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.

Device Description

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.

AI/ML Overview

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.

Summary

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March 6, 2018

Dimesol USA, LLC % David M. Marcus, J.D., Ph.D. Associate McNees Wallace & Nurick LLC 21 East State Street. Suite 1700 Columbus, OH 43215

Re: K171750

Trade/Device Name: Citric Complete™ Dry Citric Acid Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: KPO Dated: February 1, 2018 Received: February 1, 2018

Dear David M. Marcus:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Charles Viviano -S

For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171750

Device Name Citric Complete™ Dry Citric Acid

Indications for Use (Describe)

This acid concentrate product is formulated for use in acute 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.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY UNDER 21 CFR 807.92

This 510(k) summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content in this 510(k) summary has been provided in conformance with 21 CFR Part 807.92.

A. Submitter's Information

(1) Name:	McNees Wallace & Nurick LLC
(2) Address:	21 East State St., Suite 1700, Columbus, OH 43215 USA
(3) Phone:	614-719-2856
(4) Fax:	614-469-4653
(5) Contact Person:	David M. Marcus, J.D., Ph.D.
(6) Preparation Date:	June 12, 2017
(7) Revised Submission Date:	January 30, 2018

On Behalf of Applicant Entity (owner of 510(k))

(1) Applicant Name:	Dimesol USA, LLC
(2) Applicant Address:	509 Fishing Creek Rd., Lewisberry, PA 17339 USA
(3) Applicant Phone:	717-938-8391
(4) Applicant Fax:	717-938-3957
(5) Establishment Reg. No:	1528807

B. Device Name

(1) Trade Name:	Citric Complete™ Dry Citric Acid
(2) Common Name:	Dialysis Concentrate for Hemodialysis (Powder) (Dry Citric Acid)
(3) Classification:	Class II, per 21 CFR 876.5820 (Hemodialysis system and accessories)
(4) Product Code:	KPO: Gastroenterology/Urology

C. Legally Marketed Predicate Devices

Rockwell Medical CitraPure® Acid Concentrate (K160847) Diasol, Inc. Citrasol Acid Concentrate (K130511) Dimesol USA, LLC MedicaLyte™ Bicarbonate Powder (K131202)

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510(K) SUMMARY UNDER 21 CFR 807.92

D. Device Description

E. Indications for Use

F. Technological Characteristics:

Comparing the proposed Citric Complete™ dry citric acid powder devices to the Rockwell Medical CitraPure® Acid Concentrates (K160847) predicate devices, the devices utilize the same chemical compositions and produce the same citric acid solutions for hemodialysis (as described in Table 1). There are no significant differences, and therefore a finding of substantial equivalence is appropriate.

510(k) Premarket Notification for Dimesol USA, LLC K171750 Citric Complete™ Dry Citric Acid

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510(K) SUMMARY UNDER 21 CFR 807.92

TABLE 1. Performance Comparison Table (Citric Acid Solutions Generated from Concentrate According to Label Directions)*

Device	Na1	Ca1	K1	Mg1	Citric Acid1	Dextrose2	Rockwell MedicalCitraPure® AcidConcentrates3
DCA-200	100	2.5	2.0	1.0	2.4	100	D4116Formulation 5
DCA-201	100	2.0	2.0	1.0	2.4	100	D4108Formulation 2
DCA-202	100	2.5	1.0	1.0	2.4	100	Formulation 4
DCA-203	100	2.5	3.0	1.0	2.4	100	D4117Formulation 6
DCA-206	100	3.0	2.0	0.75	2.4	200	See 510(k) SummaryTable 14
DCA-225	100	3.0	2.0	1.0	2.4	100	D4124Formulation 7
DCA-226	100	2.0	3.0	1.0	2.4	100	D4110Formulation 3
DCA-228	100	3.0	3.0	1.0	2.4	100	Formulation 9

*The Component and Yield columns apply equally to the Device and Predicate Device.

1 mEq/L

2 mg/dL

3 Formulation references are to the row number of the 510(k) summary for K160847.

4 Although this exact formulation is not disclosed in the itemized compositions, it is entirely within the ranges provided in Table 1 of the 510(k) summary for K160847.

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510(K) SUMMARY UNDER 21 CFR 807.92

Comparing the proposed Citric Complete™ dry citric acid powder devices to the Diasol, Inc. CitriSol Acid Concentrate (K130511) predicate devices utilize the same chemical compositions and produce the same citric acid solutions for hemodialysis (as described in Table 2). There are no significant differences, and therefore a finding of substantial equivalence is appropriate.

TABLE 2. Performance Comparison Table (Bicarbonate Stream Dialysate Generated from Concentrate According to Label Directions)*

Device	Na1	Ca1	K1	Mg1	Citric Acid1	Dextrose2	Diasol, Inc.CitriSol Acid Concentrate
DCA-200	100	2.5	2.0	1.0	2.4	100	CS45225-10DEX100
DCA-202	100	2.5	1.0	1.0	2.4	100	CS45125-10DEX100
DCA-203	100	2.5	3.0	1.0	2.4	100	CS45325-10DEX100
DCA-231	100	2.5	2.0	0.75	2.4	100	CS45225-75-DEX100

*The Component and Yield columns apply equally to the Device and Predicate Device.

1 mEq/L

2 mg/dL

Comparing the proposed Citric Complete™ dry citric acid powder devices to the MedicaLyte™ Bicarbonate Powder (K131202) predicate devices are packaged in identical low density polyethylene bags (same material composition and processing) from the same manufacturer (Elkay Plastics Co., Inc. located at 6000 Sheila Street, Commerce, California 90040). There are no significant differences, and therefore a finding of substantial equivalence is appropriate.

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510(K) SUMMARY UNDER 21 CFR 807.92

Performance Testing:

Performance testing was conducted on three batches each of DCA-200, DCA-201, DCA-202, DCA-203, DCA-206, DCA-225, DCA-226, DCA-228, and DCA-231. Testing was accomplished by formulating the dialysis liquid concentrate pursuant to the instructions on the device labels, and measuring the concentrations of all components to ensure that following the label instructions generates the liquid concentrate specified on the label. All testing was conducted pursuant to ANSI/AAMI/ISO 13958:2014, specifically with reference to sections 4.1.2.2 and 4.1.2.1. One sample from each batch was tested (with multiple replicates for each sample tested per the validated test method). The concentrations were then averaged to determine average concentrations for each device. All samples of each device tested were within acceptable limits as set by ANSVAAMI/ISO 13958:2014. Therefore, the performance of these devices is considered to be satisfactory.

Biocompatibility Testing:

The low density polyethylene bags were subjected to biocompatibility testing for Testing was conducted in compliance with the cytotoxicity, sensitization and irritation. ANSI/AAMI/ISO 10993 standards.

Cytotoxicity of substances extractable from the polyethylene bags was measured using the Minimal Essential Media Elution test following ANSI/AAMI/ISO 10993-05. An extract of the polyethylene bags was added to cell monolayers and incubated. The cell monolayers were examined and scored based on the 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.

Pig Maximization Sensitization Testing was conducted following Guinea ANSI/AAMI/ISO 10993-10. Thirty-four guinea pigs were used for the study (twenty-two tested and twelve in the control group). The animals were dosed with formulations of either test or control solution in three phases (two inductions and one challenge). Dermal appearance at the dose sites was scored after challenge phase patch removal. The low density polyethylene bag extracts were graded for erythema and edema following the challenge phase. No positive results whatsoever were detected for the low density polyethylene bag extracts. Therefore, the data

510(k) Premarket Notification for Dimesol USA, LLC

K171750 Citric Complete™ Dry Citric Acid

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510(K) SUMMARY UNDER 21 CFR 807.92

indicates that the polyethylene bags do not cause sensitization reactions under the conditions of the study, and are considered non-sensitizing.

Intracutaneous Reactivity Irritation Testing (Rabbits) was conducted following ANSI/AAMI/ISO 10993-10. Three animals were used for the study. The low density polyethylene bag extracts were intracutaneously injected. Each site was graded for tissue reaction. The low density polyethylene bag extracts were graded for erythema and edema, with the final score determined by scoring each injection site, and subtracting the score of the control from the test article score. 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 on Device Contents:

Endotoxin analysis was performed on each device. Testing was performed in accordance with ANSI/AAMI/ISO 13958:2014 section 4.1.2, under which the limit for endotoxins is 0.5 endotoxin units/mL or less. One sample from each of three batches of each device was tested (with multiple replicates for each sample tested per the validated test method). The standard is drafted for final dialysate rather than concentrate, which required further of the concentrate prepared according to the instructions of the device label to overcome inhibition and enhancement due to the testing methodology. The standard dialysis fluid generated from the devices is well within the acceptable limits.

G. Conclusion

The Citric Complete™ dry citric acid powder devices are believed to be substantially equivalent in design, materials, and indications for use to the commercially available Rockwell Medical CitraPure® Acid Concentrates (K160847) predicate devices, the Diasol, Inc. CitriSol Acid Concentrate (K130511) predicate devices, and the MedicaLyte™ Bicarbonate Powder (K131202) predicate devices, and are therefore expected to be as safe, as effective, and perform as well as the predicate devices.

Regulation Number and Section

§ 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.