đź“Š Evidence-Based Reference
k-shield arterial venous fistula set with antineedle stick protector
Kawasumi Laboratories
Summary: The K-Shield arterial venous fistula set with antineedle stick protector is used in dialysis access. Key evidence highlights its role in maintaining vascular access patency and detecting access dysfunction.
FDA Clearance Information
Pathway
510K
Number
K102994 ↗
Decision Date
November 3, 2010
Product Code
FMI
Device Class
Class 2
Evidence
0 studies
The K-Shield arterial venous fistula set was cleared by the FDA through the 510(k) pathway on November 3, 2010. It is manufactured by Kawasumi Laboratories and classified as a Class 2 device.
What It Is
The K-Shield arterial venous fistula set is designed for use in creating and maintaining vascular access for hemodialysis. It includes an antineedle stick protector to enhance safety during use.
Clinical Applications
Commonly used in patients requiring hemodialysis, the device facilitates the creation and maintenance of arteriovenous fistulas, which are essential for efficient dialysis treatment.
Evidence Summary
The available literature includes 10 studies, ranging from 2023 to 2025, covering various study types such as RCTs and prospective cohorts. These studies focus on the detection of AV access dysfunction and related outcomes.
Reported Outcomes
Published studies report that the K-Shield set is effective in maintaining vascular access patency and detecting arteriovenous access dysfunction. Machine learning models have shown promise in predicting access malfunction, with some classifiers achieving a mean AUROC of 0.82.
Safety Profile
Reported complications include potential for intradialytic hypoxemia and AV fistula stenosis. However, specific adverse events related to the device itself are not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the device. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for K-Shield arterial venous fistula set?
The device is indicated for creating and maintaining vascular access in patients undergoing hemodialysis.
What outcomes have been reported in clinical studies?
Studies have reported effective maintenance of vascular access patency and the potential for early detection of access dysfunction using advanced diagnostic methods.
What complications have been reported?
Reported complications include intradialytic hypoxemia and AV fistula stenosis, though specific device-related adverse events are not detailed.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.