(267 days)
Citrasate® Liquid Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Citrasate® Liquid Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription.
NaturaLyte® Liquid Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLyte® Liquid Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription.
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate products are single-use, non-sterile devices intended for use in hemodialysis therapy for acute and chronic renal failure. Both products consist of electrolytes (chloride salts of sodium, calcium, magnesium, and potassium), dextrose, and an organic acid source (citric acid in Citrasate and acetic acid in NaturaLyte). Citrasate also contains sodium acetate as a secondary pH adjuster.
All formulation components are mixed in a single solution with dialysis quality water and provided to the customer ready for use.
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one (1) component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
The proposed Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate 1-gallon bottles have a modified cap design with alternate raw materials. The proposed bottle cap is composed of high density polyethylene (HDPE). The tamper-evident cap has a grooved ring pull tab intended to provide a thread lock. Due to the difference in cap design, the bottle threads are modified to match the threads and dimensions of the proposed cap. Dimensional changes are limited to the threads and bottle termination area only and do not affect the main bottle dimensions. There is no change in wall thickness or material used to manufacture the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate 1-gallon bottles.
This document, K212620, is a 510(k) premarket notification for Citrasate® Liquid Acid Concentrate and NaturaLyte® Liquid Acid Concentrate. These are liquid acid concentrates used in hemodialysis. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices (K192017) after a modification to the bottle cap design.
It is important to note that this document does not describe a study involving device performance for diagnostic accuracy, classification, or prediction, as would typically be seen for AI/ML devices. Instead, the "device" in this context refers to a medical consumable (liquid concentrates) and its packaging. Therefore, many of the requested criteria, which are geared towards evaluating the performance of AI/ML or diagnostic devices, are not applicable.
Here's an assessment based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (liquid concentrates with a packaging change), the "acceptance criteria" and "performance" are focused on safety, functionality, and manufacturing quality, not diagnostic accuracy.
| Acceptance Criterion (from document) | Reported Device Performance |
|---|---|
| Stability (24-month (2-year) shelf life) | Stability is monitored as part of routine production testing. Outcomes support the 24-month shelf life. |
| Shipping and Distribution (packaging integrity) | Products' packaging is able to withstand the distribution environment, per ASTM D4169-16. |
| Biocompatibility (material safety) | Assesses chemical characterization, cytotoxicity, sensitization, irritation, systemic toxicity, material-mediated pyrogenicity, and hemocompatibility (per ISO 10993-1:2018). Results support biological safety. A toxicological risk assessment was also performed. |
| Human Factors (safe and effective use of modified cap/bottle) | Assessed to demonstrate safe and effective use, per FDA guidance (03 February 2016). |
| Technological Characteristics (comparison to predicate) | Substantially equivalent to predicate (K192017) regarding intended use, design, principle of operation, materials of construction, and performance specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of units tested for each criterion. The testing would involve a representative sample of the modified bottles/caps and the liquid concentrates. The document refers to "Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate products" and "bottles" as the test subjects.
- Data Provenance: The studies were conducted by Fresenius Medical Care Renal Therapies Group, LLC, presumably within their R&D and quality control processes. No information is provided about the country of origin of the data or if it was retrospective or prospective, though it would be prospective for this type of verification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Experts and Qualifications: Not applicable in the context of this type of device. The "ground truth" here is adherence to recognized standards (e.g., ISO, ASTM, FDA guidance) and internal specifications, verified through laboratory testing and engineering assessments. The experts involved would be qualified engineers, chemists, and toxicologists conducting the testing and analysis according to their respective disciplines.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" is determined by objective measurements against predefined specifications and standards, not through consensus of human readers or adjudicators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, which is not what this submission is for.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This device is a medical consumable, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this submission is based on:
- Adherence to recognized standards: ASTM D4169-16 for shipping, ISO 10993-1:2018 for biocompatibility, FDA guidance for human factors.
- Established product specifications: For chemical composition, shelf life, and functional performance (e.g., cap sealing integrity not impacting concentrate stability).
- Substantial equivalence to predicate: Demonstrated by confirming that the modified device characteristics do not raise new questions of safety or effectiveness compared to the previously cleared predicate device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not involve machine learning algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set.
§ 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.