(147 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Chemical composition equivalent to predicate devices | "In vitro testing was performed to determine the chemical composition and range of composition. The results of these tests confirmed that the proposed device is equivalent to the proposed device for these parameters." |
| Intended use equivalent to predicate devices | "This indication statement is essentially the same as the indication statement for the predicate device." |
| Packaging equivalent to predicate devices | "Comparing the proposed device to the predicate devices utilize the same range of chemical compositions, packaging and formulations. There are no significant differences." |
| Safe and Effective (implied by substantial equivalence) | "Testing performed on the Rockwell Medical Technologies, Inc. Dri-Sate Acid Concentrate Solutions and Powders for Bicarbonate Dialysate indicates that it is safe, effective, and performs as well as the predicate device, when used in accordance with the instructions for use." |
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.
§ 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.