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K Number
K033497
Device Name
BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM
Manufacturer
C.R. BARD, INC.
Date Cleared
2004-02-04

(91 days)

Product Code
FGE
Regulation Number
876.5010
Type
Special
Panel
GU
Reference & Predicate Devices
K020682
Predicate For
K063532,K082093
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Bard® LUMINEXX™ 3 Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

Device Description

The Bard® LUMINEXX™ 3 Biliary Stent and Delivery System is a stenting device, designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes a self-expanding Bard® LUMINEXX™ 3 biliary stent pre-loaded on a flexible delivery system. Highly radiopaque markers on the ends of the stent facilitate stent placement. The Bard® LUMINEXX™ 3 Biliary Stent and Delivery System is available in several diameters and lengths.

AI/ML Overview

The provided text does not contain information about acceptance criteria, device performance metrics, or a study demonstrating that the device meets such criteria. The document is a 510(k) premarket notification letter for the Bard® LUMINEXX™ 3 Biliary Stent and Delivery System, which focuses on establishing substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information. The text does not include details on:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size for the test set or data provenance.
  3. Number of experts used to establish ground truth or their qualifications.
  4. Adjudication method for the test set.
  5. A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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.