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The 2-way PORGES™ FOLYSIL™ silicone Foley catheter is used for urethral urinary catheterisation for short term drainage of vesical urines. Only straight 2-way PORGES™ FOLYSIL™ silicone Foley catheter with a maximum 15 ml balloon volume may be used in a supra-pubic way (except the grooved catheters). The 3-way PORGES™ FOLYSIL™ silicone Foley catheter is used for urethral urinary catheterisation to allow short term drainage of the vesical urines, irrigation/injection following surgery.

The PORGES™ FOLYSIL™ silicone Foley catheter is of the retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate the balloon with sterile water. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. Sterile water is used for inflation of the balloon. The distal end has opposite eye holes, which are used for drainage. On the Tiemann tip there is one hole. Straight cylindrical, "over the guide wire" and Tiemann tips are available versions of this product. On the opposing end of the shaft, are a connecting funnel and a Luer activated valve. This product is available in sizes 12 Fr to 24 Fr, smooth and profile (grooved) shafts. Profile shafts provide drainage channels along the shaft length.

PORGES™ FOLYSIL™ silicone Foley catheter - Acceptance Criteria and Study Details

The provided document describes the acceptance criteria and testing for the PORGES™ FOLYSIL™ silicone Foley catheter, primarily referencing the FDA "Guidance for the content of premarket notifications for conventional and antimicrobial Foley catheters" dated September 12, 1994, and ASTM F 623-89.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that the device "meets the following performance requirements per testing conducted," implying all items listed are successfully met. Specific quantitative performance values are not provided in this summary.

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

The document does not specify the exact sample sizes used for each individual test. It broadly states that "testing conducted according to ASTM F 623-89, when appropriate, and/or PORGES testing/acceptance criteria" was performed.

• Data Provenance: The studies were conducted by PORGES S.A. based on established US FDA guidance and ASTM standards. The country of origin for the data is implicitly France, where PORGES S.A. is located, and the testing was conducted as part of their 510(k) submission to the US FDA. The studies are prospective in the sense that they were conducted specifically for the submission to demonstrate compliance.

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

This section is not applicable. The device is a physical medical device (catheter), and the "ground truth" for its performance is established through physical and mechanical testing against predefined engineering and biocompatibility standards, not through expert consensus on interpretation.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data interpretation (e.g., medical images). The testing involves objective physical measurements and adherence to specified performance limits.

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

This section is not applicable. The device is a physical medical device (catheter), not an AI algorithm intended for diagnostic interpretation that would involve human readers. Therefore, an MRMC study and AI assistance effect size are not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This section is not applicable. The device is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for the device's performance is based on:

• Established engineering standards: Specifically, ASTM F 623-89, which details test methods for Foley catheters.
• Biocompatibility standards: ISO 10993-1, which outlines biological evaluation of medical devices.
• FDA guidance: The "Guidance for the content of premarket notifications for conventional and antimicrobial Foley catheters" dated September 12, 1994, provides the framework and specific performance expectations.
• Internal PORGES testing/acceptance criteria: These would likely be derived from or in alignment with the above external standards and guidance.

These standards define objective, measurable physical and material properties that the device must exhibit to be considered safe and effective for its intended use.

8. Sample Size for the Training Set

This section is not applicable. The device is a physical medical device, not an AI algorithm requiring a training set of data.

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

This section is not applicable, as there is no training set for a physical medical device.

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