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510(k) Data Aggregation

    K Number
    K151300
    Device Name
    AVERT Contrast Modulation System
    Manufacturer
    OSPREY MEDICAL, INC.
    Date Cleared
    2015-10-15

    (153 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K140425,K150485
    Predicate For
    K153141
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Osprey Medical AVERT™ System allows for controlled infusion and contrast volume reduction during manual injection of radiopaque contrast media. The AVERT™ System is to be used for angiographic coronary and peripheral procedures with the following agents: Iodixanol 270 or 320 mgUml, Iohexol 300 or 350 mgI/ml, and Iopamidol 300 or 370 mgI/ml.

    Device Description

    The Osprey Medical AVERT™ Contrast Modulation System provides a second fluid pathway that modifies the overall system resistance as experienced during the physician's manual injection and allows for excess (i.e. contrast that is not needed for diagnostic or therapeutic purposes) contrast media to be diverted into a reservoir and away from the patient during the manual injection of contrast media while maintaining adequate image quality. Excess contrast is typically a result of refluxed contrast within the patient's vasculature retrograde to the desired image area. The AVERT™ System allows for the modulated reduction of contrast media during manual injections in coronary or peripheral imaging procedures. The AVERT™ System is a device for physician utilization during efforts to minimize total patient contrast volumes.

    The AVERT™ System consists of a reusable, non-sterile apparatus (contrast modulator), which applies a force to a disposable sterile modulation reservoir with a standard, off-the-shelf 4-way stopcock and extension line. The contrast modulator utilizes an internal mechanism to apply a force to the modulation reservoir; allowing for modulated diversion of manual contrast injections. The force can be easily and quickly adjusted by moving the location of the pin as identified on the outer housing of the system, thereby increasing or decreasing the amount of force applied to the modulation reservoir. The contrast modulator is attached to a wheeled stand and is positioned near the patient, outside of the sterile field.

    AI/ML Overview

    The provided text does not contain detailed acceptance criteria or a comprehensive study report with all the requested information for the AVERT Contrast Modulation System. The document is an FDA 510(k) summary and approval letter, which primarily focuses on establishing substantial equivalence to a predicate device.

    However, based on the Summary of Non-Clinical Testing section and the Clinical Testing section, I can extract some relevant information and identify what is missing:

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria (Implied)Reported Device Performance
    Non-Clinical Testing
    Flow rateMeets product specification and performance requirementsAll testing passed and demonstrated product performance met all prior established acceptance criteria.
    Peak pressure reductionMeets product specification and performance requirementsAll testing passed and demonstrated product performance met all prior established acceptance criteria.
    Contrast diversionMeets product specification and performance requirementsAll testing passed and demonstrated product performance met all prior established acceptance criteria.
    Flow rate adjustabilityMeets product specification and performance requirementsAll testing passed and demonstrated product performance met all prior established acceptance criteria.
    Mechanical cycle testingMeets product specification and performance requirementsAll testing passed and demonstrated product performance met all prior established acceptance criteria.
    Image analysis (non-clinical)Adequate image quality maintainedAll testing passed and demonstrated product performance met all prior established acceptance criteria. (Also mentioned in simulated use: "included assessment of injection pressure, contrast diversion, image analysis. All testing passed...")
    Compatibility with Osprey Medical Contrast Monitoring SystemMeets product specification and performance requirementsAll testing passed and demonstrated product performance met all prior established acceptance criteria.
    Sterility Assurance Level (SAL)10⁻⁶Validated in accordance with ISO 11135-1:2007. All testing passed to provide a Sterility Assurance Level of 10⁻⁶.
    BiocompatibilityMeet prior established acceptance criteriaCytotoxicity, sensitization, irritation (intracutaneous reactivity), systemic toxicity, hemocompatibility, genotoxicity, chemical characterization testing passed and met prior established acceptance criteria.
    Clinical Testing
    Contrast Volume ReductionPre-specified level of statistical significance"The study demonstrated a mean difference in contrast volume between the AVERT and control groups, achieving the pre-specified level of statistical significance, while maintaining adequate image quality." and "This reduction in contrast was achieved without device-related adverse events."
    Image Quality (Clinical)Adequate image quality maintained"The study demonstrated a mean difference in contrast volume between the AVERT and control groups, achieving the pre-specified level of statistical significance, while maintaining adequate image quality."
    Device-related Adverse EventsNo device-related adverse events"This reduction in contrast was achieved without device-related adverse events."

    Missing Information/Not Provided in the Document:

    • Specific quantitative values for "product specification and performance requirements" for most non-clinical tests (e.g., what was the acceptance range for flow rate, peak pressure reduction, etc.?).
    • The exact "pre-specified level of statistical significance" for the clinical study's primary endpoint.

    2. Sample Size for the Test Set and Data Provenance

    • Sample Size for Test Set: Not explicitly stated for either non-clinical or clinical testing.
      • For the non-clinical tests, it simply states "All testing passed."
      • For the clinical study, it's described as a "prospective, randomized, multi-center clinical evaluation," but the number of patients/cases is not provided.
    • Data Provenance:
      • Non-Clinical: Performed by Osprey Medical or contracted labs. Location not specified, but likely within the US given the FDA submission.
      • Clinical: "Prospective, randomized, multi-center clinical evaluation." The country of origin is not specified, but multi-center implies multiple locations.

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

    • Non-Clinical: Not applicable in the same way as imaging studies. Acceptance criteria were likely based on engineering specifications and regulatory standards.
    • Clinical: The document mentions "maintaining adequate image quality" in relation to the clinical study. However, it does not specify how many experts assessed image quality, their qualifications, or how a "ground truth" for image diagnostic adequacy was established for the clinical images.

    4. Adjudication Method for the Test Set

    • Non-Clinical: Not applicable. Testing results either met criteria or did not.
    • Clinical: No information is provided regarding an adjudication method for image quality or clinical outcomes in the clinical trial.

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

    • No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or reported.
      • The clinical study was a comparison of the AVERT system (with standard therapy) versus standard therapy alone (peri-procedural hydration), focusing on contrast volume reduction and safety, not on human reader performance or AI assistance. The device is a physical system to modulate contrast delivery, not an AI diagnostic tool.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    • Yes, implicitly. The non-clinical Device performance testing (flow rate, pressure reduction, contrast diversion, etc.) and Simulated use (animal) testing represent standalone performance of the device's mechanical and fluidic functions. The device itself is a mechanical system, not an AI algorithm.
    • The clinical study evaluates the device's effect in a human-in-the-loop scenario (physician using the device), comparing overall outcomes against standard care.

    7. Type of Ground Truth Used

    • Non-Clinical:
      • Engineering Specifications: For flow rates, pressure, cycle testing, etc.
      • Regulatory Standards: For sterility (ISO 11135-1:2007) and biocompatibility (ISO 10993-1:2009).
    • Clinical:
      • Measured Contrast Volume: Objective quantitative measurement.
      • Clinical Observations/Outcomes: For device-related adverse events.
      • Clinical Assessment of Image Quality: This is described qualitatively as "adequate image quality," but the specifics of its establishment are not detailed.

    8. Sample Size for the Training Set

    • Not applicable/Not mentioned. The AVERT system is a mechanical device, not an AI algorithm that requires a training set. The term "training set" is typically used for machine learning models.

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

    • Not applicable. As above, this is not an AI device.
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