(488 days)
The intended use of this system, comprising of the following components, is to provide water to dilute dialysate for use in HEMODIALYSIS applications.
- Carbon Tank (see description inside the application)
- Cation Deionization Tank
- Anion Deionization Tank
- Mixed Bed Deionization Tank
- Mixed Bed Deionization Tank (used as a polisher tank)
The combination of the above listed components will deliver water which exceeds AAMI Standards for water used to dilute dialysate for HEMODIALYSIS. The system does not come into contact with any patient and is used solely as indicated. The components are used in this series (without exception) and are not designed to be bypassed at any point. The process requires additional components which are added or furnished by the end user. These include a UNIT-ULTRAVIOLET DISINFECTION and an ULTRAFILTER, with a rating of .05 micron, to reduced the risk of pyrogens being passed through the system. The instruction manual outlines several tests which are required prior to use prior to every patient shift. The final decision to use the water for HEMODIALYSIS rests with the medical director.
Deionization has long been a standard to treat water used in hemodialysis. Because of the patient safety include several hemodialysis. Because of the pactanding system must include several types of Deionization, as a freestanding addressed each issue in designing the satety precautions. We have addressed cach component is outlined below.
Technological Characteristics (ocheach time sufficient to remove 1. A carbon can't with an empey as blaced in front of the deionization any chloramines is placed in front of hoth conscate The deionization equipment consists of both separate equipment. equipment. The defonibility of the arrangement of the tanks is as follows:
Carbon Tank (used to remove chloramines and chlorines) Cation Tank (used to remove positively charged particles) (used to remove negatively charged particles) Anion Tank (used to removing polisher to cleanse the water) Mixed Bed (used as a final polisher) Mixed Bed
Other integral pieces of equipment are
The lines which flow the product. These must be from TOC The fines which first. Special materials are used in the hoses to The hose runs are as short as prevent the growth of bacteria. prevent the growth of Bacount of "Hide Out" space for bacteria possible to reduce ene amount of the Unit" is placed in line to The "Ultraviolet remove any remaining bacteria from the line. remove any removes 99.9% of the bacteria that is present. The use of "Ultra-violet Rays" creates pyrogens or the destroyed bodies of the bacteria. These pyrogens are further removed by using a "Submicron Filter" which is normally sized at .05 micron. This Filter is capable of collecting most anything that escapes the deionization process and the "Ultraviolet Disaffection Unit". A acronization probled at the inlet to the Hemodialysis This monitor measures the quality of the water coming from Stream. the deionization equipment. The monitor features an inline cell, which continually measures the quality of the water. It has both an audible and visual alarm to alert the operator to any alarm condition. The set point is adjustable but we recommend the setting at 2 megohms. This setting alerts the operator that the system is nearing exhaustion and steps are necessary to protect the patients.
The document describes the Exchange Carbon and Deionization Tanks for Hemodialysis, manufactured by Fluid Process Systems, Inc., which is intended to provide water to dilute dialysate for use in hemodialysis applications.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Water Quality (based on AAMI/ANSI Standards):
| Parameter | Acceptance Criteria (AAMI/ANSI Standards) | Reported Device Performance (from summary) |
|---|---|---|
| Resistivity | 1 megohm (minimum) | The monitor's set point is recommended at 2 megohms, which "alerts the operator that the system is nearing exhaustion and steps are necessary to protect the patients." The summary also states, "the deionization equipment will produce water meeting AMMI/ANSI Standards" and that "the deionization meets the standards more readily" than specified. |
| Chloramines | Removal | "A carbon tank... is placed in front of the deionization equipment to remove any chloramines." |
| Chlorines | Removal | "A carbon tank... is placed in front of the deionization equipment to remove any... chlorines." |
| Bacteria | Removal | "The Ultraviolet Disinfection Unit removes 99.9% of the bacteria that is present." |
| Pyrogens | Removal | "These pyrogens are further removed by using a 'Submicron Filter' which is normally sized at .05 micron." |
| Total Organic Carbon (TOC) | Restricted | "The lines which flow the product... must be from TOC first. Special materials are used in the hoses to prevent the growth of bacteria." |
Additional Performance Claims / Design Features fulfilling safety criteria:
- Capacity: Sized with sufficient capacity to provide time and methodology for end-users to run equipment.
- Redundancy: System always supported by a mirror image, which can be placed in service in minutes.
- Checkpoints: Multiple checkpoints (inlet water volume, chloramines/chlorines Post-carbon tank, UV unit operation, Ultrafilter flow, Resistivity Monitor condition/water quality) are included and required to be checked prior to each patient shift.
- Ultraviolet Disinfection Unit: Removes 99.9% of bacteria.
- Submicron Filter (.05 micron): Removes pyrogens and other contaminants escaping deionization and UV disinfection.
- Resistivity Monitor: Features an inline cell, continuous monitoring, audible and visual alarm, adjustable set point (recommended 2 megohms).
- Log Book: Operational log required to record parameters prior to each patient shift.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a specific "sample size" in terms of number of units tested. The document mentions that "Equipment was placed in normal operation during a non-patient shift and water was circulated through the equipment for a period of time. Test samples were taken from the through put of the deionization tanks using treated water and non-treated water." The quantity of "test samples" taken is not specified.
- Data Provenance: The data was collected under "normal operating clinical conditions." The country of origin is not explicitly stated, but the submission is to the U.S. FDA by Fluid Process Systems, Inc. in El Paso, Texas, suggesting the testing was likely conducted in the USA. The study design is prospective in the sense that the new equipment was set up and tested for its performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device. This is not a diagnostic device where expert ground truth on patient data is typically established (e.g., radiologists interpreting images). Instead, the device's performance is measured against established chemical and physical water quality standards (AAMI/ANSI Standards), which are objective and do not require expert human interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. As the "ground truth" is based on objective chemical and physical measurements against AAMI/ANSI standards, there is no need for expert adjudication of results. The measurements speak for themselves against the quantitative criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., images). This device is a water purification system, and its effectiveness is determined by objective water quality measurements, not by human interpretation of clinical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was done. The testing described focuses on the device's ability to produce water meeting specified standards. The results of "test samples were taken from the through put of the deionization tanks" directly reflect the standalone performance of the equipment. While operators are required to check the system, the fundamental performance of the deionization process itself is independent of human interpretation during the test condition.
7. The Type of Ground Truth Used
The ground truth used is based on established industry standards for water quality in hemodialysis: AAMI/ANSI Standards. These standards provide objective, quantitative benchmarks for resistivity, and implicitly for the removal of contaminants like chloramines, chlorines, bacteria, and pyrogens.
8. The Sample Size for the Training Set
Not applicable. This device is a water purification system, not an artificial intelligence (AI) or machine learning (ML) algorithm that requires a "training set" of data. The performance is based on physical and chemical processes, not on learned patterns from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As a non-AI/ML device, there is no "training set" or "ground truth for the training set" involved in its development or evaluation.
§ 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.