đź“Š Evidence-Based Reference
Phd Personal Hemodialysis Instrument-1m101 Phd Water Pre-Treatment Kit-1w605 Phd Hard Plumbing Kit-1w604 Phd Blood Tub
Aksys
Summary: The phd personal hemodialysis instrument by Aksys is a dialysis-access device cleared by the FDA. It is primarily used for home hemodialysis. Key evidence highlights its role in managing end-stage kidney disease.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K010131 ↗
Decision Date ?
March 26, 2002
Product Code ?
KDI
Device Class ?
Class 2
Evidence ?
0 studies
The phd personal hemodialysis instrument was cleared by the FDA via the 510(k) pathway on March 26, 2002. It is manufactured by Aksys and classified as a Class 2 medical device.
What It Is
The phd personal hemodialysis instrument is designed for home hemodialysis, allowing patients with end-stage kidney disease to perform dialysis independently. It includes a water pre-treatment kit and hard plumbing kit to facilitate the process.
FDA-Cleared Indications
- For use as a personal hemodialysis system in the treatment of patients with end-stage renal disease.
- For use with the associated water pre-treatment kit, hard-plumbing kit, and blood tubing as specified in the device labeling.
Clinical Applications
- Home hemodialysis for appropriately trained patients with end-stage renal disease.
- Hemodialysis treatment using extracorporeal blood circulation and dialysate prepared by the system.
- Use of the water pre-treatment kit to prepare the water supply for hemodialysis.
- Use of the hard-plumbing kit to support installation of the home dialysis system.
- Use of compatible blood tubing during hemodialysis treatment.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs, observational studies, and case series. The studies span from 2003 to 2025, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the phd personal hemodialysis instrument is effective in managing end-stage kidney disease, with some evidence suggesting improved patient outcomes compared to traditional in-center dialysis. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with hemodialysis, such as infection and vascular access issues. The evidence does not provide detailed safety data specific to this device.
Evidence Limitations
The evidence lacks detailed efficacy and safety metrics specific to the phd personal hemodialysis instrument. Further research is needed to explore long-term outcomes and device-specific complications.
Practical Considerations
- This is a system with multiple components; the instrument, water pre-treatment kit, hard-plumbing kit, and blood tubing must be compatible and installed according to the labeling.
- Use requires appropriate patient and caregiver training, a suitable home water supply and drainage setup, and clinical supervision by a dialysis team.
- The blood tubing is a disposable extracorporeal circuit component and should be used only for the labeled treatment and according to the manufacturer's instructions.
- MRI safety information is not established in the supplied FDA record. The instrument and associated components should not be brought into the MRI environment unless their current labeling specifically permits it.
- Patient selection, vascular access, anticoagulation, water quality, infection control, and emergency planning are clinical requirements determined by the treating nephrology team.
Frequently Asked Questions
What are the clinical indications for phd personal hemodialysis instrument?
The device is indicated for home hemodialysis in patients with end-stage kidney disease.
What outcomes have been reported in clinical studies?
Studies suggest improved patient outcomes with home hemodialysis, but specific metrics are not detailed.
What complications have been reported?
Reported complications include general hemodialysis risks such as infection and vascular access issues.
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.