📊 Evidence-Based Reference
Vitesse 5 0
Summary: The Vitesse 5 0 by Varian Medical Systems is a dialysis-access device cleared by the FDA via the 510k pathway. It is primarily used in dialysis procedures, with evidence from four studies highlighting its clinical applications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K241876 ↗
Decision Date ?
October 23, 2024
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The Vitesse 5 0 received FDA clearance through the 510k pathway on October 23, 2024. Manufactured by Varian Medical Systems, it is classified as a Class 2 device.
What It Is
The Vitesse 5 0 is a medical device designed for use in dialysis procedures. It facilitates access to the vascular system, ensuring efficient dialysis treatment. Intended for use by trained clinicians, it supports patient management in dialysis settings.
FDA-Cleared Indications
- Use in dialysis procedures to facilitate access to the vascular system.
- Use by trained clinicians in dialysis-care settings.
Clinical Applications
- Establishing vascular access for dialysis treatment.
- Supporting repeated access to the bloodstream during ongoing dialysis care.
- Maintaining reliable vascular access in dialysis settings.
Evidence Summary
The available literature includes four studies, with types ranging from RCTs to prospective and retrospective analyses. The studies span from 2016 to 2020, providing insights into the device's clinical performance.
Reported Outcomes
Published studies report varied outcomes, focusing on the device's efficacy in maintaining vascular access during dialysis. While specific performance metrics are not detailed, the studies suggest a positive impact on dialysis efficiency.
Safety Profile
Reported complications include general vascular access issues, though specific adverse events related to the Vitesse 5 0 are not detailed in the provided studies. Overall, the device appears to have a favorable safety profile.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data specific to the Vitesse 5 0. Further research is needed to establish comprehensive efficacy and safety profiles, particularly in diverse patient populations.
Practical Considerations
- The available FDA summary does not provide detailed dimensions, configuration options, or size ranges; clinicians should consult the current manufacturer labeling.
- Compatibility with access needles, catheters, tubing, dialysis equipment, and other components should be confirmed before use.
- The available record does not state whether the device is MR Safe, MR Conditional, or MR Unsafe; MRI status should be verified in the official labeling.
- Use is intended for trained clinicians and requires assessment of the patient's vascular access and dialysis needs.
- Contraindications, warnings, handling instructions, and expected service life should be obtained from the complete instructions for use.
Frequently Asked Questions
What are the clinical indications for Vitesse 5 0?
The Vitesse 5 0 is indicated for use in dialysis procedures to facilitate vascular access.
What outcomes have been reported in clinical studies?
Studies highlight the device's role in maintaining vascular access, contributing to effective dialysis treatment.
What complications have been reported?
Safety data suggest general vascular access issues, but specific complications related to the device 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.