(142 days)
The Cordis Biliary Stent intended ↓se is to maintain patency of a bile duct which is obstructed from malignant neoplasms.
The Cordis Biliary Stent is a helical coil made of flexible radiopaque 5400 Grade Tantalum (Ta). The stent is available in 7.0 mm diameter size. The nominal expanded length of the stent is 1.5 cm and 3.0 cm. The stent is supplied mounted and crimped onto a balloon catheter delivery system, the size of which determines the delivered diameter of the stent.
The provided text describes a medical device (Cordis Biliary Stent) and its intended use, but it does not contain information about acceptance criteria, a specific study proving it meets those criteria, or details regarding AI/algorithm performance. Therefore, I cannot generate the requested table and information.
The document is a "Summary of Safety and Effectiveness" from 1996, which is a regulatory filing for a conventional medical device, not an AI or algorithm-based device. It focuses on demonstrating substantial equivalence to predicate devices through design, construction, indication for use, and performance characteristics (evaluated via in-vitro and in-vivo testing), rather than setting and proving performance against specific acceptance criteria in the manner you've described for AI/algorithm studies.
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MAY
-8 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
General Provisions -
Biliary Stents Common or Usual Name:
Cordis Biliary Stent Proprietary Name:
11. Name of Predicate Devices
Classification lll.
Class II, 21CFR 876.5010, Biliary Catheters and Accessories.
IV. Performance Standards
Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
V. Intended Use and Device Description
The Cordis Biliary Stent intended ↓se is to maintain patency of a bile duct which is obstructed from malignant neoplasms.
The Cordis Biliary Stent is a helical coil made of flexible radiopaque 5400 Grade Tantalum (Ta). The stent is available in 7.0 mm diameter size. The nominal expanded length of the stent is 1.5 cm and 3.0 cm. The stent is supplied mounted and crimped onto a balloon catheter delivery system, the size of which determines the delivered diameter of the stent.
VI. Biocompatibility
All appropriate biocompatibility tests as specified by ISO 10993 Part 1 - Biological Evaluation of Medical Devices, were successfully performed on the Cordis Biliary Stent.
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VII. Summary of Substantial Equivalence
The Cordis Biliary Stent is similar in its basic design, construction, indication for use and performance characteristics to other commercially available biliary stents. In-vitro and in-vivo testing was conducted to support substantial equivalence to the predicate devices.
ALLARIA
§ 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.