Search Results

The Rockwell Medical Technologies' Bicarbonate Dialysate Concentrate Mixer is designed to mix the Rockwell Medical Technologies Concentrate Powders for Bicarbonate Dialysis with purified water to produce a bicarbonate concentrate solutions for hemodialysis for use in 3stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors. The Rockwell Medical Technologies, Inc. Concentrate Powders for Bicarbonate Dialysis which are mixed with water in the Bicarbonate Dialysate Concentrate Mixer™ are indicated for use in acute and chronic hemodialysis.

The Rockwell Medical Technologies' Bicarbonate Dialysate Concentrate Mixer is designed to mix the Rockwell Medical Technologies Dri-Sate Bicarbonate Concentrate Mixes with purified water to produce a bicarbonate concentrate solution for hemodialysis for use in 3-stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors.

Hemodialysis therapy removes blood wastes by diffusion through a dialyzer membrane into a dialysate solution flowing on the opposite side of the dialyzer membrane. Hemodialysis also involves using a differential transmembrane pressure to ultrafilter water from the blood usually resulting in a net patient weight loss during the treatment.

The Rockwell Medical Technologies' Bicarbonate Dialysate Concentrate Mixer is designed to be used with The Rockwell Medical Supply, LLC. Dri-Sate™ Bicarbonate Concentrate Hemodialysis Mixes which contain sodium bicarbonate and sodium chloride and in another formulation, only sodium bicarbonate (for Cobe Machines). These Dri-Sate™ Bicarbonate Concentrate Hemodialysis Mixes have been previously cleared by the FDA in 510(k) Number K954527 on March 18, 1996. Copies of the 510(K) clearance letter and samples of the labels/instructions for use for these powders are included in Appendix II of this Notification. These are formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and acid concentrate in a three-stream hemodialysis machine.

These powders when proportioned/ mixed with pre-treated or purified water meeting or exceeding AAMI Standards, may be used in conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. These proportioned hemodialysis solutions are 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 semipermeable cellulosic or non-cellulosic membrane which serves as a molecular weight selective barrier to the passage of molecules beyond a certain molecular weight

The provided text describes a 510(k) summary for the Rockwell Medical Technologies, Inc. Bicarbonate Dialysate Concentrate Mixer. Based on the information presented, here's an analysis regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific, quantifiable acceptance criteria (e.g., pH range, conductivity range, concentration accuracy) for the performance of the Bicarbonate Dialysate Concentrate Mixer.

Instead, the "performance" is implicitly defined by the device's substantial equivalence to predicate devices and its ability to produce a bicarbonate concentrate solution for hemodialysis as intended.

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

• Test Set Sample Size: Not specified.

• Data Provenance: The document explicitly states:

  • "In vitro testing was not performed was not included in this 510(k) Notification." (000052, Summary of Non-Clinical Tests)
  • "Clinical testing was not performed." (K032521, Clinical Test Results)

  Therefore, there is no disclosed test set or primary data provenance in the provided document. The basis for the claims of safety, effectiveness, and substantial equivalence relies on comparison to predicate devices and the understanding of the underlying technology, rather than new empirical testing.

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

Not applicable, as no in vitro or clinical testing was performed for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as no in vitro or clinical testing was performed for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The device is a concentrate mixer, not an imaging or diagnostic device that would typically involve human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study was not done. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

Not applicable, as no in vitro or clinical testing was performed. The "ground truth" for the submission is based on the established safety and effectiveness of the predicate devices and the technological equivalence argument.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm.

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

Not applicable. This device is not an AI/ML algorithm.

Ask a specific question about this device