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510(k) Data Aggregation

    K Number
    K021811
    Device Name
    UNIDRIVE II PLUS DISPOSABLE TUBING SET
    Manufacturer
    MTP MEDICAL TECHNICAL PROMOTION GMBH
    Date Cleared
    2002-06-19

    (16 days)

    Product Code
    ERL
    Regulation Number
    874.4250
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K003994
    Why did this record match?
    Device Name :

    UNIDRIVE II PLUS DISPOSABLE TUBING SET

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MTP Unidrive® II Plus Disposable Tubing Set is intended to be utilized with the Karl Storz Unidrive® II Plus System for the controlled infusion of sterile irrigant solution during ENT endoscopic surgical surgery.

    Device Description

    The MTP Unidrive® II Plus Disposable Tubing Set is utilized with the Karl Storz Unidrive® II Plus System. It is sold as sterile and single use device.

    AI/ML Overview

    This 510(k) submission (K021811) for the MTP Unidrive® II Plus Disposable Tubing Set does not contain information about acceptance criteria or a study proving that the device meets those criteria.

    Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K003994, manufactured by KSEA). Substantial equivalence means the new device is as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).

    Here's why the requested information is not available in this document:

    • Acceptance Criteria and Device Performance: The document does not specify quantitative acceptance criteria or report specific performance metrics for the MTP Unidrive® II Plus Disposable Tubing Set. The primary demonstration of safety and effectiveness relies on its similarity to the predicate device.
    • Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): Because the submission is based on substantial equivalence and not a performance study evaluating novel claims, none of these study-related details are provided. The FDA's decision is based on comparing the new device's characteristics to the predicate device, not on clinical trial data or performance testing that would typically involve such metrics.

    Summary of what is provided regarding equivalence:

    The "SUBSTANTIAL EQUIVALENCE TABLE FOR MTP Unidrive® II Plus DISPOSABLE TUBING SET" (page 1) details the comparative features:

    ManufacturerMTPKSEA (K003994) (Predicate Device)
    ComponentsIrrigation tubing, roller pump tubing, tubing connectors, and an irrigation bag piercing spikeSame
    Irrigation tubing lengthsInput: 150 cm Output: 310 cmSame
    Tubing, connector, & spike materialsMedical grade elastomer and plasticsSame
    Sterile, Single UseYesSame
    Sterilization MethodEthylene OxideSame
    PackagingPeel pouchesSame
    Intended UseFor use with the Karl Storz Unidrive® II Plus System for the controlled infusion of sterile irrigant solution during ENT endoscopic surgical surgerySame

    The FDA's letter (pages 2-3) confirms the "substantial equivalence determination," allowing the device to be marketed. This decision is based on the MTP device having the "same basic features and intended uses" as the predicate device (KSEA K003994). This regulatory pathway (510(k)) does not typically require extensive novel clinical performance studies if substantial equivalence can be demonstrated.

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