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hemodialysis single patient system sps 550 vsb
Baxter Healthcare
Summary: The Hemodialysis SPS 550 VSB by Baxter Healthcare is a single patient hemodialysis system. It is primarily used for renal replacement therapy in patients with chronic kidney disease. Key evidence includes studies on disinfection methods and dietary potassium restriction.
FDA Clearance Information
Pathway
510K
Number
K894838 ↗
Decision Date
September 7, 1989
Product Code
FKP
Device Class
Class 2
Evidence
0 studies
The Hemodialysis SPS 550 VSB was cleared by the FDA via the 510(k) pathway on September 7, 1989. It is manufactured by Baxter Healthcare and classified as a Class 2 device under product code FKP.
What It Is
The Hemodialysis SPS 550 VSB is a medical device designed for single patient use in hemodialysis. It facilitates the removal of waste products and excess fluid from the blood when the kidneys are not functioning adequately. It is intended for use in clinical settings by trained healthcare professionals.
Clinical Applications
This device is commonly used in patients with chronic kidney disease requiring dialysis. It is suitable for hospital settings and outpatient dialysis centers, providing a controlled environment for renal replacement therapy.
Evidence Summary
The available literature includes three studies ranging from 1986 to 2018. These studies encompass randomized controlled trials and reviews, focusing on aspects such as dietary potassium restriction and disinfection methods in dialysis.
Reported Outcomes
Published studies report that dietary potassium restriction may have neuroprotective effects in chronic kidney disease patients. Additionally, methods for enhancing lithium elimination and disinfection protocols for dialysis equipment have been explored, though specific efficacy outcomes for the SPS 550 VSB are not detailed.
Safety Profile
Reported complications include potential neuromuscular issues associated with chronic kidney disease, as highlighted in the study on dietary potassium. Safety data specific to the SPS 550 VSB is not extensively covered in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of direct studies on the SPS 550 VSB's efficacy and safety. Further research is needed to explore specific outcomes and complications associated with this device. Existing studies focus more on related clinical practices rather than the device itself.
Frequently Asked Questions
What are the clinical indications for hemodialysis SPS 550 VSB?
The device is indicated for use in patients requiring hemodialysis due to chronic kidney disease, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report potential neuroprotective effects of dietary potassium restriction in CKD patients, but specific outcomes for the SPS 550 VSB are not detailed.
What complications have been reported?
Reported complications include neuromuscular issues in CKD, though specific safety data for the SPS 550 VSB is limited.
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.