(29 days)
Continu-Flo® solution sets with the proposed check valve have the same intended use as the currently marketed sets. The intended use of these sets is the administration of fluids from a container to the patient's vascular system. Continu-Flo® sets contain a check valve which prevents backflow of solution from the secondary medication container into the primary container during the administration of secondary medication.
The proposed Continu-Flo® sets contain a check valve which prevents backflow of solution from the secondary medication container into the primary container during administration of secondary medication. The current check valve is a disc valve and is positioned in the set tubing between the drip chamber and Y-injection site. The new check valve is a duck bill valve and is positioned inside the Y-injection site housing of the set.
There is one material in the proposed check valve design which is new to Baxter devices. The valve itself will be formulated from a new polyisoprene material. The materials used on the proposed check valve cap and housing, are the same as those in use on the current check valve body and Y-injection site housing on Continu-Flo® solution sets. All other materials in the solution sets remain unchanged.
The provided 510(k) summary for the Continu-Flo® Solution Sets with Modified Check Valve does not contain the detailed, quantitative acceptance criteria and study results typically found in a contemporary medical device submission for AI/ML validation. This is a pre-AI/ML device, and the submission predates the extensive regulatory guidance and expectations around performance metrics for such technologies.
However, based on the information provided, we can infer the acceptance criteria and the nature of the study conducted for this specific, non-AI device.
Inferred Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device prevents backflow of solution from secondary medication container into primary container during administration of secondary medication. | "The data indicate that the proposed check valve meets or exceeds all functional requirements and support its suitability for use in Continu-Flo® sets." |
| Material Biocompatibility: New polyisoprene material is safe and appropriate for medical device use. | "The biological and chemical reactivity of the new polyisoprene material have been assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. The material was found to be acceptable for its intended use." |
| Physical Characteristics: Maintains other performance characteristics of the predicate device (e.g., flow rates, leak integrity). | Implied by the statement "All other components of the solution administration sets remain unchanged" and the overall substantial equivalence claim. |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The document only states "Data regarding the functional performance of the proposed check valve have been generated." It doesn't provide the number of units tested or the number of tests performed.
- Data Provenance: Not explicitly stated, but given it's a submission by Baxter Healthcare Corporation, it's highly likely to be internal, prospective testing conducted in a laboratory setting by the manufacturer. Country of origin is the United States (Baxter is based in Illinois).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not specified. For this type of device (medical tubing with a check valve), "ground truth" would be established through direct physical and chemical testing against defined specifications, rather than expert interpretation of data.
- Qualifications of Experts: N/A for establishing ground truth in this context. The experts involved would be engineers, material scientists, and quality control personnel.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. Functional and material tests would yield objective quantitative or qualitative results that either meet or do not meet pre-defined specifications. There would be no need for expert adjudication in the way it's used for AI diagnostic performance.
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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:
- MRMC Study: No. This is not an AI/ML device, and no human "readers" are involved in its primary function or assessment.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No. This is not an AI/ML algorithm. The performance described is that of the physical device itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth Type: Objective functional testing results and material characterization data. For the functional aspects, the ground truth is whether the valve physically prevents backflow under tested conditions. For materials, the ground truth is whether the material meets specified biocompatibility and physicochemical standards (e.g., as per ISO 10993-1, USP Physicochemical tests).
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This device does not involve a "training set" in the context of AI/ML.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As there is no AI/ML component, there is no training set or associated ground truth establishment process in this context.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.