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510(k) Data Aggregation

    K Number
    K981130
    Device Name
    KSEA ENDO TIP SYSTEM
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1998-08-19

    (142 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These instruments are intended for use by qualified surgeons or physicians to provide access to the patient's body and allow insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic surgical and diagnostic procedures.

    Device Description

    The KSEA EndoTIP System are manual reusable surgical devices provided to the end-user in a non-sterile condition. The KSEA EndoTIP System is comprised of a threaded hollow cannula with a blunt penetrating distal end. The body contact materials are surgical grade stainless steel.

    AI/ML Overview

    This 510(k) summary is for a Class II medical device, the KSEA EndoTIP System, which is a manual, reusable surgical cannula. Given the nature of this device (a blunt-tipped cannula), the submission focuses on substantial equivalence to existing predicate devices rather than an AI-driven or diagnostic performance study.

    Therefore, many of the requested criteria related to AI performance, such as acceptance criteria based on metrics, training/test sets, expert adjudication, MRMC studies, and standalone performance, are not applicable (N/A) to this specific submission.

    Here's a breakdown of the requested information based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Intended Use: Device provides access to the patient's body and allows insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic surgical and diagnostic procedures.Substantially Equivalent: The KSEA EndoTIP System is stated to be "substantially equivalent to the predicate devices since the basic features and intended uses are similar." The summary explicitly states: "The minor differences in design and dimensions between the KSEA EndoTIP System and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices."
    Safety and Effectiveness: No new issues of safety and effectiveness raised compared to predicates.Demonstrated through substantial equivalence argument. No specific performance metrics (e.g., insertion force, tissue damage) are provided in this summary, as the argument relies on the known safety and performance of similar predicate devices.
    Material Composition: Body contact materials are surgical grade stainless steel.The device description explicitly states: "The body contact materials are surgical grade stainless steel."
    Sterility: Provided in a non-sterile condition.The device description explicitly states: "manual reusable surgical devices provided to the end-user in a non-sterile condition."

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

    N/A. This submission is based on a substantial equivalence argument, comparing the design and intended use of the KSEA EndoTIP System to predicate devices. It does not involve a "test set" of clinical data in the sense of a clinical performance study with patient samples. The "data provenance" would refer to the characteristics and performance of the predicate devices.

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

    N/A. As no clinical "test set" was used to establish performance metrics, there was no need for experts to establish ground truth in this context. The substantial equivalence argument implicitly relies on the FDA's and the manufacturer's understanding of the safety and effectiveness of the predicate devices, which would have been established through prior regulatory reviews and clinical experience.

    4. Adjudication Method for the Test Set

    N/A. There was no "test set" requiring adjudication.

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

    N/A. This device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

    6. Standalone (Algorithm Only) Performance Study

    N/A. This device does not incorporate an algorithm or AI component.

    7. Type of Ground Truth Used

    The "ground truth" for this submission is the established safety and effectiveness of the predicate devices on which the substantial equivalence argument is based. The FDA's acceptance of the substantial equivalence relies on the regulatory history and known performance of those similar devices in the market.

    8. Sample Size for the Training Set

    N/A. This submission does not involve machine learning or a "training set."

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

    N/A. There was no training set for this device.

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