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The Rockwell Medical Technologies, Inc., Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate 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. Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acctate contain, water, salt, dextrose, and non-sugar electrolytes formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate solution. These concentrate solutions, when proportioned/ mixed in a threestream dialysis machine with pre-treated or purified water meeting AAMI Standards and a bicarbonate concentrate solution, may be used in conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. The Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate presented in this 510K Notification are intended to be used in three stream hemodialysis machines in which an acidified concentrate is proportioned into one stream, a bicarbonate, chloride and sodium concentrate solution is proportioned into the second stream of the hemodialysis machine, and water is proportioned into the third stream. These three streams are then mixed to prepare a final proportioned hemodialysis solution. These types of 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 or hemodialyzers. These bicarbonate hemodialysis solutions are separated from the patient's blood by 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.

This 510(k) summary describes a medical device, Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate, and its substantial equivalence to predicate devices. However, it does not contain the level of detail regarding acceptance criteria and performance studies that would typically be found for a device being evaluated for novel performance claims.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in a quantitative, measurable sense beyond "equivalent to the proposed device for these parameters." It primarily relies on demonstrating substantial equivalence in chemical composition and range.

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

• Sample Size: Not specified. The document states "In vitro testing was performed to determine the chemical composition and range of composition." without indicating the number of batches, units, or samples tested.
• Data Provenance: Not specified, but based on the nature of in vitro testing for chemical composition, it would be laboratory-generated data from the manufacturer's testing of their product. It is inherently prospective for the device being submitted.

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

• Not Applicable. The ground truth for chemical composition is established by analytical testing and comparison to established specifications or predicate device compositions, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

• Not Applicable. As the testing is for chemical composition, there's no "adjudication" in the clinical sense. Results would be objectively measured and compared.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is not relevant for a dialysis concentrate. MRMC studies are typically used to evaluate the diagnostic performance of imaging devices or algorithms where human interpretation is involved.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a chemical concentrate, not an algorithm or AI. The concept of "standalone performance" in this context is not relevant.

7. The Type of Ground Truth Used

• Analytical/Chemical Specifications and Predicate Device Composition. The "ground truth" for the device's performance is its chemical composition and how it compares to established standards for safety and effectiveness in dialysis concentrates, as well as the known composition of the predicate devices.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided. This device is hardware/chemical in nature, not an AI or machine learning algorithm that requires a "training set." The understanding of its function comes from chemical principles and comparison to existing, approved products.

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

• Not Applicable. As there is no training set mentioned or implied for this type of device, this question is not relevant.

Summary of Device Evaluation Approach:

The submission for Rockwell Medical Technologies, Inc. Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate relies on demonstrating substantial equivalence to existing legally marketed predicate devices. The primary evidence presented is that the proposed device:

• Has the same intended use.
• Utilizes the same range of chemical compositions, packaging, and formulations as the predicate devices.
• Underwent "in vitro testing" to confirm its chemical composition and range.
• No clinical testing was performed.

The FDA's 510(k) clearance process often allows for substantial equivalence determinations without extensive clinical trials if the new device is sufficiently similar to a predicate device in terms of technology, materials, and intended use, and if non-clinical testing can adequately demonstrate equivalence. In this case, chemical analysis was deemed sufficient.

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