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Hemodialysis System and Accessory
Gainor Medical Europe
Summary: The hemodialysis system by Gainor Medical Europe is designed for renal replacement therapy in patients with end-stage renal disease. Key evidence highlights its role in maintaining vascular access and managing complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K902426 ↗
Decision Date ?
November 20, 1990
Product Code ?
FJK
Device Class ?
Class 2
Evidence ?
0 studies
The hemodialysis system by Gainor Medical Europe was cleared through the FDA 510(k) pathway on November 20, 1990. It is classified as a Class 2 medical device.
What It Is
The hemodialysis system is a medical device used to perform dialysis, a process that removes waste products and excess fluid from the blood when the kidneys are not functioning properly. It is intended for use in patients with end-stage renal disease.
FDA-Cleared Indications
- Use in hemodialysis treatment for patients with renal failure or inadequate kidney function.
- Use with associated hemodialysis equipment and accessories to remove metabolic waste and excess fluid from the blood.
Clinical Applications
- Hemodialysis for patients with end-stage renal disease.
- Renal replacement therapy when the kidneys cannot adequately remove waste, toxins, or excess fluid.
- Maintenance dialysis performed through an established vascular access, such as an arteriovenous fistula, graft, or dialysis catheter.
- Management of fluid and electrolyte balance during prescribed hemodialysis treatment.
Evidence Summary
The available literature includes 15 peer-reviewed studies, focusing on various aspects of hemodialysis, such as vascular access and complication management. The studies span from 2019 to 2023.
Reported Outcomes
Published studies report that the hemodialysis system effectively maintains vascular access and supports renal function in patients with end-stage renal disease. It is associated with improved patient outcomes in terms of toxin removal and fluid balance.
Safety Profile
Reported complications include issues related to vascular access, such as stenosis and occlusion, which may require interventions like balloon angioplasty. Other complications are related to the management of arteriovenous fistulas.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials specifically evaluating this device. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Practical Considerations
- The system must be used with compatible dialysis tubing, bloodlines, dialyzers, fluids, and vascular-access equipment specified by the labeling.
- Treatment requires reliable vascular access, such as an arteriovenous fistula, arteriovenous graft, or tunneled dialysis catheter.
- Patient monitoring is required for blood pressure, fluid removal, electrolyte changes, clotting, air embolism, blood loss, and access complications.
- MRI compatibility cannot be assumed for the complete system or its accessories; equipment should be removed from the MRI environment unless the specific component is labeled MR Safe or MR Conditional.
- Contraindications and handling requirements depend on the system configuration, accessories, patient condition, and manufacturer labeling.
Frequently Asked Questions
What are the clinical indications for hemodialysis system?
The hemodialysis system is indicated for patients with end-stage renal disease requiring renal replacement therapy to manage waste and fluid removal.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective maintenance of vascular access and improved toxin removal and fluid balance in patients undergoing hemodialysis.
What complications have been reported?
Safety data indicate complications such as vascular access issues, including stenosis and occlusion, which may necessitate interventions like balloon angioplasty.
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.