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510(k) Data Aggregation

    K Number
    K960937
    Device Name
    SUCTION SAFETY DEVICE
    Manufacturer
    R D INTL.
    Date Cleared
    1996-06-05

    (89 days)

    Product Code
    MJJ
    Regulation Number
    870.4400
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SUCTION SAFETY DEVICE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The RDI Suction Safety Device is intended to be used during open heart surgery and placed in a suction line to permit flow only away from the heart, prevent buildup of line pressure, and limit line vacuum.

    Device Description

    The RDI Suction Safety Device is a three function assembly that is positioned in a suction line. The Suction Safety Device contains to valves. The first valve is a check valve that insures unidirectional flow. The second valve is a combination valve that relieves excess pressure and relieves excess vacuum.

    AI/ML Overview

    Here's an analysis of the provided information regarding the RDI Suction Safety Device, focusing on acceptance criteria and supporting studies, formatted as requested.

    RDI SUCTION SAFETY DEVICE - K960937

    This device is not an AI/ML powered device, therefore some of the requested information (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance, etc.) is not applicable. The documentation primarily focuses on demonstrating substantial equivalence to a predicate device and basic functional and safety testing.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Acceptance CriterionReported Device Performance
    BiocompatibilityFluid contact materials comply with Tripartite Biocompatibility Guidance for external devices, blood path direct, short term use.Complies
    SterilizationValidated AAMI/ISO Method 1 validation for Gamma radiation sterilization.Validated
    PyrogenicityNon-pyrogenic.Non-pyrogenic
    Functional - Pressure Relief"Similar to predicate" (Delta Vacuum Relief Valve 510(k) 760894 performance).Found to be similar to predicate
    Functional - One-Way Flow"Similar to predicate" (Delta Vacuum Relief Valve 510(k) 760894 performance).Found to be similar to predicate
    Functional - Vacuum Relief"Similar to predicate" (Delta Vacuum Relief Valve 510(k) 760894 performance).Found to be similar to predicate
    Package IntegrityPass in accordance with ASTM F1140-88.Passed in accordance with ASTM F1140-88
    Shipping/Distribution IntegrityPass in accordance with NSTA Project 1A vibration/drop tests.Passed in accordance with NSTA Project 1A vibration/drop tests
    Shelf Life/Accelerated AgingEstablish a two-year shelf life.Successful two year shelf life
    Substantial EquivalenceDemonstrated substantial equivalence to the Delta Vacuum Relief Valve (K760894).Substantially Equivalent

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

    This information is not provided in the summary for the functional, material, or packaging tests. As this is not an AI/ML device, the concept of a "test set" in the context of clinical data or image analysis is not relevant. The testing described is laboratory-based functional and physical testing of the device itself.

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

    This information is not applicable/not provided. The "ground truth" for this device's performance is established through direct physical and functional testing against defined standards and specifications, or by direct comparison to a predicate device's measured performance, rather than through expert review of clinical data.

    4. Adjudication Method for the Test Set

    This information is not applicable/not provided. Adjudication methods are typically associated with clinical studies or expert review processes, which are not described for this device.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

    No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, especially with and without AI assistance. The RDI Suction Safety Device is a physical medical device, not a diagnostic tool utilizing AI.

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

    Not applicable. This device does not involve an algorithm or AI component.

    7. The Type of Ground Truth Used

    The "ground truth" for this device's performance evaluation relies on:

    • Standardized Test Methods: Adherence to established industry standards like ASTM F1140-88, NSTA Project 1A, AAMI/ISO for sterilization, and Tripartite Biocompatibility Guidance.
    • Predicate Device Performance: Direct comparison of observed performance (pressure relief, one-way flow, vacuum relief) to the measured functional characteristics of the Delta Vacuum Relief Valve (K760894). The predicate device's performance serves as the benchmark.

    8. The Sample Size for the Training Set

    Not applicable. This device does not utilize machine learning or AI, and therefore does not have a "training set" in that context.

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

    Not applicable. As there is no training set, there is no ground truth established for it.

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