(94 days)
Dayton Water Systems' UltraPure Water Treatment System for Hemodialysis is intended for use in hemodialysis treatment. It is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.
UltraPure Water Treatment System For Hemodialysis (modified) with Pretreatment PH Citric Acid Feed System
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment.
The document is a letter from the FDA regarding a 510(k) premarket notification for a "UltraPure Water Treatment System For Hemodialysis". It discusses regulatory approval and general compliance requirements, but it does not include any performance data or study details.
Therefore, I cannot fulfill your request to provide the table of acceptance criteria and the study details.
§ 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.