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510(k) Data Aggregation

    K Number
    K100045
    Device Name
    OCTO
    Manufacturer
    DALIM SURGNET CORPORATION
    Date Cleared
    2010-06-25

    (168 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K073719
    Predicate For
    K112196
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OCTO™ is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

    Device Description

    The OCTOTM is a sterile, disposable laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen .

    AI/ML Overview

    The provided text describes the 510(k) submission for the OCTO™ laparoscopic accessory, focusing on its substantial equivalence to a predicate device. The information presented is primarily about performance testing related to the device's mechanical functionality and surgical utility, rather than AI-driven diagnostic or prognostic capabilities. Therefore, many of the requested categories related to AI performance metrics (e.g., expert consensus, MRMC studies, training set details) are not applicable to this document.

    Here's an analysis of the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Bench Testing)Reported Performance (Summary)
    Comparative leak rate test (without instruments, with instruments, after vigorous manipulation of instruments vs. predicate device(s))Performed; demonstrates functionality and mechanical safety. The conclusion states the device is "as safe, as effective, and performs in a substantially equivalent manner to the predicate device."
    Insufflation flow ratePerformed; demonstrates functionality and mechanical safety.
    Insertion-withdrawal forces of instrumentsPerformed; demonstrates functionality and mechanical safety.
    Determination of minimum size of skin incisionPerformed; demonstrates functionality and mechanical safety.
    Evaluation of OCTOTM Port device fixationPerformed; demonstrates functionality and mechanical safety.
    Acceptance Criteria (Animal Test)Reported Performance (Summary)
    Ease of port insertionPerformed; demonstrates ability for OCTO™. The conclusion states the device is "as safe, as effective, and performs in a substantially equivalent manner to the predicate device."
    Ease of instrument insertion and withdrawalPerformed; demonstrates ability for OCTO™.
    Ability to maintain pneumoperitoneumPerformed; demonstrates ability for OCTO™.
    Ability to manipulate instruments for laparoscopic surgeryPerformed; demonstrates ability for OCTO™.
    Ability to conduct a typical laparoscopic procedure (cholecystectomy)Performed; demonstrates ability for OCTO™.
    Ability to hold OCTO™ Port in position during surgeryPerformed; demonstrates ability for OCTO™.

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

    • Bench Testing: No specific sample sizes are mentioned for the bench tests. The data provenance is implied to be laboratory testing.
    • Animal Testing: No specific sample size (number of animals) is mentioned for the animal tests. The data provenance is animal studies.
    • Retrospective/Prospective: Not applicable, as this is primarily a device performance evaluation, not a clinical study on human data.

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

    • Not applicable. The tests described are physical and mechanical performance tests, and animal studies, not expert-based diagnostic evaluations.

    4. Adjudication Method for the Test Set

    • Not applicable. Adjudication methods are typically relevant for human-read interpretations or clinical outcomes, not for mechanical device performance.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

    • No. This is a submission for a laparoscopic accessory, not an AI-driven diagnostic device. Therefore, no MRMC study or AI improvement statistics are relevant or provided.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

    • Not applicable. This device does not involve an algorithm.

    7. The Type of Ground Truth Used

    • Bench Testing: Ground truth is based on engineering specifications, physical measurements, and comparison to predicate device performance (e.g., measured leak rates, forces, dimensions).
    • Animal Testing: Ground truth is based on direct observation of the device's functionality during animal surgical procedures by the testing personnel.

    8. The Sample Size for the Training Set

    • Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

    • Not applicable. There is no training set.
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