(200 days)
The ConvertX™ Nephroureteral Stent System with releasable drainage catheter is delivered percutaneously and is intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent, as well as providing external drainage.
For patients for whom external drainage is not, or no longer desirable, the releasable drainage catheter may be removed, leaving the stent to provide internal drainage from the ureteropelvic junction to the bladder.
The ConvertX Nephroureteral Stent System is a sterile, single-use non-vascular intervention device inserted using percutaneous access techniques to re-establish internal drainage between the ureteropelvic junction and the bladder, and stent the ureter. The ConvertX System allows for external drainage and access as needed.
The ConvertX Nephroureteral Stent System is a single lumen device that has a detachable ureteral stent with proximal and distal pigtails. Both proximal and distal pigtails contain drainage holes. The proximal pigtail forms in the renal pelvis, while the distal pigtail forms in the bladder. The distal pigtail has a tapered, atraumatic tip. Drainage can occur internally (from the ureteropelvic junction to the bladder) or externally (from the ureteropelvic junction to the outside of the patient). A loop suture is attached to the proximal pigtail enabling the pigtail, straightened for delivery, to be closed in the renal pelvis.
The ConvertX Nephroureteral Stent System's Hub has three ports which are used for both ends of the loop suture, external drainage of urine and the ureteral stent release wire. One end of the loop suture and the release wire are connected to pull tabs. The releasable drainage catheter and loop suture may be detached from the ureteral stent when external drainage is no longer necessary, leaving the stent in place. While still attached, the releasable drainage catheter may be used to withdraw the ureteral stent. The ConvertX Nephroureteral Stent System is radiopaque throughout its length.
The ConvertX Nephroureteral Stent System is comprised of the following components:
- Ureteral Stent
- Releasable Drainage Catheter with Hub
The following accessories are provided with the ConvertX Nephroureteral Stent System: - Metal Stiffening Cannula
- Luer Cap
The provided text describes the 510(k) premarket notification for the ConvertX™ Nephroureteral Stent System. The document focuses on establishing substantial equivalence to predicate devices through non-clinical performance testing. It does not include information about studies involving human subjects or AI algorithms.
Therefore, many of the requested criteria related to clinical studies, AI performance, ground truth establishment, expert involvement, and sample sizes for training/testing sets cannot be extracted from this document.
Here's an attempt to answer the applicable parts of your request based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "The ConvertX Nephroureteral Stent System, including its packaging, met the predetermined acceptance criteria. No new safety or performance issues were raised during testing." However, the specific numerical or descriptive acceptance criteria for each performance test are not detailed in this summary. Instead, it lists the types of tests performed.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Met predetermined acceptance criteria | Met predetermined acceptance criteria. No new safety or performance issues were raised during testing. |
| Compliance with standards | Complied with ASTM F1828-97, ASTM F623-99, ISO 10555-1:2013, FDA Guidance for Ureteral Stents, ASTM F2182-11a, ASTM F2119-07, ASTM F2052-15, ASTM F2503-13, and ASTM F640-12. |
| Indications for Use | Intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access and providing external drainage. For patients where external drainage is not desired, the releasable catheter can be removed, leaving the stent for internal drainage. (See full description in "Indications for Use" section). |
| Performance/Technological Characteristics | See the comparison table below |
Comparison Table of ConvertX Nephroureteral Stent System vs. Predicate Devices (Contains performance characteristics, implicitly showing the ConvertX meets similar performance as predicates)
| Performance / Technological Characteristic | ConvertX Nephroureteral Stent System | Expel Nephroureteral Stent System Twist Loc Hub (K141344) | Expel Ureteral Stent System (K141344) |
|---|---|---|---|
| Indications for Use | The ConvertX Nephroureteral Stent System with releasable drainage catheter is delivered percutaneously and is intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent, as well as providing external drainage. For patients for whom external drainage is not, or no longer desirable, the releasable drainage catheter may be removed, leaving the stent to provide internal drainage from the ureteropelvic junction to the bladder. | The Expel Nephroureteral Stents are delivered percutaneously and are intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent, as well as providing external drainage. | The Expel Ureteral Stent System is delivered percutaneously and is intended to establish drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally. |
| Common Name | Ureteral Stent | Ureteral Stent | Ureteral Stent |
| Classification | Class II, Performance Standards | Class II, Performance Standards | Class II, Performance Standards |
| Regulation Number | 21 CFR 876.4620 | 21 CFR 876.4620 | 21 CFR 876.4620 |
| Product Code | FAD | FAD | FAD |
| Single Use Only | Yes | Yes | Yes |
| Provided Sterile | Yes | Yes | Yes |
| Sterilization Method | EtO | EtO | EtO |
| Diameters | 10.3 French | 8.3 and 10.3 French | 8.3 and 10.3 French |
| Stent Lengths | 20, 22, 24, 26, 28 cm | 22, 24, 26, 28 cm | 22, 24, 26, 28 cm |
| Guidewire Compatibility | 0.038" | 0.038" | 0.038" |
| Stent Material | Polyurethane | Polyurethane | Polyurethane |
| Drainage Catheter Material | Polyurethane | Polyurethane | NA |
| Loop Suture Material | Polyethylene | Nylon | Nylon |
| Tapered Stent Tip | Yes | Yes | Yes |
| Radiopaque | Yes | Yes | Yes |
| MRI Compatible | Yes | Yes | Yes |
| Urine Compatible | Yes | Yes | Yes |
| Maximum Indwelling Time | Not to exceed 30-days | Not to exceed 30-days | Not to exceed 90-days |
| Delivery Method | Percutaneous | Percutaneous | Percutaneous |
| Method of conversion from nephroureteral stent to ureteral stent | Disconnect | Removal / Exchange | NA |
| Biocompatibility | Meets requirements of 10993-1 | Meets requirements of 10993-1 | Meets requirements of 10993-1 |
| Accessory Devices | Stiffening Cannula, Luer Cap | Cannulas, Plug/Cap, Stabilizer, Pigtail Straightener | Cannulas, Stabilizer, Pigtail Straightener |
2. Sample size used for the test set and the data provenance
The document describes non-clinical testing (e.g., mechanical, material, and compatibility tests), not a clinical study involving a "test set" of patient data. Therefore, this information is not applicable. The provenance of the data is from BrightWater Medical's internal testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was non-clinical performance testing against engineering and material specifications, not a study requiring expert clinical ground truth.
4. Adjudication method for the test set
Not applicable. See point 3.
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 a physical medical device (stent), not an AI algorithm, and the documentation describes non-clinical performance testing, not a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This documentation is for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described, the "ground truth" would be the engineering specifications, material standards (e.g., ASTM, ISO), and regulatory requirements (e.g., FDA guidance documents). The device was tested to meet these predefined physical and performance characteristics.
8. The sample size for the training set
Not applicable. This is not a study involving a "training set" for an AI or machine learning model.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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).