(140 days)
The Cardiva Medical VasoStasis™ Vascular Closure System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The VasoStasis Vascular Closure System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures, using 5 or 6 Fr introducer sheaths.
The VasoStasis Vascular Closure System consists of the following components: (1) a sterile. disposable catheter (VasoStasis™ VCS Catheter), and (2) a sterile, disposable tensioning device (VasoStasis™ VCS Tensioner). The VasoStasis Vascular Closure System, in conjunction with manual compression, provides hemostasis at femoral access sites after femoral arterial catheterization while allowing continued perfusion of the lower extremities. The VasoStasis VCS Catheter is a single lumen, low profile catheter with an elastomeric membrane at the distal tip. The membrane is covered by a tip guide, which protects the membrane as the cledeployed catheter is inserted into the artery through a previously placed introducer sheath. A small loon handle is at the proximal end of the device and moves axially to deploy or de-deploy a Nitinol coil within the membrane. Once the catheter is introduced into the vessel, the membrane is positioned distal to the introducer sheath and deployed by pushing the loop handle forward. In its fully deployed state, the membrane nominally achieves 13 F in diameter. The Cardiva VasoStasis VCS Tensioner clips on the VasoStasis VCS Catheter shaft on the surface of the skin at the entrance to the arteriotomy and holds the catheter secure while the membrane is deployed in the vessel.
Acceptance Criteria and Study for Cardiva Medical VasoStasis™ Vascular Closure System
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the Cardiva Medical VasoStasis™ Vascular Closure System does not explicitly state pre-defined acceptance criteria in terms of specific numerical thresholds for success rates or complication rates against which the observed performance was directly measured. Instead, it refers to "performance requirements" that the system met or exceeded, and then presents the clinical study results as evidence of safety and effectiveness, implying these results are within acceptable ranges.
However, based on the narrative, the implicit acceptance criteria can be inferred from the positive statements made about the study outcomes.
| Acceptance Criteria (Inferred from Narrative) | Reported Device Performance (Clinical Study Results) |
|---|---|
| Device Success Rate (>70%) | Observed device success rates: >70% in US II, US I, and Canadian clinical evaluations. |
| Major Complication Rate ( |
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).