(195 days)
The BioPure HX2 Reverse Osmosis water purification system is designed to purify pre-treated water using reverse osmosis for making dialysate for hemodialysis applications. The device is intended to be a component in a complete water purification system. It must be preceded by pretreatment devices, and may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.) standards. BioPure HX2 is intended for use in water rooms in a hospital, clinic, or dialysis center. The device includes an integrated heat disinfection process.
The BioPure HX2 is available two different double pass configurations that supply 5 gallons per minute (gpm) and 11 gpm. Version HX2P-05 is a double pass triple membrane RO that produces up to 5 gpm of product water. Version HX2P-11 is a double pass six membrane RO that produces up to 11 gpm of product water.
The device is a water purification system that uses reverse osmosis to remove contaminants from water that is used to dilute dialysis concentrate to form dialysate for use in hemodialysis equipment. The key feature of BioPure HX2 RO system is that it consists of two trains (1st and 2nd pass) of membrane elements. Feed water enters the unit and is directed through a pump into the 1st pass RO membrane. The pump applies a high hydrostatic pressure that forces water from the concentrated (feed) side to the dilute (product) side of the RO membrane. The product water is then pumped directly through the 2nd pass membrane elements to further improve water quality of the final product water. As water flow across the membrane all types of water contaminants except dissolved gasses are removed and the purified product water is then supplied to hemodialysis equipment.
The BioPure HX2 is capable of generating purified water that meets AAMI water quality requirements for hemodialysis at a minimum of 3 US gallons/minute (11.30 liters/min). It must be used with appropriate pre and post treatment units, including at a minimum carbon adsorption media pretreatment in order to remove chlorine/chloramines. Additional pre and post treatment requirements may vary and are dependent on the quality of the local feed water supply and individual facility requirements.
The BioPure HX2 system is designed to maintain low microbiological levels in the flow pathway through regular heat disinfection and chemical sanitization. Notable components and features of the BioPure HX2 include:
- Break Tank
- Immersion Heater
- 1st Pass RO Booster Pump
- 1st Pass RO membrane
- 2nd Pass RO Booster Pump
- 2nd Pass RO membrane
- Particle and Pyrogen Filter (Optional)
- Piping
- Water quality monitoring system
- Programmable logic controller (PLC)
- Heat disinfection and chemical sanitization capability
- Audible and visual alarms
- Automatic divert to drain mode upon start-up and anytime product quality parameters are not met.
- System control via a touch-screen user interface
The BioPure HX2 Reverse Osmosis Water Purification System is intended to purify pre-treated water for use in hemodialysis applications. The device is evaluated primarily against the requirements listed in FDA's Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis (May 1997) and the FDA recognized consensus standards - ISO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies and ISO 13959:2009 Water for hemodialysis and related therapies.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly present a table of acceptance criteria with corresponding performance data in a structured format as requested. Instead, it lists the types of performance data provided to the FDA to support substantial equivalence. Based on the descriptive information, the key performance criterion is the ability to generate purified water meeting AAMI water quality requirements at a minimum flow rate.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Water Quality | Meets AAMI water quality requirements for hemodialysis | This is a general statement. Specific AAMI parameters (e.g., conductivity, levels of specific contaminants) are not detailed in this summary document. |
| Minimum Flow Rate (HX2P-05) | Up to 5 gallons per minute (18.93 liters/min) | This meets or exceeds the stated minimum requirement of 3 US gallons/minute (11.30 liters/min). |
| Minimum Flow Rate (HX2P-11) | Up to 11 gallons per minute (41.64 liters/min) | This meets or exceeds the stated minimum requirement of 3 US gallons/minute (11.30 liters/min). |
| Microbiological Levels Control | Designed to maintain low microbiological levels through regular heat disinfection and chemical sanitization | The validation studies for Heat Disinfection Process and Chemical Sanitization confirm this aspect. |
| Safety & Effectiveness | Deemed safe and effective for its intended use | This is the overall conclusion drawn from all submitted testing. |
2. Sample Size for Test Set and Data Provenance:
The document does not specify the sample sizes used for individual test sets for each type of validation (e.g., System and RO Membrane Performance, Heat Disinfection Process Validation). The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. However, as this is a 510(k) submission to the US FDA, the testing would generally be expected to follow US regulatory guidelines and standards.
3. Number of Experts and Qualifications for Ground Truth:
This device is a water purification system, not a diagnostic device requiring expert interpretation of medical images or data. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of clinical diagnosis is not applicable. The "ground truth" for this device is based on objective chemical and physical measurements to confirm water quality parameters and system performance against established standards (AAMI, ISO). Validation of these measurements would be conducted by qualified engineers and technicians with expertise in water purification systems and relevant analytical techniques.
4. Adjudication Method:
Given that the ground truth is established through objective measurements and validated processes against predefined standards, an adjudication method (such as 2+1 or 3+1 used in medical image interpretation) is not relevant. Performance is determined by direct measurement against quantitative acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study is not applicable to a water purification system. MRMC studies are typically used to evaluate the diagnostic performance of medical imaging devices or AI algorithms where human readers interpret medical cases. This device's function is to purify water, not to assist human readers in making diagnoses.
6. Standalone Performance:
Yes, the testing described for the BioPure HX2 involves evaluating its standalone performance as a water purification unit. The listed data types such as "System and RO Membrane Performance", "Heat Disinfection Process Validation", and "Chemical Sanitization Validation" are all assessments of the device's inherent capabilities and performance without human-in-the-loop directly influencing the water purification process itself. While human operators manage the system, the performance metrics relate to the automated and technical functions of the device.
7. Type of Ground Truth Used:
The ground truth used for this device is based on objective measurements and established scientific/engineering standards.
- AAMI Water Quality Requirements: These are standards for the chemical and microbiological purity of water used for hemodialysis.
- ISO 26722:2009 and ISO 13959:2009: These are international standards for water treatment equipment and water quality for hemodialysis.
- FDA Guidance: Provides regulatory expectations for such devices.
The "ground truth" is therefore derived from:
- Analytical Chemistry Results: Measuring levels of contaminants, conductivity, etc.
- Microbiological Testing: Assessing bacterial counts.
- Engineering Specifications and Performance Data: For flow rates, pressure, temperature, etc.
- Validation Protocols: Demonstrating the effectiveness of disinfection and sanitization cycles.
8. Sample Size for the Training Set:
The concept of a "training set" is typically associated with machine learning or AI models. The BioPure HX2 is a physical medical device (water purification system) and not an AI algorithm that undergoes a training phase. Therefore, there is no "training set" in this context. The device's design, engineering, and manufacturing would be based on established principles and validated through the testing mentioned above.
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.
§ 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.