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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.

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.

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

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.

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The Fresenius bibag system is used with Fresenius three stream proportioning hemodialysis systems equipped with the bibaq module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

The Fresenius 2008T Hemodialysis Machine with bibag System is the cleared 2008T Hemodialysis Machine that has been modified to enable use of a specialized, single use, sealed bag (the "bibaq") containing USP grade dry sodium bicarbonate powder to produce a saturated solution of sodium bicarbonate. The addition of the bibag system to the hemodialysis machine allows operators the option of producing a saturated sodium bicarbonate solution on-line through automated mixing of AAMI grade water and dry sodium bicarbonate powder within the bibag source disposable rather than with liquid bicarbonate concentrates. The bibag system is comprised of: (1) the bicarbonate concentrate generator (known as the bibag module); and (2) the bag of dry sodium carbonate concentrate. A specialized bibag connector (is attached? to the hemodialysis machine.] The bibag disposable hangs on two nozzles located in the bibag connector.

The provided document describes the Fresenius 2008T Hemodialysis Machine with bibag™ system. The primary goal of the submission is to demonstrate that the modified hemodialysis machine, incorporating the bibag system, is substantially equivalent to predicate devices and functions as intended.

Here's an analysis of the acceptance criteria and the study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify sample sizes for any of the individual tests. It states that "Verification and validation testing were performed," but details on the number of units or test cycles are not provided. The data provenance is implied to be from internal lab testing conducted by Fresenius Medical Care North America. There is no information regarding country of origin for data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for device modification, the testing would typically be prospective, controlled laboratory testing.

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

This type of information is not applicable to this submission. The tests performed are objective engineering and performance validations (e.g., electrical safety, EMC, software validation, material biocompatibility, dissolution). These tests rely on predefined engineering standards and specifications, not on expert consensus or interpretation of medical images or outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. The tests described are objective and pass/fail based on meeting predefined thresholds and standards. There is no mention of subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed and is not applicable to this type of device modification. This is a technical modification to a hemodialysis machine, not a diagnostic or AI-assisted interpretation tool that would benefit from such a study.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable as the device is a medical machine with integrated functionality, not a standalone algorithm. The "system performance testing" would be considered the standalone performance, but it refers to the entire machine and bibag system in operation.

7. Type of Ground Truth Used

The "ground truth" for the various tests was based on:

• Pre-determined acceptance criteria derived from
  • International and national medical device standards: IEC 60601-1-2 (EMC), UL 60601-1 (Electrical Safety), CAN/CSA-C22.2 No. 601.1-M90 (Electrical Safety).
  • Pharmacopoeial standards: USP requirements for dissolution testing of materials.
  • Biocompatibility standards: USP 32-NF26 biological tests .
  • AAMI standards: AAMI RD61:2006 for Bioburden & Endotoxin testing.
  • Internal engineering specifications: For software validation, regression testing, and overall system functionality.

8. Sample Size for the Training Set

This is not applicable. This device is a modified hemodialysis machine, not an AI/ML algorithm that requires a training set. The "training" for the device refers to its design and manufacturing processes, which are validated through the testing described.

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

This is not applicable for the same reason as point 8.

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