(126 days)
The ASI Deionizer and Carbon Exchange Tank Service for hemodialysis are intended to be used in a hemodialysis facility according to ANSI/AAMI-RD62:2006 standards to supply purified water for use in hemodialysis. These exchange tanks are components of a larger water treatment system employing adequate pretreatment and post treatment sections. These exchange tanks are not to be used alone. Upon exhaustion, these tanks will be replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether, or in the case of Carbon Tanks, with tanks containing virgin carbon. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.
Aqua Sciences, Inc. Mixed Bed Deionization Exchange Tanks (DI) are Fiberglass Reinforced Polypropylene (FRP) tanks filled with mixed bed deionizing resin. The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings, PVC heads and tank distributors. The DI Exchange Tanks are dedicated for ion exchange resin only. Our tanks are designed to deliver Association for the Advancement of Medical Instrumentation (AAMI) standard water through an ion exchange process.
Aqua Sciences, Inc. Carbon Exchange Tanks are Fiberglass Reinforced Polypropylene (FRP) tanks filled with new activated carbon. The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings, PVC heads and tank distributors. The Carbon Exchange Tanks are dedicated for carbon only and used to remove chlorine and chloramines.
Based on the provided 510(k) submission for the AQUA Sciences Inc. Deionization (DI) Exchange Tanks and Carbon Exchange Tanks, here's a description of the acceptance criteria and the study that proves the device meets them:
I. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Description | Device Performance |
|---|---|
| Water Quality Standard Compliance: Supply purified water according to ANSI/AAMI-RD62:2006 for hemodialysis. | "Results verify product complies with AAMI RD:62 Standard." The submission states that "nonclinical tests were conducted on product water from a replicated intended exchange tank configuration. Results verify product complies with AAMI RD:62 Standard." This directly addresses the standard compliance. The specific performance metrics within AAMI RD:62 (e.g., maximum allowable levels of ions, microbes, etc.) are implicitly met by this statement, though not explicitly detailed in the summary provided. |
| Deionization Efficacy: Effectively remove positive and negative charged dissolved solids and salts from water. | Achieved through "mixed bed deionizing resin." "Deionization Exchange tanks from both Aqua Sciences. Inc. and AmeriWater are utilized to remove positive and negative charged dissolved solids and salts from the water. Both companies utilize mixed bed resins consisting of cation and anion resin." While no numerical performance for removal efficiency is given, the claim is made that the device is utilized for this purpose, aligning with the predicate. |
| Chlorine/Chloramine Removal Efficacy: Effectively remove chlorine and chloramines from feed water. | Achieved through "new activated carbon" and "granular activated carbon with a minimum iodine number of 900." "Activated Carbon Filtration is utilized by both Aqua Sciences, Inc. and AmeriWater to remove chlorine and chloramines from the feed water. Aqua Sciences, Inc. uses carbon in accordance with AAMI current standards. Both companies use two (2) carbon filters in series configuration. Aqua Sciences, Inc. and AmeriWater both use granular activated carbon with a minimum iodine number of 900." No specific numerical "removal rate" is given, but the method and compliance with AAMI standards are stated. |
| Compatibility/Integration: Function as components of a larger water treatment system (not used alone). | Implicitly met by design and stated use. "These exchange tanks are components of a larger water treatment system employing adequate pretreatment and post treatment sections. These exchange tanks are not to be used alone." The acceptance is based on the design and intended use as a component. |
| Tank Integrity/Material: Tanks are Fiberglass Reinforced Polypropylene (FRP). | Directly stated as a design feature. "Aqua Sciences, Inc. Mixed Bed Deionization Exchange Tanks Device Description: (DI) are Fiberglass Reinforced Polypropylene (FRP) tanks filled with mixed bed deionizing resin." and "Aqua Sciences, Inc. Carbon Exchange Tanks are Fiberglass Reinforced Polypropylene (FRP) tanks filled with new activated carbon." |
| Common Fittings/Heads: Similar inlet and outlet fittings, PVC heads and tank distributors common to the industry. | Directly stated as a design feature. "The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings, PVC heads and tank distributors." and similar phrasing for carbon tanks. |
II. Study Details
The provided 510(k) summary describes a comparative study for substantial equivalence rather than a full, de novo clinical trial for a novel device. The study primarily relies on nonclinical tests and a comparison to a predicate device.
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "nonclinical tests were conducted on product water from a replicated intended exchange tank configuration." It does not specify the number of tests performed, the volume of water processed, or the number of units tested.
- Data Provenance: The document does not explicitly state the country of origin for the test data, but given the company's address is in New York, USA, and the submission is to the FDA, it is highly probable the testing was conducted in the USA. The tests appear to be prospective in nature, as they were "conducted" for the purpose of this submission to verify compliance.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This criterion is not applicable in the traditional sense for this type of device and study. The "ground truth" for water purification is established by adherence to a predefined standard (ANSI/AAMI-RD62:2006). The "experts" would be the personnel conducting the laboratory analyses and interpreting the results against the AAMI standard. Their qualifications (e.g., trained lab technicians, chemists) are not specified but are implied to be sufficient for water quality testing.
-
Adjudication Method for the Test Set:
- None specified/Not Applicable: For objective chemical and physical water quality tests, an adjudication method like 2+1 or 3+1 is not typically used. The results are quantitative and compared directly to the specified limits in the AAMI standard.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is relevant for diagnostic imaging AI devices where human readers interpret medical images. The Aqua Sciences device is a water purification component, not an imaging or diagnostic AI device.
-
Standalone (Algorithm Only Without Human-in-the-Loop Performance):
- Not applicable. This relates to AI/software performance. The device is a physical water purification component. Its "performance" is based on its ability to purify water, not on an algorithm's output.
-
Type of Ground Truth Used:
- The primary "ground truth" used is established industry standards (ANSI/AAMI-RD62:2006). The water quality parameters (e.g., conductivity, levels of specific ions, contaminants, chlorine/chloramine residual) dictate the "truth" of the water's purity. Analytical laboratory results from the "replicated intended exchange tank configuration" were compared against these predefined standard limits.
-
Sample Size for the Training Set:
- Not applicable. This device does not involve machine learning or AI models that require a training set.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for a machine learning model, this question does not apply.
In summary, the substantial equivalence claim for the Aqua Sciences Inc. Deionization and Carbon Exchange Tanks is based primarily on:
- Direct comparison of design, materials, and intended use to a legally marketed predicate device (AmeriWater Purification System for Hemodialysis (K991519)).
- Demonstration through nonclinical objective laboratory testing that the product water from their system complies with the established ANSI/AAMI-RD62:2006 standard for purified water used in hemodialysis. This compliance with a recognized standard serves as the "proof" the device meets its core acceptance criteria.
§ 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.