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This intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.

This submission is to add an additional size (Fr 08) to the currently cleared 16-inch Pocket and Plus Pocket configurations of VaPro 2.

The VaPro 2 Pocket Line Extension is a hydrophilic coated, single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. VaPro 2 Pocket Line Extension has the following features:

• Hydrophilic-coated PVC catheter (phthalate free)
• Two smooth catheter eyelets
• Protective sleeve
• Protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion
• Color-coded funnel.
• Urine Collection bag (for the Plus Pocket version)

The packaging contains a sealed water compartment chamber from which the water migrates to the catheter compartment and hydrates (lubricates) the catheter. The outer packaging is designed to facilitate access for those with limited dexterity. The Pocket version is designed to be discreet and easy to store. In the Plus Pocket configuration, the urinary catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical.

The provided text is a 510(k) summary for a medical device (VaPro 2 Pocket Line Extension, a urological catheter). It outlines the device's characteristics, intended use, and a comparison to predicate and reference devices. However, this document does not contain any information about a study proving the device meets acceptance criteria related to standalone or human-in-the-loop AI performance, nor does it discuss ground truth establishment, expert consensus, or sample sizes for AI model training or testing.

The document details the following non-clinical testing for the catheter:

• Physical performance properties: Met requirements of EN 1618, EN 1616, EN 13868. The Plus Pocket version also met ISO 8669-2 and ASTM-D1003-13.
• Biocompatibility testing: Met requirements of ISO 10993-1, 10993-5, 10993-12. The Plus Pocket version also met ISO 10993-11.
• Sterilization: Met requirements of ISO 11137-1, ISO 11137-2, AAMI/ANSI/ISO 11737-1, and AAMI/ANSI/ISO 11737-2.

This information refers to traditional medical device performance and safety testing, not the type of studies typically conducted for AI/ML-based medical devices (e.g., diagnostic algorithms, image analysis software). Therefore, I cannot extract the requested information about AI model acceptance criteria, study methodologies, or performance metrics from this document.

For a K-number submission like this, the device is considered substantially equivalent to a predicate device, meaning it has the same intended use and similar technological characteristics, and any differences do not raise different questions of safety and effectiveness. The "acceptance criteria" here are that the physical and biological characteristics of the new device are comparable to those of the predicate device and meet relevant performance standards, as indicated by the brief description of non-clinical testing.

If you are looking for information regarding AI model validation in FDA submissions, you would typically find it in K-numbers for devices that explicitly leverage artificial intelligence or machine learning for their primary function, such as diagnostic assistance or image interpretation. This document does not describe such a device or study.

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