(324 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Performance: Conforms to FDA "Guidance for the content of premarket notifications for ureteral stents" (Feb 10, 1993) | "The PORGES™ Silicone double loop ureteral stent referenced in this submission is held to the same design, manufacture, and performance specifications as the predicate devices. Substantial equivalence... has been demonstrated in conformity with the FDA 'Guidance for the content of premarket notifications for ureteral stents'..." Specific tests performed include: - Flow rate through the stent - Elongation and tensile strength of the stent after an 18-month soaking period in different buffer solutions. - Loop strength |
| Biocompatibility: Conforms to ISO 10993-1 | "The PORGES™ Silicone double loop ureteral stent passes biocompatibility testing per ISO 10993-1." |
| Implantation Period: Suitability for extended use | "The data currently available for the silicone stents enables them to be validated for an implantation period of up to 12 months." |
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.
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).