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510(k) Data Aggregation
(20 days)
The Manan™ Biliary Drainage Catheter is for percutaneous biliary drainage.
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.
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.
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(210 days)
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