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510(k) Data Aggregation

    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
    Predicate For
    K120640,K121336,K132169,K132203,K143404
    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 < 5 mg / 10 days, ECH < 5 mg / 10 days remained on the tube set."Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) data shows that the limit of EO < 5 mg / 10 days and ECH < 5 mg / 10 days that remain on the tube set will not be exceeded."
    Biocompatibility: Meet standards for cytotoxicity, irritation, and delayed type hypersensitivity.Biocompatibility testing performed in accordance with ISO 10993-5, ISO 10993-10, and ISO 10993-12. (Implies compliance with these standards.)
    Material/Product Integrity: Packaging and product integrity maintained."Package and product integrity were tested in accordance with ISO11607-1, Packaging for Terminally Sterilized Medical Devices and ASTM-F-1980-02, Standard for Accelerated Aging of Sterile Medical Device Packages." (Implies compliance with these standards.)
    Electrical Safety: Comply with general requirements for medical electrical equipment safety.Tested in accordance with IEC 60601-1 and IEC 60601-1-2. (Implies compliance with these standards.)
    Quality Management System: Compliance with relevant quality management standards."The DPIS 2000 Unit has been developed in accordance with 21 CFR 820, ISO 13485:2003 & ISO 14971:2007"
    Substantial Equivalence: Same intended use, indication for use, operating principles, and design features as predicate devices.Stated that the system is "substantially equivalent to the Substantial AirSeal Predicate Device (K071571, K083211, K092504) Equivalence: and to the Insufflation Predicate Device (K063367)."

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: The document does not specify the sample sizes used for any of the individual bench tests (e.g., pneumoperitoneum, sterility, biocompatibility, packaging). It only states that these tests were performed.
    • Data Provenance: The data is from "bench tests" performed by the manufacturer, SurgiQuest, Inc., in Orange, CT, USA. It is retrospective in the sense that the tests were conducted prior to the 510(k) submission, but it's not clinical data (prospective or retrospective patient data).

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

    This information is not applicable as the device is a medical instrument (trocar, cannula, insufflator), not an AI/software device that requires expert-established ground truth for a test set. The validation relies on established engineering, biological, and sterility standards.

    4. Adjudication Method for the Test Set

    This information is not applicable for the same reason as point 3. Testing involves compliance with predefined standards and measurements, not subjective expert adjudication.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • Not applicable. This device is hardware (trocar, cannula, insufflator) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study and AI assistance effect size are irrelevant.

    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

    • Not applicable. This device is hardware and does not have a "standalone algorithm" performance to report.

    7. The Type of Ground Truth Used

    • The "ground truth" for this device is based on established engineering standards, biological safety standards (biocompatibility), and sterilization efficacy standards. For example, a sterility assurance level (SAL) of ≤ 10-6 is an industry-accepted "ground truth" for terminal sterilization. Similarly, the limits for residual ethylene oxide are defined by standards. For functional performance (pneumoperitoneum), the "ground truth" is whether the system performs as intended without significant issues on a test bench.

    8. The Sample Size for the Training Set

    • Not applicable. This device is hardware and does not have a "training set" in the context of an AI/machine learning model. The development of the device would involve engineering design and iterative testing, but not a formally defined "training set" in the sense of AI.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable. As per point 8, there is no training set for this type of medical device submission.
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