LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K132169
    Device Name
    SURGIQUEST AIRSEAL IFS
    Manufacturer
    SURGIQUEST, INC.
    Date Cleared
    2013-08-22

    (38 days)

    Product Code
    GCJ,HIF
    Regulation Number
    876.1500
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K103692,K121336
    Predicate For
    N/A
    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 System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") consists of the following 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 subject device of this filing is a modification to the original filing. The modification is to allow the operation of two trocars simultaneously, one AirSeal trocar and one conventional trocar. The predicate filing was a modification to allow the simultaneous operation of two AirSeal* trocars.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study information for K132169, based on the provided text:

    1. Acceptance Criteria and Reported Device Performance

    The provided text does not explicitly state quantitative acceptance criteria in a table format. Instead, it describes general functionalities that the device's testing aimed to demonstrate.

    Acceptance Criteria (Implied)Reported Device Performance
    Ability to create and maintain a port of entry.The device was tested to show its ability to create and maintain a port of entry during simulated laparoscopic surgery.
    Ability to maintain adequate pneumoperitoneum.The device was tested to show its ability to maintain adequate pneumoperitoneum during the course of laparoscopic surgery.
    Ability to aid in the evacuation of smoke.The device was tested to show its ability to aid in the evacuation of smoke.
    Sterility of reusable devices.Sterility validation was done in accordance with ISO 11137:2006 and AAMI TIR 27:2001, achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
    Operation of two trocars simultaneously (one AirSeal, one conventional).The subject device is a modification to allow simultaneous operation of one AirSeal trocar and one conventional trocar (the predicate filing allowed two AirSeal trocars). Testing would have validated this.

    2. Sample Size for Test Set and Data Provenance

    • Sample Size for Test Set: Not explicitly stated. The text refers to "Engineering Test summaries" but does not provide details on the number of units or test runs.
    • Data Provenance: The tests are described as "Engineering Tests." It's highly probable these were conducted internally by SurgiQuest, Inc. in the US (Milford, CT is their location). The data is prospective in nature, as it involves active testing of the device's performance.

    3. Number of Experts and Qualifications for Ground Truth of Test Set

    Not applicable. The tests described are engineering performance tests, not clinical studies requiring expert interpretation of medical data.

    4. Adjudication Method for Test Set

    Not applicable, as this was an engineering performance study, not a clinical study requiring adjudication of expert interpretations.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    Not applicable. This submission concerns an insufflator and trocar system, and the studies mentioned are engineering performance tests, not studies analyzing human reader performance with medical images.

    6. Standalone Performance Study

    Yes, the studies described ("Engineering Test 0627131045 01" and "Engineering Test 0627131059 01") are standalone performance studies. They assess the device's technical capabilities (e.g., smoke evacuation, CO2 consumption) directly.

    7. Type of Ground Truth Used

    The ground truth for these engineering tests would be derived from:

    • Measured physical parameters: Data obtained from sensors and instruments measuring aspects like gas flow, pressure, CO2 consumption, and smoke evacuation rates during simulated procedures.
    • Engineering specifications and standards: Adherence to established performance parameters as defined by internal design specifications and relevant industry standards (e.g., ISO for sterility).

    8. Sample Size for Training Set

    Not applicable. This is an engineering device, not an AI/machine learning algorithm that requires a training set of data.

    9. How Ground Truth for Training Set Was Established

    Not applicable.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1