(178 days)
Recommended for introduction of balloons, catheters and other diagnostic and interventional devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
The NuMED D'VILL Introducer is recommended for introduction of balloons, catheters and other diagnostic and interventional devices. The introducer consists of a dilator, and sheath with hemostasis valve and side port on the proximal end of the sheath assembly. There is a single image band embedded in the distal end of the sheath tubing for imaging purposes. The sheath is Pebax braided with stainless steel and a PTFE liner and will accommodate a 0.035" guidewire. The dilator is LDPE. The D'VILL is available in 10, 12 and 14F sizes and 30 and 85cm lengths.
The document provided is a 510(k) summary for the D'Vill Introducer, a medical device. It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information about a study proving the device meets specific acceptance criteria based on performance data.
The "Performance Testing" section on page 4 lists several tests performed:
- Surface Inspection
- Size Designation – Sheath and Dilator
- Freedom from Leakage – Sheath and Hemostasis Valve
- Peak Tensile Force - 3 locations
- Strength of Union Between Hub and Dilator
- Dimensional Requirements – Sheath, Stopcock, and Dilator
- Luer Hub Testing
- Kink/Flexibility Testing – Sheath and Dilator
- Sterilization Testing
- Biocompatibility Evaluation – Short duration contact with circulating blood (
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).