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510(k) Data Aggregation
K Number
K010131Device Name
PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB
Manufacturer
AKSYS, LTD.
Date Cleared
2002-03-26
(434 days)
Product Code
KDI
Regulation Number
876.5860Why did this record match?
Applicant Name (Manufacturer) :
AKSYS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Indicated for treatment of the chronic or acute uremic patient where hemodialysis, including high flux dialysis, is prescribed by the physician.
- Indicated for hemodialysis in a variety of environments, to include acute care facility, chronic dialysis facility, self care facility, or home setting, where the patient has been trained and certified to be competent in the use of this device by the attending physician.
Device Description
The PHD Personal Hemodialysis System is an automated high flux hemodialysis system using a double needle configuration. It is designed to perform safe and effective personal hemodialysis as prescribed by the patient's physician, while minimizing the time and effort to perform each treatment. A computer-like touch screen prompts the operator through each step of the procedure. The PHD System consists of several components that combine to deliver hemodialysis and perform ultrafiltration. These include the PHD Instrument (PHDi), the PHD Water Pre-Treatment System (WPS), the PHD Blood Tubing Set (BTS), the PHD Chemical Concentrate Bottles (CCBs), and the PHD Transducer Protector (TP). The PHD Instrument orchestrates and performs the entire pre-treatment, treatment, and post treatment cycle. It accomplishes this by working in conjunction with the WPS (or equivalent), BTS, CCBs, TP, and a commercially available hollow fiber membrane dialyzer. Between treatments, the system automatically cleans and disinfects the blood tubing set, dialyzer, and all other components in the fluid pathway. Also, the machine checks the efficiency and integrity of the dialyzer. The PHD Instrument electronically stores information about the patient, prescription, treatment schedule, and machine set-up while allowing for updates according to individual needs.
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