LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K183701
    Device Name
    Stryker ChestShield Sterilization Tray System
    Manufacturer
    Paragon Medical
    Date Cleared
    2019-05-07

    (127 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K173615
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Stryker ChestShield Sterilization Tray System is intended to organize, enclose, sterilize, transport, and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated figid sterliization container in order to maintain sterility of the enclosed devices. The Stryker ChestShield Sterilization Tray System has been validated for use in the following sterilization cycle:

    Pre-vacuum Steam
    EnclosureRigid Container
    Temperature132°C (270°F)
    Sterilization Time4 minutes
    Minimum Dry Time30 minutes
    Maximum Weight119.23 lb. / 8.72 kg

    'The validated load configuration for the Stryker Chestin Tray System included single-use implants (plates, bone screws, etc.), single-use instruments (drills), reusable surgical instruments (benders, etc.) and lumened instruments.

    Device Description

    The Stryker ChestShield Sterilization Tray System is a tray system designed to store implants and surgical instrumentation. The tray system consists of an anodized aluminum implant module with an inlay which stores the implantable components and stainless steel instrument trays, which have stainless steel and silicone brackets to contain the reusable and singleuse instruments. Both the implant module and instrument trays have laser-etched and silkscreened artwork to assist the end user in correct placement of the contents. The tray components have stainless steel lids which feature a slide latch. The trays and implant module are organized and stored in a stainless steel rack. The tray system does not maintain sterility; the rack is placed in a rigid sterilization container to act as a sterile barrier for sterilization. The tray system provided in a nonsterile condition and must be sterilized prior to and after each use.

    AI/ML Overview

    The provided document is a 510(k) summary for the Stryker ChestShield Sterilization Tray System. It describes the device, its intended use, and comparative information with a predicate device. The document also details the non-clinical performance testing conducted to demonstrate substantial equivalence to the predicate device.

    Here's an analysis of the acceptance criteria and study that proves the device meets them:

    1. A table of acceptance criteria and the reported device performance

    The acceptance criteria for the Stryker ChestShield Sterilization Tray System are primarily tied to its functionality as a sterilization tray within a specific sterilization cycle. The performance is demonstrated through validation against established standards.

    Acceptance Criteria CategorySpecific Criteria/StandardReported Device Performance/Validation
    Sterilization EfficacyEffective steam sterilization of fully loaded tray.Sterilization Validation: Demonstrated effective steam sterilization using a fully loaded Stryker ChestShield Sterilization Tray System sterilized in a rigid sterilization container with a pre-vacuum air removal autoclave cycle. Evaluated resistance of biological indicators (BIs) with 10^6 Geobacillus stearothermophilus spores to 132°C pre-vacuum steam autoclave half-cycle exposures. Validated per ANSI/AAMI/ISO 17665-1:2006.
    Dry Time EfficacyAdequate dry time after sterilization.Dry Time Validation: Evaluated dry time after sterilization cycles. (Specific performance value for dry time is 30 minutes, likely met based on successful validation).
    Material CompatibilityCompatible with steam sterilization process.Material Compatibility with Sterilization Process: Subject device is compatible with steam sterilization. Confirmed by direct testing.
    BiocompatibilityNon-cytotoxic.Biocompatibility (ISO 10993-5): "Subject device is identical in formulation and processing to the predicate device; therefore, cytotoxicity results of the predicate are applicable to the subject device." Predicate tested as non-cytotoxic (Grade 2 or less cell lysis and reactivity) using MEM Elution method.
    Functional Quality/DurabilityMaintained functional quality, material compatibility, and traceability after repeated cycles and simulated use.Lifecycle Testing: Leveraged from predicate device. Performed on predicate device to verify maintenance of functional quality requirements, material compatibility, and traceability after repeated pre-vacuum steam sterilization cycles, automated washing cycles, and simulated functional use.
    Design Compliance/SafetyComplies with AAMI/ANSI ST77:2013 for handle strength.Design Verification: Leveraged from predicate device. Performed on predicate device to demonstrate compliance with AAMI/ANSI ST77:2013 for handle strength. Also included containment verification during transport and simulated use, stacking verification, and edge sharpness testing.
    Cleaning EfficacyEffective removal of soil from all designated surfaces.Cleaning Validation: Leveraged from predicate device. Manual and automated cleaning validations performed on predicate device using worst-case configured tray system per AAMI TIR 30:2011. Results met acceptance criteria of residual protein
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1