(266 days)
AquaBplus: The AquaBplus is a modular reverse osmosis unit 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. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The 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.
AquaB LITE: The AquaB LITE is a modular reverse osmosis unit 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. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and mav need to be followed by posttreatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
The AquaBplus and AquaB LITE are reverse osmosis (RO) water purification systems that use pretreated soft water to produce dialysis water for hemodialysis (HD) devices and for the preparation of dialysis concentrates.
The AquaBplus system is a modular system consisting of a base module that can be used on its own or in conjunction with other modules. AquaBplus is the base module. AquaBplus B2 is a second RO unit that can be added to increase the quality of dialysis water. AquaBplus HF is a flow heater unit that can be added to provide heat disinfection for the RingMain. The AquaBplus HF module can also supply hot product water to connected HD devices.
The AquaB LITE system is a basic version of the AquaBplus system. Like the AquaBplus, it is a modular system consisting of a base module that can be used on its own or in conjunction with other modules. AquaB LITE is the base module and B2 LITE is a second RO unit that can be added to increase the quality of dialysis water. AquaBplus HF is a flow heater unit that can be added to provide heat disinfection for the RingMain. The AquaBplus HF module can also supply hot product water to connected HD devices.
This document is a 510(k) Premarket Notification letter for the AquaBplus and AquaB LITE water purification systems, which are used for hemodialysis. The document summarizes the device, its intended use, and the performance data that supports its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:
Important Note: The provided document is an FDA 510(k) clearance letter and its associated summary. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed results from a clinical or AI-driven study with specific acceptance criteria in the manner an AI/ML medical device might. The "performance data" sections focus on safety, general functionality, and adherence to relevant standards rather than a comparative effectiveness study with human readers or standalone AI performance. Therefore, many of the requested points regarding AI/ML study design (e.g., sample size for test/training sets, expert ground truth, MRMC studies) are not applicable or detailed in this type of submission.
The "device" in this context is a water purification system, not an AI/ML algorithm for image analysis or diagnosis.
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of "acceptance criteria" and "reported device performance" in the way one might for an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC thresholds). Instead, the performance data section outlines the types of tests conducted to demonstrate that the device functions as intended and meets relevant standards to be deemed substantially equivalent. The acceptance criteria are implicitly meeting the specified standards and ensuring safety and effectiveness compared to the predicate.
| Test Conducted | Test Method Description & Implicit Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Essential Performance | Demonstrating that the device meets the following standards: |
- ISO 23500-1 (Preparation and quality management of fluids for haemodialysis and related therapies – Part 1: General requirements)
- ISO 23500-2 (Preparation and quality management of fluids for haemodialysis and related therapies – Part 2: Water treatment equipment for haemodialysis applications and related therapies)
- ISO 23500-3 (Preparation and quality management of fluids for haemodialysis and related therapies – Part 3: Water for haemodialysis and related therapies) | "Testing to demonstrate that the device meets the... standards." (Implicitly, the device did meet them to receive clearance.) |
| Software | Conformance with IEC 62304 Edition 1.1 (Medical device software – Software life cycle processes) | "Software verification within this submission is provided in accordance with IEC 62304..." (Implicitly met requirements). |
| Disinfection Validation| Validation of chemical and heat disinfection labeling in accordance with FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff" (17 March 2015). (Acceptance: Disinfection processes are effective as labeled.) | "Validation of chemical and heat disinfection labeling..." (Implicitly, the validation was successful). |
| Functional Verification| Complete system testing to verify the performance (e.g., conductivity and temperature) and functional (e.g., operating modes and generated alarms) requirements of the device. (Acceptance: Device operates as per design specifications for various parameters and modes.) | "Complete system testing to verify the performance... and functional... requirements of the device." (Implicitly, the device performed as required.) |
| Packaging | Packaging and transport verification according to ASTM D4169-16. (Acceptance: Packaging adequately protects the device during transport.) | "Packaging and transport verification according to ASTM D4169-16." (Implicitly, the packaging was found adequate.) |
| Biocompatibility | Testing conducted in accordance with ISO 10993-1:2020 and FDA guidance. Endpoints evaluated: Chemical Characterization, Toxicological Risk Assessment, Cytotoxicity, Sensitization, Irritation, Material-Mediated Pyrogenicity, Hemocompatibility. (Acceptance: Materials in contact with dialysis water are biologically safe.) | "Biocompatibility testing was conducted... The following endpoints were evaluated to support the biological safety..." (Implicitly, the testing supported biological safety.) |
| Electrical Safety & EMC| Electrical safety testing in accordance with ANSI/AAMI ES 60601-1:2005. Electromagnetic compatibility (EMC) in accordance with IEC 60601-1-2 Edition 4.0. (Acceptance: Device meets electrical safety and EMC requirements.) | "Electrical safety testing was conducted... EMC was conducted..." (Implicitly, the testing demonstrated compliance.) |
| Software V&V | System software verification testing to demonstrate effectiveness and confirm operation, in accordance with IEC 62304 and various FDA guidance documents on software functions, OTS software, and cybersecurity. (Acceptance: Software performs effectively and reliably, and meets regulatory guidelines for medical device software.) | "System software verification testing was performed to demonstrate the effectiveness of the software and to confirm the operation of the device." (Implicitly, positive results, leading to clearance.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of this device's testing. There is no "test set" of patient data or images as would be seen for an AI diagnostic algorithm. The testing described is hardware and software functional testing, validation against standards, and biocompatibility testing. These are typically performed on a limited number of physical units or material samples.
- Data Provenance: Not applicable. The "data" here refers to test results from engineering and laboratory evaluations, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The ground truth for a water purification system is defined by engineering specifications, international standards (e.g., AAMI/ANSI/ISO), and validated chemical/microbiological testing methods, not by expert medical interpretation of images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept pertains to resolving discrepancies in expert labeling of data for AI/ML models.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI-assisted diagnostic tools that interact with human readers (e.g., radiologists interpreting images). The AquaBplus/AquaB LITE are water purification systems; they do not involve human diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an AI algorithm. Its "performance" is its ability to purify water according to specified parameters and standards, which is assessed through direct measurement and functional testing, not an isolated algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by:
- International and Federal Standards: ISO 23500 series, AAMI/ANSI. These define the acceptable parameters for water quality for hemodialysis.
- Engineering Specifications: Designed conductivity, temperature, flow rates, and failure modes.
- Validated Test Methods: Biocompatibility tests (e.g., ISO 10993), disinfection validation protocols, electrical safety, and EMC standards.
- Predicate Device Performance: The predicate device serves as a benchmark for substantial equivalence.
8. The sample size for the training set
- Not applicable. There is no "training set" as this device does not use machine learning.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for one.
§ 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.