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510(k) Data Aggregation

    K Number
    K971310
    Device Name
    AESCULAP JET IRRIGATION SYSTEM
    Manufacturer
    AESCULAP, INC.
    Date Cleared
    1997-07-18

    (101 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K012986
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Aesculap's Jet Irrigation System is designed for use with Aesculap's Bipolar Coagulator. The Jet Irrigation System delivers either precisely measured drip irrigation or a continuous jet stream of irrigation to the tip of Aesculap's Bipolar Irrigation Forceps. The use of drip irrigation serves to prevent overheating and tissue adherence during bipolar coagulation. Continuous "jet" irrigation provides a clearer visual field.

    Device Description

    The Jet Irrigation System presented in this submission is designed for use with Aesculap's Bipolar Coagulator (GN060). The Jet Irrigation Unit (GN090) delivers either precisely measured drip irrigation or a continuous jet stream of irrigation to the tip of Aesculap's Bipolar Irrigation Forceps (GK840R - GK847R).

    AI/ML Overview

    The provided text describes a 510(k) submission for the Aesculap Jet Irrigation System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance in the way a clinical trial for a novel AI device would.

    Therefore, many of the requested fields (AI-specific performance, ground truth, expert adjudication, MRMC studies, standalone performance, training set) are not applicable to this type of regulatory submission for a medical device that is not an AI diagnostic tool.

    Here's the information based on the provided text, with "N/A" (Not Applicable) for fields that don't fit this type of device and submission:

    Acceptance Criteria and Device Performance Study

    The submission does not detail specific quantitative acceptance criteria or a clinical study proving the device meets those criteria in the context of diagnostic accuracy or AI performance. Instead, it focuses on compliance with established standards and substantial equivalence to a predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    Safety and DesignSubstantially equivalent in design features and technological characteristics to Codman's Malis Irrigation System.Shares similar features and function with corresponding devices distributed by Aesculap and Codman.
    Electrical SafetyCompliance with Underwriters Laboratories, Inc. requirements for medical and dental equipment.Unit complies with UL requirements.
    Endoscopic SafetyCompliance with IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment) for Bipolar Irrigation Forceps.Forceps meet IEC 601-2-18 requirements.
    Manufacturing QualityManufacturing in accordance with ISO and German Din Standards.Aesculap AG has received ISO 9001 certification.
    • Note: The "reported device performance" here describes compliance with standards and equivalence as claimed in the 510(k) summary, not a quantitative performance metric from a diagnostic study.

    2. Sample size used for the test set and the data provenance:

    • Sample Size: N/A (No specific test set or patient data is mentioned for performance evaluation in the context of a diagnostic device.)
    • Data Provenance: N/A

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • N/A (Ground truth generation by experts is not relevant for this type of device submission.)

    4. Adjudication method for the test set:

    • N/A

    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:

    • N/A (This device is not an AI diagnostic tool, so an MRMC study is not applicable.)

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

    • N/A (This device is not an AI algorithm.)

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • N/A

    8. The sample size for the training set:

    • N/A (No training set is mentioned as this is not an AI/ML device.)

    9. How the ground truth for the training set was established:

    • N/A
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