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The Millennium Huber Plus Safety Infusion Set is a safety IV administration set with a noncoring, ninety-degree, right-angle Huber needle, used to access surgically implanted vascular ports. The Huber needle is used to administer fluids or to withdraw blood. The Huber Plus system facilitates safe removal of the needle by encapsulating the needle within the attachment wings to help prevent needlestick injuries when using the device for vascular port access.

The Millennium Huber Plus Safety Infusion Set is a standard non-coring right angle Huber needle and administration set with a needlestick prevention feature. The Huber Plus Safety Infusion Set is designed for use with a vascular access infusion system. The Millennium Huber Plus Safety Infusion Set is fabricated from biocompatible, medical grade materials. The needle is inserted into the vascular access port in a standard manner for fluid infusion or for blood sampling. Removal of the needle is done as with any standard Huber needle, using a one-handed (dominant hand) technique to pull out the needle, and stabilizing the port with the nondominant hand. As the needle is removed, the passive needlestick prevention feature actuates automatically when the users hands are positioned correctly and can be easily seen, felt, and heard by the user to ensure that the needle cover is secure. The Millennium Huber Plus Safety Infusion Set is supplied sterile and nonpyrogenic, for single use only.

The provided K993848 510(k) summary for the Millennium Huber Plus Safety Infusion Set does not detail specific quantitative acceptance criteria or a comprehensive study report with quantified performance metrics typically expected in a modern medical device submission. Instead, it relies on a qualitative demonstration of equivalency and a simulated use study.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance Table:

Detailed Study Information:

The provided document describes two main types of studies: "Equivalency performance testing" and a "Simulated Use Study." However, the details for both are minimal by modern standards.

1. Sample Size and Data Provenance:

   • Equivalency Performance Testing: The text does not provide a sample size. It states "components and its two predicate devices," implying a comparison with the ALL-MED Non-Coring Needle Winged Administration Set and the Angel Wing Safety Blood Collection and Infusion Set. The provenance of this data (e.g., country of origin, retrospective/prospective) is not mentioned.
   • Simulated Use Study: The text does not provide a sample size for this study. The provenance is not mentioned.

2. Number of Experts and Qualifications:

   • Equivalency Performance Testing: Not specified.
   • Simulated Use Study: Not specified. The study likely involved users, but whether these were "experts" in the sense of clinical specialists establishing ground truth is not indicated.

3. Adjudication Method:

   • Equivalency Performance Testing: Not specified.
   • Simulated Use Study: Not specified. Given the reported outcome ("no incidences of sharps injuries or incidences where the safety feature failed to be activated"), it implies direct observation and binary outcome recording rather than a complex adjudication process.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC study was not done. The device is a physical medical device (infusion set), not an AI or imaging diagnostic tool that would typically involve human readers. Therefore, the concept of improving human reader performance with AI assistance is not applicable.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. This device is a physical medical device with a mechanical safety feature, not an algorithm.

6. Type of Ground Truth Used:

   • Equivalency Performance Testing: Likely based on direct measurements of mechanical properties, fluid flow, or other functional aspects related to the performance of the device components compared to predicates.
   • Simulated Use Study: The ground truth for "sharps injuries" and "safety feature activation failure" would be direct observation by study personnel. This is a form of observational ground truth.

7. Sample Size for Training Set:

   • Not applicable. This device is a physical medical device, not an AI model that requires a training set.

8. How Ground Truth for Training Set was Established:

   • Not applicable. (See point 7)

Summary of Limitations:

The 510(k) summary K993848 provides a high-level overview consistent with submissions from the year 2000. It lacks the quantitative detail, specific metrics, statistical analysis, and transparent reporting of study methodologies that are common in more recent device submissions, especially for AI/ML-enabled devices. The "acceptance criteria" are largely implicit and based on demonstrating equivalence to predicate devices and a qualitative assessment of the safety feature's function in a simulated environment.

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