(96 days)
The Roca.IJ Soft Stents are used for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic techniques.
The stents are not intended as a permanent indwelling devices, it is recommended that:
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The indwelling time not exceed 6 days when the device is used with the removal string;
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The indwelling time not exceed 365 days when the device is used without the removal string.
The RocaJJ Soft Stents system is a set consisting of a tubular double pigtail stent made up of flexible radiopaque polyurethane, with a polypropylene-monofilament suture loop in order to facilitate the extraction of the ureteral stent.
The devices may include a pusher with a radiopaque tip, and a guidewire. Otherwise, these sets may include only a pusher.
The RocaJJ Soft Stents are from 4.8 to 8.0 Fr in diameter and from 24 to 30 cm in specified length.
This document is a 510(k) Summary for the RocaJJ Soft Stents. It describes the device, its intended use, and demonstrates substantial equivalence to predicate devices based on various bench tests.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength | All bench testing results confirmed that the products described in this submission met the necessary specification. |
| Sterilization Validation | Validated in accordance with recognized industry standards. |
| Transportation Validation | Validated in accordance with recognized industry standards. |
| Tensile Strength | Test performed, results confirmed adequate mechanical strength. |
| Ultimate Elongation | Test performed, results confirmed adequate mechanical strength. |
| Opening Force of Retaining Loops | Test performed, results confirmed adequate mechanical strength. |
| Drainage Capacity | Test performed, results confirmed adequate mechanical strength. |
| Biocompatibility | Confirmed in accordance with ISO 10993. |
| Shelf Life Validation | Validated in accordance with recognized industry standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size used for each bench test. The data provenance is described as "bench testing conducted by Promepla SAM," indicating in-house testing. There is no information regarding the country of origin of data or whether it was retrospective or prospective, as these are bench tests, not clinical studies involving patients.
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):
This information is not applicable to this submission. The "ground truth" for the acceptance criteria listed is based on engineering specifications and recognized industry standards (e.g., ISO 10993 for biocompatibility), not expert interpretation of medical data. Therefore, there were no medical experts establishing ground truth for these bench tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically relevant for clinical studies where there's a need to resolve discrepancies in expert interpretation of medical images or patient outcomes. For bench testing, individual tests are performed to specified criteria, and the results either pass or fail.
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. The RocaJJ Soft Stents are a medical device (ureteral stent), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is not an AI algorithm; it's a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance of the RocaJJ Soft Stents is based on:
- Engineering specifications and design requirements: These define what the stent is supposed to do (e.g., withstand certain forces, drain effectively).
- Recognized industry standards: Such as ISO 10993 for biocompatibility.
- Comparison to predicate devices: Demonstration of similar performance characteristics to legally marketed devices.
8. The sample size for the training set:
This information is not applicable. This is a physical medical device and does not involve AI or machine learning models that require a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for a physical medical device.
§ 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).