(157 days)
The Isopure Complete Water Purification System each device is intended for use in Hemodialysis and is intended to remove organic and inorganic chemical contaminants and microbitorial contaminants from water used to dilute dialysate substances. These systems are to be use in Hospitals and/or Hemodialysis facilities.
The Isopure Complete Water Purification System for direct feed Hemodialysis Facilities Indirect feed utilizing the MD610, MD620, MD630, MD640 Ultra Filter System. Each indirect feed model has the following optional configuration: MD610 – Single distribution pump with a series of ultra-filters based on the required flow of the facility. The MD610 has no Deionization capabilities. MD620 – Dual multi-stage distribution pumps with a series of ultra-filters based on the required flow of the facility. The MD620 has no Deionization capabilities. MD630 – Single multi-stage distribution pump with a series of ultra-filters based on the required flow of the facility. The MD630 is equipped to process a single bank of medical grade Deionization exchange tanks. MD640 – Dual multi-stage distribution pumps with automatic pump alternation with a series of ultra-filters based on the required flow of the facility. The MD640 is equipped to process dual banks of medical grade Deionization exchange tanks. The MD640 is capable of operating continuously by automatically alternating between the two banks of exchange tanks.
I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The document is a 510(k) premarket notification letter from the FDA regarding the "Isopure Complete Water System for Hemodialysis". It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. However, it does not contain details about:
- Specific acceptance criteria for device performance (e.g., purity levels of water, removal efficiency of contaminants).
- Any study performed by the manufacturer to demonstrate compliance with performance metrics.
- Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or details about training sets.
This document is a regulatory approval letter, not a scientific study report or a detailed performance validation document.
§ 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.