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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

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:

1. Shipping and Distribution Testing: Demonstrated "the integrity and robustness of the bag system packaging within the distribution environment."
2. 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.
3. 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.
4. Human Factors Validation Testing: Concluded the solutions were "safe and effective for their intended users, uses, and use environments."
5. 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.

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pureFLOW solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

The pureFLOW solutions are single-use, sterile, ready-to-use dialysis solutions consisting of sodium chloride, potassium chloride, magnesium chloride, calcium chloride (400 series only), sodium bicarbonate, and glucose. The pureFLOW dialysis solutions containing calcium are available in four (4) formulations which differ in potassium chloride concentration. The calcium-free pureFLOW dialysis solutions are available in two (2) formulations which differ in potassium chloride concentration. pureFLOW solutions are single-use, steam sterilized dialysis solutions for use in Continuous Renal Replacement Therapy (CRRT). The pureFLOW 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 pureFLOW 400 series solutions are used for treatment modalities using heparin anticoagulation while the calcium-free pureFLOW 500 series solutions are used for treatment modalities using regional citrate anticoagulation.

The provided document, K233159, is an FDA 510(k) summary for the pureFLOW dialysis solutions. This document primarily describes the device, its intended use, and the performance testing conducted to demonstrate substantial equivalence to a predicate device. It does not contain information related to software-based AI/ML device performance or clinical studies using human readers.

Therefore, I cannot fulfill most of the requested points as the information is not present in the provided text. The document explicitly states:

• 5.8.4. Software Verification and Validation Testing: "Not applicable. The pureFLOW solutions do not contain software."
• 5.8.6. Clinical Studies: "No clinical studies were performed."

Given this, there is no information on:

• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Acceptance criteria for AI/ML performance.
• Study design for AI/ML performance, including sample sizes, data provenance, expert qualifications, or adjudication methods for ground truth.
• Effect size of human reader improvement with AI assistance.
• Training set details for AI/ML models.

However, I can extract information regarding the general performance testing and the context of the device:

Device: pureFLOW dialysis solutions (pureFLOW 402, 400, 406, 401, 502, 504)
Intended Use: As a dialysate in Continuous Renal Replacement Therapy (CRRT).

Here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

Based on the provided document, the "performance" is demonstrated through various physical, chemical, and biological tests to ensure the product's quality, safety, and functionality as a sterile dialysis solution and its container system. The document lists "Key Performance Specifications/Characteristics" for the chemical components of the solutions. It also details the various "Performance Testing" conducted. While these are not acceptance criteria in the sense of AI/ML metrics (like sensitivity, specificity), they are the performance criteria for this physical device.

2. Sample sizes used for the test set and the data provenance:

• The document does not specify exact sample sizes for each of the performance tests (e.g., how many bags were tested for hanging, welding, etc.).
• Data provenance (country of origin, retrospective/prospective) is not applicable or provided, as these are primarily laboratory/engineering tests on manufactured product, not clinical data sets.

3. 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):

• This is not applicable as the device is not an AI/ML product for which expert-annotated ground truth is required. Performance is demonstrated through physical, chemical, and biological testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable for the reasons stated above.

5. 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. The document explicitly states: "No clinical studies were performed." and "The pureFLOW solutions do not contain software." Therefore, no MRMC study was conducted, and this question is not relevant to the described device.

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

• No. The device does not contain software or an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For this type of medical device (physical product, dialysate solution), "ground truth" is established by adherence to predefined engineering specifications, chemical composition limits, sterility requirements, and biocompatibility standards, validated through laboratory testing, rather than clinical outcomes or expert consensus on diagnostic images.

8. The sample size for the training set:

• Not applicable. The device does not involve a "training set" in the context of AI/ML.

9. How the ground truth for the training set was established:

• Not applicable.

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