(132 days)
The DIASAFE®plusUS is intended for the preparation of ultrapure dialysate from pre-treated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g., RO system, central delivery system).
The microbiological quality (microbial count [CFU/mL] and endotoxin measurement [EU/mL]) of the incoming water should be
The DIASAFE®plusus (P/N F00007039) is a non-sterile dialysis fluid filter that produces ultrapure dialysate as defined in ANSI/AAMI/ISO 11663. The filter reduces microbial contaminants including endotoxins in the dialysate during hemodialysis treatment. The DIASAFE® plusus is installed and exchanged on 2008 Series hemodialysis machines using the DIAFIX™ Lock System. The DIAFIX™ Lock System is a standard feature on 2008 Series hemodialysis machines and is installed during machine production.
Mixed dialysate is forced through an open filter port across the fibers of DIASAFE® plusus. A bypass valve at the other end is closed which forces the dialysate across the fiber membrane. Dialysate passes through the porous membrane and into the filtrate compartment where it is allowed to flow through the uncapped side ports and into the hemodialyzer. Microorganisms and molecules too large to pass through the membrane are trapped in the fibers until they are flushed out, and/or disinfected during a routine cleaning cycle
The provided text describes the regulatory clearance (510(k)) for the DIASAFE®plusUS, a water purification system for hemodialysis. The document outlines acceptance criteria and the results of various performance tests conducted to demonstrate the device's substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Conducted | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacteria Retention | The filter shall retain bacteria to produce ultrapure dialysate with a microbial count 300 mL/hr mmHg (3.75 L/min bar) at 37°C | Pass, results within acceptance criteria |
| Dialysis Fluid Composition | Dialysate composition shall not be adversely affected after passing through the DIASAFE®plusUS | Pass, results within acceptance criteria |
| Filter Integrity | The filter connectors, caps, housing, and welding shall not leak at a filtration pressure 300 mL/hr mmHg). |
- Integrity/Composition: The ground truth is the observation that the device components remain intact and the dialysate composition is not adversely affected, matching the engineering specifications.
These are not based on expert consensus, pathology, or outcomes data in the medical diagnostic sense, but rather on direct physical and chemical measurements.
8. The sample size for the training set
This information is not applicable. The DIASAFE®plusUS is a physical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device.
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.