FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM

• K Number: K081996
• Device Name: FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
• Manufacturer: FLEXIBLE STENTING SOLUTIONS, INC.
• Date Cleared: 2009-09-15 ( 428 days)
• Product Code: FGE
• Regulation Number: 876.5010
• Type: Traditional
• Panel: Gastroenterology/Urology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

FlexStent® Biliary Self-Expanding Stent System is indicated for the palliation of malignant strictures in the biliary tree.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a medical device (FlexStent® Biliary Self-Expanding Stent System). It confirms the device's substantial equivalence to a predicate device for a specific indication (palliation of malignant strictures in the biliary tree).

However, this document does not contain any information about acceptance criteria for device performance, study details, or ground truth establishment. The letter is solely focused on regulatory clearance based on substantial equivalence, and it explicitly states that "The safety and effectiveness of this device for use in the vascular system have not been established." This indicates that the 510(k) process relied on demonstrating equivalence to a previously approved device, rather than providing new clinical performance data against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or the number/qualifications of experts.
• Adjudication methods.
• Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth used.
• Sample size for the training set or how its ground truth was established.

This is a common characteristic of 510(k) clearances, which often do not require new clinical studies if substantial equivalence can be demonstrated through other means (e.g., performance testing, comparison to predicate device characteristics).

Regulation Number and Section

§ 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.