(79 days)
The SmartSite Needle Free Valve Administration Sets are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The SmartSite valve allows the user to add medication into the primary line without the use of a needle. The SmartSite valve may also be used with low pressure power injectors rated for a maximum setting of 325psi.
As originally submitted, the SmartSite Administration Sets (K960280) are intended to be used for IV administration of drugs and fluids, and the specific purpose for the SmartSite Valve is to allow the user to add drugs and fluids into the primary line without the use of a needle. This Traditional 510(k) Premarket Notification will add a new indication for the SmartSite Valve and qualified extension sets to allow use with low pressure devices up to 325psi. When used with a low pressure power injector, the SmartSite Valve must be secured to other devices with a luer lock connection and the other devices must also be rated for up to 325 psi. This new indication will require no changes to the current device design, materials, manufacturing processes, method of operation or basic scientific technology.
The provided document is a 510(k) summary for the Cardinal Health, Alaris® Products SmartSite Valve Sets with Additional Indication. It is a submission for a medical device and describes its intended use and performance data. However, it does not include the detailed information requested regarding specific acceptance criteria, study design elements (sample sizes, expert qualifications, adjudication methods), or detailed performance metrics.
Based on the provided text, here’s a summary of what can be extracted and an explanation of why other requested information is not available:
Acceptance Criteria and Reported Device Performance
The document states: "The performance data indicate that the Cardinal Health, Alaris Products SmartSite Sets with Additional Indication meets specified requirements and is substantially equivalent to the predicate device."
However, the document does not provide a table of acceptance criteria or specific reported device performance metrics. It focuses on demonstrating substantial equivalence to a predicate device (SmartSite Administration Sets, K960280) for a new indication (use with low-pressure power injectors up to 325 psi). The "specified requirements" are implied to be related to safety and functionality under the new indication, but the specific values or thresholds are not detailed.
Limitations in the Provided Document for Detailed Study Information
The document is a "Summary of Safety and Effectiveness" which often provides a high-level overview. It specifically mentions "Performance Data" but does not elaborate on the details of the studies conducted. Therefore, the following information is not present in the provided text:
- Sample sizes used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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: Not applicable. This device is an administration set, not an AI-powered diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned, but for a physical device, ground truth would likely refer to engineering specifications, stress testing results, and biological compatibility, rather than clinical diagnostic "ground truth."
- The sample size for the training set: Not applicable, as this is a physical device and not an AI/algorithm-based product that undergoes "training."
- How the ground truth for the training set was established: Not applicable.
Summary of What is Available:
- Device Name: SmartSite Needle Free Valve Administration Sets
- New Indication: Allows use with low pressure power injectors for which the maximum pressure setting is 325 psi.
- Predicate Device: SmartSite Administration Sets (K960280)
- Basis for Approval: Substantial equivalence to the predicate device and performance data indicating it "meets specified requirements."
- Nature of Study: While not explicitly detailed, the "Performance Data" section implies that tests were conducted to ensure the device's compatibility and safety under the new 325 psi pressure indication. These would typically be engineering and material science tests.
§ 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.