(164 days)
The DSU, MSU, SSU Filters are intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. The DSU, MSU, SSU Filters assist in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore, it must be used in conjunction with other water treatment equipment (i.e., RO, DI, etc.).
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The provided text is a 510(k) summary letter from the FDA regarding a medical device called the "Nephros Inc. DSU, MSU, SSU Filter." This document is a regulatory approval letter and an "Indications for Use" statement.
Based on the content, it's clear that this document concerns a water purification system for hemodialysis and is not an AI/ML medical device. Therefore, the concepts of acceptance criteria, test sets, ground truth, experts, adjudication, MRMC studies, standalone performance, and training sets as typically applied to AI/ML device evaluations are not applicable to this submission.
The document discusses substantial equivalence to predicate devices, regulatory compliance, and general controls, which are standard for traditional medical devices. There is no information about algorithms, software performance, or diagnostic/prognostic capabilities that would necessitate the metrics and study designs you've asked about.
§ 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.