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Standard versions: Drainage of the upper urinary tract over fistulas or ureteral obstructions (e.g. periureteral tumour), Cicatrisation stent. Reinforced versions: Management of ureteral stenoses, Partial enlargement of the diameter: localised stenoses connected with ureteropelvic junction syndrome, Total enlargement of the diameter: stenoses over all or part of the ureter.

The PORGES™ Silicone double loop ureteral stents are supplied in kits, containing the following components: A double loop ureteral stent and an obturator, A guide-wire, where applicable, A pusher (where applicable supplied with a clamp). The catheter is manufactured entirely from silicone elastomer. The ureteral stents are made of the same yellow silicone tubing as the predicate silicone ureteral stent. They are steerable or non-steerable, and radiopaque. Most references are available in 06/07/08 CH/Fr and in different lengths, ranging from 12 to 30 cm. Renal and vesical loops may be either closed or open. The straight section may be totally or partially reinforced. The eyes are lateral and staggered and are situated every 2 cm along the entire length of the stent (except for the no eye on the straight section version). The ureteral stents have either a fixed core guide-wire, a movable core guide-wire or no guide-wire, depending upon the method of use. The steerable ureferal stents have connectable pushers, and the non-steerable stents have simple pushers. The ureteral stent kits are supplied sterile and for single use only.

The provided text is a 510(k) summary for the PORGES™ Silicone double loop ureteral stent. It confirms substantial equivalence to predicate devices based on design, manufacturing, and performance specifications, and biocompatibility testing. However, it does not provide detailed acceptance criteria and a study that proves the device meets those criteria in the format requested.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated. The document refers to "testing and results" but does not provide details on the number of stents tested for each performance metric.
• Data Provenance: Not explicitly stated. The submitter is PORGES S.A. from France, suggesting the testing likely occurred in Europe or was overseen by a European entity, but this isn't confirmed for the data itself. The document does not specify whether the data is retrospective or prospective; it describes in vitro performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The ground truth for performance testing of a medical device like a ureteral stent is typically objective measurements from laboratory or simulated-use tests, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies involving expert interpretation (e.g., radiology reads), not for the in vitro performance testing described here.

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

Not applicable. This is not an AI/software device, and therefore, no MRMC comparative effectiveness study involving human readers and AI assistance would be conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI/software device. The performance tests are for the physical properties of the stent itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance tests (flow rate, elongation/tensile strength, loop strength, biocompatibility) is based on objective laboratory measurements against established engineering standards and regulatory guidance (e.g., ISO 10993-1, FDA guidance for ureteral stents).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As this is not a machine learning or AI device, there is no training set or ground truth in that context.

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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

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.

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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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The PORGES™ Silicone prostatectomy catheter is used for :

• short term drainage of the vesical urines, -
• irrigation/injection and drainage following surgery,
• infigurer.hijformate surgery : hemostasis of the prostate area.

The PORGES™ Silicone prostatectorny catheter is a balloon catheter of the retention type, commonly called THE FORGES " Silkone prosidioning outhere is a banetransparent silicone elastomer with a radiopaque a Toley datable 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 Shall. One laimer is for araning halas to anyth a third lumen, it is used in conjunction with the first lumen for the ballow with other water in used for inflation and deflation of the balloon. The distal end has opposite eye holes, which are used for drainage.
Nominal balloon inflation volumes are 15 to 30 cm³ or 30 to 50 cm³ with the 15 to 30 cm³ balloon being used Nominal banoon innation for normal usage, and 30 to 50 cm³ when a larger balloon is indicated.
to head of outher in place rehaft, are an connecting funnel and a Luer activated valve of which the colour varies according to the size of the catheter.
This product is available in sizes 18 Fr to 24 Fr, with DUFOUR, DELINOTTE, COUVELAIRE or standard tip. Total length of all catheters : 42 cm. One catheter has an open tip to fit over a guide wire.

The provided document is a 510(k) summary for the PORGES™ Silicone prostatectomy catheter, which is a medical device and not an AI/ML-driven device. Therefore, the questions related to AI/ML device performance, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable.

However, I can extract the acceptance criteria for the device based on the provided text.

The device's performance requirements are assessed against the FDA "Guidance for the content of premarket notifications and functional testing of conventional and anti-reflux Foley catheters" dated September 12, 1994, and/or PORGES's own testing/acceptance criteria.

Here's a table based on the provided text, outlining the acceptance criteria (i.e., the performance requirements the device must meet) and what the document reports about the device performance regarding these criteria. It's important to note that the document generally states the device meets or passes these criteria, but it does not provide specific numerical outcomes or detailed results of the tests in this 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a traditional medical device (catheter) and not an AI/ML product, the remaining questions are not directly applicable. However, I will address them to explicitly state why they are not relevant in this context.

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical, sterile, single-use medical device. Performance is evaluated through physical and material tests, not typically with "test sets" in the context of data. The document does not specify general "data provenance" but mentions testing according to FDA guidance and/or PORGES internal criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on image interpretation) is not relevant for the physical performance testing of a catheter. The "ground truth" here is compliance with established engineering and safety standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve disagreements among human reviewers in clinical data analysis for AI/ML. The performance of this device is assessed against predetermined physical and material specifications.

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: Not applicable. This device is not an AI algorithm, so MRMC studies or human-with-AI vs. without-AI comparisons are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, the "ground truth" is adherence to established mechanical, material, and biocompatibility standards (e.g., ASTM F 623-89, ISO 10993-1, and internal PORGES criteria).

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable. As there is no training set for an AI/ML model, "ground truth" for it is not established.

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