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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.

The VaPro 2 Plus and VaPro 2 Plus Pocket 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 Plus and VaPro 2 Plus Pocket 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
• Available with a Firmer Style Catheter (Standard packaging only with packaging differentiated as F-Style)
• Urine Collection bag
  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.
  The catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical.

The provided text describes the regulatory clearance of a medical device, the VaPro 2 Plus and VaPro 2 Plus Pocket intermittent catheters, based on substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.

The document is a 510(k) summary for a urological catheter, which is a physical medical device. The "brief description of non-clinical testing" mentions standards for physical performance (e.g., EN 1618, ISO 8669-2), biocompatibility (ISO 10993 series), and sterilization (ISO 11137 series). These are standard tests for physical medical devices to ensure safety and function, but they are not related to artificial intelligence performance, diagnostic accuracy, or human-algorithm interaction.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for training set.
9. How ground truth for the training set was established.

This document is focused on the regulatory clearance process for a physical medical device and asserts substantial equivalence, not the performance evaluation of an AI-powered diagnostic or assistive tool.

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Actreen® Hi-Lite Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by adult and pediatric patients with chronic urine retention or voiding dysfunction.

The B. Braun Actreen® Hi-Lite Intermittent Urinary Catheters include the Actreen® Hi-Lite Cath and Actreen® Hi-Lite Set. The Actreen® Hi-Lite Set is identical to the Actreen® Hi-Lite Cath, except that the Actreen® Hi-Lite Set includes a urine collection bag which is pre-attached to the catheter. The proposed devices are flexible tubular devices that are inserted through the urethra and used to pass fluids from the urinary tract. The Actreen® Hi-Lite Intermittent Urinary Catheters are offered in a 14.5 inch length, a variety of gauge sizes and straight or curved tip configurations to accommodate the individual anatomy of both male and female users. The outer packaging was designed to facilitate easier, no touch access for those with limited dexterity, while the hydrophilic lubrication makes this single use catheter ready to use.

This document is a 510(k) submission for a medical device called "Actreen® Hi-Lite Intermittent Urinary Catheters". It's a regulatory document seeking FDA approval, not a scientific study report with detailed acceptance criteria and performance metrics for a diagnostic or AI device. Therefore, the requested information elements related to AI models, ground truth, expert consensus, sample sizes for training/test sets, MRMC studies, and associated effect sizes are not applicable here.

However, I can extract the relevant information regarding performance testing that was conducted to support the substantial equivalence claim for this medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that performance testing was performed according to EN 1616: 1997 - Sterile Urethral Catheters for Single Use. The acceptance criteria would be defined within this standard. The document does not explicitly list specific numerical acceptance criteria or detailed performance results beyond stating that the testing was performed and supports substantial equivalence.

2. Sample size used for the test set and data provenance:

This document is for a physical medical device (urinary catheter), not a software or AI diagnostic. Therefore, there isn't a "test set" in the context of data used for algorithm validation. The "testing" refers to physical and biological evaluations of the catheter's materials and functionality according to established standards.

• Sample Size: Not specified in the provided summary.
• Data Provenance: Not applicable in the context of image data or clinical patient data. The testing is for the manufactured device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as there is no "ground truth" derived from expert interpretation in the context of a physical catheter's performance testing for regulatory approval.

4. Adjudication method for the test set:

Not applicable. There's no interpretive test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a physical medical device, not an AI-powered diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device.

7. The type of ground truth used:

Not applicable in the AI/diagnostic sense. The "ground truth" for a physical device's performance is determined by adherence to established engineering and biocompatibility standards (e.g., material strength, sterility, non-toxicity, fluid flow rates if measured).

8. The sample size for the training set:

Not applicable. There is no training set for a catheter.

9. How the ground truth for the training set was established:

Not applicable. There is no training set for a catheter.

Summary of what the document does provide regarding the device and its testing:

• Device: Actreen® Hi-Lite Intermittent Urinary Catheters
• Purpose of Testing: To demonstrate substantial equivalence to a predicate device (Actreen® Mini Intermittent Urinary Catheters, K151772) for FDA 510(k) clearance.
• Types of Testing Performed:
  • Biocompatibility Testing: Performed in accordance with ISO 10993-1. The classification was for surface-contacting devices on mucosal membranes, with prolonged exposure (greater than 24 hours but less than 30 days).
  • Performance Testing: Performed according to EN 1616: 1997 - Sterile Urethral Catheters for Single Use.
• Conclusion: Based on the results of biocompatibility and performance testing, the proposed device is considered substantially equivalent to the predicate devices.

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