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510(k) Data Aggregation

    K Number
    K103213
    Device Name
    FINESS ENDOSCOPE STERILIZATION TRAY
    Manufacturer
    Entellus Medical, Inc.
    Date Cleared
    2011-02-02

    (93 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K013003
    Why did this record match?
    Device Name :

    FINESS ENDOSCOPE STERILIZATION TRAY

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

    The FinESS Endoscope Sterilization Tray is intended for use to encase and protect the FinESS Endoscope for sterilization in STERRAD 100NX using the standard cycle setting and NX Sterilization Systems using the advanced cycle setting.

    • The sterilization cycle parameters of the STERRAD sterilizers are preset by the manufacturer and are not adjustable.
    • The maximum product load per FinESS Endoscope Sterilization Tray includes 1 FinESS Endoscope and 2 light post adapters.
      The FinESS Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.
    Device Description

    The FinESS Endoscope Sterilization Tray is comprised of a bottom, a clear lid, and silicone inserts designed to secure the FinESS Endoscope in place. The lid is clear and secured to the tray with a snap fit mechanism. The FinESS Endoscope Sterilization Tray contains perforations in the base and lid to allow the sterilant to penetrate. The use of commercially available sterilization wrap allows the tray to maintain sterility after sterilization.

    AI/ML Overview

    The FinESS Endoscope Sterilization Tray (K103213) is intended to encase and protect the FinESS Endoscope for sterilization.

    1. Acceptance Criteria and Reported Device Performance:

    Test TypeAcceptance CriteriaReported Device Performance
    Design VerificationDevice and material stability following repeated exposure to sterilization cycles.All results met the acceptance criteria.
    BiocompatibilityAcceptable primary dermal irritation and dermal sensitization post exposure to multiple sterilization cycles.All results met the acceptance criteria.
    Sterilization Efficacy (SAL)An SAL (Sterility Assurance Level) of 10⁻⁶ could be achieved with STERRAD NX and 100NX systems.Achieved an SAL of 10⁻⁶ when used with the STERRAD NX and STERRAD 100NX sterilization systems. Sterilization testing of inoculated FinESS Endoscope Sterilization Tray and similarly inoculated Predicate tray showed that both devices are capable of allowing SAL of 10⁶.

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

    The document does not explicitly state a specific sample size for each test (design verification, biocompatibility, sterilization efficacy).
    The data provenance is not specified (e.g., country of origin, retrospective or prospective), but given the context of a 510(k) submission, it would be laboratory-generated data from the manufacturer (Entellus Medical, Inc.).

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

    This information is not explicitly provided. For sterilization efficacy, ground truth (SAL of 10⁻⁶) is typically established through standardized microbiological testing methods, often performed by trained microbiologists or specialists in sterilization science within a testing laboratory.

    4. Adjudication method for the test set:

    Not applicable. The performance testing involves objective measures (e.g., material integrity, microbiological kill rates) rather than human interpretation requiring adjudication.

    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:

    Not applicable. This device is a sterilization tray and does not involve AI or human "readers" or diagnostic interpretations.

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

    Not applicable. This device is a physical medical device (sterilization tray), not an algorithm or AI system.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    The ground truth for the performance testing included:

    • Design Verification: Established standards for material stability and device integrity after sterilization cycles.
    • Biocompatibility: Established toxicological and irritation thresholds in accordance with relevant standards (e.g., ISO 10993 series).
    • Sterilization Efficacy: A Sterility Assurance Level (SAL) of 10⁻⁶, which is a universally accepted standard for sterilization, demonstrating a one in a million chance of a non-sterile unit. This is determined through biological indicator testing and D-value calculations.

    8. The sample size for the training set:

    Not applicable. This device is a physical medical device, and the testing described is performance validation, not machine learning model training.

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

    Not applicable. There is no training set involved as this is not a machine learning or AI device.

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