(30 days)
The Cordis S.M.A.R.T. ™ .018" Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The Cordis S.M.A.R.T. ™ .018" Nitinol Stent Transhepatic Biliary System is a system consisting of a self-expanding, open mesh, nitinol stent preloaded onto a sheathed delivery catheter. The delivery system is designed to deliver the stent to the stricture site via transhepatic access. Once positioned at the stricture site, the sheath is withdrawn and the stent is released. Upon release, the stent expands and conforms to the inner lumen of the biliary duct.
The provided text is a 510(k) submission for a medical device (Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System) seeking clearance from the FDA. This type of submission is focused on demonstrating substantial equivalence to a previously legally marketed device, rather than proving efficacy through clinical trials with specific acceptance criteria and performance metrics as would be seen for AI/ML-based devices.
Therefore, the information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not present in this document because it is not relevant to a 510(k) submission for this type of device. The clearance is based on pre-clinical testing demonstrating equivalence to the predicate device, not on specific clinical performance metrics.
Specifically, the document states:
- "The Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System is substantially equivalent to the predicate device. The equivalence was confirmed through pre-clinical testing."
A 510(k) for a stent, especially one from 1999, would typically involve:
- Mechanical and material testing: Demonstrating strength, fatigue resistance, corrosion resistance, and other physical properties of the stent are equivalent to or better than the predicate.
- Biocompatibility testing: As mentioned, "All materials used... are biocompatible." This involves standard ISO 10993 tests.
- Delivery system performance: Evaluation of the catheter's ability to navigate, deploy, and retrieve (if applicable) the stent.
- Dimensional equivalency: Ensuring the stent and delivery system dimensions are comparable to the predicate.
Therefore, I cannot provide the requested information for acceptance criteria and the study that proves the device meets them because the provided text describes a 510(k) premarket notification for a physical medical device (a stent) and does not contain the details of an AI/ML study, performance metrics, or clinical acceptance criteria as would be needed for software or AI/ML evaluations.
§ 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.