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510(k) Data Aggregation

    K Number
    K984456
    Device Name
    COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Date Cleared
    1999-01-11

    (27 days)

    Product Code
    DTN
    Regulation Number
    870.4400
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K971669
    Predicate For
    K994389
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The COBE® HVR® 4000 Filtered Hardshell Venous Reservoir is intended to be used in adult cardiac surgical procedures requiring cardiopulmonary bypass for periods up to six hours.

    Device Description

    The COBE® HVR" 4000 Fittered Hardshell Venous Reservoir is a sterile device with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. The device is an open venous blood reservoir with integral cardiotomy filter.

    AI/ML Overview

    Here's an analysis of the provided text regarding the COBE® HVR® 4000 Filtered Hardshell Venous Reservoir, focusing on acceptance criteria and study details:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K971669) rather than establishing novel safety and effectiveness acceptance criteria. Therefore, the "acceptance criteria" are implied to be that the modified device performs similarly or equivalently to the predicate device across various in-vitro tests. The "reported device performance" refers to the results of these comparative tests.

    Acceptance Criteria (Implied: Equivalent to Predicate Device K971669)Reported Device Performance (Implied: Achieved Equivalence)
    Venous Blood Flow PerformanceDemonstrated equivalence to predicate device
    Defoaming CapacityDemonstrated equivalence to predicate device
    Filtration EfficiencyDemonstrated equivalence to predicate device
    Operating Volume (Range: Minimum & Maximum)Demonstrated equivalence to predicate device
    Breakthrough VolumeDemonstrated equivalence to predicate device
    Unrecoverable VolumeDemonstrated equivalence to predicate device
    Filter Loading CapacityDemonstrated equivalence to predicate device
    Blood Trauma EffectsDemonstrated equivalence to predicate device

    Note: The document explicitly states, "In-vitro tests were performed to demonstrate that the modified COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir described in this submission is substantially equivalent to the original, unmodified COBE® HVR® 4000 Filtered Hardshell Venous Reservoir (K971669)." This indicates that the goal of the study was to show similar performance, rather than meet specific numerical thresholds that aren't provided.

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

    • Sample Size: The document does not specify the sample size used for the in-vitro tests. It only lists the types of tests performed.
    • Data Provenance: The data is described as "In-vitro tests." This indicates the data was generated in a laboratory setting, likely in the US (where COBE Cardiovascular, Inc. is located). The data is prospective in the sense that it was generated specifically for this submission to demonstrate equivalence.

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

    This section is not applicable to this submission. The "ground truth" for this type of device modification (material change in a component) is established through technical performance testing against a known predicate device, not through expert consensus or interpretation of medical images/outcomes.

    4. Adjudication Method for the Test Set

    This section is not applicable. Since the testing involved in-vitro performance measurements, there's no need for an adjudication method as would be used in studies involving human interpretation or clinical outcomes.

    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

    This section is not applicable. This submission is for a medical device (a venous reservoir used in cardiopulmonary bypass), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and concepts of human reader improvement with AI are irrelevant here.

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

    This section is not applicable. Again, this involves a medical device, not an algorithm or AI system.

    7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

    The "ground truth" for this study is the established performance characteristics of the predicate device (COBE® HVR® 4000 Filtered Hardshell Venous Reservoir, K971669). The in-vitro tests aimed to demonstrate that the modified device's performance aligns with, or is equivalent to, these known characteristics.

    8. The Sample Size for the Training Set

    This section is not applicable. This is a device modification submission, not a machine learning model development. There is no concept of a "training set" in this context.

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

    This section is not applicable for the same reasons as point 8.

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