(270 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 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 singleuse, non-sterile devices intended for use in hemodialysis therapy for acute and chronic renal failure. Both products consist of electrolytes (chloride salts of sodium, 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 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.
This document is a 510(k) summary for Fresenius Medical Care's Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and providing detailed study results for a new device's performance.
Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth generation for performance studies is not directly available in this document because these liquid acid concentrates are not software, AI, or imaging devices that would typically undergo such evaluations.
However, I can extract the available information regarding performance testing that supports their substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit "acceptance criteria" in the format typically seen for algorithm performance (e.g., sensitivity, specificity thresholds). Instead, performance is assessed through various verification and validation activities to ensure the products are safe and effective and substantially equivalent to existing predicate devices.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Stability (Shelf Life) | Maintain product integrity and efficacy for 24 months. | "Stability evaluations were conducted... to support the 24-month (2-year) shelf life. Stability is monitored as part of routine production testing. The 24-month shelf life is supported by real time stability evaluations." (Section 5.8.1) |
| Shipping & Distribution | Withstand the physical stresses of the distribution environment. | "Shipping and distribution verification testing was performed... in accordance with ASTM D4169-16... Results support that the products' packaging is able to withstand the distribution environment." (Section 5.8.2) |
| Biocompatibility | Demonstrate biological safety for direct and indirect blood contact lasting >24 hours to 30 days. Includes chemical characterization, cytotoxicity, sensitization, irritation, systemic toxicity, material mediated pyrogenicity, and hemocompatibility. | "The following endpoints were assessed to support the biological safety... Chemical characterization, Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Material mediated pyrogenicity, Hemocompatibility. A toxicological risk assessment was also performed." (Section 5.8.3) |
| Human Factors/Usability | Ensure safe and effective use of the device. | "The Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate were validated for their safe and effective use in accordance with FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices..." (Section 5.8.4) |
| Substantial Equivalence | The device's technological characteristics (intended use, design, principle of operation, materials, performance) are comparable to predicate devices and raise no new safety/efficacy concerns. | "The intended use, design, principle of operation, and materials of construction of the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are substantially equivalent to those of the predicate devices. Differences... do not raise new concerns..." (Section 5.9) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified in terms of numerical units for each test (e.g., number of stability batches, number of shipping units, or biological samples). The document mentions "real time stability evaluations" and implies a representative number of products were subjected to shipping, biocompatibility, and human factors testing.
- Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." The studies appear to be conducted internally by Fresenius Medical Care during the device development and validation process ("Performance testing was conducted"). These are likely prospective studies as part of product validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For biocompatibility, this would typically involve toxicologists and material scientists. For human factors, usability engineers would be involved.
4. Adjudication Method for the Test Set
- No information provided. Adjudication methods are typically relevant for subjective assessments, especially in clinical or image-based studies, which are not applicable here.
5. 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
- No, an MRMC comparative effectiveness study was not done. This type of study is specific to imaging devices, especially those that involve AI assistance for human interpretation. The devices in question are liquid acid concentrates for hemodialysis, which do not involve diagnostic interpretation by human readers or AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. These devices do not contain software or algorithms in the context of diagnostic performance. The document explicitly states: "Not applicable. The Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate do not contain software." (Section 5.8.6).
7. The Type of Ground Truth Used
- For Stability: The ground truth is the chemical and physical integrity/composition of the concentrates over time, as measured by analytical methods.
- For Shipping Verification: The ground truth is the intactness of the packaging and product after simulated shipping stresses, determined by visual inspection and potentially functional tests.
- For Biocompatibility: The ground truth involves established biological responses and toxicology principles. This would be based on validated assays and expert toxicological assessment against recognized safety limits.
- For Human Factors/Usability: The ground truth relates to the absence of use errors and the ability of intended users to safely and effectively use the product, assessed through observation and user feedback against pre-defined safety and efficacy goals.
8. The Sample Size for the Training Set
- Not applicable. These products are physical chemical concentrates, not AI/ML algorithms that require a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As these are not AI/ML algorithms, there is no training set or associated ground truth establishment process in that context.
§ 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.