Search Results

The VaPro™ 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 Plus™ 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 intermittent catheter is a hydrophilic coated, single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter comes in a protective sleeve and is offered with a protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion. The packaging contains a vapor strip that hydrates the catheter coating which then lubricates the catheter. The outer packaging was designed to facilitate access for those with limited dexterity.
The VaPro Plus has the addition of a collection bag that is connected to the catheter for use when drainage into a suitable receptacle is not feasible or practical.

This document describes a 510(k) premarket notification for the VaPro™ intermittent catheter and VaPro Plus™ intermittent catheter, submitted by Hollister Incorporated. The FDA determined the device is substantially equivalent to legally marketed predicate devices.

The information provided does not describe the acceptance criteria, reported device performance, or a study that specifically proves the device meets acceptance criteria in the manner typically presented for AI/ML devices outlining metrics like sensitivity, specificity, or AUC, as requested in your prompt. This document pertains to the regulatory clearance of a physical medical device (an intermittent catheter), not a software or AI/ML algorithm.

Therefore, many of the specific questions you asked are not applicable to the content of this regulatory submission. However, I can extract the relevant information regarding performance testing that was submitted to the FDA for this device.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of quantitative acceptance criteria and reported device performance in the format of specific metrics (e.g., accuracy, sensitivity, specificity, etc.) typically associated with AI/ML systems. Instead, the performance evaluations are related to the safety and functionality of the physical catheter.

Summary of Performance Testing Conclusions:

• Biocompatibility: Complied with ISO 10993 standards based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1.
• Product Evaluation: Supports device functionality.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The filing mentions "biocompatibility testing" and "product evaluation" but does not detail the sample sizes, data provenance, or specific methodologies (like retrospective or prospective studies) in the context of human data. The testing mentioned would likely involve laboratory tests on the device materials and components, not a "test set" of patient data for evaluating an algorithm's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable/not provided. Ground truth establishment by experts, especially in the context of image interpretation or clinical outcomes, is relevant for AI/ML studies. For a physical medical device like a catheter, "ground truth" would relate to its physical properties, material safety, and functional performance, which are assessed through laboratory and possibly limited human user studies, not typically by expert consensus on a "test set" in the radiological or pathological sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. Adjudication methods are used to resolve discrepancies in expert interpretations when establishing ground truth for evaluating AI/ML algorithms. This concept does not apply to the biocompatibility and functionality testing of a physical medical device as described.

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

This information is not applicable/not provided. MRMC studies are used to evaluate diagnostic imaging systems and AI/ML algorithms in a clinical setting by comparing human reader performance with and without AI assistance. This device is an intermittent catheter, not a diagnostic imaging system or an AI/ML diagnostic tool.

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

This information is not applicable/not provided. Standalone performance is relevant for AI/ML algorithms. This document concerns a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "Performance Testing Conclusions" mentioned:

• Biocompatibility: The "ground truth" would be established by the ISO 10993 standards and FDA guidance (#G95-1), which define acceptable biological responses and material safety profiles. Compliance with these standards is determined through specific laboratory tests, not expert consensus in the clinical sense, pathology, or outcomes data in the usual context of AI/ML evaluation.
• Product evaluation: The "ground truth" for device functionality would be based on engineering specifications and performance requirements relevant to a medical catheter (e.g., flow rates, material tensile strength, durability, ease of use, lubricity).

8. The sample size for the training set

This information is not applicable/not provided. The concept of a "training set" belongs to AI/ML development. This document describes a physical medical device.

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

This information is not applicable/not provided. As above, "training set" and its ground truth are concepts for AI/ML.

In summary: The provided document is an FDA 510(k) clearance letter for a physical medical catheter. It describes the device, its intended use, and indicates that biocompatibility and product evaluation were performed to establish substantial equivalence to predicate devices. It does not contain the specific performance metrics or study designs typically requested for AI/ML device evaluations.

Ask a specific question about this device

The VaPro Plus 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 Plus intermittent catheter is a hydrophilic coated single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter comes in a protective sleeve and is offered with a protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion. The packaging contains a vapor strip that hydrates the catheter coating which then lubricates the catheter. The outer packaging was designed to facilitate access for those with limited dexterity. The catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VaPro™ Plus Intermittent Catheter:

The document provided is a 510(k) Summary for the VaPro™ Plus Intermittent Catheter,
which primarily aims to demonstrate substantial equivalence to previously cleared predicate
devices. As such, the information typically requested for AI/ML device evaluations (e.g.,
detailed performance metrics, sample sizes for test/training sets, expert qualifications for
ground truth, MRMC studies) is not present. This type of submission focuses on
demonstrating that the new device has the same intended use and similar technological
characteristics to existing devices, and that any differences do not raise new questions of
safety or effectiveness.

Therefore, the requested information cannot be fully provided based on the given text.
However, I can extract the information that is present and explain why other details are
missing in this specific context.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit via Substantial Equivalence): The primary acceptance
criterion for a 510(k) submission is demonstrating "substantial equivalence" to a legally
marketed predicate device. This means the device must have the same intended use and the
same technological characteristics, or, if there are differences in technological
characteristics, these differences must not raise different questions of safety and
effectiveness, and the device must be safe and effective.

The performance is implicitly measured against the predicate devices for each
characteristic.

Study Proving Acceptance Criteria:
The study that proves the device meets the (implicit) acceptance criteria for a 510(k)
submission is the "Performance Testing," which consists of:

• Biocompatibility testing: Performed based on FDA G95-1 and ISO 10993 standards.
• Product evaluation: To demonstrate device functionality.

The submission concludes that "Results indicate compliance to the standard" for
biocompatibility and "Product evaluation also supports device functionality." This is the
evidence presented to support the device's acceptable performance and safety/effectiveness
relative to its substantial equivalence claim.

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

• Sample size for the test set: Not specified in the provided document. The 510(k)
  summary focuses on substantial equivalence of design and materials, not clinical
  performance metrics derived from a "test set" in the context of AI/ML or diagnostic
  device evaluation.
• Data provenance: Not specified. Biocompatibility and product functionality testing
  are typically performed in a laboratory setting, not with human patient data.

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

• Number of experts: Not applicable. This information pertains to expert-defined
  ground truth, which is not relevant for the type of testing (biocompatibility,
  functionality) described for this device.
• Qualifications of experts: Not applicable for the reasons above.

4. Adjudication method for the test set

• Adjudication method: Not applicable. There is no "test set" in the AI/ML or
  diagnostic sense requiring expert 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

• MRMC study: No. This is not an AI-assisted diagnostic or imaging device, so MRMC
  studies are not relevant. This is a physical medical device (catheter).
• Effect size: Not applicable.

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

• Standalone performance: Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

• Type of ground truth: For biocompatibility, the "ground truth" is compliance with
  established international standards (ISO 10993) and FDA guidance (G95-1). For
  functionality, it's meeting predefined engineering specifications and functional tests
  for the catheter. There is no "expert consensus," "pathology," or "outcomes data" in
  the traditional sense used as ground truth for this type of device submission.

8. The sample size for the training set

• Sample size for the training set: Not applicable. This is not an AI/ML device, so
  there is no "training set."

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

• How ground truth was established: Not applicable.

Ask a specific question about this device