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    K Number
    K013721
    Device Name
    SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
    Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO., INC.
    Date Cleared
    2001-12-28

    (49 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K991236
    Why did this record match?
    Device Name :

    SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER

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

    Protective cover or sheath is placed over an ultrasound transducer / probes / scanbead instruments. The cover allows use of the transdacer in Naming and intra-operative uitesound, while helping to proven transfer of microorganisms, body fluids, and and intra-operative uitesound, while helping to proven during rease of the tearile and non-sterile covers). The cover also provides a means for maintenance of a sterile fold (sterile covers only). non-sterile covers). The cover also provides a modis for manished sterile and non-sterile, single use patient / procedure, disposable.

    Device Description

    The Synthetic Polyisoprene Ultrasound Transducer Cover provides a thin, conformal covering to fit various and specific ultrasound transducer geometries. The cover is manufactured as either a one-or two-piece design that provides a covering that helps prevent the transmission of pathogens as the ultrasound transducer is reused from one patient to another. The cover material is polyisoprene synthetic rubber similar to that of non-latex medical examination / surgical gloves. Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include: General Purpose Synthetic Polyisoprene Transducer Covers (sterile and non-sterile) Endocavity Synthetic Polyisoprene Transducer Covers (sterile and non-sterile) Surgi-Tip™ Intraoperative* Synthetic Polyisoprene Transducer Covers (sterile) *Polyethylene cord cover w/ Synthetic Polyisoprene tip Covers are packaged in both sterile and non-sterile "procedure kit" form for single patient / procedure, disposable use. Cover kits are supplied with fasteners, and with or without coupling gel packet. Transducer covers are also combined with disposable needle guide devices into custom kits that CIVCO builds for ultrasound OEMs and end users.

    AI/ML Overview

    The provided text describes a 510(k) submission for a Synthetic Polyisoprene Ultrasound Transducer Cover, arguing for its substantial equivalence to a legally marketed predicate device, the CIVCO NeoFlex™ Ultrasound Transducer Cover (K991236).

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are not explicitly stated as numerical targets for performance metrics (e.g., "tear strength > X MPa"). Instead, the criteria are qualitative and comparative, demonstrating that the new device performs "effectively similar" to the predicate device in key areas.

    ParameterAcceptance Criteria (Implied)Reported Device Performance (Synthetic Polyisoprene)
    Intended Use / Indications for UseSame as predicate device.Same. (Provides a thin, conformal protective cover system for ultrasound transducer usage in body surface, endocavity, and intra-operative patient environments; helps to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer, and helps to maintain the sterile field where applicable; disposable device - for single patient/procedure use.)
    DesignSame as predicate device (one- or two-piece, closed end, rolled or attached to polyethylene, various dimensional configurations to accommodate different transducers).Same.
    MaterialMeet recommended safe levels of US FDA CFR, Title 21, Section 177.2600 and 182.5991. Not contain natural protein allergen residuals present in latex.Polyisoprene, synthetic rubber. Materials meet recommended safe levels. Does not contain natural protein allergen residuals present in latex.
    ManufacturingSame as predicate device (dip-molding/rubber vulcanization, packaged in class 10,000 cleanroom per Federal Std 209e, packaging system per ANSI/AAMI/ISO 11607).Same.
    Quality SystemsComply with FDA/QSR cGMP 21CFR Part 820. ISO 9001 / EN46001 / ISO 13485.Same.
    SterilityWhen applicable, achieve sterility by 100% EtO method, validated ANSI/AAMI/ISO 11135, with SAL 10-6.Same.
    Device Body Contact CategorySame as predicate device (surface devices, intact skin/mucosal membranes/breached surfaces; limited contact duration (
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