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510(k) Data Aggregation

    K Number
    K122355
    Device Name
    VANISHPOINT BLOOD COLLECTION SET
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Date Cleared
    2013-08-23

    (385 days)

    Product Code
    JKA,FPA
    Regulation Number
    862.1675
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K112512,K030573
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the VanishPoint® Blood Collection Set is to provide safe and reliable access to the vascular system to obtain blood specimens from patients.

    The VanishPoint® Blood Collection Set is also indicated for intermittent or short-term intravenous administration of fluid (up to 2 hours). It may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

    The VanishPoint Blood Collection Set aids in the prevention of needlestick injuries.

    Device Description

    The VanishPoint® Blood Collection Set is safety device that is sterile and non-pyrogenic and is designed for collection of blood specimens or intravenous administration of fluid. The device will initially be available with either 7" or 12" tubing, ¼" length needles and gauge sizes of 19, 21, 23 and 25.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "VanishPoint® Blood Collection Set". The submission focuses on adding an additional indication for intermittent or short-term intravenous administration of fluid, as the device was previously cleared for blood collection only.

    Here's an analysis of the acceptance criteria and study data based on the provided text:

    1. Table of Acceptance Criteria and the Reported Device Performance:

    The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it focuses on demonstrating substantial equivalence to a predicate device for the new indication. The performance is described qualitatively.

    Acceptance Criteria (Implied)Reported Device Performance
    Suitability for additional indication (intermittent/short-term IV fluid administration)A simulated use study utilizing healthcare professionals was performed. The subject device was found suitable for the intended uses and is as safe and effective and performs at least as safely and effectively as the legally marketed predicate device.
    No new issues of safety and effectiveness with the new indication"The operation, similar design and materials between the predicate devices and the subject device do not raise new issues of safety and effectiveness when used as labeled."
    Functional testing (unchanged by new indication)Previously presented functional testing (needle pullout force, trigger force, tubing connection strength, tubing strength, air, liquid leakage, and complete needle retraction) remained unaffected by the addition of the new indication. (Implies these met prior acceptance criteria).
    BiocompatibilityBiocompatibility testing was performed and had acceptable results (under the previously cleared 510(k)).
    Sterilization ValidationSterilization Validation was completed (SAL 10^-6) according to applicable standards.
    ExtractablesAn extractable study was performed with acceptable results to support the additional indication.

    2. Sample size used for the test set and the data provenance:

    • Test Set Sample Size: The document mentions a "simulated use study utilizing healthcare professionals" but does not specify the sample size for this study.
    • Data Provenance: The study was a simulated use study, implying a controlled environment rather than real-world patient data. The country of origin is not explicitly stated, but the submission is to the FDA in the USA, suggesting the study was likely conducted in the USA or in a manner compliant with US regulatory guidelines. The study appears to be prospective in nature, designed specifically to evaluate the new indication.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • The document states "a simulated use study utilizing healthcare professionals".
    • Number of experts: Not specified.
    • Qualifications of experts: The general term "healthcare professionals" is used, but specific qualifications (e.g., nurses, phlebotomists, years of experience) are not detailed. Their role in establishing "ground truth" would likely be as evaluators of the device's performance in a simulated setting, providing feedback on usability, safety, and effectiveness.

    4. Adjudication method for the test set:

    • The document does not specify an adjudication method. For a simulated use study, "adjudication" in the sense of resolving discrepancies in expert interpretations of images or clinical findings is less applicable. The evaluation would likely involve collecting structured feedback or success/failure rates from the healthcare professionals.

    5. 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:

    • No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (blood collection set), not an AI-powered diagnostic or assistive tool involving human readers interpreting cases. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device.

    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

    • No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument, not an algorithm or software. Its performance inherently involves human interaction (healthcare professionals using it).

    7. The type of ground truth used:

    • For the simulated use study, the "ground truth" would be established by the observation and assessment of the device's performance by the healthcare professionals according to predefined criteria for safe and effective use during the simulated procedures. This would likely involve direct observation of usability, deployment of the safety mechanism, fluid administration rates if applicable, and absence of malfunctions. It is not based on pathology, expert consensus on a diagnostic finding, or long-term outcomes data in the usual sense.

    8. The sample size for the training set:

    • Not applicable. This device is a physical medical instrument, not an AI model or algorithm that requires a "training set" in the computational learning sense.

    9. How the ground truth for the training set was established:

    • Not applicable. As stated in point 8, there is no "training set" for this type of medical device.
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