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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 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. VaPro 2 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)
  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, (Standard and Pocket), was designed to facilitate access for those with limited dexterity. The Pocket version was designed to be discreet and easy to store.

This document is a 510(k) premarket notification for a medical device called the "Vapro 2 Intermittent Catheter." It is a request to the FDA to determine if the new device is substantially equivalent to legally marketed predicate devices.

The information provided here concerns the performance of a physical medical device (a catheter), not a software or AI-driven device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/software performance (e.g., accuracy, sensitivity, specificity, human reader improvement) is not applicable here.

The document discusses non-clinical testing to demonstrate performance and safety, which is standard for physical medical devices but doesn't align with the detailed AI/software performance metrics requested in the prompt.

Therefore, I cannot provide the requested information regarding AI/software performance metrics from this document because it is about a physical medical device and not an AI/software device.

However, I can extract information about the non-clinical testing performed for this physical device:

• Acceptance Criteria & Reported Performance (Non-Clinical Physical Properties):

  • Physical Performance Properties: VaPro 2 "met all applicable requirements of EN 1618, EN 1616 and EN 13868." (Specific thresholds not detailed in this summary).
  • Biocompatibility Testing: VaPro 2 "met the requirements of ISO 10993-1, 10993-11 and 10993-12." (Specific thresholds not detailed in this summary).
  • Sterilization: VaPro 2 "met all requirements of ISO 11137-1, ISO 11137-2, AAMI/ANSI/ISO 11737-1 and AAMI/ANSI/ISO 11737-2." (Specific thresholds not detailed in this summary).

• Sample Size Used for Test Set and Data Provenance: Not applicable in the AI/software context. For physical device testing, sample sizes would be determined by the specific ISO/EN standards cited, but these details are not provided in this summary.

• Number of Experts, Qualifications, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth, Training Set Sample Size, Training Set Ground Truth: These questions are specifically tailored to AI/software performance evaluation and are not relevant or described in this document about a physical medical device. The "ground truth" for a physical catheter's performance is typically established by laboratory testing against engineering specifications and international standards.

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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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