(266 days)
This product is used for temporary internal drainage from the ureteropelvic junction to the bladder. They are not intended to remain indwelling more than twelve months.
The Black Silicone Filiform Double Pigtail Stent Set is a sterile, single-use device. The stents are available with outside diameters of 6.0, 7.0, or 8.5 Fr and specified lengths ranging from 20 to 30 centimeters. The stents are flexible, tubular double pigtail stents constructed of radiopaque silicone rubber. Sideports extend along the body of the stent as well as on the pigtails to provide drainage. The stents are secured in the urinary tract with pigtail loops on the proximal and distal ends. A braided tether for repositioning and removal of the device is located on the proximal pigtail (bladder end) of the stent. Along the stent are graduation marks to provide visualization during stent advancement and placement. The Black Silicone Filiform Double Pigtail Stent Set includes a stent, wire guide, a stent positioner with a lockable fitting, and a T-inserter. The lockable fitting on the proximal end of the stent positioner secures the position of the stent positioner on the wire guide and allows for one-pass placement of the stent. The Black Silicone Filiform Double Pigtail Stent Set is labeled for a 12-month indwell time; however, the tether should be removed after 14 days.
This document describes the Cook Incorporated Black Silicone Filiform Double Pigtail Stent Set (K172017), a ureteral stent. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study report with specific acceptance criteria and performance metrics. Therefore, several requested details, particularly quantitative data from a clinical or standalone performance study, are not available in this document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various tests performed to assure "reliable design and performance." However, it does not explicitly state quantitative acceptance criteria or detailed numerical results for each test. Instead, it generally concludes that the device passed these tests and functions as intended.
| Test Performed | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (General conclusion from document) |
|---|---|---|
| Sterility | (Expected to meet industry standards for sterile medical devices) | "Assure reliable design and performance" |
| Packaging | (Expected to ensure product integrity and sterility) | "Assure reliable design and performance" |
| Biocompatibility | (Expected to meet ISO 10993 standards) | "Assure reliable design and performance" |
| Flow Rate | (Expected to demonstrate adequate fluid drainage) | "Assure reliable design and performance" |
| Retention Strength | (Expected to demonstrate secure placement in the urinary tract) | "Assure reliable design and performance" |
| Tensile Strength | (Expected to demonstrate material integrity under tension) | "Assure reliable design and performance" |
| Curl Restoration | (Expected to demonstrate ability of pigtail to form and maintain shape) | "Assure reliable design and performance" |
| Kink Radius | (Expected to demonstrate resistance to kinking) | "Assure reliable design and performance" |
| Radiopacity | (Expected to be sufficiently visible under fluoroscopy) | "Assure reliable design and performance" |
| MRI Testing | (Expected to demonstrate compatibility with MRI environment) | "Assure reliable design and performance" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the listed tests. It also does not provide any information about data provenance (e.g., country of origin, retrospective or prospective) as these tests appear to be bench or lab-based performance tests, not clinical studies involving patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to the type of testing described. The tests listed are primarily engineering and material performance assessments, not clinical evaluations requiring expert interpretation of ground truth in the context of diagnostic accuracy or clinical outcomes.
4. Adjudication Method
This information is not applicable. The listed tests are objective, laboratory or bench tests, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This device is a passive medical implant (ureteral stent) and not an AI-powered diagnostic or assistive tool, so such a study would not be relevant.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)
The device is a physical medical device, not an algorithm. Therefore, a "standalone algorithm only" performance study is not applicable. The document describes bench and material performance tests as listed in the table, which could be considered "standalone" in the sense that they evaluate the device itself without human intervention beyond conducting the test.
7. Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, clinical outcomes, expert consensus) is not directly applicable here. For the listed tests, the "ground truth" would be established by the physical and chemical properties of the materials, engineering specifications, and established testing methodologies (e.g., ISO standards for biocompatibility or sterility).
8. Sample Size for the Training Set
This information is not applicable. This device is not an AI-driven system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
In summary, the provided document is a 510(k) summary for a traditional medical device (a ureteral stent). It focuses on demonstrating substantial equivalence through a comparison to a predicate device and presenting a list of engineering and material performance tests. It does not contain the detailed quantitative data, clinical study results, or AI-specific information that many of the questions pertain to.
§ 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).