Search Results

The Ready-to-use Hydrophilic Catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder -voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.

The Ready-to-Use Hydrophilic Catheter is a single use, disposable polyurethane catheter. It is coated and placed in the water, packed and sealed in a foil bag and sterilized. The catheter is prelubricated with a coating containing polyvinylpyrrolidone, which binds the water molecules to the surface of the catheter creating a smooth and even lubricating film. The Ready-to-Use Hydrophilic Catheter is available for men, women and children, in three different tip configurations of Nelaton (straight and rounded), Tapered (curved and tapered) and Olive (curved and olive), in single or combination with an insertion aid (a sleeve) which provides an easy grip, allowing for insertion without touching. There are two polished drainage eyelets on the catheter in various configurations and types. The Tiemann catheter has a bended tip along with a guide stripe (in the shaft) and/or aligned with a raised ridge (on the funnel), which will help ensure the catheter tip is still correctly oriented when approaching the bladder.

The provided text describes a 510(k) premarket notification for a "Ready-to-Use Hydrophilic Catheter." The acceptance criteria and the study that proves the device meets them are outlined in the "Summary of Non-Clinical Testing" section (page 6).

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All tests met the pre-determined acceptance criteria." It does not provide specific numerical acceptance criteria or detailed numerical performance results for each test. Instead, it lists the properties tested and the standards used.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for the non-clinical bench testing. It also does not discuss data provenance in terms of country of origin or whether studies were retrospective or prospective, as these are non-clinical bench tests, not clinical studies involving human subjects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable. The tests conducted were non-clinical bench tests (e.g., strength, flow rate, biocompatibility) based on international and internal standards, which do not involve expert consensus for ground truth determination in the same way clinical studies with human subjects or image analysis algorithms would. The "ground truth" for these tests is defined by the objective pass/fail criteria established within the cited standards.

4. Adjudication Method for the Test Set:

This information is not applicable for non-clinical bench tests. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert reviews where there's a need to resolve discrepancies among multiple human readers or observers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical performance testing of the device itself, not a study evaluating human readers' performance with or without AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable as the device is a physical medical catheter, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to report.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is based on objective measurements and established pass/fail criteria defined by the relevant international standards (e.g., ISO 20696, ASTM D 1894, ISO 10993-1, AAMI/ANSI/ISO 11137, ASTM F1980) and the manufacturer's internal methods for coating adhesion.

8. The Sample Size for the Training Set:

This question is not applicable as the device is a physical medical catheter and does not involve a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reason as point 8.

Ask a specific question about this device