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510(k) Data Aggregation

    K Number
    K202515
    Date Cleared
    2020-11-24

    (84 days)

    Product Code
    Regulation Number
    880.6850
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    NUVO Implant System – NUVO Instrument Kit Cases

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

    Indications for Use for Drill Stop Pre-Mounted Kit and Drill Stop Kit: Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Instrument Kits are intended to allow sterilization of the enclosed medical devices. Instrument Kits require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The Kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat using one of the following cycles: Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minute dry time Gravity displacement -Exposure at 132 °C for 15 minutes, 30-minute dry time. Instrument Kits are intended for sterilization of nonporous loads. The combined weight of the Kit and the associated instruments is 194.90 grams. The weight of the 189.12 grams. Instrument Kits are recommended not to be stacked during sterilization.

    Device Description

    The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject kit cases are manufactured in polymer. The design of the subject devices include grommets manufactured from polyphenylsulfone that retain the instruments within the tray. The subject device kit cases are provided nonsterile to the end-user.

    AI/ML Overview

    The provided text describes the acceptance criteria and the study conducted for the NUVO Implant System - NUVO Instrument Kit Cases, a device intended for sterilizing other medical devices.

    Here's the breakdown of the information requested:

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

    Acceptance CriteriaReported Device Performance
    Manual cleaning validation:
    Visual Inspection: No Visible SoilPassed
    Hemoglobin Test:
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