(126 days)
The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
The AquaBplus is a microcontrolled, fully automatic reverse osmosis which uses pretreated soft water for the production of highly deionized water for use by hemodialysis devices and for the preparation of dialysis concentrates.
The intended use of the reverse osmosis device is to remove organic and inorganic ions and microbiological contaminants from the feed water to fulfill the requirements of ISO 13959 'water for haemodialysis and related therapies'.
The feed water must be of drinking water standard, filtered, free of iron, softened and free of chlorine. Potentially critical limits must be monitored by regular checks.
Bacterial growth in the system must be prevented by continuous operation of the system with a minimum of idle times and by preventive measures such as chemical disinfection. If there is a need, the quality of the permeate could be raised by using the AquaBplus B2 as a second reverse osmosis (2nd membrane filtration step). The AquaBplus B2 is a module that will be installed after the AquaBplus (=main reverse osmosis).
To allow an automatic heat disinfection of the permeate ring main, the module AquaBplus HF could be installed afterwards the AquaBplus/AquaB2. The heat disinfection could take place in dialysis free times.
The produced dialysis permeate will be transferred to the permeate ring main by pressure, where it will be distributed to the different withdrawal units of the dialysis machines. Alternatively permeate could be transferred into a permeate storage tank system. A permeate distribution system (pump, filter, tubing) follows normally to a permeate storage system. In most cases, the feed line into the permeate storage tank is realized as a ring main. Because the most installation type is the ring main and to ease the following description, the components following the AquaBplus system is simply called "ring main".
The provided text is a 510(k) Summary for the AquaBplus Water Purification System. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than conducting a detailed clinical study with acceptance criteria in the typical sense of a medical diagnostic or AI device.
Therefore, many of the requested categories for describing acceptance criteria and study details cannot be directly extracted or are not applicable. I will provide information based on what is available in the text.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ISO 23500 | Demonstrated compliance |
| Compliance with ISO 11663 | Demonstrated compliance |
| Compliance with ISO 13959 | Demonstrated compliance |
| Compliance with IEC 60601-1 | Demonstrated compliance |
| Compliance with IEC 60601-1-2 | Demonstrated compliance |
| Compliance with IEC 60601-1-6 | Demonstrated compliance |
| Compliance with IEC 62304 | Demonstrated compliance |
| Compliance with ISO 10993 | Demonstrated compliance |
| Compliance with ISO 14971 | Demonstrated compliance |
| Compliance with ISO 26722 | Demonstrated compliance |
| Meeting device specifications | All specifications met |
| Functional testing | Passed |
| Safety testing | Passed |
| Performance testing | Passed |
Ability to remove organic and inorganic ions and microbiological contaminants from feed water to fulfill ISO 13959 water for haemodialysis and related therapies | The system is capable of meeting relevant standards and specifications for use in hemodialysis and related therapies. |
Explanation: The "acceptance criteria" here are primarily regulatory and performance standards that the device must meet to demonstrate safety and effectiveness for its intended use and to establish substantial equivalence to predicate devices. The "reported device performance" indicates that the AquaBplus system passed all these tests and standards.
Study Details (Based on available information)
- Sample size used for the test set and the data provenance: Not applicable. This was a series of non-clinical performance tests (software validation, chemical and microbiological testing, biocompatibility testing, electrical and electromagnetic safety testing, usability testing, and performance testing against device specifications) performed on the device itself, not on a dataset of patient information.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this type of device is compliance with engineering, safety, and performance standards, established through recognized testing methodologies and standards, rather than expert interpretation of patient data.
- Adjudication method for the test set: Not applicable. This type of device verification does not involve adjudication of expert opinions. Rather, it involves objective measurements against established standards.
- 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 is not an AI/diagnostic device that would involve human readers or an MRMC study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone water purification system. Its performance was evaluated in isolation regarding its ability to meet specified standards.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" was compliance with established international and national standards for medical devices and water purification systems for hemodialysis (e.g., ISO 13959, ISO 23500, IEC 60601-1, ISO 10993).
- The sample size for the training set: Not applicable. This is not a machine learning or AI device that would involve a training set.
- 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.