(282 days)
The double loop ureteral stents are used for:
- drainage of the upper urinary tract over fistulas or ureteral obstacles
- healing of the ureter
The Vortek® Hydro-Coated Double loop ureteral stents are flexible tubular devices supplied with a hydrogel coating. They are designed with open renal and open vesical ends to be inserted with a guidewire using a pusher. The stents are radiopaque for fluoroscopic visualization. They have eyes on the straight part. Stent diameters and length vary to accommodate the patient's anatomy. For some models, a withdrawal thread is attached on the proximal end to allow removal. Non-steerable pushers are simple tubes, the clamp can be used to immobilize the pusher onto the guidewire. Steerable pushers are equipped with a blue handle/Luer Lock female connector and made of an inner tube that can move forward and backward inside an external tube, to allow connection/disconnection of the stent.
The ureteric catheter supplied with a connector fitted with a Luer tip can be used for inserting the guidewire or injecting contrast medium.
Vortek Hydro-Coated Double Loop Ureteral Stents in this submission and the predicate Vortek Double Loop Ureteral Stents are supplied in kits which are comprised of the following components:
- An open/open double loop ureteral stent with a hydrogel coating
- A non-steerable pusher provided with a clamp, or a steerable pusher
- Available in certain kits: A withdrawal thread attached to the stent
- A radiopaque 0.035-inch (0.89mm) diameter guidewire: PTFE-coated stainless steel guidewire or fully hydrophilic nitinol guidewire
- A ureteric (also called ureteral) catheter
This FDA 510(k) summary provides information on the Vortek® Hydro-Coated Double Loop Ureteral Stents. Unfortunately, the document does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a dedicated performance evaluation section that would answer your specific questions about device performance against acceptance criteria.
The document primarily focuses on establishing "substantial equivalence" of the new Vortek Hydro-Coated device to previously cleared predicate devices (Vortek Ureteral Double Loop Stents, K881744 and K981591) based on performance, indication, design, and materials.
Here's what can be inferred and what is explicitly missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Missing. This document does not provide a table of specific acceptance criteria (e.g., specific measurable thresholds for attributes like lubricity, friction, degradation rates, etc.) and the reported performance of the device against those criteria. It summarily states that "Substantial equivalence is supported by bench testing comparing Vortek Hydro-Coated Double Loop Ureteral Stents to the predicate device and biocompatibility testing performed on the Vortek Hydro-Coated Double Loop Ureteral Stents." This indicates that bench tests were performed, but the detailed results and criteria are not provided here.
2. Sample Size Used for the Test Set and Data Provenance:
- Missing. The document does not specify any sample sizes used for bench testing. It only mentions "bench testing," which implies laboratory-based tests rather than human subject testing for this part of the submission. Therefore, data provenance relevant to human subjects (country of origin, retrospective/prospective) is not applicable or provided for this type of testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. Since the described testing is bench testing (e.g., comparing physical properties or biocompatibility), the concept of "ground truth" established by human experts in the context of diagnostic accuracy (like radiologists) does not apply.
4. Adjudication Method:
- Not applicable. As above, adjudication methods are relevant to expert consensus on diagnostic or clinical outcomes, not to bench testing of physical device properties.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This document explicitly states that substantial equivalence is supported by "bench testing" and "biocompatibility testing." There is no mention of an MRMC comparative effectiveness study, which is typically for AI/diagnostic imaging devices where human readers' performance is evaluated with and without AI assistance. This device is a physical medical device (a ureteral stent), not a diagnostic algorithm.
6. Standalone Performance Study (Algorithm Only):
- No. This is not an algorithm or AI device, so the concept of standalone performance does not apply.
7. Type of Ground Truth Used:
- For the bench testing, the "ground truth" would likely be objective, measurable physical properties (e.g., friction coefficients, tensile strength, degradation rates) determined by validated laboratory methods, and comparisons to the predicate device's measured properties or defined standards. For biocompatibility, it would be based on ISO standards for medical devices. The document does not detail how these specific ground truths were established, only that tests were performed.
8. Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established:
- Not applicable. As this is not an AI/ML algorithm, there is no training set or associated ground truth.
In summary, the provided document is a 510(k) clearance letter and executive summary for a physical medical device (a ureteral stent). It confirms the device's substantial equivalence based on bench and biocompatibility testing but does not offer the granular detail about acceptance criteria, specific performance metrics, sample sizes, or clinical study designs that would be typical for an AI/ML diagnostic device or a more complex clinical trial.
§ 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).