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510(k) Data Aggregation

    K Number
    K965030
    Device Name
    BRANNON ARTERIO-VENOUS PORTSYRINGE
    Manufacturer
    VASCULAR LOGICS, INC.
    Date Cleared
    1997-03-04

    (77 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K960049
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    The piston syringe, made available in a 6cc size, of this 510(k) notification, known as the Brannon Arterio-Venous PortSyringe, A-VPS, is a combination of two legally marketed devices: (1) a piston syringe, and (2) a blood specimen collection device, BSCD. Additionally, the A-VPS is identical to the Brannon PortSyringe K960049, except the A-VPS includes a centrally disposed inner cannula within its barrel. The BSCD is integral with the plunger unit, with the BSCD communicating with the inner lumen of an attached indwelling catheter via the centrally disposed narrow conduit of the plunger and the centrally disposed inner-cannula within the barrel of the syringe. The fluid collection needle is sealed by a rubber sleeve.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Brannon Arterio-Venous PortSyringe (A-VPS):

    1. Table of Acceptance Criteria and Reported Device Performance

    Based on the provided text, the primary function of the A-VPS is to aspirate fluid, keep it separate from blood being collected, and then transfer blood into vacuum specimen tubes. The acceptance criteria and performance are largely implied through comparison to predicate devices and bench testing results. Specific numerical acceptance criteria are not explicitly stated.

    Acceptance Criteria (Implied/Derived)Reported Device Performance
    Functional Equivalence:
    1. Ability to aspirate fluid into the syringe barrel"One is then able to aspirate the sodium-heparin solution into the barrel of the syringe, as with the predicate piston syringes."
    2. Ability to transfer whole blood to vacuum specimen tubes"The vacuum within the specimen tube induces whole blood to flow from the inner lumen of the indwelling catheter... and into the vacuum specimen tube."
    3. Separation of aspirated fluid (e.g., sodium-heparin) from blood being collected"The bench investigation shows that a heparin fluid aspirated into the barrel of the syringe will remain separate from a fluid within the plunger-conduit."
    4. Hermetic seal at piston inner-cannula interface"The ability of the rubber piston to maintain a hermetic seal at the level of the piston inner-cannula interface was demonstrated to be effective, as evidenced by the absence of detectable mixing of the two fluids..."
    5. Prevention of distal piston advancement when a vacuum tube is inserted"The A-VPS is designed such that the piston will not advance distally when a vacuum tube is inserted into its tube holder."
    6. Insignificant amount of sodium-heparin aspirated into inner cannula (initial aspiration)"The small volume of sodium-heparin aspirated into the lumen of the inner-cannula, with the initial aspiration, is insignificant, as the total amount of sodium is 0.004mEq." and "The minute amount of sodium heparin aspirated into the inner-cannula with the initial aspiration is insignificant, as demonstrated with our bench testing."
    Safety & Effectiveness (Clinical):
    7. Safe use in a clinical setting"Pneumatic phlebotomy procedures were made safer with improved efficiency and proficiency." (referring to syringe K960049, stated as substantially identical in use to A-VPS)
    8. Effective use for multiple blood samples"The patient population included intensive care unit patients requiring multiple blood samples for vacuum specimen tubes and bottles."

    2. Sample Size Used for the Test Set and Data Provenance

    • Bench Investigation: The text states, "During the bench investigation, the A-VPS was used in consecutive aspirations and there were no failures." However, a specific numerical sample size (e.g., number of devices tested, number of aspirations) for the bench test set is not provided.
    • Clinical Trial: The clinical trial reported was for "syringe K960049," which is described as having substantially identical use to the A-VPS. The text states:
      • Sample Size: Not explicitly stated, but mentions "intensive care unit patients requiring multiple blood samples." No specific number of patients or samples is given.
      • Data Provenance: Prospective, as it was an "investigation" conducted in January 1989. The country of origin is USA (University of Iowa Hospitals and Clinics, UIHC).

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    • Bench Investigation: Not applicable. The "ground truth" for separation of fluids and mechanical operation in the bench test appears to be based on direct observation and measurement (e.g., "absence of detectable mixing," calculation of mEq). No explicit experts are mentioned for establishing this ground truth beyond the researchers conducting the bench study.
    • Clinical Trial (for predicate K960049): The text mentions a report in the "UIHC publication Pacemaker, October 1989." This suggests a peer-reviewed or internal report. While the study was conducted at a hospital, the specific number of experts (e.g., physicians, nurses, lab technicians) involved in assessing "safety and effectiveness" or establishing ground truth for the clinical outcomes is not provided. Their qualifications are implied by their affiliation with a university hospital.

    4. Adjudication Method for the Test Set

    • Bench Investigation: No explicit adjudication method is mentioned. The assessment appears to be direct observation of "absence of detectable mixing" and functional tests (consecutive aspirations with no failures).
    • Clinical Trial: No explicit adjudication method is mentioned for the clinical trial. The conclusion ("cumbersome phlebotomy procedures were made safer with improved efficiency and proficiency") suggests clinical observation and assessment, but details on how safety and efficiency were adjudicated are not provided.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No, an MRMC comparative effectiveness study was not done. The studies mentioned are a bench investigation for the A-VPS and a clinical trial for a predicate device (K960049). Neither of these describes an MRMC design where human readers' performance with and without AI assistance is compared.

    6. Standalone (Algorithm Only) Performance Study

    • No, a standalone (algorithm only) performance study was not done. The device being described is a physical medical device (syringe), not an AI algorithm.

    7. Type of Ground Truth Used

    • Bench Investigation: Direct observation of fluid separation and functional performance (e.g., no failures in consecutive aspirations, absence of detectable mixing, calculation of sodium-heparin amount, verification of piston immobility).
    • Clinical Trial (for predicate K960049): Clinical outcomes (e.g., "safer with improved efficiency and proficiency") and the ability to obtain "multiple blood samples for vacuum specimen tubes and bottles." This could be considered outcomes data or expert clinical assessment.

    8. Sample Size for the Training Set

    • Not applicable. The device is a physical medical device, not a machine learning model or algorithm that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable. As stated above, this is a physical device and doesn't involve a machine learning training set.
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