(102 days)
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
| Acceptance Criteria / Performance Requirement | Reported Device Performance |
|---|---|
| Flow rate through the drainage lumen | Device meets performance requirements via testing. |
| Resistance of the balloon to rupture (claimed volume, 7 days usage environment) | Device meets performance requirements via testing. |
| Resistance of inflated balloon to distortion/pull-through from bladder outlet | Device meets performance requirements via testing. |
| Maintenance of balloon inflation to fill volume over extended time | Device meets performance requirements via testing. |
| Manufacturing tolerances for catheter tip, balloon, and shaft diameters | Device meets performance requirements via testing. |
| Ability of inflated catheter (7 days submerged) to reliably deflate to ≤ 4 Fr. sizes of labeled shaft size, including deflation time | Device meets an applicable performance requirement via testing. |
| Shaft tensile strength | Device meets performance requirements via testing. |
| Tip adherence | Device meets performance requirements via testing. |
| Balloon burst | Device meets performance requirements via testing. |
| Biocompatibility (per ISO 10993-1) | Device passes biocompatibility testing per ISO 10993-1. |
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.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.