration of the stent while in situ. The tips of the stent are tapered to facilitate atraumatic insertion through the papilla. The stent is visible under fluoroscopy. The 8F and 10F stent design contains flaps on each end. The 6F stent design has a flap on one end and a split-end feature on the other end.
The stent is offered in outer diameters of 2.0mm (6F), 2.6mm (8F), or 3.4mm (10F), and in various lengths to accommodate variations in pancreatic anatomy across individuals (40, 60, 80, 100, 125, 150, 175, 200, and 225 mm). The ARCHIMEDES™ is designed to be an alternative to plastic stents that maintains the same clinical purpose. In particular, it is used in a manner similar to current FDA-cleared plastic pancreatic stents. The primary difference is that the ARCHIMEDES™ biodegrades in-situ rather than requiring an additional procedure for removal needed of plastic stents.
The Minimal Strength Retention (MSR) time for the material - i.e., the minimum amount of time for which the device retains at least 10% of an initial strength parameter and remains intact with no breaks is 12 days. Full-degradation or no stent presence is reached within
The provided FDA 510(k) clearance letter and summary for the ARCHIMEDES™ Biodegradable Pancreatic Stent do not contain the specific acceptance criteria and detailed performance results for the device. While it states that "All tests met required acceptance criteria," the actual criteria and reported numerical performance are not explicitly listed.
Furthermore, the document alludes to "eight clinical studies" but provides no details whatsoever about their methodology, sample sizes, data provenance, expert qualifications, adjudication methods, or specific outcomes. It's a high-level statement without any actionable data.
Therefore, many of your requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot, based on the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-clinical Performance | |
| Visual Inspection | Met required acceptance criteria (no specific details provided) |
| Outer diameter, Length | Met required acceptance criteria (no specific details provided) |
| Stent Swelling Characterization | Met required acceptance criteria (no specific details provided) |
| Flow Rate | Met required acceptance criteria (no specific details provided) |
| Inherent Viscosity | Met required acceptance criteria (no specific details provided) |
| Guidewire Compatibility | Met required acceptance criteria (no specific details provided) |
| Endoscope Compatibility | Met required acceptance criteria (no specific details provided) |
| Introducer Sleeve Compatibility | Met required acceptance criteria (no specific details provided) |
| Simulated Use | Met required acceptance criteria (no specific details provided) |
| Trackability | Met required acceptance criteria (no specific details provided) |
| Pushability | Met required acceptance criteria (no specific details provided) |
| Flexibility/Kink Resistance | Met required acceptance criteria (no specific details provided) |
| Retraction Force | Met required acceptance criteria (no specific details provided) |
| Tensile Strength | Met required acceptance criteria (no specific details provided) |
| Fluoroscopic Visibility | Met required acceptance criteria (no specific details provided) |
| Degradation | Met required acceptance criteria (no specific details provided) |
| Biocompatibility (per ISO 10993-1:2009) | |
| MEM Elution Cytotoxicity | Met required acceptance criteria (no specific details provided) |
| Implantation | Met required acceptance criteria (no specific details provided) |
| Guinea Pig Maximization Sensitization | Met required acceptance criteria (no specific details provided) |
| 28 Day Dual Route IV/IP Systemic Toxicity | Met required acceptance criteria (no specific details provided) |
| Acute Systemic Injection | Met required acceptance criteria (no specific details provided) |
| Intracutaneous Reactivity | Met required acceptance criteria (no specific details provided) |
| Material Mediated Pyrogen | Met required acceptance criteria (no specific details provided) |
| Chemical Extractables Studies & Toxicological Risk Assessment | Met FDA's Guidance document (no specific details provided) |
| Sterilization (per ISO 11135-1) | Met Sterilization requirements (no specific details provided) |
| Ethylene Oxide Sterilization Residuals (per ISO 10993-7) | Met Ethylene Oxide Sterilization Residuals requirements (no specific details provided) |
| Minimal Strength Retention (MSR) | The device retains at least 10% of an initial strength parameter and remains intact with no breaks for 12 days. |
| Full Degradation | Full-degradation or no stent presence is reached within |
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.