(133 days)
The PORGES™ Ureteral catheters are used for ureteral catheterisation:
- drainage catheters: straight catheters with bevel, olive or cylindrical tip, elbowed catheter with olive tip
- catheters for retrograde ureteropyelography (R.U.P.): Chevassu, cone or Braasch -
- interventional catheters: flush, open straight, open elbowed. The appropriate quide-wire size for each catheter is shown on the box.
The PORGES™ Ureteral catheters consist of a single lumen catheter in medical grade radiopaque polymer, graduated every cm along 50 cm, and fitted with either a metal or a polymer removable stylet or no stylet. The stylet allows straightening of the catheter for easier insertion. A wax knob is added on the external end of the stylet for easy retreat of the coudé tip catheters are fitted with a silicone stop ring on the stylet between the catheter and the wax knob to hold the renal tip of the stylet away from the catheter's renal tip.
The ureteral catheters are available with different types of renal tips and in sizes ranging from 03 FR to 12 FR.
The preamendment devices have been designed for R.U.P. (retrograde ureteropyelography).
PORGES has validated the following uses for the new range of ureteral catheters :
- . drainage
- R.U.P. (= retrograde uretero pyelography) .
- interventional ("per operating") use with a Seldinger guide wire (not supplied)
The PORGES™ Ureteral catheters are supplied sterile and for single use only.
The provided text is a 510(k) summary for the PORGES™ Ureteral catheters. It does not describe an AI/ML powered device, but rather a traditional medical device (catheters). Therefore, many of the requested details, such as those pertaining to AI model performance, multi-reader multi-case studies, and ground truth establishment for AI training sets, are not applicable and cannot be extracted from this document.
However, I can provide the relevant information regarding the device's acceptance criteria and the study that proves it meets them, based on the provided text.
Acceptance Criteria and Device Performance for PORGES™ Ureteral Catheters
The PORGES™ Ureteral catheters are traditional medical devices, and their acceptance criteria and proof of compliance are based on demonstrating substantial equivalence to predicate devices through technical characteristics and performance testing, rather than AI/ML model performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Specifications) | Reported Device Performance (Test Results) |
|---|---|
| Functional Performance: | |
| - Flow rate | Successfully passed, demonstrating substantial equivalence to predicate devices. |
| - Tensile strength | Successfully passed, demonstrating substantial equivalence to predicate devices. |
| - Tear strength of bulbs (for Chevassu and cone-tip catheters) | Successfully passed, demonstrating substantial equivalence to predicate devices. |
| - Passage of contrast medium | Successfully passed, demonstrating substantial equivalence to predicate devices. |
| Biocompatibility: | Successfully passed biocompatibility testing per ISO 10993-1. |
| Material Equivalence: | Similar materials (medical grade thermoplastic like polyvinyl chloride, polyamide, polyurethane, PEBA) to predicate devices. The choice of material provides a slight difference in stiffness but "does not affect clinical properties." |
| Tip Performance: | The straight open tip of interventional ureters allows placement over a guide-wire, performing similarly to the "straight whistle tip of both Porges' and Bard's currently marketed catheters." |
| Design and Manufacturing: | Held to the same design, manufacture, and performance specifications as the predicate devices. |
| Safety and Effectiveness: | Confirmed by biocompatibility and mechanical/physical tests; device performs "as well as or better than the predicate devices." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify exact sample sizes for the mechanical/physical and biocompatibility tests. It broadly states that "The PORGES™ Ureteral catheters referenced in this submission are held to the same design, manufacture, and performance specifications as the predicate devices." Testing was performed on the PORGES™ Ureteral catheters to demonstrate substantial equivalence.
- Sample Size: Not explicitly stated for specific tests.
- Data Provenance: The tests were conducted on the PORGES™ Ureteral catheters themselves, manufactured by PORGES S.A. in France. The study is prospective in the sense that the new device was tested against established standards and predicates.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a physical medical device, not an AI/ML algorithm. "Ground truth" in this context refers to established engineering and biocompatibility standards, not expert consensus on image interpretation or similar AI-related tasks.
4. Adjudication Method for the Test Set
This information is not applicable as the device is a physical medical device. Test results for mechanical, physical, and biocompatibility properties are typically objective measurements against defined thresholds, not subjective evaluations requiring 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
This information is not applicable as the device is a physical medical device, not an AI/ML system, and therefore, an MRMC study related to AI assistance would not have been conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical medical device, not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" (or basis for evaluation) for this device is based on established engineering and material science standards and pre-clinical laboratory tests. This includes:
- Objective measurements: for flow rate, tensile strength, tear strength, and passage of contrast medium. These are quantitative assessments against predefined specifications for the device's functional performance.
- Biocompatibility standards: specifically ISO 10993-1.
- Comparison to predicate devices: The "ground truth" for substantial equivalence often means demonstrating performance "as well as or better than" legally marketed predicate devices, which have a known history of safe and effective use.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical medical device, not an AI/ML system. There is no "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is a physical medical device, not an AI/ML system.
§ 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.