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    K Number
    K103692
    Device Name
    SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
    Manufacturer
    SURGIQUEST, INC.
    Date Cleared
    2011-05-25

    (159 days)

    Product Code
    HIF,GCJ
    Regulation Number
    884.1730
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    k071571,k083211,k092504,k063367
    Why did this record match?
    Device Name :

    SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000

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

    The SurgiQuest AirSeal ® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.

    Device Description

    The SurgiQuest AirSeal® Optical Trocar & Cannula Device Description: System with integrated Insufflator DPIS 2000 (the "DPIS System") consists of of the following 2000 major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor controlled insufflation, recirculation and filtration unit (the "DPIS 2000 Unit"). The cannula, trocar and tube sets are sterile, single-use products. The DPIS 2000 Unit is non-sterile and reusable.

    The DPIS 2000 Unit is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode; or (c) Smoke Evacuation Mode.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and noting what is absent for a comprehensive understanding:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided text describes various tests and standards met by the device, rather than explicit "acceptance criteria" presented as quantitative thresholds. However, we can infer the performance statements from what was tested and validated.

    Acceptance Criteria (Inferred from testing)Reported Device Performance
    Pneumoperitoneum Maintenance: Ability to create and maintain pneumoperitoneum in all operating modes (Insufflation, AirSeal, Smoke Evacuation)."Bench test results demonstrate that the DPIS 2000 System is safe and effective in creating and maintaining pneumoperitoneum in all three modes."
    Sterility Assurance Level (SAL): SAL of ≤ 10-6."A sterility assurance level (SAL) is ≤ 10-6 achieved."
    Ethylene Oxide and Ethylene Chlorohydrin Residuals: EO
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