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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.

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.

1. 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.
2. 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.
3. 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.
4. 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.
5. 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)
6. 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.
7. The sample size for the training set: Not applicable. This is not a machine learning or AI-driven device requiring a training set.
8. 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.

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THE INTENDED USE OF THESE DEVICES IS TO ALLOW THE HEMODIAL YSIS FACILITY TO MIX SODIUM BICARBONATE POWDER WITH PURIFIED WATER THAT MEETS AAMI STANDARDS FOR HEMODIAL YSIS TREATING TO BUIL ALLOW MIXED SOLUTION TO BE AUTOMATICALLY DELIVERED TO THE ALLYSIS MACHINES. IT IS ALSO INTENDED TO AUTOMATICALLY DELIVER A PRE-MIXED CONCENTRATE SOLUTION TO THE DIALYSIS MACHINE.

The central mixing and delivery sodium bicarbonate system (tank) is filled with AAMI standard water, into which a specific amount of sodium bicarbonate powder is poured. It is then mixed in the tank, checked for proper solution, then delivered either manually, or automatically to each patient station on the treatment floor, where it is then mixed/diluted by the dialysis machine for the intended treatment.

The central delivery concentrate system works much the same way, with the exception that the solution is not mixed in the system provided by Better Water, Inc. The solution is either pre-mixed and bulk transferred, or it is mixed in a separate piece of equipment, and then transferred to the bulk storage and delivery system, provided by Better Water, Inc.

This document, K992793, is a 510(k) summary for the Central Concentrate Delivery System for Dialysis and the Central Bicarbonate Mixing/Delivery System manufactured by Better Water, Inc. As such, it is a Premarket Notification for a medical device and does not contain the detailed study information typically found in a clinical trial report or a performance study.

The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove specific performance metrics against pre-defined acceptance criteria through a dedicated study. Instead, the focus is on showing that the new device is as safe and effective as a legally marketed device.

Therefore, many of the requested elements for a detailed performance study will not be available in this document.

However, I can extract the relevant information from the provided text as accurately as possible given the nature of a 510(k) summary:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

Since this is a 510(k) submission demonstrating substantial equivalence, the "acceptance criteria" are implicitly met if the device is found to be as safe and effective as the predicate device. The "device performance" is therefore considered equivalent to the predicate. Specific quantitative metrics are not typically provided in this section of a 510(k) summary.

• Mix sodium bicarbonate powder with purified water to AAMI standards for hemodialysis.
• Automatically deliver the mixed bicarbonate solution to dialysis machines.
• Automatically deliver a pre-mixed concentrate solution to dialysis machines. |
  | AAMI Standards Compliance | The central mixing and delivery sodium bicarbonate system is filled with AAMI standard water and mixes sodium bicarbonate powder to meet AAMI standards for hemodialysis. (Implies the final solution meets AAMI standards after mixing). |

Note: The document explicitly states the sodium bicarbonate system is filled with "AAMI standard water" and mixes powder to "AAMI standards for hemodialysis treating." This suggests compliance with specific AAMI (Association for the Advancement of Medical Instrumentation) standards related to water quality and dialysate composition. However, it does not specify which AAMI standards (e.g., ANSI/AAMI RD62) or provide specific test results demonstrating this compliance.

Study Details (Limitations due to 510(k) Nature)

1. Sample size used for the test set and the data provenance:

   • Not specified. This document is a 510(k) summary, which generally relies on a comparison to a predicate device rather than a de novo clinical trial with a "test set" in the context of device performance metrics. If any testing was done (e.g., bench testing for AAMI compliance), the sample size and provenance are not detailed here.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not specified. This type of information is pertinent to studies involving human interpretation or subjective assessments, which is not the primary focus of demonstrating substantial equivalence for a central fluid delivery system.

3. Adjudication method for the test set:

   • Not applicable/Not specified. See explanation above.

4. 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:

   • Not applicable. This device is a fluid delivery system for dialysis, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable/Not specified. This is not an algorithmic device in the sense of AI or image analysis. Performance would be assessed through engineering verification and validation, but specific "standalone performance" in the context of AI is not relevant.

6. The type of ground truth used:

   • Not explicitly stated in terms of a "ground truth" for a study. For a device like this, the "ground truth" would likely be based on:
     • Engineering specifications: The device is designed to meet certain flow rates, mixing ratios, and solution concentrations.
     • AAMI standards: Compliance with AAMI standards for water and dialysate quality.
     • Predicate device's performance: The fundamental "ground truth" for a 510(k) is the established safety and effectiveness of the legally marketed predicate device.

7. The sample size for the training set:

   • Not applicable/Not specified. This is not a machine learning or AI device that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable/Not specified. See explanation above.

Summary of Device and Substantial Equivalence:

The document states that the device is substantially equivalent to the G.E.M Water Systems, International Sodium Bicarbonate Mixers/Delivery Systems #K970674. This means that Better Water, Inc. provided evidence to the FDA that their Central Concentrate Delivery System for Dialysis and Central Bicarbonate Mixing/Delivery System perform similarly in terms of intended use, safety, and effectiveness to the predicate device. The information presented is primarily a high-level summary for regulatory notification, not a detailed technical report of a performance study.

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