(711 days)
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
| 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.
§ 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.