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510(k) Data Aggregation

    K Number
    K982594
    Device Name
    ENDO-SCRUB/ENDO-SCRUB 2
    Manufacturer
    XOMED, INC.
    Date Cleared
    1998-08-27

    (34 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENDO-SCRUB/ENDO-SCRUB 2

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

    The Endo-Scrub 2 is intended to clear accumulated debris from the inserted end of the scope without removing the scope from the surgical site, maintaining visualization during the procedures. It is indicated for use with mechanical endoscopic sinus instruments and with fiber optic lasers in endoscopic nasal and sinus surgery.

    The Endo-Scrub 2 is intended to clear the end of a rigid rod endoscope, in order to maintain good visualization of endoscopic procedures without having to remove the scope from the surgical site.

    The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery with standard mechanical instruments and lasers.

    Device Description

    The Endo-Scrub 2 Pump is an AC powered microprocessor controlled pump with adjustable irrigation and aspiration cycles. Pump action initiated by depression of the foot control or optional clip-on sheath switch results in a "scrub cycle". The Endo-Scrub 2 Sheath consists of an anodized aluminum sheath attached to an ABS handle with a Luer connector for irrigation tubing.

    AI/ML Overview

    The provided document is a 510(k) summary for the XOMED Endo-Scrub/Endo-Scrub 2 device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria in the detailed manner requested.

    Instead, the document states:

    • No performance standards have been adopted under Section 514 of the Act.
    • The device will be tested to ensure compliance with voluntary standards:
      • IEC 60601-1-1: 1988 General Safety Requirements (Amendment 1:1991; Amendment 2:1995)
      • IEC 60601-1-2: 1993 Medical Electrical Equipment - Part 1: General Safety Requirements 2. Collateral Standard: Electromagnetic Compatibility Requirements and Tests

    The submission also explicitly states that the Endo-Scrub 2 is otherwise identical to the currently marketed Xomed Endo-Scrub (K902683/A) in general intended use, as well as in general technical characteristics and does not present new issues of safety or effectiveness. This indicates that the device was approved based on substantial equivalence to a predicate device, rather than new extensive performance studies.

    Therefore, I cannot provide the requested information from the given text as it does not contain:

    1. A table of acceptance criteria and the reported device performance: Only general safety and electromagnetic compatibility standards are mentioned, not specific performance metrics.
    2. Sample size used for the test set and the data provenance: No testing data is provided.
    3. Number of experts and qualifications for ground truth: Not applicable as no specific clinical performance study is detailed.
    4. Adjudication method: Not applicable.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
    6. Standalone performance study: Not detailed.
    7. Type of ground truth used: Not applicable.
    8. Sample size for the training set: Not applicable.
    9. How ground truth for the training set was established: Not applicable.

    The FDA's letter confirms that the device was approved based on its substantial equivalence to a predicate device (K902683/A), meaning new clinical efficacy and safety data beyond demonstrating equivalence to the existing device were likely not required.

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