(89 days)
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.
| Acceptance Criteria Category | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Safety | Equivalent to the predicate device (G.E.M Water Systems, International Sodium Bicarbonate Mixers/Delivery Systems #K970674) in terms of patient and user safety during central delivery of concentrates and central mixing/delivery of sodium bicarbonate solution for hemodialysis. |
| Effectiveness | Equivalent to the predicate device in its ability to: |
- 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)
-
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.
-
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.
-
Adjudication method for the test set:
- Not applicable/Not specified. See explanation above.
-
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.
-
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.
-
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.
- 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:
-
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."
-
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.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.