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510(k) Data Aggregation
(185 days)
The Ultrapure & Industrial Services (UIS) Deionization Tanks are exchangeable/rechargeable mix bed tanks intended to remove ions from the water to a sufficient level to allow safe treatment of Hemodialysis patients. These deionization tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post treatment. Upon, exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or new resin altogether.
The Ultrapure & Industrial Services Carbon Exchange Tanks are activated carbon tanks intended to remove chlorine and chloramines from the water to allow safe treatment of Hemodialysis patients. These carbon tanks are not be used alone, but are intended to be part of a larger water treatment system employing adequate pretreatment and post-treatment. Upon exhaustion, these tanks will be replaced with other tanks containing new activated carbon.
All Ultrapure & Industrial Services 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.
Deionizers: Ultrapure & Industrial Services Mixed Bed Deionization Exchange Tanks (DI) are Fiberglass Reinforced Polypropylene (FRP) tanks filled with mixed bed deionization resin. The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings, PVC or Noryl 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 to remove contaminantes from water being fed to the system. The DI system exchanges hydrogen ion (H+) for cations and hydroxyl ions (OH-) for anions in the feed water. The hydrogen and hydroxyl ions then combine to form pure water (H2O). The tanks are based on the AmeriWater Dialysis Deionizer Exchange Tanks K991519.
Similar to predicate AmeriWater, Ultra-Pure segregated aseptic exchange deionizer service in an on-line worker/polisher arrangement with a temperature compensated 1 megobm/cm resistance light monitor with audible alarm between the worker/polisher and a 0-19 megohm/cm temperatura compensated digital readout resistance meter with adjustable remote audio and visual alarm. Upon exhaustion, these tanks are replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether.
Carbon: Ultrapure & Industrial Services Carbon Exchange Tanks are Fiberglass Reinforced Polypropylene (FRP) tanks filled with new activated carbon. This carbón filtration, often referred to as granular activated carbón (GAC), will remove chlorine and chloramine that are almost always present in the source water through a chemical process knows as "adsorption". The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings; PVC or Noryl heads and tank distributors. The Carbon Exchange Tanks are dedicated for carbon only. Ultrapure & Industrial Services always recommends that two tanks be installed in series, with the first tank providing the primary purification and the second tank serving as backup. Same recommendation is offered by the predicate. The tanks are based on the AmeriWater Dialysis Carbon Exchange Tanks K991519.
Dialysis segregated exchange process carbon service utilizes new virgin coal based granular activated carbon (GAC) of 12X40 mesh size with an iodine number of 1000 or greater.
The tanks are disinfected with chlorine and cleaned before delivery to the dialysis application. Batch codes and dates are used to insure quality and freshness of the tanks. The tanks are re-bedded under our FDA/OS system with batch control of capacity, quality and microbiological control. Ultrapure & Industrial Services process includes a use of medical-grade carbon only followed by a 24-hour soak to fully wet the carbon followed by complete back-washing to remove any contaminants and provide a more natural pH product.
The provided document describes the Ultrapure & Industrial Services Deionization and Carbon Exchange Tanks for Dialysis. Here's an analysis of the acceptance criteria and the study conducted to prove the device meets these criteria:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device are based on the ANSI/AAMI RD62:2006 standards for water used in hemodialysis. The performance is assessed by measuring the reduction of various components in the water to within these standards.
Table of Acceptance Criteria and Reported Device Performance:
| Component | AAMI Suggested Maximum Level (mg/L) | Reported Treated Water (mg/L) | Meets or Exceeds AAMI Standard |
|---|---|---|---|
| Aluminum | 0.010 | <0.001 | Yes |
| Antimony | 0.006 | <0.001 | Yes |
| Arsenic | 0.005 | <0.001 | Yes |
| Barium | 0.100 | <0.01 | Yes |
| Beryllium | 0.0004 | <0.0001 | Yes |
| Cadmium | 0.0010 | <0.0001 | Yes |
| Calcium | 2.000 | <0.001 | Yes |
| Chromium | 0.014 | <0.001 | Yes |
| Copper | 0.100 | <0.001 | Yes |
| Fluoride | 0.200 | <0.01 | Yes |
| Iron | N/A (Reduced from 0.027 mg/L) | <0.001 | Yes |
| Lead | 0.005 | <0.001 | Yes |
| Magnesium | 4.000 | <0.001 | Yes |
| Mercury | 0.0002 | <0.0001 | Yes |
| Nitrate (as N) | 2.000 | <0.01 | Yes |
| pH | N/A (Adjusted from 7.91) | 7.00 | Yes |
| Potassium | 8.000 | <0.001 | Yes |
| Resistivity | N/A (Increased from <0.001) | 0.699 (Megohm/cm) | Yes |
| Selenium | 0.090 | <0.001 | Yes |
| Silver | 0.005 | <0.001 | Yes |
| Sodium | 70.000 | 0.289 | Yes |
| Sulfate | 100.00 | <0.01 | Yes |
| Thallium | 0.002 | <0.001 | Yes |
| Total Dissolved Solid (TDS) | N/A (Reduced from 180.50 mg/L) | 0.64 | Yes |
| Zinc | 0.100 | <0.001 | Yes |
| TOC | AAMI standard (reduced to non-detectable limits) | Non-detectable | Yes |
| Chlorine/Chloramine | AAMI standard (removed) | Removed | Yes |
Note: For pH, Iron, Resistivity, and TDS, AAMI standards are generally about achieving specific ranges or significant reduction, rather than a single maximum level. The document states "Meets or Exceeds AAMI Standard" for these, implying the treated water quality is acceptable.
2. Sample Size for Test Set and Data Provenance
The study used six water samples for validation purposes:
- Three samples of raw feed water (beginning foundation).
- Three samples from the final DI unit (to validate performance).
The data provenance is not explicitly stated in terms of country of origin, but the test labs used (AmeriWater, Culligan, Oxidor Testing Laboratory) are located in the United States (Ohio, Illinois, Texas). The study appears to be prospective as it involved simulating operational conditions and drawing samples specifically for this validation.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth in the traditional sense of medical image analysis or clinical outcomes. Instead, the "ground truth" for the water quality parameters is established by conformance to AAMI standards, which are recognized industry standards for water for hemodialysis. The testing was carried out by three independent laboratories:
- AmeriWater Laboratories
- Culligan Water Testing Laboratory
- Oxidor Testing Laboratories
While these are not "experts" in the human reviewer sense, their accreditation and adherence to AAMI standards serve as the authoritative basis for the ground truth of water quality. Their qualifications are inherent in being recognized industrial testing laboratories specialized in water analysis.
4. Adjudication Method for the Test Set
There was no "adjudication method" in the typically understood sense (like 2+1 reader consensus for imaging). The water samples were sent to three separate labs for analysis.
- AmeriWater and Culligan Laboratories tested for conformance to AAMI Standards (water chemistry parameters listed in the table).
- Oxidor Testing Laboratory tested for Total Organic Carbon (TOC).
The results from these labs appear to have been compiled and reported directly, with all labs collectively confirming AAMI standard performance. There is no mention of a process to resolve disagreements between labs, implying consistent results or that different labs focused on different aspects of the testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study, which assesses improvements in human reader performance with AI assistance, is not applicable to the device described here, which is a water purification component and not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance
A standalone performance study was done in the sense that the device (water purification system) was operated under simulated conditions, and its output water quality was directly measured by independent laboratories. This is equivalent to "algorithm only" performance for a non-AI physical device. The device's performance was evaluated based on its ability to purify water to AAMI standards without any human intervention or interpretation during the purification process itself.
7. Type of Ground Truth Used
The type of ground truth used is expert consensus / industry standard compliance, specifically ANSI/AAMI RD62:2006 standards. The chemical and physical properties of the treated water were measured and compared against these established standards to determine if the device performed adequately.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. It is a physical water purification system with resins and carbon, not a machine learning algorithm. Therefore, there is no training data in the context of AI.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this physical device, this question is not applicable. The device's design and manufacturing are based on established chemical engineering principles and specifications for the components (resins, carbon), rather than being "trained" on data.
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