The Di-Chem Inc. Hemo-Lyte C cartridge is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure, or intoxication with dialyzable substances.

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Di-Chem Hemo-Lyte C Cartridge, a dry powder sodium bicarbonate concentrate for hemodialysis. The submission demonstrates substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria (from ANSI/AAMI 13958:2014)	Reported Device Performance
In vitro Chemical Composition	All electrolytes identified on the device label shall be present within ±5% or ±0.1mEq/L (whichever is greater), except Sodium (±2.5%). Glucose within ±5% or ±0.05g/L (whichever is greater). (Expressed as dialysis fluid concentrations).	"The results of the testing met the requirements of ANSI/AAMI 13958:2014... and is chemically equivalent to the predicate devices for all the listed chemical weight formulations."
Transportation Durability	Device can be shipped and transported safely and effectively.	"The results indicate that the proposed Hemo-Lyte C cartridge can be shipped and transported so that they may be received and used in a safe and effective way." (Tested per ASTM D4169-16, DC13, Assurance Level I, Schedules: A, C, F, I, E, and A).
Biocompatibility	Meets ISO 10993 requirements for biological safety.	"Biocompatibility testing was performed in accordance with ISO 10993 requirements." Includes Cytotoxicity, Sensitization, Acute Systemic Toxicity, ASTM Hemolysis, Material Mediated Pyrogenicity, Intracutaneous Reactivity, Chemistry Characterization, Biological Evaluation Report, and Toxicological Risk Assessment.
Shelf-Life Performance	Maintains labeled value for sodium bicarbonate and conforms to ANSI/AAMI 13958:2014 standards at the conclusion of the storage period.	"The results of these tests showed the proposed device met the ANSI/AAMI 13958:2014 requirements at the conclusion of the storage period."
Bench Testing (Nipro SURDIAL DX compatibility)	Functions as intended with the Nipro SURDIAL DX Hemodialysis machine, maintaining proper physical, chemical characteristics of the dialysate (concentration of bicarbonate, pH, conductivity).	"The results from the performance testing show the proposed device functions as intended with the Nipro SURDIAL DX Hemodialysis machine... Visual inspection, confirmation of proper cartridge fit to machine, concentration of bicarbonate in initial dialysate sample, initial pH of dialysate sample, initial conductivity of dialysate sample, concentration of bicarbonate in final dialysate sample, final pH of dialysate sample, and final conductivity of dialysate sample. Conductivity and pH values were also recorded every 30 minutes during the 4-hour test cycle per cartridge."
Endotoxin Content	Below the stated limit of 0.5 EU/ml (per ANSI/AAMI 13958:2014).	"All of the samples were below the stated limit of 0.5 EU/ml."

2. Sample Size Used for the Test Set and Data Provenance

It appears there are multiple test sets for different aspects of the device.

In vitro Chemical Composition: The sample size for this specific test is not explicitly stated. The text mentions "Testing was performed in accordance with our standard operating procedures utilizing validated equipment and analytical methods." The data provenance is internal testing by Di-Chem, Inc. (retrospective).
Transportation Testing: The sample size is not explicitly stated, but it was performed on "the proposed Hemo-Lyte C cartridge." Data provenance is internal testing by Di-Chem, Inc. (retrospective).
Biocompatibility Testing: The sample size for each specific ISO 10993 test is not detailed. Data provenance is internal testing by Di-Chem, Inc. (retrospective).
Shelf-Life Verification: The sample size is not explicitly stated, but it involved "aged product." Data provenance is internal testing by Di-Chem, Inc. (retrospective).
Bench Testing (Nipro SURDIAL DX compatibility): "12 total cartridges consisting of 3 samples from each of the proposed weight sizes were tested." This would be (3 samples/weight size * 5 weight sizes) = 15 cartridges, not 12, or 12 cartridges distributed among the weight sizes. The text says "3 samples from each of the proposed weight sizes were tested" and later "12 total cartridges". It is unclear if these are referring to the same thing, or if 12 are a subset of the 15. Assuming it refers to the 12 total, the provenance is internal testing by Di-Chem, Inc. (retrospective).
Endotoxin Analysis: "60 total test samples comprised of three different lots of sodium bicarbonate. 30 samples from the pre-stability performance testing and 30 samples from the conclusion of the shelf-life study were tested." Data provenance is internal testing by Di-Chem, Inc. (retrospective).

The data provenance for all tests is from internal testing conducted by Di-Chem, Inc. and is retrospective in nature, as it refers to performance testing completed before the 510(k) submission. No specific country of origin for the data is mentioned beyond the manufacturing company's location in the US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The concept of "experts" and "ground truth" in the traditional sense (e.g., medical diagnoses for AI algorithms) does not directly apply here. This is a medical device for preparing a dialysate solution, and the "ground truth" is defined by established engineering and chemical standards (ANSI/AAMI 13958:2014, ASTM D4169-16, ISO 10993). The "experts" would be the engineers, chemists, and quality control personnel within Di-Chem, Inc. responsible for conducting and interpreting the tests according to these standards, but their specific number and qualifications (e.g., "radiologist with 10 years of experience") are not detailed.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. Adjudication (e.g., 2+1, 3+1) is typically used in clinical studies involving multiple human readers to establish a reconciled ground truth for diagnostic accuracy, which is not the nature of these non-clinical, bench, and chemical tests. The results are compared against defined numerical specifications from recognized standards.

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 would be relevant for diagnostic imaging devices where human readers interpret results, and it is not applicable to a hemodialysis cartridge that involves chemical and physical performance verification.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The Hemo-Lyte C Cartridge is a physical medical device, not an AI algorithm. Its performance is inherent to its physical and chemical properties and interaction with a hemodialysis machine.

7. The Type of Ground Truth Used

The ground truth for all performance tests is based on established regulatory and industry standards, specifically:

ANSI/AAMI 13958:2014 (Concentrates for Hemodialysis and Related Therapies) for chemical composition, shelf-life, and endotoxin limits.
ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems) for transportation durability.
ISO 10993 (Biological evaluation of medical devices) for biocompatibility.

These standards define the acceptable range and performance characteristics of such devices.

8. The Sample Size for the Training Set

This question is not applicable. Training sets are relevant for machine learning algorithms. The Hemo-Lyte C Cartridge is a physical device, and its development and verification rely on traditional engineering and chemical testing, not machine learning or AI models that require training data.

9. How the Ground Truth for the Training Set was Established

This question is not applicable, as there is no training set for this type of device.

Summary

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August 12, 2022

Di-Chem, Inc. Keith Buchholz Compliance Manager 12297 Ensigh Avenue North Champlin, MN 55316

Re: K202508

Trade/Device Name: Hemo-Lyte C Cartridge Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: KPO Dated: June 30, 2022 Received: July 12, 2022

Dear Keith Buchholz:

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 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For: Gema Gonzales, MS Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202508

Device Name Hemo-Lyte C Cartridge

Indications for Use (Describe)

The Di-Chem Inc. Hemo-Lyte C cartridge is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure, or intoxication with dialyzable substances.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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SUBMITTER:	Di-Chem, Inc.12297 Ensign Avenue NorthChamplin, MN 55311Ph. 763-422-8311 Fax. 763-422-8472
510(k) #	K202508
FDA Registration #	2183415
CONTACT:	Keith Buchholz
SUMISSION DATE:	July 7, 2020
DEVICE NAME:	Hemo-Lyte C Cartridge
COMMON NAME:	Sodium Bicarbonate Concentrate for Hemodialysis
REGULATION NAME:	Hemodialysis system and accessories
REGULATION NUMBER:	21 CFR 876.5820
PRODUCT CODE:	KPO
REGULATORY CLASS:	Class II
PRODUCT CODE NAME:	Dialysate Concentrate for Hemodialysis
CLASSIFICATION PANEL:	Gastroenterology/Urology
PRIOR SUBMISSIONS:	There are no prior submissions for this device
PREDICATE DEVICES:	Primary Predicate Devices:Gambro Renal Products BiCart® (K940601, K013724)B Braun Medical Solcart B (K072760, K102194)

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DEVICE DESCRIPTION:

The Di-Chem Hemo-Lyte C sodium bicarbonate cartridge for hemodialysis is a dry powder concentrate used to prepare sodium bicarbonate concentrate solution for use in conventional hemodialysis. The Hemo-Lyte C cartridge is a single use/non-refillable polypropylene cartridge containing a measured amount of sodium bicarbonate (USP Hemodialysis grade) which enables the online preparation of bicarbonate hemodialysis solution on commercially available hemodialysis machines/monitors equipped for use with bicarbonate cartridges. Testing has demonstrated that this device can be safely used on the Nipro Surdial DX with a maximum dialysate flow rate of 600 ml for up to 4 hours. Use with other machines and/or outside the testing parameters have not been verified and therefore is not recommended.

Hemo-Lyte C Cartridge Ingredient Ranges

Criteria	Specification
Formulary Ingredient Range	Sodium Bicarbonate 650g, 720g, 760g,1100g, 1250g
Concentrate Type	Dry Powder Sodium BicarbonateConcentrate
Proportioning Ratio(Concentrate to Water)	45X

The Hemo-Lyte C cartridge sodium bicarbonate concentrate sizes we plan to market upon acceptance of this 510(k) notification include the following. (Note: Any future new formulas within the previously approved predicate device ranges listed above will be implemented in accordance with our design control and maintained in accordance with our device design history files.)

Hemo-Lyte C Cartridge Volumes

Hemo-LyteCartridge ProductName	Grams Per CartridgeSodium Bicarbonate
DBC-650	650g
DBC-720	720g
DBC-760	760g
DBC-1100	1100g
DBC-1250	1250g

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PREDICATE DEVICES:

The Di-Chem, Inc. Hemo-Lyte C Cartridge hemodialysis dry bicarbonate concentrate is substantially equivalent to the Gambro Renal Products BiCart® (K940601, K013724) and the B. Braun Medical Solcart B (K072760, K102194). The proposed device utilizes the same fundamental technology and is comprised of the same material, same chemical formulation, same intended use, and the same machine interface port size as the predicate devices.

INDICATIONS FOR USE:

The Di-Chem Inc. Hemo-Lyte C cartridge is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure, or intoxication with dialyzable substances.

This indications for use statement is essentially equivalent to the indications for use statement for the predicate devices.

TECHNOLOGICAL CHARACTERISTICS: (PREDICATE DEVICES)

Comparing the proposed device to the predicate devices shows that they share the exact same indications for use; they are comprised of the exact same chemical component in the exact same range of chemical weights, the same packaging material composition, and the exact same machine interface dimensions.

There are no significant differences.

SUMMARY OF NON-CLINICAL TESTS:

In vitro testing was performed to verify the chemical composition of the proposed device was identical to that of the predicate devices and within the ranges set forth by ANSI/AAMI 13958:2014. Testing was performed in accordance with our standard operating procedures utilizing validated equipment and analytical methods. The results of the testing met the requirements of ANSI/AAMI 13958:2014 (Concentrates for Hemodialysis and Related Therapies) which specifies that all electrolytes identified on the device label shall be present within ±5% or ±0.1mEq/L and qlucose within ±5% or ±0.05g/L (expressed as dialysis fluid concentrations), whichever is greater of the stated concentration, with the exception of sodium, which shall be present within ±2.5% of the labeled

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concentration. The results of these tests confirmed the proposed Hemo-Lyte C device met the listed range requirements stated in ANSI/AAMI 13958:2014 and is chemically equivalent to the predicate devices for all the listed chemical weight formulations.

SUMMARY OF PERFORMANCE TESTING:

Transportation Testing:

Transportation testing per ASTM D4169-16, DC13, Assurance Level I, Schedules: A, C, F, I, E, and A was performed on the proposed Hemo-Lyte C cartridge. The results indicate that the proposed Hemo-Lyte C cartridge can be shipped and transported so that they may be received and used in a safe and effective way.

Biocompatibility Testing:

Biocompatibility testing was performed in accordance with ISO 10993 requirements. The following testing was performed to support the biological safety of the proposed Hemo-Lyte C cartridge.

Cytotoxicity A
Sensitization
Acute Systemic Toxicity
ASTM Hemolysis A
Material Mediated Pyrogenicity
Intracutaneous Reactivity
Chemistry Characterization
Biological Evaluation Report
A Toxicological Risk Assessment

Sterilization and Shelf-Life Testing:

The proposed Hemo-Lyte C device is not provided in sterilized form and they are non-sterile when used.

Shelf-Life verification testing was performed on aged product to ensure the proposed Hemo-Lyte C cartridge maintained and met the labeled value for sodium bicarbonate and conformed to the standards laid out in ANSI/AAMI 13958:2014. The results of these tests showed the proposed device met the ANSI/AAMI 13958:2014 requirements at the conclusion of the storage period.

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Bench Testing:

The Di-Chem Hemo-Lyte C sodium bicarbonate cartridges were evaluated for physical, chemical, and non-clinical testing to demonstrate all the requirements for "sodium bicarbonate cartridges" for use on the Nipro SURDIAL DX Hemodialysis System are met.

12 total cartridges consisting of 3 samples from each of the proposed weight sizes were tested. The following tests were performed. Visual inspection. confirmation of proper cartridge fit to machine, concentration of bicarbonate in initial dialysate sample, initial pH of dialysate sample, initial conductivity of dialysate sample, concentration of bicarbonate in final dialysate sample, final pH of dialysate sample, and final conductivity of dialysate sample. Conductivity and pH values were also recorded every 30 minutes during the 4-hour test cycle per cartridge to ensure the proper functionality of the cartridge.

The results from the performance testing show the proposed device functions as intended with the Nipro SURDIAL DX Hemodialysis machine.

Endotoxin Analysis on Device Contents:

Endotoxin analysis was performed on 60 total test samples comprised of three different lots of sodium bicarbonate. 30 samples from the pre-stability performance testing and 30 samples from the conclusion of the shelf-life study were tested in accordance to ANSI/AAMI 13958:2014. All of the samples were below the stated limit of 0.5 EU/ml.

CLINICAL TEST RESULTS:

Clinical testing was not performed.

SUBSTANTIAL EQUIVALENCE: (PREDICATE DEVICES)

The proposed Hemo-Lyte C cartridge device is manufactured utilizing the same chemical, primary packaging material, chemical composition ranges, machine interface dimensions, packaging materials and intended use as the Gambro and B. Braun predicate devices.

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The indications for use statement is essentially equivalent to the indications for use statement for the predicate devices.

CONCLUSIONS:

Comparing the proposed Hemo-Lyte C cartridge bicarbonate concentrate device to the predicate devices shows they are substantially equivalent in intended use, chemical composition, chemical formulations, packaging materials and device labeling. The resulting bicarbonate concentrations for all of the cartridge sizes are identical and the resulting solution is used in exactly the same way.

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.