📊 Evidence-Based Reference
Virginia Water Systems Water Purification System for Hemodialysis
Virginia Water Systems
Summary: The Virginia Water Systems Water Purification System is designed for hemodialysis. It is primarily used to ensure water purity in dialysis settings. Key evidence findings are not directly available from the linked studies.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K991916 ↗
Decision Date ?
January 14, 2000
Product Code ?
FIP
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on January 14, 2000. It is manufactured by Virginia Water Systems and is classified as a Class 2 device under product code FIP.
What It Is
The Virginia Water Systems Water Purification System is a device used to purify water for hemodialysis. It ensures that the water meets the necessary quality standards for safe dialysis treatment, preventing contamination and ensuring patient safety.
FDA-Cleared Indications
- Purification of water used for hemodialysis.
- Use as part of a water-treatment system supporting hemodialysis equipment.
Clinical Applications
- Providing treated water to hemodialysis machines.
- Supporting water-quality control in outpatient dialysis centers.
- Supporting water-quality control in hospital-based dialysis units.
- Treating facility water before it is used in hemodialysis treatment.
Evidence Summary
The available literature includes four studies, though none directly pertain to the water purification system. The studies are registered on ClinicalTrials.gov, with unknown types and outcomes.
Reported Outcomes
Published studies report no specific outcomes related to the Virginia Water Systems Water Purification System, as the linked studies do not focus on this device.
Safety Profile
Reported complications include no specific safety data related to the Virginia Water Systems Water Purification System, as the linked studies do not provide relevant safety information.
Evidence Limitations
The evidence lacks direct studies on the Virginia Water Systems Water Purification System. There is a need for targeted research to evaluate its efficacy and safety in clinical settings.
Practical Considerations
- The system must be installed, operated, disinfected and maintained according to its labeling and the dialysis facility's water-quality program.
- Compatibility depends on the facility's incoming water supply, pretreatment equipment, distribution loop, dialysis machines and applicable water-quality standards.
- Routine monitoring and maintenance are necessary; treatment performance can be affected by filter condition, membrane performance, disinfectant exposure and source-water changes.
- This is a facility water-treatment system, not an implantable or patient-contact device, so MRI safety labeling for implanted devices does not apply.
- The system does not replace clinical assessment, dialysis-machine maintenance or testing of treated water before and during use.
Frequently Asked Questions
What are the clinical indications for Virginia Water Systems Water Purification System?
The device is indicated for use in purifying water for hemodialysis to ensure patient safety and treatment efficacy.
What outcomes have been reported in clinical studies?
No specific outcomes have been reported in the linked studies regarding this device.
What complications have been reported?
No specific complications have been reported in the linked studies regarding this device.
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.