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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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These I.V. Extension Sets are intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the intravascular administration of fluids and medications. The I.V. Extension Sets provide for the entry to an intravascular administration set system without the need of a sharp needle by allowing for the penetration of a split septum injection sites or split septum Y-sites using an 11 gauge blunt plastic cannula.

The B.E.C. Safe Mate I.V. Extension Sets consist of a PVC tubing set which has a male luer (slip, fixed luer-lock, or rotating luer-lock) connector at one end intended to connect to an I.V. catheter or needle. At the distal end (or ends in the case of the bifurcated extension set or T-Connector extension set) is a female luer and/or split septum Needleless Injection Site for connection to an I.V. administration set. Extension set lengths may vary from 4" up to 36" or longer. The PVC tubing may be of standard bore (approximately 0.115" I.D.) or Minibore (approximately 0.040" I.D.) design and may be configured into a J-loop to facilitate tape fixation. Extension sets may also have one or more split septum Y-sites for the infusion of other liquid medications. Clamps (slide, clip, or roller) may also be included.

This document, K962801, describes an I.V. extension set, but it does not contain the information requested about acceptance criteria and a study proving the device meets those criteria. The provided text is a 510(k) summary, which focuses on describing the device, its intended use, and its substantial equivalence to predicate devices based on materials and components.

Therefore, I cannot extract the following information:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The I.V. Administration Sets of this Notification provide a means for administering Parenteral solutions from a standard solution container intravenously to a patient.

The I.V. Administration Sets of this Notification provide a means for administering Parenteral solutions from a standard solution container intravenously to a patient. The sets include a rigid plastic spike or other means for attachment to a solution source, a length of PVC tubing, a clamp for controlling solution flows through the tubing and a male luer lock connector. Some configurations of the sets include needleless injection sites, check valves and air-venting filters.

This document is a 510(k) summary for an Intravascular Administration Set from July 10, 1996. It details a medical device classification and states its substantial equivalence to previously marketed devices. However, it does not provide any information about acceptance criteria, device performance metrics, clinical studies, or data provenance. The document predates many of the standardized reporting requirements for clinical performance studies, especially those involving AI or detailed efficacy metrics.

Therefore, I cannot fulfill the request for information regarding performance, study design, expert involvement, or ground truth as this information is not present in the provided text. The document focuses solely on establishing substantial equivalence based on materials, manufacturing, and general function, rather than presenting a performance study with detailed acceptance criteria.

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The Needleless Injection Site is intended to provide additional protection against inadvertent "neeedlestick" injuries to health care providers during the administration of fluids and medications. The Needleless Injection Site provides for the entry to an intravascular administration set or catheter without the need of a sharp needle by allowing for the use of a blunt cannula.

The BEC Needleless Injection Site consists of a tubular body with a male luer lock attachment at one end. This attachment is designed to connect to a female luer lock or luer slip connector of a catheter or other intravascular administration device. The other end of the tubular body is provided with an enlarged section adapted to receive a cylindrical retaining ring which surrounds and compresses a pre-slit, natural rubber 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.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for a "BEC Needleless Injection Site," focusing on its description, intended use, and substantial equivalence to previously cleared devices.

Here's a breakdown of why I cannot fulfill your request with the given input:

• No Acceptance Criteria or Performance Data: The document states, "Technological data and performance data were submitted for the IMED predicate device." However, it does not provide those data or list any specific acceptance criteria for the BEC Needleless Injection Site itself. It
  relies on the substantial equivalence to a predicate device (IMED Corporations Needleless Injection Site submitted under 510(k) #K944320) which had such data submitted.
• No Study Details: Since performance data or acceptance criteria are not presented, there are no details about any study (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set) to evaluate.

Therefore, I cannot populate the table or answer the specific questions because the necessary information is not present in the provided text.

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