(154 days)
The Matrix Series Digital Reverse Osmosis Water Treatment System is an accessory device designed to safely and effectively provide water purification for use in hemodialysis applications. The water produced will meet the minimum water quality requirements as specified by Association for the Advancement of Medical Instrumentation (AAMI) standard RD62:2003 when used as directed. Dependent on feed water quality this unit may be used in conjunction with other approved water treatment components.
The Matrix Series Digital Reverse Osmosis Water Treatment System is an accessory device that is intended for use with a hemodialysis applications and is intended to remove organic and inorganic substances and microbial contaminants from tap water used to dilute dialysate concentrate to form dialysate. The Matrix Series Digital Reverse Osmosis Water Treatment System will produce water as prescribed by the Association for the Advancement of Medical Instrumentation (AAMI) RD62:2003 standard provided adequate flow rate of the feed (tap) water and compliance with existing drinking water standards and proper pre-treatment.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Matrix Series Digital Reverse Osmosis Water Treatment System:
It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed report of a new clinical or performance study with specific acceptance criteria and performance metrics in the way a novel device might be evaluated.
Acceptance Criteria and Reported Device Performance
The core acceptance criterion for this device is its ability to produce water that meets the standards set by the Association for the Advancement of Medical Instrumentation (AAMI) RD62:2003 standard for hemodialysis water quality.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Delivery of AAMI Standard Water for Hemodialysis | "The Matrix Series Digital Reverse Osmosis Water Treatment System will produce water as prescribed by the Association for the Advancement of Medical Instrumentation (AAMI) RD62:2003 standard provided adequate flow rate of the feed (tap) water and compliance with existing drinking water standards and proper pre-treatment." (Page 1, 4) |
| "will produce purified water that will meet the minimum water quality requirements as specified by Association for the Advancement of Medical Instrumentation (AAMI) standard RD62:2003 when used as directed." (Page 4, 9) |
Study Information
Based on the provided 510(k) summary, the device's acceptance is based on demonstrating substantial equivalence to predicate devices, not on a new, standalone performance study with detailed clinical or non-clinical data as one might expect for a novel device.
- Sample size used for the test set and the data provenance: Not explicitly stated as a separate "test set" in the context of a new performance study. The evaluation is primarily a comparison to predicate devices, relying on their historical performance and regulatory clearance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is the AAMI RD62:2003 standard, which is an industry-accepted benchmark, not an expert-derived opinion for a specific test set.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There's no human adjudication process described for a test set.
- If a multi-reader multicase (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 imaging or diagnostic device involving human readers or AI.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No; a standalone algorithm performance study is not relevant for this type of device. The "standalone" performance is the water treatment system's output meeting AAMI standards. The FDA's conclusion explicitly states: "Clinical Performance Data: Not required for determination of substantial equivalence for this type and class of device." (Page 4, 8)
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for compliance is the AAMI RD62:2003 standard for water quality in hemodialysis. This is a technical performance standard.
- The sample size for the training set: Not applicable. This is not a machine learning or AI-driven device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of How the Device Meets Acceptance Criteria
The Matrix Series Digital Reverse Osmosis Water Treatment System meets its acceptance criteria by demonstrating substantial equivalence to existing, legally marketed predicate devices (Better Water K920186, Isopure MD 400 K993200, and MD 600 K041163 Series Water Systems).
The basis for this substantial equivalence primarily rests on:
- Technological Characteristics: Similar "wetted-contact materials," pump size, and membrane selection to the Better Water predicate.
- Operational Features: The electronic PLC and Operator Interface Touch Screen features are deemed equivalent to those in the Isopure predicate devices.
- Intended Use: The device shares the same intended use as an accessory for hemodialysis applications.
- Performance Claim: The device is intended to and will produce water meeting the AAMI RD62:2003 standard, mirroring the performance of the predicate devices.
The 510(k) process allows a new device to be cleared if it is "substantially equivalent" to a predicate device, meaning it has the same intended use and technological characteristics as the predicate, or if it has different technological characteristics, those characteristics do not raise different questions of safety and effectiveness, and the device is as safe and effective as the predicate device.
In this case, the manufacturer asserts that "Any difference between the device and the Predicate Devices have no significant influence on the safety or effectiveness of the product," and that the device will meet the specific AAMI standard for water quality, which is the established acceptance criterion for such devices. No new clinical or detailed performance studies were required by the FDA because of this demonstrated substantial equivalence.
§ 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.