(54 days)
The Gambro® Water Treatment System is intended to be used by hemodialysis clinics for the purification of water to be used for the dilution of dialysate concentrate and in the reprocessing of dialyzers for reuse.
Not Found
The provided text describes an FDA 510(k) clearance letter for the Gambro® Water Purification System. This document is a regulatory approval, not a scientific study describing device performance against acceptance criteria in the way a clinical trial or AI algorithm validation would.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement, because these details are not present in the provided FDA clearance letter. This type of document confirms regulatory compliance and substantial equivalence, not the results of a detailed performance study.
The document only states the "Indications for Use" for the device, which are:
- Purification of water to be used for the dilution of dialysate concentrate by hemodialysis clinics.
- Purification of water to be used in the reprocessing of dialyzers for reuse by hemodialysis clinics.
§ 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.