(260 days)
Renal Access Cobra Catheter: This device is intended for delivery of contrast media as well as access, advancement, or exchange of wire guides in the renal area.
Kumpe Access Catheter: These devices are intended for access and catheterization of the urinary tract, including the following applications: Delivery of contrast media, Navigation of a tortuous ureter, Access, advancement, or exchange of wire guides
The Renal Access Cobra Catheter consists of tubing with a proximal connector cap and a winged female Luer lock adapter. The catheter has a total length of 65 cm and an outer diameter of 6.0 French. The catheter tubing is composed of a polymer reinforced with braided wire. The distal end of the catheter has a hook shaped curve. The tubing French size and compatible wire guide size are printed on one side of the winged female Luer lock adapter; on the other side is the name of the manufacturer.
The Kumpe Access Catheter consists of tubing with a proximal cap and female Luer lock adapter. The catheter has a total length of 65 cm and an outer diameter of 5.0 French. The catheter tubing is composed of a polymer reinforced with braided wire. The distal tubing configuration is angled at approximately 45 degrees. The tubing French size, compatible wire guide size, and manufacturer are printed on the cap.
The provided text is a 510(k) summary for the Renal Access Cobra Catheter and Kumpe Access Catheter. It outlines the device's indications for use, comparison to a predicate device, and performance data. However, it does not contain specific acceptance criteria or details of a study that proves the device meets those criteria in the format requested.
The document lists the types of testing performed but does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance (as this is a physical device, not an AI/software device).
- The type of ground truth used (as this refers to diagnostic accuracy, which is not applicable here).
- Sample size for the training set or how ground truth for a training set was established (again, not applicable to a physical medical device).
Instead, the document states that "The following testing was performed in order to demonstrate that the proposed Renal Access Cobra Catheter and Kumpe Access Catheter met applicable design and performance requirements." and then lists general categories of performance tests:
- Dimensional and Compatibility Testing
- Radiopacity Testing
- Kink Radius Testing
- Blockage and Leakage Testing
- Tensile Testing
- Biocompatibility Testing
- Environmental Testing
- Sterilization Testing
- Accelerated Age Testing
The conclusion drawn is: "The results of these tests support a conclusion that the Renal Access Cobra Catheter and Kumpe Access Catheter will perform as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate device."
Therefore, based on the provided text, it is not possible to fully answer your request. The document describes a traditional 510(k) submission for a physical medical device, which focuses on demonstrating substantial equivalence to a predicate device through a series of engineering and biocompatibility tests, rather than clinical performance studies with specific accuracy metrics like those found with AI or diagnostic devices.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.