(266 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a dry citric acid powder for hemodialysis, not on any computational or analytical capabilities that would involve AI/ML. The document explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is described as an "acid concentrate product formulated for use in acute and chronic hemodialysis," and the description clearly states that it is used to "remove waste products and toxins from the patient's blood during acute and end-stage renal failure," which is a therapeutic treatment.
No
Explanation: The device description clearly states that this product is an "acid concentrate product" or "dry citric acid powder devices for citric acid concentrate dialysis" used in conjunction with hemodialysis machines. It is comprised of various chemical compounds and is a component of the hemodialysis solution used to remove waste products and toxins from a patient's blood. This is a therapeutic function, not a diagnostic one. Its purpose is to treat, not to diagnose a condition or provide information about a disease.
No
The device description clearly states the device is comprised of physical components (USP grade sodium chloride, USP grade magnesium chloride, etc.) and is a dry powder product. It is intended to be used in conjunction with hardware (hemodialysis machines).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the product is "formulated for use in acute and chronic hemodialysis" and is used in conjunction with other components in a hemodialysis machine. Hemodialysis is a treatment for kidney failure, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details the chemical components of the powder and how it is used to prepare a hemodialysis solution. This solution is then used to remove waste products and toxins from a patient's blood during treatment, not to analyze a sample of blood or other bodily fluid for diagnostic purposes.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is a component used in a therapeutic process (hemodialysis), not a diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KPO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 cytotoxicity, sensitization and irritation. Testing was conducted in compliance with the 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.
Guinea Pig Maximization Sensitization Testing was conducted following 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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
2
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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3
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)
4
510(K) SUMMARY UNDER 21 CFR 807.92
D. 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.
E. Indications for Use
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.
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
5
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 Medical
CitraPure® Acid
Concentrates3 |
|---------|-----|-----|-----|------|--------------|-----------|------------------------------------------------------|
| DCA-200 | 100 | 2.5 | 2.0 | 1.0 | 2.4 | 100 | D4116
Formulation 5 |
| DCA-201 | 100 | 2.0 | 2.0 | 1.0 | 2.4 | 100 | D4108
Formulation 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 | D4117
Formulation 6 |
| DCA-206 | 100 | 3.0 | 2.0 | 0.75 | 2.4 | 200 | See 510(k) Summary
Table 14 |
| DCA-225 | 100 | 3.0 | 2.0 | 1.0 | 2.4 | 100 | D4124
Formulation 7 |
| DCA-226 | 100 | 2.0 | 3.0 | 1.0 | 2.4 | 100 | D4110
Formulation 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.
6
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.
7
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
8
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.