(266 days)
This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyte™ bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as Medicalyte Bicarbonate™, in a 45x three-stream artificial kidney (hemodialysis) machine.
The Citric Complete™ dry citric acid powder devices for citric acid concentrate dialysis are comprised of USP grade sodium chloride, USP grade magnesium chloride, USP grade calcium chloride. USP grade potassium chloride. USP grade dextrose, and USP grade citric acid. These products may be used in conventional, commercially available hemodialysis machines or monitors as one of the necessary components of three-component hemodialysis solution. The hemodialysis concentrate solutions presented in this 510(k) premarket notification are intended to be used in 45x three-stream hemodialysis machines in which bicarbonate concentrate is proportioned into one stream, a citric acid solution prepared from the Citric Complete™ dry citric acid powder is proportioned into a second stream, and water is proportioned into the third stream of the hemodialysis machine proportioning system. These three streams are then mixed by the hemodialysis machine to prepare the final proportioned hemodialysis solution. The final hemodialysis solution is separated from a patient's blood by semi-permeable membranes which permit the passage of waste products and toxins contained in the patient's blood circulating through the hemodialyzer, and such waste products and toxins pass through the semi-permeable membranes into, and exit with the hemodialysis solution. By such treatment, waste products and toxins are removed from the patient's blood during acute and end-stage renal failure.
The provided text is a 510(k) summary for a medical device called "Citric Complete™ Dry Citric Acid." This document details the device's technical characteristics, its indications for use, and a comparison to legally marketed predicate devices to demonstrate substantial equivalence. It also describes various performance and biocompatibility tests conducted to support this claim.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes several performance and biocompatibility tests, but it does not present them in a single table with clearly delineated acceptance criteria and reported output values for all characteristics. Instead, the acceptance criteria are embedded within the description of each test.
Here's a compilation based on the provided text:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Testing (Chemical Composition) | Chemical concentrations of components in the formulated dialysis liquid concentrate must be within acceptable limits as set by ANSI/AAMI/ISO 13958:2014, specifically sections 4.1.2.2 and 4.1.2.1. | "All samples of each device tested were within acceptable limits as set by ANSI/AAMI/ISO 13958:2014. Therefore, the performance of these devices is considered to be satisfactory." (Specific values for each component are not provided, but Table 1 and Table 2 show the target concentrations (mEq/L and mg/dL) for various formulations, implying these were met). |
| Biocompatibility Testing (Cytotoxicity) | Minimal Essential Media Elution test (ANSI/AAMI/ISO 10993-05): Score of two or less (degree of cellular destruction). | "In three samples of extract from the low density polyethylene bags, no cell lysis or intractyoplasmic granules were detected, resulting in three individual scores, as well as an average score, of zero, which is within the acceptable level of two or less pursuant to ANSI/AAMI/ISO 10993-05. Therefore, the low density polyethylene bags are considered non-cytotoxic." |
| Biocompatibility Testing (Sensitization) | Guinea Pig Maximization Sensitization Testing (ANSI/AAMI/ISO 10993-10): No positive results for erythema and edema. | "No positive results whatsoever were detected for the low density polyethylene bag extracts. Therefore, the data indicates that the polyethylene bags do not cause sensitization reactions under the conditions of the study, and are considered non-sensitizing." |
| Biocompatibility Testing (Irritation) | Intracutaneous Reactivity Irritation Testing (Rabbits) (ANSI/AAMI/ISO 10993-10): Final score well below the standard limit for erythema and edema. | "The final score for the low density polyethylene bag extracts was well below the standard limit. Therefore, the low density polyethylene bags are considered nonirritants." |
| Endotoxin Analysis | Limit for endotoxins is 0.5 endotoxin units/mL or less, as per ANSI/AAMI/ISO 13958:2014 section 4.1.2 (for final dialysate). | "The standard dialysis fluid generated from the devices is well within the acceptable limits." (No specific numeric value for the reported performance is provided, simply a statement of compliance). |
2. Sample Size Used for the Test Set and Data Provenance:
- Performance Testing (Chemical Composition): "One sample from each batch was tested (with multiple replicates for each sample tested per the validated test method)." There were "three batches each of DCA-200, DCA-201, DCA-202, DCA-203, DCA-206, DCA-225, DCA-226, DCA-228, and DCA-231." This means 27 samples were tested (9 device types * 3 batches/device type). The data provenance is not specified (e.g., country of origin), but it's clearly prospective testing conducted for the submission.
- Biocompatibility Testing (Cytotoxicity): "Three samples of extract from the low density polyethylene bags." This means 3 samples were tested. Provenance is not specified, but it's prospective testing.
- Biocompatibility Testing (Sensitization): "Thirty-four guinea pigs were used for the study (twenty-two tested and twelve in the control group)." This means 34 animals were used in the study. Provenance is not specified, but it's prospective animal testing.
- Biocompatibility Testing (Irritation): "Three animals were used for the study." This means 3 animals were used. Provenance is not specified, but it's prospective animal testing.
- Endotoxin Analysis: "One sample from each of three batches of each device was tested (with multiple replicates for each sample tested per the validated test method)." This implies 27 samples were tested (9 device types * 3 batches/device type). Provenance is not specified, but it's prospective testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided in the document. The device is a chemical concentrate for hemodialysis, and the testing described involves chemical analysis, in vitro cytotoxicity, and in vivo animal biocompatibility. These tests rely on laboratory measurements and standardized protocols (e.g., ISO standards), not on human expert interpretation to establish a ground truth.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving human readers or evaluators, especially in diagnostic imaging or clinical assessment where interpretation of results can vary. For chemical and biological testing as described here, the results are quantitative or based on clear biological reactions, and therefore, an adjudication method for human interpretation is not relevant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where the performance of human readers, with or without AI assistance, is being evaluated on medical cases. The device in question is a chemical concentrate, not a diagnostic tool requiring human interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a "standalone algorithm only" performance study was not done. This concept is also primarily applicable to AI/ML software devices. The "standalone" performance here refers to the physical and chemical characteristics of the concentrate itself, as measured in a lab setting, which is what the performance and biocompatibility testing addresses, albeit without the terminology typically used for AI/ML devices.
7. The Type of Ground Truth Used:
The "ground truth" for the tests performed can be characterized as follows:
- Performance Testing (Chemical Composition): The ground truth is the expected chemical composition of the formulated dialysis liquid concentrate as specified by the device labeling and the established limits in ANSI/AAMI/ISO 13958:2014. This is a technical specification/standard-based ground truth.
- Biocompatibility Testing (Cytotoxicity, Sensitization, Irritation): The ground truth is based on biological reactions observed in standardized laboratory tests and animal models, compared against established safety criteria defined in ISO 10993 standards. This is a biological/standard-based ground truth.
- Endotoxin Analysis: The ground truth is the maximum permissible endotoxin level as defined in ANSI/AAMI/ISO 13958:2014. This is a technical specification/standard-based ground truth.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. This device is a chemical product, not an AI/ML algorithm that requires a training set. The tests performed are to verify the inherent properties of the chemical components and their formulation, as well as the safety of the packaging.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided for the reason stated in point 8.
§ 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.