(80 days)
The Mar Cor Purification Millenium HX Portable Reverse Osmosis Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment.
The Millenium HX can be connected to hemodialysis equipment used in hospitals, clinics and in home environments, in conjunction with the appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S) standards.
The device is a portable 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. Feed water enters the unit and is directed through a pump into a 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. 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 Millenium HX is capable of generating purified water that meets AAMI water quality requirements for hemodialysis at a minimum of 0.26 US gallons/minute (1.0 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 Millenium HX 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 Millenium HX include:
- RO membrane .
- System pump .
- Water quality monitoring system .
- Operating panel and programmable logic controller (OPLC) .
- Heat disinfection and chemical sanitization capability .
- Audible and visual alarms .
- Automatic divert to drain mode upon start-up and anytime product water TDS is . above the quality set-point
- System control via a touch-screen user interface .
The provided text is a summary of a 510(k) premarket notification for a medical device (Millenium HX Portable Reverse Osmosis Water Purification System). It does not describe a clinical study of the type that would typically involve acceptance criteria, sample sizes for test/training sets, expert adjudication, or MRMC studies for AI devices.
Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices through non-clinical performance data. Here's a breakdown based on the information provided, highlighting why it doesn't align with the requested format for AI device studies:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a table with specific, quantitative acceptance criteria and corresponding reported device performance values in the way one would for an AI algorithm's diagnostic accuracy. However, it does state that the device is "capable of generating purified water that meets AAMI water quality requirements for hemodialysis at a minimum of 0.26 US gallons/minute (1.0 liters/min)." This implies a performance criterion related to water flow and quality.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. The device is a water purification system, and its performance is evaluated through engineering tests, not a clinical test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. Ground truth for a water purification system is established through laboratory measurements and adherence to engineering standards (like AAMI water quality), not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies, not for the objective performance validation of a mechanical device like a water purification system.
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
This is not applicable. An MRMC study is used to evaluate the impact of an AI algorithm on human reader performance, which is not relevant for a water purification device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The Millenium HX is a physical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be the objective measurements of water quality and flow rates, verified against established standards such as AAMI water quality requirements for hemodialysis and potentially other federal (U.S.) standards.
8. The sample size for the training set
This is not applicable. The concept of a "training set" is relevant for machine learning algorithms, not for a physical water purification system undergoing engineering validation.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
Summary of the Study and Device Performance (based on provided text):
The "study" refers to the non-clinical performance data provided by Mar Cor Purification to the FDA. This data aims to demonstrate that the Millenium HX is safe and effective for its intended use and is substantially equivalent to predicate devices.
Acceptance Criteria (Implied) and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Water Quality: Meet AAMI water quality requirements for hemodialysis. | The Millenium HX is capable of generating purified water that meets AAMI water quality requirements for hemodialysis. |
| Flow Rate: Minimum purified water production. | Minimum of 0.26 US gallons/minute (1.0 liters/min). |
| Contaminant Removal: Effective removal of water contaminants (except dissolved gasses). | "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." |
| Microbiological Control: Maintain low microbiological levels. | "The Millenium HX system is designed to maintain low microbiological levels in the flow pathway through regular heat disinfection and chemical sanitization." (Validated through "Heat Disinfection Process Validation" and "Chemical Sanitization Validation"). |
| Safety: Electrical safety and electromagnetic compatibility. | "Electrical Safety and Electromagnetic Compatibility" data was provided. |
| Materials: Material compatibility and biocompatibility. | "Material Compatibility and Biocompatibility" data was provided. |
| Software Functionality: Proper operation of control system. | "Software Validation" data was provided. |
| Rinsing Effectiveness: Verification of chemical sanitization and cleaning rinsing. | "Chemical Sanitization and Cleaning Rinsing Verification" data was provided. |
| Risk Mitigation: Acceptable risk profile. | "Risk Analysis" data was provided. |
| Operating Conditions Performance: Water quality verification over range of operating conditions. | "System and RO Membrane Performance Flow and product water quality verification over range of operating conditions" data was provided, indicating the device maintains performance under varying conditions. "Automatic divert to drain mode upon start-up and anytime product water TDS is above the quality set-point" further confirms its ability to ensure quality. |
Study Details:
- Type of Study: Non-clinical performance data and validation testing, not a clinical trial involving human subjects or an AI algorithm evaluation.
- Data Provenance: The studies were conducted by the manufacturer, Mar Cor Purification. Country of origin not explicitly stated, but the company address is in Minneapolis, MN, USA. The nature of the tests suggests they are prospective engineering and laboratory validations.
- Ground Truth: Objective measurements against established engineering and water quality standards (e.g., AAMI RD62:2006).
Conclusion from document: Mar Cor Purification concluded that the Millenium HX is safe and effective for its intended use based on the provided information and performance data, and is substantially equivalent to legally marketed predicate devices. The FDA subsequently cleared the device.
§ 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.