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

The catheters are comprised of a 2 lumen shaft with proximal funnel, inflation valve and distal retaining balloon. One lumen is for draining fuleds to and from the urinary tract. The second lumen is to inflate and deflate the balloon. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. The balloon fill volumes in ml and shaft size in French Gauge (Fr), Charriere (Ch) or millimeter (mm) are indicated on the funnel of each individual cathter and the distal tip type can be indicated on the individual pack label and / or outer carton. Sizes range from 6 to 30 Ch / Fr.

AI/ML Overview

The provided text describes a 510(k) submission for the SunMed Foley Catheter, which is a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for clinical studies that establish acceptance criteria for an AI/algorithm-driven device.

Therefore, the input does not contain the information necessary to answer the questions about acceptance criteria and a study proving device performance as typically understood for AI/algorithm devices.

Specifically, the document discusses:

Intended Use: Draining fluids to and from the urinary tract.
Product Description: Two-lumen shaft with proximal funnel, inflation valve, and distal retaining balloon.
Predicate Device: Rusch Silicon Coated Foley Catheter (K980870).
Substantial Equivalence: Claimed due to equivalent intended use, manufacturing materials, operating principles, and physical, operational, and biological specifications.

There is no mention of an AI/algorithm, performance metrics, acceptance criteria, test sets, ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies.

In summary, the provided document relates to a traditional medical device (Foley catheter) and does not include the details required to answer your specific questions, which are geared towards the evaluation of AI/algorithm-driven medical devices.

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K Number

K955632

Device Name

ORTHOPLUG SOFT BONE DESIGN

Manufacturer

SUNMED, INC.

Date Cleared

1996-02-27

(78 days)

Product Code