(116 days)
Bicarby™ Dialysate solutions are indicated for use as a dialysis fluid for adult patients in acute care settings, requiring Kidney Replacement Therapies (KRT).
Ci-Ca Dialysate solutions are indicated for use as a dialysis fluid for adult patients in acute care settings, requiring Kidney Replacement Therapies (KRT).
The Bicarby and Ci-Ca solutions are single-use, sterile, ready-to-use dialysis solutions consisting of sodium chloride, potassium chloride, magnesium chloride, calcium chloride (select solutions), sodium bicarbonate, and glucose. The calcium-containing solutions are available in five (5) formulations, while the calcium-free solutions are available in three (3) formulations. The Bicarby and Ci-Ca solutions are single-use, steam sterilized dialysis solutions for use in Kidney Replacement Therapy (KRT). The solutions are each provided in a 2-compartment bag. One compartment contains 4.75 L of a slightly alkaline bicarbonate solution and the other compartment contains 0.25 L of an acidic electrolyte, glucose solution. The 2 solutions are mixed before use by opening the peel seam between the compartments, yielding 5 L of a ready-to-use sterile solution. The dialysate bags are made of a gas barrier foil, a material manufactured without PVC, latex, or plasticizer. The calcium-containing solutions are designed for modalities using heparin anticoagulation, while the calcium-free solutions are intended for modalities using regional citrate anticoagulation (RCA). The calcium-free solutions sustain the anticoagulatory effect of citrate in the filter. Therefore, a separate infusion of calcium is mandatory when using these solutions.
The provided FDA 510(k) clearance letter (K243786) is for Bicarby and Ci-Ca Dialysate solutions, which are dialysis fluids. This type of device is classified as a Class II medical device (Hemodialysis system and accessories, product code KPO).
The provided documentation describes the acceptance criteria and supporting studies for these dialysate solutions, not for a software algorithm or AI-powered medical device that would have performance metrics like sensitivity, specificity, or AUC. The studies conducted are primarily focused on the physical, chemical, and biological safety and performance of the solution and its container system, rather than an AI device's diagnostic or predictive capabilities.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set sample size, ground truth for training set) are not applicable to this type of device and the information provided in the 510(k) summary.
Below is a summary of the available information relevant to acceptance criteria and supporting studies for the Bicarby and Ci-Ca Dialysate solutions:
Acceptance Criteria and Device Performance (Not Applicable in the traditional sense for an AI device)
For this type of device (dialysis solutions), "acceptance criteria" relate to meeting specifications for chemical composition, sterility, packaging integrity, and biocompatibility rather than diagnostic performance metrics. The document details the key performance specifications for the chemical components.
Table of Acceptance Criteria (Key Performance Specifications) and Reported Device Performance
| Chemical Component | Acceptance Criteria (Ionic Contribution, mEq/L, mixed) - as designed/specified | Reported Device Performance (Implied to meet specification) |
|---|---|---|
| Calcium-containing solutions | ||
| Sodium (Na+) | 140 | Implied to meet 140 |
| Potassium (K+) | 0, 2, 3, or 4 | Implied to meet 0, 2, 3, or 4 |
| Magnesium (Mg2+) | 1.0 or 1.5 | Implied to meet 1.0 or 1.5 |
| Calcium (Ca2+) | 2.5 or 3.0 | Implied to meet 2.5 or 3.0 |
| Chloride (Cl-) | 109, 111, 112, or 113 | Implied to meet 109, 111, 112, or 113 |
| Bicarbonate (HCO3-) | 35 | Implied to meet 35 |
| Glucose (g/L) | 1 | Implied to meet 1 |
| Calcium-free solutions | ||
| Sodium (Na+) | 133 or 140 | Implied to meet 133 or 140 |
| Potassium (K+) | 2 or 4 | Implied to meet 2 or 4 |
| Magnesium (Mg2+) | 1.5 | Implied to meet 1.5 |
| Calcium (Ca2+) | 0 | Implied to meet 0 |
| Chloride (Cl-) | 116.5, 118.5, or 120.5 | Implied to meet 116.5, 118.5, or 120.5 |
| Bicarbonate (HCO3-) | 20 or 25 | Implied to meet 20 or 25 |
| Glucose (g/L) | 1 | Implied to meet 1 |
Note: The document states these are the "Key Performance Specifications," meaning the solutions are manufactured to these specific ionic contributions. The "Reported Device Performance" is implied to meet these specifications as part of the manufacturing and quality control process, which are regulated under GMP but specific quantified "performance" results are not provided in this 510(k) summary.
Study Information (as applicable to a dialysis solution):
A. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Not Applicable in the context of an AI device's test set. The studies conducted are primarily engineering, chemical, and biological evaluations, not data-driven performance assessments.
* For Biocompatibility, "testing was conducted to evaluate the material changes in accordance with ISO 10993-1:2018 and FDA guidance document...". This implies lab-based testing.
* For Human Factors Validation Testing, it was stated that "The Bicarby and Ci-Ca solutions were found to be safe and effective for their intended users, uses, and use environments." The sample size for this human factors study is not provided in the summary.
B. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
* Not Applicable. No "ground truth" establishment by medical experts for a test set of images/data is relevant here. The ground truth for chemical composition is defined by the formula and analytical testing. Biocompatibility experts would assess the results of the specific biological tests.
C. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not Applicable. This concept is for clinical or diagnostic studies involving human readers, not for chemical solutions or their packaging.
D. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
* No. This is a dialysis solution, not an AI diagnostic system.
E. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not Applicable. This is a medical device (dialysate solution), not an algorithm.
F. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* For chemical composition: Defined chemical formula and analytical testing standards.
* For physical properties (e.g., shipping, connector integrity): Engineering specifications and test standards.
* For biocompatibility: Reference to international standards (ISO 10993-1:2018) and established biological endpoints (Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Hemocompatibility, Genotoxicity) with a toxicological risk assessment.
G. The sample size for the training set
* Not Applicable. This is a manufactured product, not a machine learning model.
H. How the ground truth for the training set was established
* Not Applicable. This is a manufactured product, not a machine learning model.
Summary of Performance Data Conducted:
The device's substantial equivalence to predicate devices was supported by the following performance data:
- Shipping and Distribution Testing: Demonstrated "the integrity and robustness of the bag system packaging within the distribution environment."
- HF-Connector Testing:
- Evaluated torque for removing protective cap and male/female connector torque.
- Evaluated breaking strength of the cone.
- Evaluated leakage and tightness of connectors.
- Evaluated pull-out force of connectors and injection ports.
- Biocompatibility Testing: Conducted in accordance with ISO 10993-1:2018 and FDA guidance. Assessed endpoints including Chemical Characterization, Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Hemocompatibility, and Genotoxicity. A toxicological risk assessment was also performed. These tests confirm the safety of the materials used in the container closure system.
- Human Factors Validation Testing: Concluded the solutions were "safe and effective for their intended users, uses, and use environments."
- Not Applicable for this device type: Electrical Safety and Electromagnetic Compatibility (EMC), Software Verification and Validation Testing, Animal Studies, Clinical Studies.
Conclusion:
The 510(k) summary concludes that the Bicarby and Ci-Ca solutions are substantially equivalent to the predicate devices and are safe and effective for their intended use, based on the non-clinical performance testing summarized above, primarily focusing on materials, packaging integrity, and chemical specifications.
§ 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.