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    K Number
    K091828
    Device Name
    SHEATHESISO ULTRASOUND TRANSDUCER COVER
    Manufacturer
    SHEATHING TECHNOLOGIES, INC.
    Date Cleared
    2009-09-28

    (101 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K013721,K991236
    Why did this record match?
    Reference Devices :

    K013721, K991236

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

    Synthetic polyisoprene probe covers are indicated for use during diagnostic ultrasound procedures in cases where patient sensitivity to natural rubber latex is speculative.

    Device Description

    The Sheathing Technologies, Inc CIS-Isoprene Ultrasound Transducer Cover provides a thin, conformal covering to fit various and specific ultrasound transducer shapes. The cover is made by dipping to form a general cylindrical shape. It is closed at the proximal end and open at the distal end for insertion of the ultrasound transducer. This device is an accessory used on diagnostic probes to help minimize cross contamination. The cover material is a Cis-1,4-polyisoprene, a synthetic version of natural rubber latex made without using natural rubber latex in the formulation. Various sizes and shapes of covers are offered to address the variations in Ultrasound Transducer configurations. Product categories/models include General Purpose SheathesISO Ultrasound Transducer Covers (sterile and non-sterile). Covers are packaged in both sterile and nonsterile, individually wrapped or in bag/box quantities, as well as in "procedure kit" form for single patient/procedure, disposable use. The "procedure kit" may include elastic fasteners, with or without coupling gel packets. Transducer covers are also combined with disposable needle guide devices into kits.

    AI/ML Overview

    This document is a 510(k) premarket notification for a Synthetic Polyisoprene Ultrasound Transducer Cover. The information provided does not describe a study involving AI or complex statistical analysis for diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility assessments. Therefore, many of the requested categories related to AI performance, expert ground truth, and comparative effectiveness studies are not applicable.

    Here's an analysis of the provided text based on your request:

    Acceptance Criteria and Reported Device Performance

    The document describes the device's characteristics and the non-clinical tests performed to demonstrate its safety and effectiveness relative to predicate devices. The "acceptance criteria" here are implied by successful completion of these tests in comparison to established standards and the predicate device's performance.

    Acceptance CriteriaReported Device Performance
    Material Composition and Design: Synthetic polyisoprene, thin, conformal covering, general cylindrical shape, closed at proximal end, open at distal end for transducer insertion.The cover material is "Cis-1,4-polyisoprene, a synthetic version of natural rubber latex made without using natural rubber latex in the formulation." It provides "a thin, conformal covering to fit various and specific ultrasound transducer shapes. It is closed at the proximal end and open at the distal end for insertion of the ultrasound transducer."
    Intended Use: Accessory used on diagnostic probes to help minimize cross-contamination, indicated for use during diagnostic ultrasound procedures where patient sensitivity to natural rubber latex is speculative."This device is an accessory used on diagnostic probes to help minimize cross contamination." Indication for Use: "Synthetic polyisoprene probe covers are indicated for use during diagnostic ultrasound procedures in cases where patient sensitivity to natural rubber latex is speculative."
    Viral Penetration: Prevent viral penetration.Successfully passed "Viral Penetration Testing."
    Stretch Testing: Possess sufficient strength and elasticity for intended application.Successfully passed "Stretch testing."
    Pinhole Testing: Prevent pinholes.Successfully passed "Pinhole testing."
    Gel Compatibility: Compatible with ultrasound gel.Successfully passed "Gel Compatibility" testing. "Sheathing Technologies's CIS-Polyisoprene ultrasound transducer cover is compatible with ultrasound gel."
    **Biocompatibility (ISO 10993-1:2003 for surface-contacting device
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