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K Number
K973114
Device Name
SILICONE BILIARY STENT/BILIARY CATHETER
Manufacturer
SPECIALTY SURGICAL PRODUCTS, INC.
Date Cleared
1997-09-19

(30 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

Percutaneous biliary drainage with the Biliary Stent is utilized for the management of both benign and malignant biliary obstruction. The stent is used to prevent or relieve sepsis, to relieve symptoms of obstruction such as pruritis, and to maintain a pathway for bile flow into the bowel for digestive function.

The stent is indicated for malignant biliary obstruction, such as primary bile duct or biliary tract carcinoma, pancreatic carcinoma, metastases to the porta hepatis, and other malignant conditions causing obstructive jaundice.

The stent can also be used in cases of benign biliary obstruction such as strictures secondary to primary or iatrogenic trauma pancreatitis, biliary calculi, or biliary leaks.

Device Description

Silicone Biliary Stent

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a Silicone Biliary Stent. It doesn't contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

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

  • A table of acceptance criteria and reported device performance.
  • Sample size or data provenance for a test set.
  • Number or qualifications of experts used for ground truth.
  • Adjudication method for a test set.
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
  • Whether a standalone algorithm performance study was done.
  • The type of ground truth used.
  • Sample size for the training set.
  • 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.