Predicate Devices

K982378, K160847, K062399, K000792, K130511

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on chemical concentrates for hemodialysis, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are in vitro chemical and microbial tests.

Therapeutic

Yes
The device is described as "acid concentrate liquids or powders for bicarbonate dialysis" and "bicarbonate concentrate liquids or powders for bicarbonate dialysis", and "acetate concentrate powders and liquids for acetate dialysis". These concentrates are used in hemodialysis, which is a therapeutic treatment.

Diagnostic

No

Explanation: The device consists of various liquid and powder concentrates used in hemodialysis. These concentrates are indicated for use as accessories with hemodialysis machines. They are not intended to diagnose any condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly indicates that the device is a physical product (liquid and powder concentrates) used in hemodialysis, not a software application.

IVD (In Vitro Diagnostic)

Based on the provided text, the devices described are not IVDs (In Vitro Diagnostics).

Here's why:

Intended Use: The intended use clearly states that these concentrates are "indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine". Hemodialysis is a treatment for kidney failure, not a diagnostic test performed on samples outside the body.
Device Description: The description details the chemical composition of the concentrates and how they are mixed with water for use in a hemodialysis machine. This process is part of a therapeutic treatment, not a diagnostic procedure.
Lack of Diagnostic Language: The text does not mention any diagnostic purpose, such as analyzing patient samples (blood, urine, etc.) to provide information about a disease or condition.
Performance Studies: The performance studies described focus on the chemical composition, endotoxin levels, and microbial counts of the concentrates themselves, ensuring they meet standards for use in hemodialysis. They do not involve evaluating the device's ability to diagnose or detect a condition.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The devices described here are components used in vivo (within the body) as part of a therapeutic treatment.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

AcetiCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSUAAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate.
CitriCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate.
BicarboCon bicarbonate concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in the exact proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with acid concentrate.
RenaCon acetate concentrate liquids or powders for acetate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 2 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis.
AcetiCon acid concentrate powders and liquids for bicarbonate dialysis are indicated for use in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate.
CitriCon acid concentrate powders and liquids for bicarbonate dialysis are indicated for use in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate.
BicarboCon bicarbonate concentrate powders and liquids for bicarbonate dialysis are indicated for use in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with acid concentrate.
RenaCon acetate concentrate powders and liquids for acetate dialysis are indicated for use in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 2 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis.

Product codes

KPO

Device Description

All liquid and powder acid and bicarbonate concentrates for bicarbonate dialysis presented in this 510(k) Notification are produced in a manner consistence with the predicate devices listed in Section 3 of this 510(k) Summary by adhering to strict cGMP guidelines and in accordance with AAMI/ANSI/ISO 13958:2014 Concentrates for Hemodialysis and Related Therapies and AAMI/ANSI/ISO 13959:2014 Water for Hemodialysis and Related Therapies. CitriCon liquids and powders contain Citric Acid and may contain Sodium Acetate along with various other ingredients (such as sodium chloride, calcium chloride, potassium chloride, magnesium chloride and dextrose, all meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed acid concentrates for bicarbonate dialysis. AcetiCon liquids and powders contain either Acetic Acid or Sodium DiAcetate along with various other ingredients (such as sodium chloride, calcium chloride, potassium chloride, magnesium chloride and dextrose, all meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed acid concentrates for bicarbonate dialysis. BicarboCon liquids and powders contain Sodium Bicarbonate and may contain Sodium Chloride, (both either meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed bicarbonate concentrates for bicarbonate dialysis. These products are not designed and/or formulated for reuse and should be considered as single-use only. These acid and bicarbonate concentrate liquid and powder formulations when proportioned/mixed with pretreated, purified water that meets or exceeds current AAMI standards may be used with conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. These hemodialysis concentrates are intended to be used in three stream hemodialysis machine in which an acidified concentrate is proportioned into one stream, a bicarbonate concentrate is proportioned into a second stream and a third stream of water that meets or exceeds current AAMI standards. Where these three streams are then mixed to prepare a final proportioned hemodialysis solution.

All liquid and powder acetate concentrates for acetate dialysis presented in this 510(k) Notification are produced in a manner consistence with the predicate devices listed in the Section 3 of this 510(k) Summary by adhering to strict cGMP guidelines and in accordance with AAMI/ANSI/ISO 13958:2014 Concentrates for Hemodialysis and Related Therapies and AAMI/ANSI/ISO 13959:2014 Water for Hemodialysis and Related Therapies. RenaCon liquids and powders contain Sodium Acetate along with various other ingredients (such as sodium chloride, calcium chloride, potassium chloride, magnesium chloride and dextrose, all meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed acetate concentrates for acetate dialysis. These products are not designed and/or formulated for re-use and should be considered as single-use only. These acetate concentrate liquid and powder formulations when proportioned/mixed with pre-treated, purified water that meets or exceeds current AAMI standards may be used with conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. These hemodialysis concentrate formulas are intended to be used in two stream hemodialysis machine in which an acetate concentrate is proportioned into one stream and a second stream of water that meets or exceeds current AAMI standards.

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)

In vitro testing was performed on laboratory prepared formulations as instructed on the device labels which bracket the extremes of each critical component in each product line proposed in this submission to determine the individual component concentration to ensure that following the label instructions generates the concentrate formulation stated on the label. Testing was conducted using validated equipment and validated analytical methods. The acceptance criteria requirements of ANSI/AAMI 13958:2014 Concentrates for hemodialysis and related therapies, which are stated in sections 4.1.2.1 and 4.1.2.2 were followed for all components. In addition to the chemical concentration testing, both endotoxin and microbial testing was performed in accordance with ANSI/AAMI 13958:2014 sections 4.1.4 and 4.1.5 and in compliance with the release requirements in ANSI/AAMI 11663:2014 section 4.1.2. Product formulations were tested for endotoxins using a commercially available and validated Limulus Amebocyte Lysate (LAL) test. All endotoxin results reported levels well below the release limit of 0.5 EU/ml. Microbial testing was performed on all formulations containing bicarbonate. All microbial count results reported levels well below the release limit of 100 CFU/ml. The results of these test confirm that the performance of the proposed devices within this submission are satisfactory and substantially equivalent to the predicate devices for the same parameters.

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.

K982378, K160847, K062399, K000792, K130511

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.

K171015, K012328, K070177, K071387

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

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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 7, 2018

Global Scientific Technologies, LLC William Griswold, Jr. President P.O Box 1347 Duncan, South Carolina 29334-1347

Re: K180679

Trade/Device Name: CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid) AcetiCon Liquid and Powder (Acid Concentrate acidified with either Acetic Acid or Sodium Di Acetate) BicarboCon Liquid and Powder (Bicarbonate Concentrate) RenaCon Liquid and Powder (Acetate Concentrate with Sodium Acetate) Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: Class II Product Code: KPO Dated: November 5, 2018 Received: November 7, 2018

Dear William Griswold, Jr.:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

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. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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.

Carolyn Y. Neuland -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

510(k) Number (if known)

K180679

Device Name

AcetiCon Liquid or Powder (Acid Concentrate acidified with either Acetic Acid or Sodium Di Acetate)

Indications for Use (Describe)

AcetiCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSUAAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments reqarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(k) Number (if known)

K180679

Device Name

CitriCon Liquid or Powder (Acid Concentrate acidified with Citric Acid and may be in combination with Sodium Acetate)

Indications for Use (Describe)

CitriCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments reqarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

510(k) Number (if known)

K180679

Device Name

BicarboCon Liquid or Powder (Bicarbonate Concentrate)

Indications for Use (Describe)

BicarboCon bicarbonate concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in the exact proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with acid concentrate.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments reqarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

5

510(k) Number (if known)

K180679

Device Name

RenaCon Liquid or Powder (Acetate Concentrate with Sodium Acetate)

Indications for Use (Describe)

RenaCon acetate concentrate liquids or powders for acetate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 2 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments reqarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

004 Indications for Use Statements Rev 1

6

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.

1. Submitter's Information:

Company Name:	Global Scientific Technologies, LLC
Physical Address:	151 Old Jones Road
City:	Greer
State:	South Carolina
Zip Code:	29651
Mailing Address:	P.O. Box 1347
City:	Duncan
State:	South Carolina
Zip Code:	29334-1347
Contact Name:	William J. Griswold, Jr.
Title:	President
Office Phone:	864-655-3590
Fax:	877-655-3502
Preparation Date:	March 12, 2018
Revision Date:	November 5, 2018

2. Device Name (21 CFR 876.5820):

2.1. Dialysate Concentrate Solutions for Hemodialysis:

2.1.1. Acid Concentrate Liquids & Powders: Trade Name(s): CitriCon & AcetiCon Acid Concentrate Liquids & Powders Common/Usual Name: Dialysate Concentrate for Hemodialysis Classification Name: Class II, Hemodialysis System and Accessories Product Code: KPO: Gastroenterology/Urology

2.1.2. Acetate Concentrate Liquids & Powders: Trade Name(s): RenaCon Acetate Concentrate Liquids & Powders Common/Usual Name: Dialysate Concentrate for Hemodialysis Classification Name: Class II, Hemodialysis System and Accessories Product Code: KPO: Gastroenterology/Urology

7

2.1.3. Bicarbonate Concentrate Liquids & Powders: Trade Name(s): BicarboCon Bicarbonate Concentrate Liquids & Powders Common/Usual Name: Dialysate Concentrate for Hemodialysis Classification Name: Class II, Hemodialysis System and Accessories Product Code: KPO: Gastroenterology/Urology

3. Predicate Device Names:

3.1. Solution Technologies K982378 (PRIMARY PREDICATE)
- 3.1.1. Device Names: Hemosol, Hemogran, Nephrosol, Nephrogran, Bicarbosol and Bicarbogran Dialysate Concentrate
3.2. Rockwell Medical Technologies. Inc K160847 & K062399 (SECONDARY PREDICATE) 3.2.1. Device Name: CitraPure Acid Concentrate
3.3. Advanced Renal Technologies, Inc K000792 (SECONDARY PREDICATE) 3.3.1. Device Name: Citrasate Acid Concentrate
3.4. Diasol, Inc. K130511 (SECONDARY PREDICATE) 3.4.1. Device Name: Citrisol Acid Concentrate
3.5. Di-Chem, Inc. K171015 (REFERENCE DEVICE) 3.5.1. Device Name: Citryte Acid Concentrate
3.6. Di-Chem, Inc. K012328 (REFERENCE DEVICE) 3.6.1. Device Name: Hemo-Lyte Bicarb Powder
3.7. Fresenius Medical Care North America K070177 (REFERENCE DEVICE) 3.7.1. Fresenius Naturalyte Liquid Acid Concentrates, 9000, 6000 and 4000 Series
3.8. Fresenius Medical Care North America K071387 (REFERENCE DEVICE) 3.8.1. Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrates, 4000 Series

8

Global Scientific Technologies, LLC AcetiCon, CitriCon, BicarboCon & RenaCon for Hemodialysis (Liquids & Powders) Traditional 510(k) Premarket Notification 510(k) SUMMARY UNDER 21 CFR 807.92 4. Device Description / Indications for Use:

4.1. CitriCon and AcetiCon Liquid and Powder Acid Concentrates and BicarboCon Liquid and Powder Bicarbonate Concentrates:
- 4.1.1. Device Description All liquid and powder acid and bicarbonate concentrates for bicarbonate dialysis presented in this 510(k) Notification are produced in a manner consistence with the predicate devices listed in Section 3 of this 510(k) Summary by adhering to strict cGMP guidelines and in accordance with AAMI/ANSI/ISO 13958:2014 Concentrates for Hemodialysis and Related Therapies and AAMI/ANSI/ISO 13959:2014 Water for Hemodialysis and Related Therapies. CitriCon liquids and powders contain Citric Acid and may contain Sodium Acetate along with various other ingredients (such as sodium chloride, calcium chloride, potassium chloride, magnesium chloride and dextrose, all meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed acid concentrates for bicarbonate dialysis. AcetiCon liquids and powders contain either Acetic Acid or Sodium DiAcetate along with various other ingredients (such as sodium chloride, calcium chloride, potassium chloride, magnesium chloride and dextrose, all meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed acid concentrates for bicarbonate dialysis. BicarboCon liquids and powders contain Sodium Bicarbonate and may contain Sodium Chloride, (both either meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed bicarbonate concentrates for bicarbonate dialysis. These products are not designed and/or formulated for reuse and should be considered as single-use only. These acid and bicarbonate concentrate liquid and powder formulations when proportioned/mixed with pretreated, purified water that meets or exceeds current AAMI standards may be used with conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. These hemodialysis concentrates are intended to be used in three stream hemodialysis machine in which an acidified concentrate is proportioned into one stream, a bicarbonate concentrate is proportioned into a second stream and a third stream of water that meets or exceeds current AAMI standards. Where these three streams are then mixed to prepare a final proportioned hemodialysis solution.

Criteria	Description/Specification
Component Formula
Range
*Acetate is derived from
either Acetic Acid or
Sodium DiAcetate
individually. Not in
combination.	Sodium 70 – 110 mEq/L
Potassium 0 – 5 mEq/L
Calcium 0 – 5 mEq/L
Magnesium 0 – 2 mEq/L
Dextrose 0 – 350 mg/dl (mg %)
*Acetate from Acetic Acid 2 – 5 mEq/L
*Acetate from Sodium DiAcetate 4 – 8 mEq/L
Physical State	Liquid - packaged in Polyethylene (PE) containers
Powder - packaged in Polyethylene (PE) containers
Proportioning Ratios
(AcetiCon : Water)	1:34 (35X), 1:35.83 (36.83X), and 1:44 (45X)

4.1.2. Summary of Concentrate Ranges:

4.1.2.1. AcetiCon Concentrates - Summary of Ranges:

9

Global Scientific Technologies, LLC

AcetiCon, CitriCon, BicarboCon & RenaCon for Hemodialysis (Liquids & Powders) Traditional 510(k) Premarket Notification 510(k) SUMMARY UNDER 21 CFR 807.92

AcetiCon Concentrate Formulas: 4.1.2.1.1.

The following lists of formulas for AcetiCon Concentrates, which are intend to market upon acceptance of this 510(k) submission, represent the most popular formulas within the component ranges submitted. Note: Any future new formulas within the approved ranges that are not listed herein will be documented using design controls and the design records will be maintained in the company's design history files.

| Prod. | Na+ DiAcetate |
|-------------------------------------------------------------------------------------------------|------ | Code mEq/L | 0-5
mEq/L | 0-5
mEq/L | 0-2
mEq/L | 0-350
mg % | Acid
2-5
mEq/L | 4-8
mEq/L |
| AC1000 | 79.00 | DA6000 | 79.00 | AC1001 | 80.00 | DA6001 | 80.00 | AC1003 | 80.00 | DA6003 | 80.00 | AC1004 | 79.00 | DA6004 | 79.00 | AC1006 | 79.00 | DA6006 | 79.00 | AC1007 | 80.00 | DA6007 | 80.00 | AC1008 | 80.00 | DA6008 | 80.00 | AC1009 | 80.00 | DA6009 | 80.00 | AC1015 | 80.00 | DA6015 | 80.00 | AC1016 | 80.00 | DA6016 | 80.00 | AC1017 | 80.00 | DA6017 | 80.00 | AC1018 | 80.00 | DA6018 | 80.00 | AC1019 | 79.00 | DA6019 | 79.00 | AC1021 | 81.00 | DA6021 | 81.00 | AC1025 | 81.00 | DA6025 | 81.00 | AC1026 | 81.00 | DA6026 | 81.00 | 510(k) SUMMARY UNDER 21 CFR 807.92
Continuation of 4.1.2.1.1 AcetiCon Concentrate Formulas | | | | Prod. Code 70-110
mEq/L | K+
0-5
mEq/L | Ca++
0-5
mEq/L | Mg++
0-2
mEq/L | Dextrose
0-350
mg % | Acetic
Acid
2-5
mEq/L | Sodium
DiAcetate
4-8
mEq/L |
| AC1027 | 81.00 | DA6027 | 81.00 | AC1029 | 81.00 | DA6029 | 81.00 | AC1030 | 81.00 | DA6030 | 81.00 | AC1031 | 81.00 | DA6031 | 81.00 | AC1032 | 84.00 | DA6032 | 84.00 | AC1033 | 84.00 | DA6033 | 84.00 | AC1035 | 81.00 | DA6035 | 81.00 | AC1036 | 81.00 | DA6036 | 81.00 | AC1037 | 81.00 | DA6037 | 81.00 | AC1038 | 80.00 | DA6038 | 80.00 | AC1039 | 80.00 | DA6039 | 80.00 | AC1040 | 80.00 | DA6040 | 80.00 | AC1041 | 77.00 | DA6041 | 77.00 | AC1042 | 80.00 | DA6042 | 80.00 | AC1047 | 80.00 | DA6047 | 80.00 | AC1048 | 80.00 | DA6048 | 80.00 | AC1049 | 80.00 | DA6049 | 80.00 | AC1050 | 84.00 | DA6050 | 84.00 | AC1051 | 81.00 | 510(k) SUMMARY UNDER 21 CFR 807.92 | | Continuation of 4.1.2.1.1 AcetiCon Concentrate Formulas | | Prod.
Code | Na+
70-110
mEq/L | K+
0-5
mEq/L | Ca++
0-5
mEq/L | Mg++
0-2
mEq/L | Dextrose
0-350
mg % | Acetic
Acid
2-5
mEq/L | Sodium
DiAcetate
4-8
mEq/L |
| DA6051 | 81.00 | AC1052 | 81.00 | DA6052 | 81.00 | AC1053 | 81.00 | DA6053 | 81.00 | AC1054 | 80.00 | DA6054 | 80.00 | AC1055 | 83.00 | DA6055 | 83.00 | AC1056 | 84.00 | DA6056 | 84.00 | AC1057 | 84.00 | DA6057 | 84.00 | AC1058 | 84.00 | DA6058 | 84.00 | AC1059 | 81.00 | DA6059 | 81.00 | AC1060 | 83.00 | DA6060 | 83.00 | AC1061 | 80.00 | DA6061 | 80.00 | AC1062 | 81.00 | DA6062 | 81.00 | AC1063 | 70.00 | DA6063 | 70.00 | AC1064 | 80.00 | DA6064 | 80.00 | AC2000 | 100.00 | DA7000 | 100.00 | AC2001 | 100.00 | DA7001 | 100.00 | AC2002 | 100.00 | DA7002 | 100.00 | AC2003 | 100.00 | DA7003 | 100.00 | AC2006 | 100.00 | | | DA7006 | 100.00 | Continuation of 4.1.2.1.1 AcetiCon Concentrate Formulas | | Prod. Code 70-110
mEq/L | K+
0-5
mEq/L | Ca++
0-5
mEq/L | Mg++
0-2
mEq/L | Dextrose
0-350
mg % | Acetic
Acid
2-5
mEq/L | Sodium
DiAcetate
4-8
mEq/L |
| AC2007 | 100.00 | DA7007 | 100.00 | AC2008 | 100.00 | DA7008 | 100.00 | AC2011 | 100.00 | DA7011 | 100.00 | AC2013 | 100.00 | DA7013 | 100.00 | AC2017 | 100.00 | DA7017 | 100.00 | AC2018 | 100.00 | DA7018 | 100.00 | AC2019 | 100.00 | DA7019 | 100.00 | AC2020 | 100.00 | DA7020 | 100.00 | AC2021 | 100.00 | DA7021 | 100.00 | AC2022 | 100.00 | DA7022 | 100.00 | AC2023 | 100.00 | DA7023 | 100.00 | AC2024 | 100.00 | DA7024 | 100.00 | AC2025 | 100.00 | DA7025 | 100.00 | AC2026 | 100.00 | DA7026 | 100.00 | AC2027 | 100.00 | DA7027 | 100.00 | AC3000 | 103.00 | DA8000 | 103.00 | AC3001 | 103.00 | DA8001 | 103.00 | AC3002 | 103.00 | DA8002 | 103.00 | 510(k) SUMMARY UNDER 21 CFR 807.92 | | AC3003 | 103.00 | Continuation of 4.1.2.1.1 AcetiCon Concentrate Formulas | | Prod.
Code | Na+
70-110
mEq/L | K+
0-5
mEq/L | Ca++
0-5
mEq/L | Mg++
0-2
mEq/L | Dextrose
0-350
mg % | Acetic
Acid
2-5
mEq/L | Sodium
DiAcetate
4-8
mEq/L |
| DA8003 | 103.00 | AC3004 | 103.00 | DA8004 | 103.00 | AC3005 | 103.00 | DA8005 | 103.00 | AC3006 | 103.00 | DA8006 | 103.00 | AC3007 | 103.00 | DA8007 | 103.00 | AC3008 | 103.00 | DA8008 | 103.00 | AC3009 | 103.00 | DA8009 | 103.00 | AC3010 | 103.00 | DA8010 | 103.00 | AC3011 | 104.00 | DA8011 | 104.00 | AC3012 | 103.00 | DA8012 | 103.00 | AC3013 | 103.00 | DA8013 | 103.00 | AC3014 | 103.00 | DA8014 | 103.00 | AC3015 | 103.00 | DA8015 | 103.00 | AC3016 | 103.00 | DA8016 | 103.00 | AC3017 | 110.00 | DA8017 | 110.00 | AC1XXX & DA6XXX series product code values are based on a proportion ratio of 1:35.83 (36.83X). | | K+ | Ca++ | Mg++ | Dextrose | Acetic | Sodium
------------------|--------------------|----------------------|----------------------|---------------------------|--------------------------------|-------------------------------------|
| 70-110
| 2.00 | 3.50 | 1.50 | 0.00 | 4.00 | |
| 2.00 | 3.50 | 1.50 | 0.00 | | 8.00 |
| 0.00 | 3.50 | 1.00 | 200.00 | 4.00 | |
| 0.00 | 3.50 | 1.00 | 200.00 | | 8.00 |
| 2.00 | 3.50 | 1.00 | 200.00 | 4.00 | |
| 2.00 | 3.50 | 1.00 | 200.00 | | 8.00 |
| 2.00 | 3.50 | 1.50 | 200.00 | 4.00 | |
| 2.00 | 3.50 | 1.50 | 200.00 | | 8.00 |
| 2.00 | 2.50 | 1.50 | 100.00 | 4.00 | |
| 2.00 | 2.50 | 1.50 | 100.00 | | 8.00 |
| 2.00 | 2.00 | 1.50 | 200.00 | 4.00 | |
| 2.00 | 2.00 | 1.50 | 200.00 | | 8.00 |
| 2.50 | 3.50 | 1.00 | 150.00 | 4.00 | |
| 2.50 | 3.50 | 1.00 | 150.00 | | 8.00 |
| 3.00 | 3.50 | 1.00 | 200.00 | 4.00 | |
| 3.00 | 3.50 | 1.00 | 200.00 | | 8.00 |
| 2.00 | 2.50 | 1.00 | 200.00 | 4.00 | |
| 2.00 | 2.50 | 1.00 | 200.00 | | 8.00 |
| 0.00 | 3.00 | 1.00 | 200.00 | 4.00 | |
| 0.00 | 3.00 | 1.00 | 200.00 | | 8.00 |
| 2.00 | 2.20 | 1.50 | 200.00 | 4.00 | |
| 2.00 | 2.20 | 1.50 | 200.00 | | 8.00 |
| 1.00 | 3.00 | 1.00 | 250.00 | 4.00 | |
| 1.00 | 3.00 | 1.00 | 250.00 | | 8.00 |
| 0.00 | 3.50 | 1.50 | 0.00 | 4.00 | |
| 0.00 | 3.50 | 1.50 | 0.00 | | 8.00 |
| 2.50 | 2.50 | 1.00 | 200.00 | 4.00 | |
| 2.50 | 2.50 | 1.00 | 200.00 | | 8.00 |
| 2.00 | 3.25 | 0.50 | 0.00 | 4.00 | |
| 2.00 | 3.25 | 0.50 | 0.00 | | 8.00 |
| 2.00 | 0.00 | 1.00 | 100.00 | 4.00 | |
| 2.00 | 0.00 | 1.00 | 100.00 | | 8.00 |
| | | | |
| Na+
| 2.00 | 2.00 | 1.00 | 200.00 | 4.00 | |
| 2.00 | 2.00 | 1.00 | 200.00 | | 8.00 |
| 2.00 | 2.50 | 1.00 | 200.00 | 4.00 | |
| 2.00 | 2.50 | 1.00 | 200.00 | | 8.00 |
| 0.00 | 2.50 | 1.00 | 200.00 | 4.00 | |
| 0.00 | 2.50 | 1.00 | 200.00 | | 8.00 |
| 2.00 | 3.00 | 1.00 | 200.00 | 4.00 | |
| 2.00 | 3.00 | 1.00 | 200.00 | | 8.00 |
| 2.00 | 3.25 | 1.00 | 200.00 | 4.00 | |
| 2.00 | 3.25 | 1.00 | 200.00 | | 8.00 |
| 1.00 | 2.50 | 1.00 | 200.00 | 4.00 | |
| 1.00 | 2.50 | 1.00 | 200.00 | | 8.00 |
| 2.00 | 1.50 | 1.00 | 200.00 | 4.00 | |
| 2.00 | 1.50 | 1.00 | 200.00 | | 8.00 |
| 3.00 | 2.50 | 0.50 | 100.00 | 4.00 | |
| 3.00 | 2.50 | 0.50 | 100.00 | | 8.00 |
| 2.00 | 2.50 | 0.50 | 100.00 | 4.00 | |
| 2.00 | 2.50 | 0.50 | 100.00 | | 8.00 |
| 3.00 | 3.00 | 1.00 | 200.00 | 4.00 | |
| 3.00 | 3.00 | 1.00 | 200.00 | | 8.00 |
| 0.00 | 2.50 | 0.50 | 200.00 | 4.00 | |
| 0.00 | 2.50 | 0.50 | 200.00 | | 8.00 |
| 2.00 | 2.50 | 0.50 | 200.00 | 4.00 | |
| 2.00 | 2.50 | 0.50 | 200.00 | | 8.00 |
| 3.00 | 2.50 | 0.50 | 200.00 | 4.00 | |
| 3.00 | 2.50 | 0.50 | 200.00 | | 8.00 |
| 2.00 | 3.00 | 1.00 | 200.00 | 4.00 | |
| 2.00 | 3.00 | 1.00 | 200.00 | | 8.00 |
| 1.00 | 3.50 | 1.00 | 200.00 | 4.00 | |
| 1.00 | 3.50 | 1.00 | 200.00 | | 8.00 |
| 3.00 | 2.00 | 1.00 | 200.00 | 4.00 | |
| 3.00 | 2.00 | 1.00 | 200.00 | | 8.00 |
| 1.00 | 2.00 | 1.50 | 200.00 | 4.00 | |
| 1.00 | 2.00 | 1.50 | 200.00 | | 8.00 |
| 1.00 | 3.00 | 1.00 | 200.00 | 4.00 | |
| 1.00 | 3.00 | 1.00 | 200.00 | | 8.00 |
| 1.00 | 2.50 | 1.00 | 200.00 | 4.00 | |
| | | | | | |
| | | | | | |
| 1.00 | 2.50 | 1.00 | 200.00 | | 8.00 |
| 1.00 | 2.50 | 0.70 | 200.00 | 4.00 | |
| 1.00 | 2.50 | 0.70 | 200.00 | | 8.00 |
| 0.00 | 0.00 | 1.00 | 200.00 | 4.00 | |
| 0.00 | 0.00 | 1.00 | 200.00 | | 8.00 |
| 4.00 | 3.50 | 1.50 | 200.00 | 4.00 | |
| 4.00 | 3.50 | 1.50 | 200.00 | | 8.00 |
| 0.00 | 0.00 | 1.00 | 200.00 | 4.00 | |
| 0.00 | 0.00 | 1.00 | 200.00 | | 8.00 |
| 3.00 | 3.25 | 1.00 | 200.00 | 4.00 | |
| 3.00 | 3.25 | 1.00 | 200.00 | | 8.00 |
| 2.00 | 1.00 | 1.00 | 200.00 | 4.00 | |
| 2.00 | 1.00 | 1.00 | 200.00 | | 8.00 |
| 0.00 | 3.25 | 1.00 | 200.00 | 4.00 | |
| 0.00 | 3.25 | 1.00 | 200.00 | | 8.00 |
| 3.00 | 2.50 | 0.75 | 200.00 | 4.00 | |
| 3.00 | 2.50 | 0.75 | 200.00 | | 8.00 |
| 3.00 | 2.50 | 1.00 | 200.00 | 4.00 | |
| 3.00 | 2.50 | 1.00 | 200.00 | | 8.00 |
| 3.00 | 2.50 | 0.75 | 200.00 | 4.00 | |
| 3.00 | 2.50 | 0.75 | 200.00 | | 8.00 |
| 1.00 | 3.00 | 1.00 | 200.00 | 4.00 | |
| 1.00 | 3.00 | 1.00 | 200.00 | | 8.00 |
| 1.00 | 5.00 | 0.00 | 200.00 | 2.00 | |
| 1.00 | 5.00 | 0.00 | 200.00 | | 4.00 |
| 5.00 | 1.00 | 2.00 | 350.00 | 5.00 | |
| 5.00 | 1.00 | 2.00 | 350.00 | | 8.00 |
| 2.00 | 3.00 | 0.75 | 0.00 | 4.00 | |
| 2.00 | 3.00 | 0.75 | 0.00 | | 8.00 |
| 2.00 | 3.00 | 0.75 | 200.00 | 4.00 | |
| 2.00 | 3.00 | 0.75 | 200.00 | | 8.00 |
| 0.00 | 3.00 | 0.75 | 200.00 | 4.00 | |
| 0.00 | 3.00 | 0.75 | 200.00 | | 8.00 |
| 3.00 | 3.00 | 0.75 | 200.00 | 4.00 | |
| 3.00 | 3.00 | 0.75 | 200.00 | | 8.00 |
| 1.00 | 3.00 | 0.75 | 200.00 | 4.00 | |
| | | | | | |
| 1.00 | 3.00 | 0.75 | 200.00 | | 8.00 |
| | | | | | |
| Na+
| 2.00 | 0.00 | 0.75 | 200.00 | 4.00 | |
| 2.00 | 0.00 | 0.75 | 200.00 | | 8.00 |
| 0.00 | 2.50 | 0.75 | 200.00 | 4.00 | |
| 0.00 | 2.50 | 0.75 | 200.00 | | 8.00 |
| 1.00 | 0.00 | 0.75 | 200.00 | 4.00 | |
| 1.00 | 0.00 | 0.75 | 200.00 | | 8.00 |
| 1.00 | 3.00 | 1.00 | 200.00 | 4.00 | |
| 1.00 | 3.00 | 1.00 | 200.00 | | 8.00 |
| 2.00 | 2.00 | 0.75 | 200.00 | 4.00 | |
| 2.00 | 2.00 | 0.75 | 200.00 | | 8.00 |
| 1.00 | 2.50 | 0.75 | 200.00 | 4.00 | |
| 1.00 | 2.50 | 0.75 | 200.00 | | 8.00 |
| 2.00 | 2.50 | 0.75 | 200.00 | 4.00 | |
| 2.00 | 2.50 | 0.75 | 200.00 | | 8.00 |
| 2.00 | 0.00 | 1.00 | 100.00 | 4.00 | |
| 2.00 | 0.00 | 1.00 | 100.00 | | 8.00 |
| 1.00 | 2.00 | 1.00 | 200.00 | 4.00 | |
| 1.00 | 2.00 | 1.00 | 200.00 | | 8.00 |
| 2.00 | 3.25 | 0.50 | 100.00 | 4.00 | |
| 2.00 | 3.25 | 0.50 | 100.00 | | 8.00 |
| 3.00 | 2.00 | 0.75 | 200.00 | 4.00 | |
| 3.00 | 2.00 | 0.75 | 200.00 | | 8.00 |
| 4.00 | 3.00 | 0.75 | 200.00 | 4.00 | |
| 4.00 | 3.00 | 0.75 | 200.00 | | 8.00 |
| 1.50 | 2.50 | 0.75 | 200.00 | 4.00 | |
| 1.50 | 2.50 | 0.75 | 200.00 | | 8.00 |
| 3.00 | 2.50 | 0.75 | 200.00 | 4.00 | |
| 3.00 | 2.50 | 0.75 | 200.00 | | 8.00 |
| 0.00 | 0.00 | 0.75 | 200.00 | 4.00 | |
| 0.00 | 0.00 | 0.75 | 200.00 | | 8.00 |
| 3.00 | 3.50 | 1.00 | 200.00 | 3.00 | |
| 3.00 | 3.50 | 1.00 | 200.00 | | 6.00 |
| 2.00 | 3.50 | 1.00 | 100.00 | 3.00 | |
| 2.00 | 3.50 | 1.00 | 100.00 | | 6.00 |
| 0.00 | 3.50 | 1.00 | 100.00 | 3.00 | |
| 0.00 | 3.50 | 1.00 | 100.00 | | 6.00 |
| | | | | | |
| 2.00 | 3.50 | 0.00 | 200.00 | 3.00 | |
| | | | | | |
| 2.00 | 3.50 | 0.00 | 200.00 | | 6.00 |
| 1.00 | 3.50 | 1.00 | 200.00 | 3.00 | |
| 1.00 | 3.50 | 1.00 | 200.00 | | 6.00 |
| 2.00 | 0.00 | 1.00 | 100.00 | 3.00 | |
| 2.00 | 0.00 | 1.00 | 100.00 | | 6.00 |
| 2.00 | 3.50 | 1.00 | 200.00 | 3.00 | |
| 2.00 | 3.50 | 1.00 | 200.00 | | 6.00 |
| 2.00 | 3.00 | 1.00 | 200.00 | 3.00 | |
| 2.00 | 3.00 | 1.00 | 200.00 | | 6.00 |
| 3.00 | 3.00 | 1.00 | 200.00 | 3.00 | |
| 3.00 | 3.00 | 1.00 | 200.00 | | 6.00 |
| 0.00 | 3.00 | 1.00 | 200.00 | 3.00 | |
| 0.00 | 3.00 | 1.00 | 200.00 | | 6.00 |
| 2.00 | 1.00 | 1.00 | 200.00 | 3.00 | |
| 2.00 | 1.00 | 1.00 | 200.00 | | 6.00 |
| 2.00 | 2.50 | 1.00 | 200.00 | 3.00 | |
| 2.00 | 2.50 | 1.00 | 200.00 | | 6.00 |
| 2.00 | 2.00 | 1.00 | 200.00 | 3.00 | |
| 2.00 | 2.00 | 1.00 | 200.00 | | 6.00 |
| 1.00 | 2.50 | 1.00 | 200.00 | 3.00 | |
| 1.00 | 2.50 | 1.00 | 200.00 | | 6.00 |
| 2.00 | 2.50 | 0.75 | 100.00 | 3.00 | |
| 2.00 | 2.50 | 0.75 | 100.00 | | 6.00 |
| 2.00 | 3.00 | 1.00 | 100.00 | 3.00 | |
| 2.00 | 3.00 | 1.00 | 100.00 | | 6.00 |
| 2.00 | 2.50 | 0.75 | 200.00 | 3.00 | |
| 2.00 | 2.50 | 0.75 | 200.00 | | 6.00 |
| 2.00 | 2.50 | 1.00 | 350.00 | 3.00 | |
| 2.00 | 2.50 | 1.00 | 350.00 | | 6.00 |
| | | | | | |

10

11

12

13

AC3XXX & DA8XXX series product code values are based on a proportion ratio of 1:34 (35X).

14

CitriCon Concentrates Summary of Ranges: 4.1.2.2

Criteria	Description/Specification
Component Formula
Range	Sodium 70 – 110 mEq/L
Potassium 0 – 5 mEq/L
Calcium 2 – 5 mEq/L
Magnesium 0 – 2 mEq/L
Dextrose 0 – 350 mg/dl (mg %)
*Citrate is derived from
Citric Acid and acetate is
derived from Sodium
Acetate (which may be
used in combination).	*Citric Acid 2.4 mEq/L
*Sodium Acetate 0 – 0.3 mEq/L
Physical State	Liquid - packaged in Polyethylene (PE) containers
Powder - packaged in Polyethylene (PE) containers
Proportioning Ratios
(CitriCon : Water)	1:34 (35X), 1:35.83 (36.83X), and 1:44 (45X)

4.1.2.2.1. CitriCon Concentrate Formulas:

The following lists of formulas for CitriCon Concentrates, which are intend to market upon acceptance of this 510(k) submission, represent the most popular formulas within the component ranges submitted. Note: Any future new formulas within the approved ranges that are not listed herein will be documented using design controls and the design records will be maintained in the company's design history files.

Prod.	Na+	K+	Ca++	Mg++	Dextrose	Citric	Sodium
Code	70-110	0-5	2-5	0-2	0-350	Acid	Acetate
	mEq/L	mEq/L	mEq/L	mEq/L	mg %	2.4 mEq/L	0-0.3 mEq/L
CC1000	79.00	2.00	3.50	1.50	0.00	2.40	0.00
CC1001	80.00	0.00	3.50	1.00	200.00	2.40	0.00
CC1003	80.00	2.00	3.50	1.00	200.00	2.40	0.00
CC1004	79.00	2.00	3.50	1.50	200.00	2.40	0.00
CC1006	79.00	2.00	2.50	1.50	100.00	2.40	0.00
CC1007	80.00	2.00	2.00	1.50	200.00	2.40	0.00
CC1008	80.00	2.50	3.50	1.00	150.00	2.40	0.00
CC1009	80.00	3.00	3.50	1.00	200.00	2.40	0.00
CC1015	80.00	2.00	2.50	1.00	200.00	2.40	0.00
CC1016	80.00	0.00	3.00	1.00	200.00	2.40	0.00
CC1017	80.00	2.00	2.20	1.50	200.00	2.40	0.00
CC1018	80.00	1.00	3.00	1.00	250.00	2.40	0.00
CC1019	79.00	0.00	3.50	1.50	0.00	2.40	0.00
CC1021	81.00	2.50	2.50	1.00	200.00	2.40	0.00
CC1025	81.00	2.00	3.25	0.50	0.00	2.40	0.00
CC1027	81.00	2.00	2.00	1.00	200.00	2.40	0.00
CC1029	81.00	2.00	2.50	1.00	200.00	2.40	0.00
CC1030	81.00	0.00	2.50	1.00	200.00	2.40	0.00
CC1031	81.00	2.00	3.00	1.00	200.00	2.40	0.00
CC1032	84.00	2.00	3.25	1.00	200.00	2.40	0.00
CC1033	84.00	1.00	2.50	1.00	200.00	2.40	0.00
510(k) SUMMARY UNDER 21 CFR 807.92
Continuation of 4.1.2.2.1 CitriCon Concentrate Formulas
Prod.	Na+	K+	Ca++	Mg++	Dextrose	Citric	Sodium
Code	70-110	0-5	2-5	0-2	0-350	Acid	Acetate
	mEq/L	mEq/L	mEq/L	mEq/L	mg %	2.4 mEq/L	0-0.3 mEq/L
CC1036	81.00	3.00	2.50	0.50	100.00	2.40	0.00
CC1037	81.00	2.00	2.50	0.50	100.00	2.40	0.00
CC1038	80.00	3.00	3.00	1.00	200.00	2.40	0.00
CC1039	80.00	0.00	2.50	0.50	200.00	2.40	0.00
CC1040	80.00	2.00	2.50	0.50	200.00	2.40	0.00
CC1041	77.00	3.00	2.50	0.50	200.00	2.40	0.00
CC1042	80.00	2.00	3.00	1.00	200.00	2.40	0.00
CC1047	80.00	1.00	3.50	1.00	200.00	2.40	0.00
CC1048	80.00	3.00	2.00	1.00	200.00	2.40	0.00
CC1049	80.00	1.00	2.00	1.50	200.00	2.40	0.00
CC1050	84.00	1.00	3.00	1.00	200.00	2.40	0.00
CC1051	81.00	1.00	2.50	1.00	200.00	2.40	0.00
CC1052	81.00	1.00	2.50	0.70	200.00	2.40	0.00
CC1054	80.00	4.00	3.50	1.50	200.00	2.40	0.00
CC1056	84.00	3.00	3.25	1.00	200.00	2.40	0.00
CC1058	84.00	0.00	3.25	1.00	200.00	2.40	0.00
CC1059	81.00	3.00	2.50	0.75	200.00	2.40	0.00
CC1060	83.00	3.00	2.50	1.00	200.00	2.40	0.00
CC1061	80.00	3.00	2.50	0.75	200.00	2.40	0.00
CC1062	81.00	1.00	3.00	1.00	200.00	2.40	0.00
CC1063	70.00	1.00	5.00	0.00	200.00	2.40	0.00
CC1065	80.00	5.00	2.00	2.00	350.00	2.40	0.30
CC2000	100.00	2.00	3.00	0.75	0.00	2.40	0.00
CC2001	100.00	2.00	3.00	0.75	200.00	2.40	0.00
CC2002	100.00	0.00	3.00	0.75	200.00	2.40	0.00
CC2003	100.00	3.00	3.00	0.75	200.00	2.40	0.00
CC2006	100.00	1.00	3.00	0.75	200.00	2.40	0.00
CC2008	100.00	0.00	2.50	0.75	200.00	2.40	0.00
CC2013	100.00	1.00	3.00	1.00	200.00	2.40	0.00
CC2017	100.00	2.00	2.00	0.75	200.00	2.40	0.00
CC2018	100.00	1.00	2.50	0.75	200.00	2.40	0.00
CC2019	100.00	2.00	2.50	0.75	200.00	2.40	0.00
CC2021	100.00	1.00	2.00	1.00	200.00	2.40	0.00
CC2022	100.00	2.00	3.25	0.50	100.00	2.40	0.00
CC2023	100.00	3.00	2.00	0.75	200.00	2.40	0.00
CC2024	100.00	4.00	3.00	0.75	200.00	2.40	0.00
CC2025	100.00	1.50	2.50	0.75	200.00	2.40	0.00
510(k) SUMMARY UNDER 21 CFR 807.92
CC2026	100.00	3.00	2.50	0.75	200.00	2.40	0.00
Continuation of 4.1.2.2.1 CitriCon Concentrate Formulas
Prod.
Code	Na+
70-110
mEq/L	K+
0-5
mEq/L	Ca++
2-5
mEq/L	Mg++
0-2
mEq/L	Dextrose
0-350
mg %	Citric
Acid
2.4 mEq/L	Sodium
Acetate
0-0.3 mEq/L
CC3000	103.00	3.00	3.50	1.00	200.00	2.40	0.00
CC3001	103.00	2.00	3.50	1.00	100.00	2.40	0.00
CC3002	103.00	0.00	3.50	1.00	100.00	2.40	0.00
CC3003	103.00	2.00	3.50	0.00	200.00	2.40	0.00
CC3004	103.00	1.00	3.50	1.00	200.00	2.40	0.00
CC3006	103.00	2.00	3.50	1.00	200.00	2.40	0.00
CC3007	103.00	2.00	3.00	1.00	200.00	2.40	0.00
CC3008	103.00	3.00	3.00	1.00	200.00	2.40	0.00
CC3009	103.00	0.00	3.00	1.00	200.00	2.40	0.00
CC3011	104.00	2.00	2.50	1.00	200.00	2.40	0.00
CC3012	103.00	2.00	2.00	1.00	200.00	2.40	0.00
CC3013	103.00	1.00	2.50	1.00	200.00	2.40	0.00
CC3014	103.00	2.00	2.50	0.75	100.00	2.40	0.00
CC3015	103.00	2.00	3.00	1.00	100.00	2.40	0.00
CC3016	103.00	2.00	2.50	0.75	200.00	2.40	0.00
CC3017	110.00	2.00	2.50	1.00	350.00	2.40	0.30

15

16

CC1XXX series product code values are based on a proportion ratio of 1:35.83 (36.83X).

CC2XXX series product code values are based on a proportion ratio of 1:44 (45X).

CC3XXX series product code values are based on a proportion ratio of 1:34 (35X).

4.1.2.3. BicarboCon Concentrates - Summary of Ranges:

Criteria	Description/Specification
Component Formula
Range	Sodium 30 – 59 mEq/L
Bicarbonate 30 – 39 mEq/L
*Chloride 0 – 20 mEq/L

The Chloride component range is calculated since chlorides are
contributed by another component. |
| Physical State | Liquid - packaged in Polyethylene (PE) containers
Powder - packaged in Polyethylene (PE) containers |
| Proportioning Ratios
(BicarboCon : Water) | 1:19.13 (20.13X), 1:25.16 (26.16X) or 1:31.2 (32.2X),
and 1:27.46 (28.46X) |

4.1.2.3.1. BicarboCon Concentrate Formulas:

The following lists of formulas for BicarboCon Concentrates, which are intend to market upon acceptance of this 510(k) submission, represent the most popular formulas within the component ranges submitted. Note: Any future new formulas within the approved ranges that are not listed herein will be documented using design controls and the design records will be maintained in the company's design history files.

17

| Prod. Code
Series | Sodium
30-59 mEq/L | Bicarbonate
30-39 mEq/L | Chloride
0-20 mEq/L | Proportion Ratio
(BicarboCon : Water) |
|----------------------|-----------------------|----------------------------|------------------------|------------------------------------------|
| BC-1 | 59.00 | 39.00 | 20.00 | 1:19.13 (20.13X) |
| BC-2 | 37.00 | 37.00 | 0.00 | 1:25.16 (26.16X) |
| BC-2 | 30.00 | 30.00 | 0.00 | 1:31.20 (32.20X) |
| BC-3 | 35.00 | 35.00 | 0.00 | 1:27.46 (28.46X) |

4.1.3. Indications for Use:

AcetiCon acid concentrate powders and liquids for bicarbonate dialysis 4.1.3.1. are indicated for use in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate.
4.1.3.2. CitriCon acid concentrate powders and liquids for bicarbonate dialysis are indicated for use in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate.
4.1.3.3. BicarboCon bicarbonate concentrate powders and liquids for bicarbonate dialysis are indicated for use in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with acid concentrate.

4.2. RenaCon Liquid and Powder Acetate Concentrates:

4.2.1. Device Description All liquid and powder acetate concentrates for acetate dialysis presented in this 510(k) Notification are produced in a manner consistence with the predicate devices listed in the Section 3 of this 510(k) Summary by adhering to strict cGMP guidelines and in accordance with AAMI/ANSI/ISO 13958:2014 Concentrates for Hemodialysis and Related Therapies and AAMI/ANSI/ISO 13959:2014 Water for Hemodialysis and Related Therapies. RenaCon liquids and powders contain Sodium Acetate along with various other ingredients (such as sodium chloride, calcium chloride, potassium chloride, magnesium chloride and dextrose, all meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed acetate concentrates for acetate dialysis. These products are not designed and/or formulated for re-use and should be considered as single-use only. These acetate concentrate liquid and powder formulations when proportioned/mixed with pre-treated, purified water that meets or exceeds current AAMI standards may be used with conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. These hemodialysis concentrate formulas are intended to be used in two stream hemodialysis machine in which an acetate concentrate is proportioned into one stream and a second stream of water that meets or exceeds current AAMI standards.

18

Where these two streams are then mixed to prepare a final proportioned hemodialysis solution.

4.2.2. Summary of Concentrate Ranges:

Criteria	Description/Specification
Component Formula Range	Sodium 130 – 145 mEq/L
Potassium 0 – 5 mEq/L
Calcium 0 – 5 mEq/L
Magnesium 0 – 2 mEq/L
Dextrose 0 – 350 mg/dl (mg %)
Sodium Acetate 33 – 45 mEq/L
Physical State	Liquid - packaged in Polyethylene (PE) containers
Powder - packaged in Polyethylene (PE) containers
Proportioning Ratios
(RenaCon : Water)	1:34 (35X)

4.2.2.1. RenaCon Concentrates - Summary of Ranges:

4.2.2.1.1. RenaCon Concentrate Formulas:

The following lists of formulas for RenaCon Concentrates, which are intend to market upon acceptance of this 510(k) submission, represent the most popular formulas within the component ranges submitted. Note: Any future new formulas within the approved ranges that are not listed herein will be documented using design controls and the design records will be maintained in the company's design history files.

4.2.2.1.1. RenaCon Concentrate Formulas
Prod.
Code	Na+
130-145
mEq/L	K+
0-5
mEq/L	Ca++
0-5
mEq/L	Mg++
0-2
mEq/L	Dextrose
0-350
mg %	Sodium Acetate
33-45
mEq/L
SA5002	140.00	2.00	3.50	0.75	0.00	38.25
SA5004	140.00	2.00	3.50	1.00	200.00	35.00
SA5005	140.00	2.00	3.25	1.00	200.00	35.00
SA5006	134.00	2.60	2.50	1.50	250.00	36.60
SA5007	138.00	2.50	3.50	1.50	100.00	38.00
SA5010	135.00	1.00	3.50	1.00	0.00	36.00
SA5017	140.00	2.00	3.50	1.50	100.00	41.00
SA5024	140.00	3.00	3.50	1.50	100.00	41.00
SA5026	140.00	3.00	3.25	1.00	200.00	40.00
SA5027	135.00	2.50	3.25	1.50	100.00	37.00
SA5029	135.00	2.00	3.50	1.00	200.00	36.00
SA5034	135.00	2.00	3.50	1.50	200.00	37.00
SA5045	140.00	2.00	3.00	1.50	200.00	38.50
SA5046	132.00	2.00	3.50	1.50	200.00	35.00

19

| Prod.
Code | Na+
130-145
mEq/L | K+
0-5
mEq/L | Ca++
0-5
mEq/L | Mg++
0-2
mEq/L | Dextrose
0-350
mg % | Sodium Acetate
33-45
mEq/L |
|---------------|-------------------------|--------------------|----------------------|----------------------|---------------------------|----------------------------------|
| SA5101 | 140.00 | 2.00 | 2.50 | 1.00 | 100.00 | 37.00 |
| SA5102 | 130.00 | 0.00 | 5.00 | 2.00 | 100.00 | 33.00 |
| SA5103 | 145.00 | 5.00 | 0.00 | 1.00 | 200.00 | 45.00 |
| SA5104 | 134.00 | 2.00 | 3.00 | 0.00 | 350.00 | 35.00 |

4.2.3. Indication for Use:

4.2.3.1. RenaCon acetate concentrate powders and liquids for acetate dialysis are indicated for use in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 2 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis.

5. Comparison of Technological Characteristics with the Predicate Devices:

5.1. The Acid, Bicarbonate and Acetate Concentrates in both liquid and powder formats presented in this 510(k) Notification share the same technological characteristics of the predicate devices listed in Section 3 of this 510(k) Summary. These formulations are manufactured under the same cGMP Guideline and adhere to the same AAMI/ANSI/IOS Standards which regulate the manufacturing of concentration as well as determine the tolerance guidelines of each chemical component of the various formulations. Under these strict guidelines, standards have been established for all manufacturers of hemodialysis concentrate liquids and powers which are required to be followed. Thereby, providing the hemodialysis market a uniform standard of safety and effectiveness for hemodialysate concentrates. The acid and bicarbonate concentrates are used together in one of 4 industry standard mix ratios as determined by the hemodialysis machine's pump setting that allow for 3 streams (acid, bicarbonate and water). The acetate concentrates are used independently of the acid and bicarbonate concentrates and utilize a unique mix ratio available in 2 stream (acetate and water) hemodialysis machines. All formulations, within their respective mix ratios, are determined by the component concentration measured in milli-equivalents per liter as prescribed by physicians for a patient's optimum hemodialysis treatment. The industry standard for the packaging liquid and powder hemodialysis concentrates follows the guidelines found in ANSI/AAMI/ISO 13958:2014 Sec 4.1.10 Containers. The liquids will be packaged in the exact same high density polyethylene containers from the exact same suppliers as Solution Technologies' predicate device in various sizes such as 1 gallon jugs and 55 gallon drums. These liquid concentrates are ready for use by the appropriate hemodialysis machine with the same intended use. The powders are packaged in the exact same low density polyethylene bags from the exact same supplier as Di-Chem's reference devices in pre-measured amounts of the various chemical components to yield a pre-determined volume of hemodialysis concentrate liquid ready for use by the

20

appropriate hemodialysis machine with the same intended use.

6. Performance Data for Safety and Effectiveness:

6.1. In vitro testing was performed on laboratory prepared formulations as instructed on the device labels which bracket the extremes of each critical component in each product line proposed in this submission to determine the individual component concentration to ensure that following the label instructions generates the concentrate formulation stated on the label. Testing was conducted using validated equipment and validated analytical methods. The acceptance criteria requirements of ANSI/AAMI 13958:2014 Concentrates for hemodialysis and related therapies, which are stated in sections 4.1.2.1 and 4.1.2.2 were followed for all components. In addition to the chemical concentration testing, both endotoxin and microbial testing was performed in accordance with ANSI/AAMI 13958:2014 sections 4.1.4 and 4.1.5 and in compliance with the release requirements in ANSI/AAMI 11663:2014 section 4.1.2. Product formulations were tested for endotoxins using a commercially available and validated Limulus Amebocyte Lysate (LAL) test. All endotoxin results reported levels well below the release limit of 0.5 EU/ml. Microbial testing was performed on all formulations containing bicarbonate. All microbial count results reported levels well below the release limit of 100 CFU/ml. The results of these test confirm that the performance of the proposed devices within this submission are satisfactory and substantially equivalent to the predicate devices for the same parameters.

7. Conclusion:

Since the cleared predicate devices listed are regulated by the same manufacturing standards and guidelines, have equivalent indication for use statements, use the same chemical components, the same chemical formulation ranges, follow the same label requirements for both liquid and powder hemodialysis concentrates, and use the same packaging materials and suppliers indicates that the proposed hemodialysis concentrate liquids and powders in this 510(k) Notification are believed to be substantially equivalent to the predicate devices in safety, effectiveness and performance as well as or better than the legally marketed predicate devices when used in accordance with the instructions for use.