(49 days)
Carbon Filters and Water Softeners are intended to be used as components of a water purification system to remove organic and inorganic substances from water that is used to dilute dialysis concentrate to form dialysate and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection
The BJJ&A water purification components utilize no new water purification techniques, carbon filtration and water softening. The predicate device system we are claiming SE to, utilizes the exact same water purification principles. The following is a comparison summary of the BJJ&A water treatment components and the predicate device.
BJJ&A and U.S. Filter both utilize a water softener made of materials, which are "NSF" and/or FDA approved. U.S. Filters' softener is installed with a single regeneration tank and electrically interlocked to shut down the RO unit operation during the softener regeneration cycle. BJJ&A softeners are installed in a single regeneration tank configuration such as USF or in a duplex-twin alternating fashion to provide softened water to the system 24 hours a day. While one regeneration tank is in a regeneration cycle the other regeneration tank is on line providing soft water to the system. This will prevent the possibility of softener regeneration or a salt dump into the water purification system during a patient shift. This also eliminates the need to shut down the RO unit for softener regeneration.
Carbon filtration is utilized by both BJJ&A and U.S. Filter to filter out chlorine and chloramines from the water. BJJ&A uses carbon filter made from materials, which are FDA or NSF approved. Both companies use two carbon filters in a series configuration with test ports installed after each filter. A minimum total contact time of 10 empty bed contact time minutes are incorporated into both designs as recommended by the FDA for chlorine and chloramine removal. Both BJJ&A and U.S. Filter recommended the chlorine and chloramine levels be checked before each patient shift. Hard plumbed bypass piping of the carbon tanks is not allowed on either component. Both components will utilize an activated carbon with an Iodine number of 900 or greater. Both BJJ&A and U.S. Filter uses in line carbon regeneration filters. U.S. Filter uses a single carbon filter in its single patient dialysis system. BIJ&A always uses a dual carbon filter in series in every dialysis water system installed, including single patient systems.
BJJ&A and U.S. Filter incorporate emergency equipment bypass lines and valving that are clearly labeled and tagged. Instructions for usage will be included with the water components and staff in-service will be provided to the clinic/customer by BJJ&A. The use of dead legged bypass piping will be avoided. Carbon filters will not have hard plumbed bypass lines. U.S. Filter emergency equipment bypass utilizes a dry bypass technique. This method uses breakable unions and isolation valves at the end of each bypass line so that stagnant water will not be present in the line in the event of an emergency bypass condition. BJJ&A emergency equipment bypass is a wt bypass method. In this method the bypass valve is installed with no more than one half pipe a diameter length in this methou the bypass valve to avoid water stagnation. The use of dead leg bypass piping is unacceptable.
BJJ&A water distribution piping will be configured with no dead legs longer than 6 pipe diameters. U.S. Filter installs sanitization/sanitant introduction valve(s) or introduction port must be incorporated to allow chemical injection of sanitants to allow sanitization of the RO must be incorporated to anow chemical injoined in connections or through the top of the storage system and storage and the the sites for sanitant introduction BJJ&A avoids having any additional deadleg bypass valving installed into the original piping system and this further avoids water stagnation.
I am sorry, but based on the provided document, I cannot answer the question as it pertains to acceptance criteria and performance study details. The document is a 510(k) Premarket Notification summary for "Water Purification Components for Hemodialysis".
The document primarily focuses on establishing substantial equivalence to a predicate device (U.S. Filter Water Purification System, K980182) by comparing device features and purification principles. It mentions that the system "will meet all the requirements put forth by the United States Food and Drug Administration (FDA) and the Association for the Advancement of Medical Instrumentation (AAMI)", and discusses technical comparisons of water softeners and carbon filtration, including contact times and bypass methods.
However, it does not contain:
- A table of acceptance criteria or reported device performance metrics.
- Details about sample sizes for test sets, data provenance, or training sets.
- Information about the number or qualifications of experts, ground truth establishment, or adjudication methods for any study.
- Any mention of multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
Therefore, since the document does not present the specific information requested about acceptance criteria and a study proving their fulfillment, I cannot extract this data.
§ 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.