(105 days)
The AmeriWater Heatsan is an optional accessory for water treatment systems intended for use in hemodialysis applications. The Heatsan is designed to heat water received from the water purification system, and circulate the heated water around the distribution loop at a controlled sanitizing temperature (minimum temperature of 185°F) for a programmed length of time (minimum hold time of 2 hours) to provide heat disinfection of the water distribution loop. The AmeriWater Heatsan is intended for use in hospitals, clinics, or dialysis centers to provide heat disinfection resulting in total viable microbial counts below 50 CFU/ml.
The AmeriWater Heatsan is intended for use in hospitals, clinics, or dialysis centers to provide heat disinfection resulting in total viable microbial counts below 50 CFU/ml. It is an integrated hot water disinfection unit that incorporates equipment to heat water received from a direct feed Water Purification System , and circulate around a distribution loop at a controlled sanitizing temperature of 185°F) for a specified length of time (minimum hold time of 2 hours). The Heatsan system has been designed to be in compliance with the requirements of ANSI/AAMI/ISO 13959:2009 Water for hemodialysis and related therapies and ANSI/AAMI//SO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies. The operation of the Heatsan unit is controlled entirely through the touch screen panel located on the front of the main control box. The touch screen displays systems performance data and the status of the device. The Heatsan unit incorporates monitoring devices and will report alarms and warnings messages via the user display. The Heatsan is used only during non-treatment hours when there are no patients being dialyzed. There is no patient contact with the device.
The unit can be configured to disinfect up to two distribution loops, either individually or together. The user can set for each day of the week which loop is to be disinfected and in what configuration. The Heatsan has been designed to provide up to 100 gallons of hot water for the purpose of sanitizing connected dialysis equipment. The number of machines that can be disinfected at any one time will be dependent on the requirement of those machines regarding the amount of water each machine needs for disinfection, the time taken to perform heat disinfection and the flow at which they require the hot water. When in "Dual" mode, sanitizing two distribution loops, the unit can potentially supply up to 200 gallons of water so that 100 gallons of water will be available for each distribution loop. Following disinfection of the first loop the unit will refill and reheat to disinfection temperature then proceed automatically to disinfect the second distribution loop.
The system allows the user to input the specific requirements of the dialysis machines to be disinfected, the days requiring heat disinfection and the times which heat disinfection can occur. If the system detects that any of the entered user values cannot be achieved by the Heatsan unit will raise an "Incorrect number" alarm warning the user that the parameters loaded cannot be achieved.
The Heatsan operation stages include Pre-heat. Heating, Hold, Water draw off, and Cool down. The typical stage duration times for disinfection are as follows: Pre-heat 120 minutes, Hold* 120 minutes, Water draw off 60 minutes, Cool down 60 minutes.
Here's an analysis of the provided text regarding the acceptance criteria and study for the AmeriWater Heatsan device, formatted to address your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| - Heat disinfection resulting in total viable microbial counts below 50 CFU/ml | Test results from microbiological testing show evidence that the device is effective in the reduction of bacteria in the water distribution system. The study demonstrated that hot water achieved a minimum of a 6-log reduction of Burkholderia cepacia and a minimum of a 3-log reduction of Mycobacterium abscessus. This level of reduction would ensure microbial counts are well below 50 CFU/ml. |
| - Minimum sanitizing temperature of 185°F (for minimum hold time of 2 hours) | The Heatsan heats water to a controlled sanitizing temperature (minimum of 185°F) for a programmed length of time (minimum hold time of 2 hours). The system maintains the temperature during the programmed hold time. (This is a design specification, and performance testing confirmed the efficacy of the disinfection process, implying these parameters were met). |
| - Absence of toxic leachables (related to water contacting materials) | Leachable testing was conducted. Results indicated no increase in water conductivity and the TOC level remained below 500 ppb for both test runs, demonstrating the absence of toxic leachables. |
| - Compliance with electrical safety requirements | Testing to IEC 61010 standards was completed by Intertek, and an ETL listing report was provided. Results indicate that the device complies with all electrical safety requirements of the standard. |
| - Software performs as intended (for moderate level of concern software) | Software validation was conducted in accordance with FDA guidance for software with a moderate level of concern. The results of validation indicate that the software performs as intended. |
| - Compliance with ANSI/AAMI/ISO 13959:2009 and ANSI/AAMI/ISO 26722:2009 (Design Compliance) | The Heatsan system has been designed to be in compliance with the requirements of ANSI/AAMI/ISO 13959:2009 Water for hemodialysis and related therapies and ANSI/AAMI/ISO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies. (This is a design claim, and the performance testing supports the effectiveness of that design in meeting the required disinfection levels.) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Microbiological Testing: "A total of three test runs were conducted with each organism." (This means 3 runs for Burkholderia cepacia and 3 runs for Mycobacterium abscessus).
- Data Provenance: Not explicitly stated as country of origin, but the testing was conducted to verify and validate the efficacy of the system in the reduction of bacteria in a water distribution system, simulating worst-case conditions. The study does not specify if it was retrospective or prospective but describes experimental runs, suggesting a prospective experimental design in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided in the document. The ground truth for microbiological effectiveness appears to be based on direct measurement of microbial reduction, not expert interpretation.
4. Adjudication Method for the Test Set
- This information is not applicable as the ground truth was established through direct microbiological measurement rather than expert review requiring 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
- No, an MRMC comparative effectiveness study was not performed. This device is an automated heat sanitization system for water distribution loops, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the microbiological performance study describes a standalone performance of the device (heat sanitization system). The system operates automatically to disinfect the water distribution loop.
7. The Type of Ground Truth Used
- For the microbiological performance, the ground truth was based on direct microbiological measurement of bacterial reduction (log reduction) in a water distribution system following an inoculation procedure.
- For biocompatibility, the ground truth was based on analytical testing for conductivity and total organic carbon (TOC) levels.
- For electrical safety, the ground truth was compliance with IEC 61010 standards verified by an ETL listing.
- For software, the ground truth was that the software performs as intended based on validation.
8. The Sample Size for the Training Set
- This device is a hardware system with software control for automated disinfection. It does not rely on a "training set" in the context of machine learning or AI algorithms that learn from data. Therefore, this information is not applicable.
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, there is no "training set" for this type of device. The system's operation is based on pre-programmed parameters and physical processes (heating, circulation), not learned patterns from a data set.
§ 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.