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510(k) Data Aggregation
(378 days)
The device is intended to remove organic and inorganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate and to produce purified water for dialyzer reprocessing and equipment rinse and disinfection.
The WPT Water purification System has been developed around the Osmonics 23G Reverse Osmosis machine and the use of deionizer exchange tanks to demineralize the feed water. The feed water passes through three separate stages in the purification process before the required quality of product water is achieved. These stages are referred to as: Pre-treatment using a Water Softener to remove scale forming minerals, a Multi-media Filter and Pre-Filter to remove suspended particulate solids and Activated Carbon Filters to remove organics e.g. chlorines and chloramines. Primary Treatment using a Reverse Osmosis (RO) Machine and/or Mixed Bed Deionizers (DI), both of which have already been approved by the FDA, to demineralize the water. Post Treatment using Mixed Bed Deionizers (DI), Ultraviolet Disinfection (UV) and a Submicron Post Filter to remove suspended solids and bacteria from product water prior to distribution to the point of use.
The provided document is a 510(k) summary for a Water Purification System intended for hemodialysis. It describes the device, its intended use, and its technological characteristics by comparing it to a predicate device. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics in the way a medical diagnostic AI device would.
The document explicitly states:
- Non-clinical tests: "Following the installation of the Water Purification System a sample of the product water, produced by the system, is taken and analyzed by an independent laboratory to determine the level of contaminants present in the water. These laboratory results are compared with the maximum permitted level for each contaminant in order to determine that the water produced by the system meets the customers requirements for purified water."
- Clinical tests: "There are no clinical tests submitted, referenced or relied upon in this submission."
Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details that are typically associated with AI-based medical devices or comparative effectiveness studies. The device is a physical water purification system, not an AI or diagnostic algorithm, and its "performance" is assessed by laboratory water quality analysis against established contaminant levels, not through metrics like sensitivity, specificity, or reader studies.
If you are looking for an example of a device that would contain the information you are requesting in its 510(k) submission, it would typically be a diagnostic imaging AI algorithm or a similar software-as-a-medical-device (SaMD).
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(203 days)
The WaterVault Cube Water Treatment System for HemoDialysis is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate.
Organic, inorganic and microbial contaminants are removed from water supplied to hemodialysis clinics for use in the dilution and preparation of dialysate solutions used in hemodialysis machines. The water treatment system includes a means of tempering the water and pretreatment, followed by reverse osmosis, ultrafiltration and UV sterilization. Pretreatment includes water softening to remove hardness and Granular Activated Carbon treatment to remove Chloramines in addition to filament cartridge filters to control particulate solids. Reverse Osmosis utilizes a pressure gradient to reverse the process water diffusion across a semipermeable membrane, concentrating the contaminants which are subsequently rejected as concentrate. Water forced through the membrane known as "Permeate" is then passed through a hollow fiber ultra filter to remove microorganisms, pyrogens and endotoxins. A UV light source that provides a minimum of 30,000 microwatts/cm2 sec limits further bacterial growth in the treated water.
The Water Vault Cube, Water Treatment System for Hemodialysis, underwent nonclinical testing to demonstrate its performance against AAMI (Association for the Advancement of Medical Instrumentation) standards for water used in the preparation of dialysate.
1. Table of Acceptance Criteria and Reported Device Performance
| Component | Acceptance Criteria (AAMI Standard mg/l) | Reported Device Performance (Permeate mg/l) | Meets or Exceeds Acceptance Criteria |
|---|---|---|---|
| Calcium | 2 | 1 | Yes |
| Magnesium | 4 | 1 | Yes |
| Sodium | 70 | 1 | Yes |
| Potassium | 8 | 1 | Yes |
| Fluoride | 0.2 | 0.1 | Yes |
| Chlorine | 0.5 | 0.02 | Yes |
| Chloramines | 0.1 | 0.02 | Yes |
| Nitrate | 2 | 0.1 | Yes |
| Sulfate | 100 | 5 | Yes |
| Copper | 0.1 | 0.01 | Yes |
| Barium | 0.1 | 0.01 | Yes |
| Zinc | 0.1 | 0.02 | Yes |
| Aluminum | 0.01 | 0.01 | Yes |
| Arsenic | 0.005 | 0.005 | Yes |
| Lead | 0.005 | 0.003 | Yes |
| Silver | 0.005 | 0.005 | Yes |
| Cadmium | 0.001 | 0.001 | Yes |
| Chromium | 0.014 | 0.005 | Yes |
| Selenium | 0.05 | 0.005 | Yes |
| Mercury | 0.0002 | 0.0002 | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The test results are based on a single sample test of a "demonstration unit."
- Data Provenance: The data is retrospective, derived from tests performed on a specific demonstration unit (Osmonics Solorss reverse osmosis unit, Serial Number 96-61650-11). The country of origin is not explicitly stated but implied to be the United States, given the FDA filing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device is based on quantifiable chemical analysis against established industry standards (AAMI Standards), not expert human assessment.
4. Adjudication Method for the Test Set
Not applicable. The device performance is assessed through direct chemical analysis (quantitative measurements), not through human adjudication.
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
Not applicable. This is a water treatment system, not an AI-powered diagnostic device, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone test was performed. The device's performance was evaluated by analyzing the "Permeate" water it produced, independently of any human intervention or interpretation, against the AAMI standards.
7. The Type of Ground Truth Used
The ground truth used is AAMI Standards for water quality in hemodialysis. This is an objective, established standard for chemical contaminant levels.
8. The Sample Size for the Training Set
Not applicable. This device is a physical water treatment system, not a machine learning algorithm that requires a training set. The "design" of the system is based on established water purification principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context.
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(62 days)
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