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510(k) Data Aggregation

    K Number
    K161358
    Device Name
    Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds
    Manufacturer
    SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
    Date Cleared
    2017-08-03

    (444 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K132671
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds are accessories for use with the Stryker Neptune 2 Waste Management System, specifically the rover. The Neptune 2 Waste Management system is intended to be used in the operating room, pathology laboratories, surgical centers and doctor's offices to collect and dispose of surgical fluid waste and to collect smoke generated by electrocautery or laser devices.

    Device Description

    The Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds are non-patient contacting, non-sterile, disposable devices that provide a fluid path from the suction tubing lines of a Stryker Neptune 2 Waste Management System to the receiving collection canisters of this system.

    AI/ML Overview

    The provided text is a 510(k) premarket notification summary for the Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds. This document describes a reprocessed medical device, which is a physical product, not a software or AI-based device.

    Therefore, the concepts of acceptance criteria, test sets, training sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this document. The study described in the document pertains to the physical and functional performance of the reprocessed surgical manifolds and their equivalence to new manifolds.

    The document discusses "Performance Testing" for the reprocessed manifolds, which includes:

    • Functional performance studies: simulated use and artificial soiling; structural integrity; installation and removal; vacuum/sealing; leakage (backflow prevention valve, drip-reduction valve, mating components); specimen collection; and performance post-accelerated aging.
    • Cleaning: visual inspection; cleaning efficacy (residual protein and residual carbohydrate); soil characterization.
    • Intermediate level disinfection.

    The conclusion is that these nonclinical tests demonstrated the reprocessed manifold to be "as safe, as effective, and performs as well or better than the legally marketed predicate Stryker Neptune 2 Manifold." This establishes substantial equivalence to the predicate device.

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