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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.

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.

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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.

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.

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