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510(k) Data Aggregation

    K Number
    K052395
    Device Name
    STERILE EQUIPMENT COVERS
    Manufacturer
    VOLCANO CORPORATION
    Date Cleared
    2005-12-01

    (92 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K050322,K032065,K961699
    Predicate For
    K103026,K121436
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sterile Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field. These covers are not intended to be used as patient drapes and have no patient contact.

    Device Description

    Sterile Equipment Covers

    AI/ML Overview

    The provided text describes the 510(k) Premarket Notification for Sterile Equipment Covers by Volcano Corp. This device is a Class II surgical drape accessory intended to cover medical equipment to maintain a sterile field, not for patient contact.

    The submission focuses on establishing substantial equivalence to predicate devices rather than proving specific performance characteristics through a detailed efficacy study with acceptance criteria and ground truth.

    Here's an analysis based on the provided text:

    1. Table of Acceptance Criteria and the Reported Device Performance:

    Acceptance Criteria CategorySpecific Criteria (Expected)Reported Device Performance (as per submission)
    Sterilization ValidationAll requirements for ethylene oxide (EO) sterilization (as per ANSI/AAMI/ISO 11135:1994), including sterility assurance level (SAL), residual limits, and packaging integrity after sterilization. This would typically involve demonstrating no microbial growth after sterilization, and acceptable levels of EO residuals."Sterilization validation testing was performed according to ANSI/AAMI/ISO 11135:1994. All requirements were met." (This is a summary statement, the detailed results are not provided in this extract).
    Intended UseThe device effectively covers medical equipment to maintain a sterile field, preventing contamination from non-sterile surfaces or personnel to the equipment. This would imply physical properties sufficient for draping and barrier function."The Sterile Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field." The performance data section does not explicitly detail testing for this, instead relying on substantial equivalence to predicates for this aspect.
    Technological CharacteristicsSimilar design, materials, and manufacturing processes to predicate devices that achieve the intended sterile barrier function."The Sterile Equipment Covers uses the same fundamental scientific technology and has the same intended use and clinical applications as that of the predicate device." No specific performance metrics or comparisons are provided in this extract.

    Study Proving Device Meets Acceptance Criteria:

    The study proving the device meets its acceptance criteria is a sterilization validation study conducted according to ANSI/AAMI/ISO 11135:1994.

    2. Sample size used for the test set and the data provenance:

    • Sterilization Validation Study: The text does not specify the sample size used for the sterilization validation testing. Typical sterilization validation studies involve multiple units per sterilization lot and multiple lots to demonstrate consistency and achieve the required Sterility Assurance Level (SAL).
    • Data Provenance: The text does not explicitly state the country of origin for the sterilization validation data, but it is implied to be part of the manufacturer's (Volcano Corp., located in Rancho Cordova, CA, USA) internal testing or a contracted lab. The study is prospective in nature, as it's a validation test performed as part of device development and regulatory submission.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • For the sterilization validation study, "ground truth" is established by the accepted standards and protocols defined in ANSI/AAMI/ISO 11135:1994. The "experts" would be the microbiologists and sterilization specialists involved in designing, executing, and interpreting the validation tests. Their qualifications would typically involve degrees in microbiology, biology, or related fields, with experience in medical device sterilization. The specific number or qualifications are not detailed in the provided text.

    4. Adjudication method for the test set:

    • For sterilization validation, there is no "adjudication method" in the human consensus sense. The results are objectively determined (e.g., presence/absence of microbial growth, chemical analysis for residuals) and compared against the pre-defined criteria of the standard. Deviations or failures would lead to re-testing or process modification.

    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:

    • No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging devices involving human interpretation, often assisted by AI. The Sterile Equipment Covers are a physical barrier device, not an AI-powered diagnostic tool.

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

    • No, a standalone algorithm performance study was not done. This device does not involve an algorithm or AI.

    7. The type of ground truth used:

    • For the sterilization validation study, the ground truth is based on microbiological assay results (e.g., sterility testing, bioburden determination), chemical analysis (e.g., ethylene oxide residual testing), and physical property testing (e.g., package integrity) as defined and accepted by the ANSI/AAMI/ISO 11135:1994 standard.

    8. The sample size for the training set:

    • There is no training set in the context of AI or machine learning for this device. The product is a physical medical device.

    9. How the ground truth for the training set was established:

    • Not applicable as there is no training set for this type of device.

    In summary:

    The provided information focuses on a 510(k) submission for a physical medical device, not an AI/software-as-a-medical-device. The primary performance evidence presented is a statement of compliance with a recognized sterilization standard (ANSI/AAMI/ISO 11135:1994), which effectively serves as the "study" proving the device meets its key safety and performance acceptance criteria for sterility. The concept of "ground truth," "experts," "AI assistance," and "training/test sets" as applied to AI/ML algorithms is not relevant to this submission.

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