đź“Š Evidence-Based Reference
Sc Hemodialysis Machine Sc Dialysate Cartridge Sc Blood Tubeset
Quanta Dialysis Technologies
Summary: The SC Hemodialysis Machine by Quanta Dialysis Technologies is a device used for hemodialysis treatment. It was FDA cleared via the 510k pathway in 2021. Key evidence includes studies on cardiovascular risk and home hemodialysis approaches.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K210661 ↗
Decision Date ?
August 12, 2021
Product Code ?
KDI
Device Class ?
Class 2
Evidence ?
0 studies
The SC Hemodialysis Machine was cleared by the FDA through the 510k pathway on August 12, 2021. It is manufactured by Quanta Dialysis Technologies and is classified as a Class 2 device.
What It Is
The SC Hemodialysis Machine is designed for use in hemodialysis, a process that removes waste products and excess fluid from the blood when the kidneys are not functioning properly. It includes a dialysate cartridge and blood tubeset, facilitating efficient dialysis treatment.
FDA-Cleared Indications
- Hemodialysis treatment for patients with renal failure or insufficient kidney function.
- Use with the SC dialysate cartridge and SC blood tubing set as components of the SC Hemodialysis System.
- Hemodialysis in clinical settings, including use by appropriately trained patients or caregivers when permitted by the labeling and clinical program.
Clinical Applications
- Intermittent hemodialysis for patients with advanced or end-stage kidney disease.
- Removal of metabolic waste products from circulating blood.
- Removal of excess fluid during dialysis treatment.
- Hemodialysis performed in an outpatient dialysis center or an approved home-hemodialysis program, according to labeling and clinician supervision.
Evidence Summary
The available literature includes 11 studies, comprising various study types such as RCTs and prospective analyses. The studies span from 2024 to 2025, focusing on cardiovascular risk, home hemodialysis, and gastrointestinal bleeding in dialysis patients.
Reported Outcomes
Published studies report on the efficacy of the SC Hemodialysis Machine in managing cardiovascular risk in CKD patients and predicting gastrointestinal bleeding hospitalization risk. Home hemodialysis approaches have also been explored, highlighting patient-centered care.
Safety Profile
Reported complications include potential renal injury due to iron accumulation during normothermic perfusion and gastrointestinal bleeding risks in hemodialysis patients. These findings underscore the importance of monitoring and managing these risks.
Evidence Limitations
The evidence is limited by the relatively short date range and the need for more comprehensive studies on long-term outcomes. Further research is needed to explore the full scope of safety and efficacy in diverse patient populations.
Practical Considerations
- The system requires compatible SC dialysate cartridges and SC blood tubing sets, along with an appropriate vascular access such as an arteriovenous fistula, graft, or dialysis catheter.
- Treatment requires trained clinical staff or properly trained home users, vascular-access monitoring, anticoagulation management when prescribed, and infection-control procedures.
- The machine is not an MRI-compatible component for use in the MRI environment; keep it outside the MRI scanner room unless the manufacturer and facility specifically authorize otherwise.
- Contraindications and warnings depend on the machine, cartridge, tubing set, dialysate, vascular access, and patient condition; users should follow the current FDA-cleared labeling and clinical protocol.
- The dialysate cartridge and blood tubing set are treatment-specific disposable components and should not be reused unless the labeling expressly permits it. The machine is reusable and requires maintenance and service according to the manufacturer’s instructions.
Frequently Asked Questions
What are the clinical indications for SC Hemodialysis Machine?
The SC Hemodialysis Machine is indicated for use in patients with chronic kidney disease requiring hemodialysis.
What outcomes have been reported in clinical studies?
Studies have reported on cardiovascular risk management, gastrointestinal bleeding risk prediction, and home hemodialysis approaches.
What complications have been reported?
Safety data indicate potential complications such as renal injury from iron accumulation and gastrointestinal bleeding risks.
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.