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510(k) Data Aggregation

    K Number
    K022574
    Device Name
    INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Date Cleared
    2002-11-12

    (102 days)

    Product Code
    NAY
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K011002,K002489,K990144,K965001
    Predicate For
    K040237,K040948,K043153,K043288,K050005,K050369,K050404,K050802,K070947,K072627,K090993,K123329
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Intuitive Surgical* Endoscopic Instrument Control System (hereinafter referred to as the "da Vinci* System") is intended to assist in the accurate control of Intuitive Surgical* Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing during general laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically-assisted cardiotomy procedures. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Instructions for Use.

    Device Description

    The working ends and elements of the Intuitive Surgical® da Vinci™ Surgical System, Endoscopic Instruments and Accessories are essentially identical in function, size and shape to the predicate devices referenced. They represent standard embodiments of standard surgical tools, which have been modified for use with the Intuitive Surgical® da Vinci™ Surgical System.

    AI/ML Overview

    This 510(k) summary describes a traditional medical device (surgical instruments), not an AI/ML-driven device. Therefore, many of the requested categories related to AI/ML performance acceptance criteria, such as "Sample size used for the test set and the data provenance", "Number of experts used to establish the ground truth for the test set", "Adjudication method", "MRMC comparative effectiveness study", and "Sample size for the training set", are not applicable to this submission.

    The acceptance criteria and evaluation method for this device are based on proving "substantial equivalence" to predicate devices through design analysis and in vitro testing, focusing on functional characteristics.

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Substantial equivalence in terms of shape, size, function, and tissue effect to predicate devices."The Intuitive Surgical® Instruments are essentially identical in terms of shape, size, function and tissue effect to the standard Class I and II endoscopic medical devices previously cited." "Design analysis and comparison as well as in vitro testing confirm that basic functional characteristics are substantially equivalent to the predicate devices cited."

    Study Details

    1. Sample size used for the test set and the data provenance: Not applicable. Performance was evaluated through design analysis and in vitro testing, not a clinical study with a "test set" in the context of AI/ML.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Performance claims are based on engineering analysis and in vitro testing, not expert consensus on a test set.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

    4. 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 is not an AI/ML device.

    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the conventional sense for AI/ML. The "ground truth" for substantial equivalence was based on predefined functional, size, and shape characteristics of existing predicate devices, against which the new device aspects were compared.

    7. The sample size for the training set: Not applicable. This is not an AI/ML device.

    8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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