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510(k) Data Aggregation

    K Number
    K240881
    Device Name
    Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)
    Manufacturer
    Covidien (Part of Medtronic)
    Date Cleared
    2024-11-01

    (214 days)

    Product Code
    GAG,GEN
    Regulation Number
    878.4740
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K221629
    Why did this record match?
    Device Name :

    Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL

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

    The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.

    Device Description

    The Signia™ circular adapters are reusable instruments that connect with the assembled Signia™ power handle and Signia™ power shell to make up the Signia™ stapler. The Signia™ circular adapters are composed of motor-mating connectors, sensor gauges and device communication interfaces to provide functionality and communication between compatible reloads and the Signia™ circular adapters are available in two shaft lengths, standard (25 cm) and extra-long (30 cm).

    The Signia™ Circular Adapter are for use with the Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, is a battery powered microprocessor controlled surgical stapler that provides push-button powered operations and firing of compatible reloads. The Signia™ stapler is intended to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. The Signia™ stapler is intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated. Signia™ Stapler can be used for both linear and circular stapling application depending on the software version installed in the Signia™ power handle.

    AI/ML Overview

    This FDA 510(k) summary for the Signia™ Circular Adapter (K240881) does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets such criteria.

    The device in question, the Signia™ Circular Adapter, is a surgical stapler component. The document describes its physical and functional characteristics, and the non-clinical testing performed to establish its substantial equivalence to a predicate device. This testing primarily focuses on device performance, safety, and manufacturing quality, not on the performance of a diagnostic or therapeutic AI/software.

    Therefore, I cannot provide a response to your request, as the provided input does not include the details regarding acceptance criteria for an AI/SaMD or a study to demonstrate its performance.

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