(279 days)
The DialGuard™ device is intended to be used for the reduction of endotoxin from:
- Dialysate prior to entering the dialyser
- Water prior to its use for preparation of dialysate
- Water prior to use for regenerating dialysers.
DialGuard™ is intended to be used on a regular preventative basis during hemodialysis treatments. Experimental data indicates that DialGuard TM will consistently reduce endotoxin levels to ≤ 0.05 EU/mL. (AAMI standard for water for dialysate is
DialGuard™ is a device used for the reduction of endotoxin from dialysate and water. It consists of a polysulfone housing filled with an affinity resin with polysulfone endcaps. The endcaps are fitted with Quick Connect couplings.
Here's an analysis of the provided text, outlining the acceptance criteria and the study used to demonstrate the device's performance, organized according to your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the DialGuard™ filter are primarily focused on its ability to reduce endotoxin levels. The performance is reported in the context of meeting or exceeding relevant standards.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Endotoxin Removal (Water for Dialysate) | Quantitative: Endotoxin levels in water for dialysate should be reduced to ** |
§ 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.