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510(k) Data Aggregation

    K Number
    K030935
    Device Name
    BERKELEY V-10 VACUUM CURETTAGE SYSTEM
    Manufacturer
    ACMI CORPORATION
    Date Cleared
    2003-06-23

    (90 days)

    Product Code
    HHI
    Regulation Number
    884.5070
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K813282
    Why did this record match?
    Device Name :

    BERKELEY V-10 VACUUM CURETTAGE SYSTEM

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

    Output:
    For rapid transcervical aspiration of the uterine cavity.

    Device Description

    The Berkeley® VC-10 Vacuum Curettage System and Accessories has been tested and compared to similar devices, and is substantially equivalent to the predicates in characteristics described and the parameters tested.

    AI/ML Overview

    The Berkeley® VC-10 Vacuum Curettage System is a medical device for rapid transcervical aspiration of the uterine cavity. The 510(k) summary provides limited information about the performance testing. However, based on the provided document, here's an analysis of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Vacuum Performance: The Berkeley® VC-10 Vacuum Unit was tested to determine vacuum performance."Performance of the system shows substantial equivalence to the predicates." The specific vacuum levels or parameters required for acceptance are not detailed, but the device met these unstated criteria.
    Sterilization Validation: Sterilization validation was performed for the disposables used with the vacuum unit."Performance of the system shows substantial equivalence to the predicates." The specific sterilization efficacy criteria are not detailed, but the device met these unstated criteria.
    Substantial Equivalence: The device should be substantially equivalent to its predicate devices: Berkeley® VC-2 Vacuum Curettage System (Preamendment) and Synevac® Vacuum Curettage System 10 (K813282) in terms of technological characteristics and performance."The Berkeley® VC-10 Vacuum Curettage System and Accessories has been tested and compared to similar devices, and is substantially equivalent to the predicates in characteristics described and the parameters tested." Also, "Performance of the system shows substantial equivalence to the predicates."

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

    • Sample Size: Not specified in the provided document.
    • Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.

    3. Number of Experts Used to Establish Ground Truth and Qualifications:

    • Number of Experts: Not applicable. This type of device (vacuum curettage system) typically does not rely on expert-established ground truth in the same way an AI or diagnostic imaging device would. Performance is measured against engineering specifications and functional testing.
    • Qualifications: Not applicable.

    4. Adjudication Method for the Test Set:

    • Adjudication Method: Not applicable. Performance testing for this device would involve objective measurements (e.g., vacuum pressure, flow rate, sterilization effectiveness) rather than subjective interpretation requiring adjudication.

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

    • MRMC Study: No, this type of study was not performed or mentioned. MRMC studies are typically relevant for diagnostic devices where human interpretation is involved. This device is a surgical tool.
    • Effect Size: Not applicable.

    6. Standalone Performance Study:

    • Standalone Study: Yes, performance testing of the Berkeley® VC-10 Vacuum Unit was conducted to determine its vacuum performance, and sterilization validation was performed for the disposables. This represents a standalone assessment of the device's functional capabilities. The results concluded substantial equivalence to predicate devices.

    7. Type of Ground Truth Used:

    • Ground Truth: For this device, "ground truth" would refer to objective engineering and functional specifications, as well as adherence to established sterilization standards. For example, vacuum performance would be measured against a predefined range of acceptable vacuum pressure and flow, and sterilization validation against established sterility assurance levels (SALs).

    8. Sample Size for the Training Set:

    • Sample Size: Not applicable. This document describes a medical device clearance based on substantial equivalence, not an AI/ML algorithm that requires a training set. The performance testing conducted is for the device itself, not for an algorithm.

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

    • Ground Truth Establishment: Not applicable, as there is no training set for an AI/ML algorithm mentioned in this submission.
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