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The catheter is indicated for use by patients with urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is for male patients only.

The SpeediCath Flex Coudé catheter is a sterile single use hydrophilic coated polyurethane catheter for men. The catheter is to be used for intermittent drainage of the bladder through the urethra by males with missing or reduced bladder control. The catheter has a flexible bendable tip that facilitates passage through the urethra to the bladder. The catheter is shielded by a sleeve, which serves as protection from the user's touch during insertion.

Here is an analysis of the provided FDA document regarding the SpeediCath Flex Coudé device, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria / Performance Aspect	Reported Device Performance
   Bench Testing
   Flow rate	Passed (according to EN1616/EN1618 & ASTM F623-99:2013)
   Coefficient of friction	Passed (according to ASTM D1894:2014)
   Tensile strength	Passed (according to EN1616/EN1618)
   Connector security	Passed (according to EN1616)
   Biocompatibility	Passed (according to ISO 10993-1 and applicable parts of FDA Blue Book Memorandum #G95-1)
   Clinical Performance (Cadaver Study)
   Insertion & navigation in difficult male urethral anatomies	Comparable to a standard coudé catheter in terms of insertion and navigation through difficult male anatomies (enlarged prostate and strictures). Implies meeting performance equivalent to established devices for these challenging cases.
   Clinical Performance (Clinical Evaluation of Published Data)	Safety and efficacy profile equivalent to the predicate and reference devices.

   Note: The document states "All tests passed" for the bench performance data, implying that the acceptance criteria for each of these tests were met.

2. Sample Size and Data Provenance

   • Test set (cadaver study): The document mentions "male cadavers with difficult urethral anatomies." It does not specify the exact number of cadavers used.
   • Data Provenance (cadaver study): Not explicitly stated, but implies a laboratory setting for the "pre-clinical study." It is a prospective observational study in a pre-clinical setting.
   • Clinical Evaluation: Based on "available published data," which would be retrospective analysis of existing clinical literature. No specific sample size mentioned for this review beyond the studies themselves.

3. Number of Experts and Qualifications for Ground Truth

   • Cadaver Study: The document does not specify the number of experts or their qualifications involved in establishing "ground truth" or evaluating insertion/navigation in the cadaver study. It only states the device "was comparable to a standard coudé catheter." This comparison would likely have been made by experienced individuals, but their number and specific qualifications are not detailed.
   • Clinical Evaluation: For the "clinical evaluation of available published data," the "experts" would be the authors of the published studies being reviewed. The document does not state how many individuals conducted this literature review or their qualifications.

4. Adjudication Method for the Test Set

   • The document does not describe any formal adjudication method (like 2+1 or 3+1) for the cadaver study or the clinical evaluation. The comparison in the cadaver study ("comparable to a standard coudé catheter") implies a direct observation and assessment, but multi-reader adjudication is not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

   • No MRMC comparative effectiveness study involving human readers with and without AI assistance was performed. This device is a medical device (catheter) for physical use, not an AI diagnostic/interpretive tool.

6. Standalone Performance (Algorithm Only)

   • Not applicable. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

   • Bench Testing: Engineering measurements and adherence to specified standards (e.g., ASTM, EN, ISO).
   • Cadaver Study: Direct observation and assessment of the device's physical performance (insertion and navigation) in anatomical models (cadavers) with known difficult anatomies (enlarged prostate and strictures). The "ground truth" is the physical reality of successful navigation and the comparative ease with a predicate.
   • Clinical Evaluation: Clinical outcomes and safety profiles reported in existing published literature for predicate and reference devices.

8. Sample Size for the Training Set

   • Not applicable as this is a physical medical device, not a machine learning algorithm. The "development" or "training" would refer to design iterations and engineering evaluations, not a data-driven training set in the AI sense.

9. How the Ground Truth for the Training Set was Established

   • Not applicable for the same reason as point 8. The "ground truth" for the device's design would stem from engineering principles, user needs, and clinical requirements for urinary catheterization.

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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.

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