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The Rockwell Medical Technologies, Inc., Dri-Sate Dry Acid Concentrates for Bicarbonate Dialysate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and bicarbonate concentrate.

The Rockwell Medical Technologies. Inc. DRI-SATE Dry Acid Concentrates containing sodium diacetate, for bicarbonate dialysis contain salt, sugar, and non-sugar and powders formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate / powder. These powders when proportioned/ mixed in a three-stream dialysis machine with pre-treated or purified water meeting or exceeding AAMI Standards and a bicarbonate concentrate solution, may be used in conventional and commercially available hemodialysis machines or monitors as a The hemodialysis powders presented in this 510K Notification are intended to be hemodialysis solution. used in three stream hemodialysis machines in which an acidified concentrate is proportioned into one stream, a bicarbonate, chloride and sodium concentrate solution which has been prepared by mixing the powder with a specified volume of water, is proportioned into the second stream of the hemodialysis machine, and water is proportioned into the third streams are then mixed to prepare a final proportioned hemodialysis solution. These types of a final hemodialysis solutions are commonly referred to as "Bicarbonate Hemodialysis Solutions." These proportioned hemodialysis solutions are then heated to body temperature and then perfused through the dialysis fluid compartment of artificial kidneys These bicarbonate hemodialysis solutions are separated from the patient's blood by or hemodialyzers. means of a semi-permeable cellulosic or non-cellulosic membrane which serves as a molecular weight selective barrier to the passage of molecules beyond a certain molecular weight. The molecular weigh cutoff of each type of membrane may vary depending on the membrane type, manufacturing process, etc. The semi-permeable membrane in a hemodialyzer permits the passage of smaller molecular weight (less than 5,000 Daltons for conventional cellulosic membranes), ionized molecules, waste products and toxins (i.e. blood urea nitrogen, creatinine, potassium, etc.) contained in the patient's blood circulating through the dialyzer, to pass through the semi-permeable membrane into the bicarbonate hemodialysis solutions, exit the hemodialyzer, enter the hemodialysis monitor and exit the monitor and are ultimately discarded. The ionic and molecular composition of the hemodialysis solution establishes the concentration gradient between the blood and the hemodialysis solution passing through the hemodialyzer which permits the effective removal of waste products and toxins found in excess in the patient's blood during acute and end-stage renal failure.

The provided document is a 510(k) summary for a medical device called "DRI-SATE Dry Acid Concentrate for Bicarbonate Dialysis." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with defined metrics.

Here's a breakdown based on the sections you requested, highlighting what is (and isn't) present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of performance metrics (e.g., sensitivity, specificity, accuracy, chemical concentrations within a specific range). Instead, the "acceptance criteria" are implied to be substantial equivalence to legally marketed predicate devices in terms of chemical composition, intended use, and efficacy.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. No clinical test set with human subjects or a defined "test set" of samples undergoing performance measurement (beyond basic in-vitro compositional analysis) is described.
• Data Provenance: The in vitro testing was performed to determine chemical composition. The document does not specify the origin of any "data" in terms of retrospective/prospective studies or country of origin, as it pertains to product composition analysis rather than clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. No ground truth establishment by experts for a test set is mentioned, as there was no clinical study. The equivalence is based on chemical and functional similarity to established predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a dry acid concentrate for dialysis, not an imaging diagnostic tool or a device where human interpretation of medical cases is relevant to its primary function in the same way as an MRMC study would assess.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not a software algorithm; it is a chemical product. The "performance" is its chemical composition and its ability to function correctly when mixed in a dialysis machine. The in vitro tests assessed the chemical composition, which can be considered relevant to its standalone performance, but it's not an "algorithm-only" study.

7. Type of Ground Truth Used

The "ground truth" implicitly used is the chemical specifications and verified performance of the predicate devices. The new device's chemical composition was compared against its own stated specifications and implicitly against the known composition profiles of the predicate devices.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" described is a non-clinical in vitro testing to determine the chemical composition and range of composition of the Dri-Sate Dry Acid Concentrate. The results of these tests confirmed that the proposed device is equivalent to the predicate devices for these parameters.

The core of the submission is a demonstration of substantial equivalence to legally marketed predicate devices (Rockwell Medical Dri-Sate Acid Concentrate Mixes and Fresenius USA, Inc. Granuflo Dialysate Concentrate) in terms of:

• Intended Use: "essentially the same"
• Technological Characteristics: "same range of chemical compositions, packaging and formulations. There are no significant differences."
• Safety and Effectiveness: Concluded to be "safe, effective, and performs as well as the predicate device" based on the in vitro testing and comparison.

Clinical testing was not performed for this 510(k) submission, reflecting that for this type of device (a concentrate used in an established medical procedure with predicate devices), in vitro chemical equivalence often suffices for demonstrating substantial equivalence.

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