FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Manan D Bag is a 600 ml drainage bag to be used for biliary, nephrostomy and other fluid drainage procedures. The bag has a twist close closure at the bottom for allowing the fluid to drain out. The bag is manufactured from either SP 2255, (an Ethylene Methyl Acrylate Copolymer film) or PVC. The catalog number will be DBAG 600 when Ethylene Methyl Acrylate Copolymer film is used, and DBAG 600V when PVC is used. The bag itself has a backing made from a non-woven polyester. This backing provides comfort for the patient. This backing will be optional on the product. A tube made from silicon is attached to the bag at one end and has a luer lock at the other for attaching to the drainage catheter. The preferred length of this tube is 30 ins. Other lengths between 24 and 42 ins. could possible be used in the future. An adjustable Velcro strap with some elasticity is supplied with the bag so it can be hung about the patient's waist, leg or shoulder.

AI/ML Overview

This document is a 510(k) summary for the Manan™ D Bag, a medical device used for fluid drainage. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information from a study with acceptance criteria or device performance data.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
MRMC comparative effectiveness study or its effect size.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This document is a regulatory submission for premarket clearance, not a performance study report. Its purpose is to show that the new device is as safe and effective as a legally marketed predicate device, primarily through comparison of design, materials, and intended use, rather than through extensive clinical or performance testing data as you've requested.

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K Number

K961986

Device Name

MANAN D BAG

Manufacturer

MANAN MEDICAL PRODUCTS, INC.

Date Cleared

1997-03-13

(296 days)

Product Code