(256 days)
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.
The Kaye Nephrostomy Tamponade Balloon Catheter Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is comprised of a balloon catheter, ureteral stent, flexible stylet, Y-connecting tube and syringe. The balloon catheter can be sold separately with the stylet and syringe. The radiopaque balloon catheter has an outer diameter of 14.0 French and a tip diameter of 17.0 French, with a working length of 25 centimeters. The clear polyethylene balloon measures 15 centimeters in length and has an inflated diameter of 12 millimeters. The flexible stylet is 8.5 French and is manufactured from polyurethane material. The flexible stylet, designed to be inserted through the proximal end of the balloon catheter, extends 2 millimeters from the balloon catheter tip when assembled. The stent is manufactured from radiopaque polyurethane with an outer diameter of 5.0 French and a length of 75 centimeters. The stent is designed with two adjustable and removable adapters located at the proximal end of the stent. The Y-connecting tube is made of non-radiopaque polyvinylchloride material with an outer diameter of 14.0 French, and a length of 30 centimeters. A 10 mL Luerlock syringe is also provided in the set and is used to inflate the balloon through the inflation check valve.
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is supplied sterile in a Tyvek peel open pouch and labeled with a three-year shelf life. The subject device has a maximum indwell time of 96 hours (4 days) for the stent and 48 hours (2 days) for the balloon catheter and is labeled as a single-use device.
The provided FDA 510(k) premarket notification for the Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set describes various performance tests to demonstrate substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for diagnostic accuracy or clinical effectiveness in the way an AI/ML device study might.
However, based on the information provided, I can infer the "acceptance criteria" and the "study" are the battery of engineering and material tests conducted to ensure the device's physical and functional properties meet expected standards for safety and effectiveness, similar to its predicates.
Here's a breakdown based on your request, interpreting "acceptance criteria" as meeting the performance requirements demonstrated by the listed tests:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an engineering device, acceptance criteria are typically validated through testing to confirm specific physical and functional properties. The document lists the tests performed, implying that successful completion of these tests (i.e., the device performed as intended during the test) constitutes meeting the acceptance criteria. Specific numerical acceptance values are not provided in this summary, but the conclusion states the device "will perform as intended" and "does not raise different questions of safety and/or effectiveness."
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Inferred from successful testing) |
|---|---|
| Material Safety & Biocompatibility | Biocompatible (demonstrated by biocompatibility testing) |
| Sterility | Sterile (demonstrated by sterility testing) |
| Packaging Integrity & Shelf-Life | Maintained integrity and sterility over shelf-life (demonstrated by packaging, distribution, stability, and shelf-life testing) |
| Balloon Catheter Performance | - Compatibility: Compatible with specified accessories/procedures. |
- Dimensions: Conformed to specified dimensions (e.g., 14 Fr outer diameter, 17 Fr tip diameter, 25 cm working length, 12 mm inflated diameter).
- Inflation Volume: Performed as specified for inflation.
- Rated Burst Pressure: Withstood specified pressure (40 psi).
- Tensile Strength: Withstood specified tensile forces.
- Radiopacity: Sufficiently radiopaque for visualization. |
| Stent Performance | - Compatibility: Compatible with specified accessories/procedures. - Dimensions: Conformed to specified dimensions (e.g., 5 Fr outer diameter, 75 cm total length, 33 cm working length).
- Tensile Strength: Withstood specified tensile forces.
- Flow Rate: Maintained adequate flow rate.
- Kink & Lumen Patency: Maintained patency and resisted kinking.
- Radiopacity: Sufficiently radiopaque for visualization. |
| Stylet Performance | - Compatibility: Compatible with the balloon catheter. - Dimensions: Conformed to specified dimensions (e.g., 8.5 Fr).
- Tensile Strength: Withstood specified tensile forces. |
| Set (Catheter & Stent) Performance | - Liquid Leakage & Gravity Flow: Performed without leakage and allowed proper gravity flow. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test mentioned (e.g., how many catheters were burst-tested, how many stents were kink-tested). These are typically standard engineering tests performed on a statistically relevant sample size from manufacturing lots, but the exact numbers are not detailed in this 510(k) summary. The data provenance is from laboratory testing conducted by the manufacturer, Cook Incorporated. Therefore, it is prospective data for the device's performance under specific test conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this device. "Ground truth" established by experts is relevant for diagnostic or AI/ML devices where human interpretation or clinical outcomes define the truth. For this medical device, the "ground truth" for the tests is defined by the physical and chemical properties of the materials and the mechanical performance under controlled laboratory conditions, verified by standardized testing methods.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations, typically in diagnostic studies. Here, the "truth" is determined by objective engineering measurements against predefined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are used to assess the impact of a diagnostic tool (often AI-assisted) on human reader performance. This device is a surgical/drainage catheter, not a diagnostic imaging device, and there is no AI assistance involved.
6. Standalone (Algorithm Only) Performance
Not applicable. This is not an AI/ML algorithm or software device. Its performance is entirely physical and mechanical.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Engineering Specifications: Defined physical dimensions, material properties, and performance limits (e.g., burst pressure, flow rate, tensile strength).
- Standardized Test Methods: Adherence to recognized industry standards for testing sterility, biocompatibility, mechanical properties, etc.
- Bench Testing Data: Quantitative and qualitative results from laboratory evaluations.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML system, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
N/A