(167 days)
The Culligan Soft Water Service Company Deionizer and Carbon Exchange tanks are primary or temporary devices to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62. These tanks remove chlorine, chloramines, total organic carbons and total dissolved solids from water used to dilute dialysis concentrate to form dialysate, in reprocessing of hemodialyzers, as supply water to the dialysis machines and equipment rinse and disinfection. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or with new resin altogether. These tanks are components of a larger water treatment system employing adequate pre-treatment and post-treatment sections. Culligan's tanks are not to be used alone.
The Culligan Soft Water Service Company, Deionizer and Carbon Exchange Service for Hemodialysis includes carbon filtration for the removal of chlorine and chloramines and deionizer (DI) exchange tanks for the removal of contaminants from the water through an ion exchange process to provide AAMI quality water for hemodialysis applications.
This document is a 510(k) summary for the Culligan Soft Water Service Company Deionizer and Carbon Exchange tanks for hemodialysis, not a study report. It states that the device is substantially equivalent to a predicate device (Ameriwater Dialysis Deionizer Exchange Service, K991519) and defines its intended use and general specifications.
Therefore, the requested information regarding acceptance criteria, study data, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is not available within the provided text. This document focuses on the regulatory submission process and establishing substantial equivalence rather than presenting performance study results.
To fulfill the request, a hypothetical example based on the type of device (water purification for hemodialysis) would typically involve:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (e.g., based on ANSI/AAMI RD62) | Reported Device Performance |
|---|---|---|
| Chlorine Removal |
§ 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.