(209 days)
The HydraGuard 10" UltraFilter is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filter aids in infection control. The filter produces water that is suitable for patient wound cleaning of equipment used in medical procedures and washing of surgeon's hands. Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water.
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The provided document is a 510(k) clearance letter for the HydraGuard 10" UltraFilter. It does not contain information about acceptance criteria for device performance or a study demonstrating the device meets such criteria in terms of clinical or diagnostic accuracy. Instead, it describes the indications for use and the regulatory classification of the device as a water purification system.
The "Indications for Use" section (page 2) describes what the device is intended for:
- To filter EPA quality drinking water.
- To retain bacteria, viruses, and endotoxin.
- To provide ultrapure water for patient washing and drinking, aiding in infection control.
- To produce water suitable for patient wound cleaning, cleaning of equipment used in medical procedures, and washing of surgeon's hands.
It explicitly states, "The filter is not intended to provide water that can be used as a substitute for USP sterile water."
Based on the provided text, the specific details regarding acceptance criteria, device performance metrics (other than the qualitative statements above), and information about a "study that proves the device meets the acceptance criteria" in the context of clinical effectiveness or diagnostic accuracy are not available. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on a detailed performance study with specific quantitative acceptance criteria as would be found for a diagnostic or AI-driven device.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert involvement, adjudication, MRMC studies, or ground truth establishment based solely on the text provided. This document is a regulatory approval letter, not a clinical study report.
§ 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.