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sc hemodialysis device sc dialysate cartridge sc blood tube set
Quanta Dialysis Technologies
Summary: The SC Hemodialysis Device by Quanta Dialysis Technologies is used for hemodialysis treatment. Key evidence highlights its role in patient-centered home hemodialysis and the impact of dialysate sodium concentration on mortality.
FDA Clearance Information
Pathway
510K
Number
K222067 ↗
Decision Date
November 10, 2022
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The SC Hemodialysis Device was cleared through the FDA 510(k) pathway on November 10, 2022. It is manufactured by Quanta Dialysis Technologies and classified as a Class 2 device.
What It Is
The SC Hemodialysis Device is designed for hemodialysis treatment, facilitating the removal of waste products and excess fluid from the blood. It is intended for use in clinical and home settings, providing flexibility in dialysis care.
Clinical Applications
Commonly used in both clinical and home settings, the SC Hemodialysis Device supports patients requiring regular hemodialysis. It is particularly relevant for patient-centered home hemodialysis programs.
Evidence Summary
The available literature includes 11 studies, comprising RCTs, observational studies, and systematic reviews, conducted between 2021 and 2024. These studies explore various aspects of hemodialysis, including patient outcomes and device efficacy.
Reported Outcomes
Published studies report that lower dialysate sodium concentrations are associated with higher mortality in hemodialysis patients. Additionally, patient-centered approaches in home hemodialysis are emphasized for improved outcomes.
Safety Profile
Reported complications include the potential for increased mortality with lower dialysate sodium concentrations. No specific device-related adverse events were highlighted in the provided evidence.
Evidence Limitations
The evidence is limited by the observational nature of some studies and the lack of randomized controlled trials specifically evaluating the SC Hemodialysis Device. Further research is needed to explore long-term outcomes and device-specific safety.
Frequently Asked Questions
What are the clinical indications for SC Hemodialysis Device?
The SC Hemodialysis Device is indicated for use in hemodialysis treatment, suitable for both clinical and home settings.
What outcomes have been reported in clinical studies?
Studies report that lower dialysate sodium concentrations are linked to higher mortality rates in hemodialysis patients.
What complications have been reported?
Reported complications include increased mortality associated with lower dialysate sodium concentrations.
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.