(62 days)
The Rockwell Medical Supply LLC. Concentrate Solutions for Acetate Dialysate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor.
The Rockwell Medical Supply, LLC. Hemodialysis concentrate solutions and for acetate dialysate contain salt (acetate, sodium, calcium, potassium and chloride), sugar (dextrose), and water containing solutions formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water. These solutions 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. The hemodialysis concentrate solutions presented in this 510K Notification are intended to be used in two stream hemodialysis machines in which an acetate concentrate is proportioned into one stream, and a specified volume of water is proportioned into the second stream of the hemodialysis machine proportioning system. These two streams are then mixed to prepare a final proportioned hemodialysis solution. These types of a final hemodialysis solutions are commonly referred to as "Acetate 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 acetate 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 molecular weigh cut-off 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 and non-ionized molecules, waste products and toxins (i.e. blood urea nitrogen, creatinine, potassium, etc.) contained in the patient's blood circulating through the cialyzer, to pass through the semi-permeable membrane into the acetate containing 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 text is a 510(K) summary for a medical device: "Concentrate Solutions for Acetate Dialysate" by Rockwell Medical, LLC. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a detailed study.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable or not provided in this type of regulatory submission. The document explicitly states: "Clinical testing was not performed."
Here's a breakdown of the information that can be extracted or inferred based on the supplied text:
Acceptance Criteria and Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly met if the proposed device is found to be substantially equivalent to the predicate device. The primary "performance" demonstrated is that the device has the same chemical composition and intended use as the legally marketed predicate device.
| Acceptance Criteria Category | Specific Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance and Compliance |
|---|---|---|
| Intended Use | The intended use of the proposed device is the same as the predicate device. | "The Rockwell Medical Supply LLC. Concentrate Solutions for Acetate Dialysate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor." |
| "This indication statement is essentially the same as the indication statement for the predicate device." | ||
| Technological Characteristics (Chemical Composition & Formulation) | The chemical composition and formulations of the proposed device are within the same range as the predicate device. | "Comparing the proposed device to the predicate devices utilize the same range of chemical compositions, packaging and formulations. There are no significant differences." |
| "In vitro testing was performed was performed to determine the chemical composition and range of composition. The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." | ||
| Packaging & Labeling | The packaging and labeling of the proposed device are substantially equivalent to the predicate device. | "...substantially equivalent in composition, intended use, packaging and labeling to other acetate hemodialysis solutions currently approved for commercial distribution in the United States by the FDA." (No further details on specific labeling attributes are provided in the summary, but the general claim is made.) |
| Safety and Effectiveness | The device is safe, effective, and performs as well as the predicate device when used as intended. (This is an overall conclusion for substantial equivalence). | "Testing performed on the Rockwell Medical LLC Concentrate Solutions for Acetate Dialysate indicates that it is safe, effective, and performs as well as the predicate device, when used in accordance with the instructions for use." (This is a conclusion drawn from the substantial equivalence assessment, not from independent clinical trials described here). |
Study Details Based on the Provided 510(K) Summary:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. There was no specific "test set" in the context of clinical performance evaluation. The "testing" referred to appears to be analytical/bench testing to confirm chemical composition.
- Data Provenance: The "in vitro testing" was performed by the submitter (Rockwell Medical, LLC). Specific details about the data's origin (e.g., country) are not provided, but it would have been conducted internally by Rockwell Medical. The study is akin to retrospective analytical comparison to the predicate device's established characteristics.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no clinical test set requiring expert ground truth. Ground truth for the chemical composition would be established through laboratory analysis following recognized standards/methods, not expert consensus in the clinical sense.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As no clinical test set requiring human adjudication was involved.
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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 solution for hemodialysis, not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is the established chemical composition and operational characteristics of the predicate device. The proposed device's chemical parameters were compared against these established ranges via in vitro chemical analysis.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that would require a "training set."
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How the ground truth for the training set was established:
- Not applicable. No training set was used.
§ 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.