(94 days)
Aquaboss® EcoRO Dia 50 Portable Water Treatment System for Hemodialysis is a device that is intended for use with a hemodialysis system. It is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. The device includes carbon filter and sediment filter. The device may include a water softener. Aquaboss® EcoRO Dia 50 Portable Water Treatment System for Hemodialysis is designed for the use in hospital or in home settings.
The Aquaboss EcoRO Dia 50 Portable Water Treatment System is a complete water purification system and consists of a reverse osmosis (RO) and pre-treatment. It s designed to feed one Hemodialysis machine with water. In order to optimize the performance of the RO system, the following items for pre-treatment are utilized: 1) cartridge filters to remove suspended solids 2) activated carbon filtration to remove organics, namely chlorine and chloramines. To minimize bacterial growth in the permeate line, permeate is circulated dead space from the membrane to the point of use (dialysis machine). Excess permeate is circulated into the raw water tank and is reprocessed. Aquaboss® EcoRO Dia 50 works on the reverse osmosis principle. Reverse Osmosis describes a process involving a pressure operated cross filtration system. The water flows under high pressure tangentially to a semi permeable membrane. As it is the case with normal filtration the system is cleaned by allowing one component (water) of the mixture to be separated to pass through the membrane with almost no hindrance whereas the other components (dissolved and non-dissolved water contents) are held back to leave the filtration unit in the concentrate flow. This is a separation process in the molecular sector which does not change the components being separated either chemically, biologically or thermally. In order to ensure that the microbiological quality of the permeate will be maintained, this system has: A dead space free stainless steel pressure vessel for the RO membrane. A hygienic design with smooth surfaces. Automatic flushing program to remove impurities from the membrane surface (impulse backwashing). Automatic flushing during standby periods to exchange stagnant water. Dead space free connection between Reverse osmosis and Dialysis machine. When requested by the facility physician, optional devices can include the following components: 1) CART (four wheel transport unit for RO system and pretreatment) (Option) 2) water softener to remove scale-forming minerals (Option) 3) Wooden box to increase sound absorption (Option). After pretreatment ((i.e. filter, water softener; charcoal filter, etc) the incoming raw water (RW) flows through the solenoid valve (Y10) into the break tank (VL). From there it is delivered by means of a pump M1 to the membrane module MM1. by passing through the reverse osmosis membrane. The feed flow (raw water and circulation) is divided into the concentrate and permeate flow after the feed flow has passed through the membrane barrier. Concentrate leaves the membrane module and passes through a needle valve (NV), which restricts the water volume flowing out, thus ensuring the production pressure. The concentrate flow regulated in this way is either circulated internally through the solenoid valve Y2 back into the tank or is conducted to the drain outlet as waste water through solenoid valve Y9. The system between Y2 and Y9, and thus the regulation of the concentrate volume to be rejected is by means of time control. Before beginning dialysis and during the reflushing periods the needle valve can be bypassed by opening the solenoid valve Y6 so that the membrane can be cleaned with a higher volume for a defined period of time. The permeate is conducted through a hose to the dialysis machine. From here it is fed by means of a coupling into the dialysis machine. Should the end user not call for the full amount of permeate, the unused water be returned to the break tank via a pressure holding valve which, in turn ensures constant ringline pressure. The following is measured in accordance with the process diagram: conductivity raw water (CIS1), Conductivity Concentrate (CIS2), Conductivity Permeate (CIS3) System pressure (PIS1),, temperature concentrate (TIS) and Temperature Permeate (TS).
The provided 510(k) summary for the Aquaboss® EcoRO Dia 50 Portable Water Treatment System for Hemodialysis does not contain specific acceptance criteria or a study dedicated to proving the device meets those criteria in the way typically expected for performance claims of diagnostic or treatment efficacy devices.
This document is a "Premarket Notification" (510(k)) which primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than detailed performance study results against specific acceptance criteria. The information provided is geared towards comparing the technological characteristics and intended use of the Aquaboss® EcoRO Dia 50 to the predicate device.
However, I can extract the relevant information based on the typical content of a 510(k), particularly regarding the intended function and how its characteristics are presented.
Here's an interpretation based on the provided text, outlining what can be inferred or what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria or detailed performance results from a dedicated study are provided in this document. The document states that the system "produces water for diluting hemodialysis concentrates according to AAMI Standards RD5; RD62 (draft) and RD52 (draft)." These AAMI standards would define the acceptance criteria for water quality (e.g., maximum levels of organic and inorganic substances, microbial contaminants). The device's performance is implicitly stated as meeting these standards through its design and the comparison to the predicate device.
| Acceptance Criteria (Inferred from AAMI Standards) | Reported Device Performance (Implied) |
|---|---|
| Water quality suitable for hemodialysis (e.g., removal of organic substances, inorganic substances, microbial contaminants) as per AAMI Standards RD5, RD62 (draft), and RD52 (draft). | The Aquaboss® EcoRO Dia 50 is designed and built to produce water meeting these standards. Its design incorporates various filtration steps and RO technology to achieve this. |
| System output rate of 50 L/h. | The system output rate is 50/h. |
| Maintenance of microbiological quality during operation and standby. | Features like a dead space-free stainless steel pressure vessel, hygienic design, automatic flushing program, and automatic flushing during standby are incorporated for this purpose. |
| Continuous monitoring of permeate conductivity and operating mode. | Conductivity of permeate and operating mode are continuously displayed, with alarms for poor water quality. |
| Chemical disinfection capability. | Can utilize chemical disinfection using peracetic acid. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a performance study with a test set of data samples. It focuses on the device's design, operational features, and comparison to a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication Method for the Test Set
Not applicable. No test set adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a water treatment system, not an AI-assisted diagnostic or decision support tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a water treatment system, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is implicitly the AAMI Standards RD5, RD62 (draft), and RD52 (draft) for water quality for hemodialysis. The device is designed and claimed to meet these engineering and chemical specifications.
8. The Sample Size for the Training Set
Not applicable. This device is a physical water treatment system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.