📊 Evidence-Based Reference
Dbb-06 Hemodialysis Delivery System
Nikkiso
Summary: The dbb-06 is a hemodialysis delivery system by Nikkiso, primarily used for kidney replacement therapy. Key evidence highlights its role in reducing inflammation with ultrapure dialysate.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K091978 ↗
Decision Date ?
March 25, 2010
Product Code ?
KDI
Device Class ?
Class 2
Evidence ?
0 studies
The dbb-06 hemodialysis delivery system was cleared by the FDA via the 510(k) pathway on March 25, 2010. It is manufactured by Nikkiso and classified as a Class 2 device.
What It Is
The dbb-06 is a hemodialysis delivery system designed to provide efficient dialysis treatment by delivering ultrapure dialysate. It is intended for use in patients requiring kidney replacement therapy.
FDA-Cleared Indications
- Used as a hemodialysis delivery system to prepare and deliver dialysate during hemodialysis.
- Intended for use in patients requiring hemodialysis treatment.
Clinical Applications
- Delivery of dialysate during routine hemodialysis.
- Use in outpatient dialysis centers and hospital dialysis units.
- Treatment support for patients with end-stage kidney disease receiving maintenance hemodialysis.
- Use with compatible hemodialysis equipment and prescribed dialysate solutions according to the manufacturer's instructions.
Evidence Summary
The literature includes 10 studies, covering a range of study types such as RCTs and prospective studies, with publication years spanning from 2022 to 2024.
Reported Outcomes
Published studies report that the use of ultrapure dialysate in the dbb-06 system can decrease dialysate contamination and reduce inflammatory markers in hemodialysis patients. The system's efficacy in solute clearance and ultrafiltration is also highlighted.
Safety Profile
Reported complications include potential inflammatory responses if dialysate purity is compromised. However, the use of ultrapure dialysate in the dbb-06 system is associated with reduced inflammation.
Evidence Limitations
There is limited research directly comparing the dbb-06 with other hemodialysis systems. Further studies are needed to explore long-term outcomes and the impact of ultrapure dialysate on patient quality of life.
Practical Considerations
- The system must be installed, operated, disinfected, and maintained according to the manufacturer's instructions and applicable dialysis-facility protocols.
- Compatibility with the dialysis machine, water-treatment system, dialysate concentrates, tubing, filters, and other disposables should be confirmed before use.
- This is a dialysis delivery system rather than a vascular access device; treatment also requires appropriate vascular access, such as an arteriovenous fistula, graft, or dialysis catheter.
- MRI safety is not established by the provided FDA record. The system should not be taken into the MRI environment unless its specific components have been evaluated and labeled for that setting.
- Patient treatment requires clinical monitoring, including blood pressure, fluid removal, electrolytes, and possible dialysis-related complications.
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 as part of kidney replacement therapy.
What outcomes have been reported in clinical studies?
Studies report reduced inflammation and effective solute clearance with the use of ultrapure dialysate in the dbb-06 system.
What complications have been reported?
Safety data indicate potential inflammatory responses if dialysate purity is not maintained, though ultrapure dialysate use mitigates this risk.
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.