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    K Number
    K050320
    Device Name
    FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT
    Manufacturer
    ASCENDIA MEDTECH AB
    Date Cleared
    2005-08-15

    (187 days)

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

    FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT

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

    The FreeeScan® Ultrasound Transducer Covers are protective covers applied to ultrasound transducers. These covers are designed to provide a sterile barrier between the non-sterile TXD's (and instrument guide adapters in some cases) and the patient/healthcare worker. The covers are intended for use during both sterile and non-sterile procedures using sector, linear, intravaginal and rectal transducers.

    The cover is latex-free and therefore beneficial in procedures with a patient with known type I hypersensitivity, or for the healthcare worker who has become type I sensitive. The transducer covers are supplied sterile or non-sterile and intended for single-use.

    Covers are packed in sterile or non-sterile "convenience" kits form for single patient/procedure, disposable use. Covers kits are supplied with needle guide devices, coupling gel packet, elastic bands, and tape.

    Device Description

    The FreeeScan® Ultrasound Transducer Cover provides a thin, conformal covering to fit various ultrasound transducer geometries. The device is manufactured as a one-piece design that provides a covering to prevent the transmission of pathogens, as the ultrasound transducer is reused from one patient to another.

    The cover material is Chloroprene (synthetic rubber), which is similar to the non-latex material used in medical examination gloves or surgical gloves. Type I natural latex allergy does not occur in response to Chloroprene since the synthetic rubber does not contain the natural protein allergen which is present in latex.

    Various sizes and shapes of covers are offered in order to fit different transducer geometries. The following product models are currently included (other shapes are likely to be added):

    • . FreeeScan® 1 - W:3.4 cm, L:45-244 cm (Drawing 5500-000002-1B)
    • FreeeScan® 4 W:10 cm, L:45-244 cm (Drawing 5500-000003-1B) .
    • FreeeScan® 6 W:9.5/11.5 cm, L:45-244 cm (Drawing 5500-000004-1B) .
    • . FreeeScan® 8 - W:7.5 cm, L:45-244 cm (Drawing 5500-000005-1B)
    • FreeeScan® 77 Ø:2.6 cm, L:30 cm (Drawing 5500-000016-1A) .
    • FreeeScan® 84 Ø:3 cm, L:30 cm (Drawing 5500-000015-1A) .

    All of these versions are composed of the same materials, they are made using the same processes and procedures, in the same facilities and on the same equipment.

    AI/ML Overview

    The provided document is a 510(k) summary for the FreeeScan® Ultrasound Transducer Cover. This document focuses on demonstrating substantial equivalence to a predicate device (CIVCO Medical's NeoFlex™ Ultrasound Transducer Cover) rather than presenting a study with specific acceptance criteria and performance metrics for the device itself in the way one might expect for an AI algorithm or diagnostic tool.

    The "acceptance criteria" here are essentially the demonstration that the FreeeScan® device is as safe and effective as the predicate device. The "study" is the comparison made against the predicate device based on various parameters.

    Here's an analysis based on the structure provided in your request, but adapted to the nature of this 510(k) submission:

    1. Table of Acceptance Criteria and Reported Device Performance

    For this 510(k) summary, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device. The "reported device performance" is a comparison to the predicate's known characteristics.

    ParameterAcceptance Criteria (Predicate Device Performance)Reported Device Performance (FreeeScan® Ultrasound Transducer Cover)
    Intended Use/Indications for UseProvides a thin, conformal protective cover system for diagnostic ultrasound transducer usage in body surface, endocavity, and intra-operative patient environments; helps to prevent transfer of micro organisms, 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. Is non-latex therefore beneficial when treating a patient with known type I hypersensitivity, or for the healthcare worker who has become type I sensitized.Same (Provides a sterile barrier, latex-free, for sterile and non-sterile procedures using various transducers).
    DesignOne-piece, closed end, rolled (condom style) with various dimensional configurations necessary to accommodate differences in ultrasound transducer geometries.The FreeeScan® Ultrasound Transducer Cover is folded. In other respects the same.
    MaterialPolychloroprene, synthetic rubber. Materials used in compounding meet recommended safe levels as specified in US FDA CFR, Title 21, Section 177.2600 and 182.5991. USP Absorbable Dusting Powder. Synthetic rubber does not contain the natural protein allergen residuals present in latex.Same (Chloroprene/synthetic rubber, latex-free).
    ManufacturingDip-molding/rubber vulcanisation. Packaged in class 10 000 clean room per Federal Std 209e. Packaging system per ANSI/AAMI/ISO 11607.Packaged in class 100 000 clean room, otherwise the same.
    Quality SystemFDA/QSR cGMP 21CFR Part 820. ISO 9001/ISO 13485/EN 46001.Same.
    SterilitySterilization (when applicable) by 100%EtO method; Validated ANSI/AAMI/ISO 11135 SAL 10-6.Same.
    Contact CategorySurface devices, intact skin/mucosal membranes/breached surfaces; limited contact duration (
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