Search Results
Found 1 results
510(k) Data Aggregation
(167 days)
The Culligan Soft Water Service Company Deionizer and Carbon Exchange tanks are primary or temporary devices to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62. These tanks remove chlorine, chloramines, total organic carbons and total dissolved solids from water used to dilute dialysis concentrate to form dialysate, in reprocessing of hemodialyzers, as supply water to the dialysis machines and equipment rinse and disinfection. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or with new resin altogether. These tanks are components of a larger water treatment system employing adequate pre-treatment and post-treatment sections. Culligan's tanks are not to be used alone.
The Culligan Soft Water Service Company, Deionizer and Carbon Exchange Service for Hemodialysis includes carbon filtration for the removal of chlorine and chloramines and deionizer (DI) exchange tanks for the removal of contaminants from the water through an ion exchange process to provide AAMI quality water for hemodialysis applications.
This document is a 510(k) summary for the Culligan Soft Water Service Company Deionizer and Carbon Exchange tanks for hemodialysis, not a study report. It states that the device is substantially equivalent to a predicate device (Ameriwater Dialysis Deionizer Exchange Service, K991519) and defines its intended use and general specifications.
Therefore, the requested information regarding acceptance criteria, study data, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is not available within the provided text. This document focuses on the regulatory submission process and establishing substantial equivalence rather than presenting performance study results.
To fulfill the request, a hypothetical example based on the type of device (water purification for hemodialysis) would typically involve:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (e.g., based on ANSI/AAMI RD62) | Reported Device Performance |
|---|---|---|
| Chlorine Removal | < 0.1 mg/L | (e.g., < 0.05 mg/L) |
| Chloramine Removal | < 0.1 mg/L | (e.g., < 0.05 mg/L) |
| Total Organic Carbon (TOC) Removal | < 2.0 mg/L | (e.g., < 1.0 mg/L) |
| Total Dissolved Solids (TDS) Removal | < 10 ppm | (e.g., < 5 ppm) |
| Flow Rate (at specified pressure) | (e.g., 5 GPM) | (e.g., 5.2 GPM) |
| Capacity (Volume processed before exhaustion) | (e.g., 10,000 gallons) | (e.g., 10,500 gallons) |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: This would refer to the number of water samples tested under various conditions and the number of exchange tanks evaluated. For example, "10 tanks were tested over a period of 6 months, with daily water samples analyzed for each parameter."
- Data Provenance: "Prospective testing conducted in a laboratory setting using water sources simulating typical municipal water supplies in the United States."
3. Number and Qualifications of Experts for Ground Truth:
- For water quality, "ground truth" is typically established by chemical analysis using validated laboratory methods rather than expert consensus. Therefore, expert qualifications would refer to the chemists or laboratory technicians performing the analyses.
- Number of Experts: (e.g., 3 laboratory technicians)
- Qualifications: (e.g., Certified Analytical Chemists with 5+ years of experience in water quality analysis, specifically trained in AAMI RD62 standards).
4. Adjudication Method:
- Not applicable for objective chemical measurements. Results are quantitative.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable as this is a water purification device, not an imaging or diagnostic AI system that interacts with human readers.
6. Standalone Performance:
- Yes, the performance of the device (tanks) is inherently standalone. It is measured by its ability to purify water to AAMI standards without human intervention in the purification process itself. The "study" would involve measuring the water quality output from the tanks under various operational conditions.
7. Type of Ground Truth Used:
- Objective Chemical Analysis: Water samples were analyzed using standard laboratory techniques (e.g., spectrophotometry for chlorine/chloramines, conductivity meters for TDS, TOC analyzers) to determine the concentration of specified contaminants. These analytical results serve as the ground truth.
8. Sample Size for Training Set:
- Not applicable in the traditional sense of machine learning. The "training" for such a device involves engineering design, material selection, and optimization of the resin beds, which is based on established principles of water chemistry and filtration, not a data-driven training set for an algorithm.
9. How Ground Truth for Training Set was Established:
- Again, not directly applicable. The performance characteristics and design parameters of the resins and tank configurations would be based on scientific literature, material specifications from resin manufacturers, pilot studies, and engineering calculations to achieve the desired removal efficiencies. This is a design and testing process, not "ground truth establishment" in the AI or diagnostic context.
Ask a specific question about this device
Page 1 of 1