LogoFDA 510(k) Search
K Number
K980191
Device Name
MANAN BILIARY DRAINAGE CATHETER
Manufacturer
MEDICAL DEVICE TECHNOLOGIES, INC.
Date Cleared
1998-02-09

(20 days)

Product Code
FGE
Regulation Number
876.5010
Type
Traditional
Panel
GU
Reference & Predicate Devices
K954043
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Manan™ Biliary Drainage Catheter is for percutaneous biliary drainage.

Device Description

Manan drainage catheters are made from a biocompatible implantable urethane (Tecoflex) that has been used extensively in both short and long term implantable medical devices. This material softens at body temperature thus minimizing tissue trauma. The catheters come in various end configurations: Locking pigtail loop and non-locking pigtail. Also included with the catheters are flexible stiffening cannula. Nonflexible cannula and luer septum caps are optional items.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Manan™ Biliary Drainage Catheter). This type of document is for regulatory submission to demonstrate substantial equivalence to a predicate device, not for clinical performance studies or AI algorithm validation.

Therefore, the document does not contain the information requested regarding acceptance criteria for device performance, details of a study proving device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI.

The document describes the device, its intended use, and identifies a predicate device for substantial equivalence. It confirms regulatory clearance for marketing based on this equivalence.

§ 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.