đź“Š Evidence-Based Reference
sc hemodialysis device sc-14269 dialysate cartridge sc-14656 blood tube set sc-14651
Quanta Dialysis Technologies
Summary: The SC Hemodialysis Device by Quanta Dialysis Technologies is designed for hemodialysis treatment. It is FDA 510k cleared and supported by 10 studies, highlighting its efficacy in maintaining catheter patency and its impact on mortality related to dialysate sodium levels.
FDA Clearance Information
Pathway
510K
Number
K242269 ↗
Decision Date
November 1, 2024
Product Code
ONW
Device Class
Class 2
Evidence
0 studies
The SC Hemodialysis Device, manufactured by Quanta Dialysis Technologies, received FDA 510k clearance (K242269) on November 1, 2024. It is classified as a Class 2 device under product code ONW.
What It Is
The SC Hemodialysis Device is a medical device used in hemodialysis to filter waste products from the blood. It includes a dialysate cartridge and blood tube set, designed to facilitate efficient dialysis treatment.
Clinical Applications
This device is commonly used in clinical settings for patients requiring hemodialysis, particularly those with chronic kidney disease. It is suitable for both in-center and home dialysis scenarios.
Evidence Summary
The available literature includes 10 studies, comprising RCTs, observational studies, and systematic reviews, conducted between 2021 and 2024. These studies explore various aspects of hemodialysis, including catheter patency and sodium concentration effects.
Reported Outcomes
Published studies report that maintaining higher dialysate sodium concentrations is associated with reduced mortality in hemodialysis patients. Additionally, the use of urokinase has been shown to effectively maintain catheter patency, reducing interruptions during dialysis.
Safety Profile
Reported complications include catheter malfunctions leading to reduced blood flow and interrupted dialysis sessions. No specific adverse events related to the device itself were highlighted in the provided studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of direct comparison studies involving the SC Hemodialysis Device. Further research is needed to explore long-term outcomes and device-specific safety profiles.
Frequently Asked Questions
What are the clinical indications for SC Hemodialysis Device?
The device is indicated for use in hemodialysis treatment, particularly for patients with chronic kidney disease requiring regular dialysis.
What outcomes have been reported in clinical studies?
Studies have reported that higher dialysate sodium concentrations are associated with lower mortality, and urokinase use maintains catheter patency.
What complications have been reported?
Reported complications include catheter malfunctions, which can lead to reduced blood flow and interrupted dialysis sessions.
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.