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510(k) Data Aggregation

    K Number
    K050826
    Device Name
    FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS
    Manufacturer
    CETRO AMERICA
    Date Cleared
    2006-04-10

    (374 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K891595,K852076,K900480,K852518,K940898
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These devices are replacement accessories for the original manufacturer's fetal monitor transducers and are intended to monitor and chart Fetal Heart Rate and maternal uterine activity.

    These devices are replacement accessories for the original manufacturer's fetal monitor transducers and are intended to obtain signals to monitor and chart Fetal Heart Rate and maternal uterine activity on a fetal monitor.

    Device Description

    Cetro America, Inc. Transducers for Ultrasonic and Tocodynamometer fetal monitoring will be used as replacements for similar transducers manufactured by Corometrics (currently GE), Hewlett Packard Medical (currently Phillips Medical) and Advanced Medical Systems (currently Spacelabs Medical) and their respective fetal monitors. The ultrasound transducer is used to detect Fetal Heart Rate (FHR) using the ultrasound Doppler shift technology. Ultrasound transducers operate in a pulsed Doppler mode with around a 33% Duty Cycle. The Tocodynamometer transducer uses a strain gauge to detect uterine contraction frequency and duration during labor.

    AI/ML Overview

    The provided text is a 510(k) summary for Cetro America, Inc.'s Transducers for Ultrasonic and Tocodynamometer fetal monitoring. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

    However, the document does not describe a study involving detailed acceptance criteria and reported device performance metrics in the way that would typically be associated with AI/ML device validation. This is a clearance for replacement medical transducers based on substantial equivalence to existing devices, not a study evaluating an AI algorithm's performance.

    Therefore, many of the requested categories (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission.

    Here's a breakdown of what can be extracted and what is not present:

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implied by demonstrating substantial equivalence to predicate devices and conformity to consensus performance standards. The "reported device performance" is not quantified with specific metrics like sensitivity, specificity, or AUC, but rather by stating that "Bench testing demonstrates that the devices perform as intended."

    CategoryAcceptance Criteria (Implied)Reported Device Performance
    Intended Use (Ultrasound)To detect, measure and record fetal heart rate and the duration and frequency of uterine contractions during labor."Same" as predicate devices (Corometrics 174 & 145, HP 1356, AMS IM-76 & IM-77). Implicitly, the device successfully detects, measures, and records FHR and uterine contractions as intended.
    Intended Use (Toco)To detect, measure and record uterine pressure to determine timing of contractions."Same" as predicate devices. Implicitly, the device successfully detects, measures, and records uterine pressure as intended.
    Target Patient PopulationGravid patients, particularly during labor."Same" as predicate devices.
    Anatomical sitesUltrasound on abdomen aimed at fetal heartbeat; Toco on abdomen at top of uterus."Same" as predicate devices.
    FHR RangeAs per monitor system specifications."Same" as predicate devices. Implicitly, it operates within the same FHR range as the monitors it's compatible with.
    Uterine Activity RangeAs per monitor system specifications."Same" as predicate devices. Implicitly, it operates within the same uterine activity range as the monitors it's compatible with.
    Patient Use/ReuseReusable."Same" as predicate devices.
    SterilityNon-sterile."Same" as predicate devices.
    Patient AttachmentAttaches with elastic belts strapped to the patient."Same" as predicate devices.
    Cable LengthEight feet."Same" as predicate devices.
    AccessoriesTransducer belts and Ultrasonic Gel."Same" as predicate devices.
    Connector DesignColor-coded and designed to fit appropriate monitoring system."Same" as predicate devices.
    Acoustic Output (Ultrasound)
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