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K Number
K973171
Device Name
NIR BILIARY STENT
Manufacturer
MEDINOL LTD.
Date Cleared
1998-11-13

(445 days)

Product Code
FGE
Regulation Number
876.5010
Type
Traditional
Panel
Gastroenterology/Urology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The NIR Biliary Stent is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

Device Description

The proposed NIR™ Biliary Stent is a balloon expandable stent designed to be used with a balloon dilatation catheter. The delivery catheter facilitates transhepatic access to the biliary tree and the stent is designed to maintain luminal patency of biliary strictures produced by malignant neoplasms.

AI/ML Overview

The provided text describes a medical device, the NIR™ Biliary Stent, and its FDA clearance (K973174). However, it does not contain information related to acceptance criteria, device performance metrics, or a study evaluating the device against such criteria.

The document details:

  • The device's name and manufacturer.
  • Its classification and predicate devices.
  • A brief description of its intended use (maintaining luminal patency of biliary strictures produced by malignant neoplasms).
  • A general statement about safety and performance, mentioning "Functional and integrity bench testing and Biocompatibility testing" were performed and supported substantial equivalence.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them from the provided text. The document states that "data supported the substantial equivalence of the NIRTM Biliary Stent to the predicate devices," but it does not elaborate on what that data was, what the acceptance criteria were, or the specifics of any studies.

§ 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.