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The Cure Dextra® Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Catheter® Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Dextra® and Cure Catheter® Closed System catheters are intermittent urinary catheters intended to be used by males and females for the purpose of bladder drainage. They are manufactured with conventional medical grade, biocompatible materials that are not made with natural rubber latex. The tip has been designed to minimize trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages.

The subject devices are pre-lubricated catheter systems that allow for patient convenience when catheterization is required. The Closed System catheter is attached to a collection bag and features polished eyelets on a straight or Coudé catheter tip. The Dextra catheter will advance from the bag with every forward stroke while the rearward strokes allow for the mechanism to get a new grip on the catheter. The urine collection bag of the Dextra catheter is reduced from 1500 ml in the predicate Closed System to 1000 ml to make it compact and portable.

This document does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of an AI/ML medical device. It is a 510(k) premarket notification for a urological catheter, a physical medical device.

Therefore, I cannot provide the requested information about acceptance criteria, performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as these concepts apply to the evaluation of AI/ML algorithms.

The document discusses:

• Device Name: Cure Dextra® and Cure Catheter® Closed System
• Device Type: Intermittent urinary catheter
• Regulation Number: 21 CFR 876.5130 (Urological Catheter and Accessories)
• Predicate Device: Cure Catheter® Closed System (K080881)
• Non-Clinical Performance Testing: A summary of tests performed to demonstrate substantial equivalence, including sterilization validation, biocompatibility, sterile packaging, shelf-life, packaging integrity, diameter/shaft length, flow rate, tensile strength, and kink stability testing. These are standard tests for physical medical devices and not related to AI/ML performance.

The submission concludes that the subject devices are substantially equivalent to the predicate device based on these non-clinical performance tests.

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