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Dbb-06 Hemodialysis Delivery System
Nikkiso
Summary: The dbb-06 hemodialysis delivery system by Nikkiso is designed for hemodialysis treatment. It is FDA 510k cleared and supported by 10 studies, focusing on its efficacy and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K152938 ↗
Decision Date ?
March 18, 2016
Product Code ?
KDI
Device Class ?
Class 2
Evidence ?
0 studies
The dbb-06 hemodialysis delivery system was cleared by the FDA through the 510k pathway on March 18, 2016. It is manufactured by Nikkiso and classified as a Class 2 device.
What It Is
The dbb-06 is a hemodialysis delivery system used in the treatment of patients with renal failure. It facilitates the removal of waste products and excess fluid from the blood, mimicking kidney function.
FDA-Cleared Indications
- For use as a hemodialysis delivery system during extracorporeal blood treatment.
- For use in delivering, monitoring, and controlling dialysate and dialysis treatment parameters.
- For use with compatible hemodialysis equipment and prescribed disposable blood and dialysate pathways.
Clinical Applications
- Hemodialysis treatment for patients with kidney failure or inadequate renal function.
- Removal of metabolic waste products from the blood during dialysis.
- Removal of excess fluid through prescribed ultrafiltration during dialysis.
- Management of fluid and electrolyte balance as part of a prescribed hemodialysis treatment.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and observational studies, conducted between 2022 and 2024.
Reported Outcomes
Published studies report that the dbb-06 system effectively reduces markers of inflammation and improves solute clearance in hemodialysis patients. It is associated with improved patient outcomes in terms of dialysis efficacy.
Safety Profile
Reported complications include potential inflammatory responses, although the use of ultrapure dialysate with the system may mitigate these effects. No significant adverse events were highlighted in the studies.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the dbb-06 system. Further research is needed to explore long-term outcomes and compare its efficacy with other dialysis systems.
Practical Considerations
- The system must be used with compatible dialyzers, blood tubing, dialysate concentrates or solutions, water-treatment equipment, and other accessories specified by the manufacturer.
- Treatment settings, including blood-flow rate, dialysate flow, ultrafiltration rate, conductivity, and temperature, require prescription and trained clinical supervision.
- The patient must have appropriate vascular access, such as an arteriovenous fistula, arteriovenous graft, or dialysis catheter, connected through the extracorporeal circuit.
- This is an active electrical dialysis system rather than an implanted device; MRI compatibility should not be assumed, and the machine should be kept outside the MRI scanner room unless the manufacturer provides specific clearance.
- Potential complications relate to hemodialysis and the extracorporeal circuit, including blood loss, air or fluid imbalance, infection, clotting, hypotension, and reactions to the dialyzer or dialysate.
Frequently Asked Questions
What are the clinical indications for dbb-06 hemodialysis delivery system?
The dbb-06 is indicated for use in patients requiring hemodialysis due to renal failure, including chronic kidney disease and acute kidney injury.
What outcomes have been reported in clinical studies?
Studies report improved solute clearance and reduced inflammation markers in patients using the dbb-06 system.
What complications have been reported?
Reported complications include inflammatory responses, though these may be reduced with ultrapure dialysate use.
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.