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The Needleless Vial Adapter is intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the administration of fluids and medications. The Needleless Vial Adapter provides for the entry into a stoppered vial without the need of a sharp needle by allowing for the use of a blunt cannula.

The B.E.C. Needleless Vial Adater consists of a Needleless Injection Site which is a tubular body with a male luer slip attachment at one end. This site is bonded to the female luer lock of the Medimop Vial Access device. The other end of the injection sites tubular body is provided with an enlarged section adapted to receive a cylindrical retaining ring which surrounds and compresses a pre-slit, natural rubber or polyisoprene septum. The septum retaining ring and enlarged section of the tubular body are adapted to receive and latch with the BEC. MED-NET or IMED shrouded plastic cannula. The pre-slit septum re-seals upon removal of the cannula.

This 510(k) submission for the BEC Needleless Vial Adapter describes the device and its intended use, but it does not contain a detailed study report with specific acceptance criteria and performance data in the format requested.

The document states that "Technological data and performance data for the injection site employed were submitted for the IMED predicate device in 510(k) #K944320." This implies that BEC is leveraging data from a previously cleared predicate device rather than conducting a new, separate study for this specific 510(k) submission to demonstrate substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer many of the specific questions about the study design.

However, based on the information provided, here's what can be extracted:

• Device Name: Access Systems Needleless Vial Adapter (also referred to as Needleless Vial Access Device)
• Intended Use: To provide additional protection against inadvertent "needlestick" injuries to healthcare providers during the administration of fluids and medications, by allowing entry into a stoppered vial without a sharp needle, using a blunt cannula.
• Predicate Device: IMED predicate device in 510(k) #K944320.
• Performance Data Source: The performance data for the injection site employed (which is a component of the BEC device) was submitted for the IMED predicate device (K944320). This indicates reliance on previously established performance, not a new study.

Absence of information regarding:

• Table of acceptance criteria and reported device performance: Not present.
• Sample size and data provenance for the test set: Not present, as no new test set study is detailed.
• Number of experts and qualifications for ground truth: Not applicable, as no new clinical or expert-based ground truth establishment is described.
• Adjudication method: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned and unlikely for this type of device.
• Standalone algorithm performance: Not applicable, as this is a medical device, not an algorithm.
• Type of ground truth used: Not applicable for a new study.
• Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
• How ground truth for the training set was established: Not applicable.

In essence, this 510(k) focuses on demonstrating substantial equivalence by referencing a predicate device and its established performance, rather than providing details of a new, standalone study with specific acceptance criteria.

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