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510(k) Data Aggregation

    K Number
    K040392

    Validate with FDA (Live)

    Device Name
    TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
    Manufacturer
    AMERICAN I.V. PRODUCTS, INC.
    Date Cleared
    2004-09-14

    (210 days)

    Product Code
    HFM
    Regulation Number
    884.2720
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K982651,K992811
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These devices are intended to be used as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.

    AIV Transducer Model Numbers: FM10835 and FM10836. These devices are a direct replacement for the EPIC EFU200-20, Ultrasound Transducer for measuring fetal heart rate.

    AIV Transducer Model Numbers: FM10839 and FM10840. These devices are a direct replacement for the Corometric's 2264LAX. TOCO Transducer for measuring uterine contractions.

    AIV Transducer Model Number: FM10841. This device is a direct replacement for the EPIC EFT200-20, TOCO Transducer for measuring uterine contractions.

    Device Description

    AIV's ultrasound (US) and tocodynamometer (TOCO) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The AIV transducers are also a replacement for similar transducers manufactured by Epic for use on Corometrics and Hewlett Packard monitors.

    The US transducers are used to detect the fetal heart rate using Doppler shift technology. The TOCO transducers detect uterine activity using a strain gauge for evaluating contractions. These transducers are intended to be a direct replacement for the Corometrics, Hewlett Packard and Epic transducers.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the fetal monitoring transducers, formatted as requested:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Acoustic Output < 20mW/cm² averageAcoustic output testing shows power is less than 20mW/cm² average.
    Assembly design equivalent to predicate deviceAIV assembly design is equivalent to predicate device assembly design.
    Performance as intended and equivalent to predicate device assembliesBench Testing demonstrates that the AIV devices perform as intended and are equivalent to predicate device assemblies.
    BiocompatibilityAIV plastics have conformed to consensus standards relating to Biocompatibility.
    Does not raise new issues of safety and effectiveness"These devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate devices."
    Does not alter fundamental technology of predicate devices"These devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate devices."
    Intended Use: Measure fetal heart rate and uterine contractions in the gravid patient (same as predicate)The AIV devices are intended to be used as replacement transducer accessories for Corometrics and Hewlett Packard monitors, for use in measuring fetal heart rates and uterine contractions, which is "Same" as the predicate devices.
    Anatomical Sites (same as predicate)The ultrasound transducer is placed on the maternal abdomen aimed at the fetal heart; the TOCO transducer is placed on the maternal abdomen over the fundal area of the uterus (Same as predicate).
    Target Patient Population (same as predicate)Gravid patients, especially during labor (Same as predicate).
    FHR Range (same as predicate: dependent upon monitor specifications)Dependent upon monitor specifications (Same as predicate).
    Uterine Activity Range (same as predicate: dependent upon monitor specifications)Dependent upon monitor specifications (Same as predicate).
    Patient Use/Reuse: Reusable (same as predicate)Reusable (Same as predicate).
    Sterility: Non-sterile (same as predicate)Non-sterile (Same as predicate).
    Description of Patient Attachment (same as predicate)These devices attach to the gravid patient with elastic straps around the waist (Same as predicate).
    Cable Length: 10 feet (predicate varied)10 feet (predicate varied, e.g., Epic had 8 feet). This is a point of minor difference but not flagged as non-equivalent.
    Accessories (same as predicate)Transducer belts and ultrasonic gel (Same as predicate).
    Connector Design (same as predicate)Transducer cable connectors are color-coded and keyed to fit the appropriate fetal monitors (Same as predicate).
    Operational Characteristics (Pulsed Doppler)AIV FM10835 = Pulsed Doppler; AIV FM10836 = Pulsed Doppler (Same as predicate).
    Ultrasound Center Frequency (approx. 1.0 MHz)AIV FM10835 = 1.0 MHz; AIV FM10836 = 1.0 MHz (predicate 5700LAX = 1.151 MHz, EFU200-20 = 1.0 MHz). The AIV devices match one predicate directly and are close to the other.

    Study Information

    1. Sample size used for the test set and the data provenance:

      • The document does not specify a sample size for a test set. This was a 510(k) premarket notification for a replacement accessory, focusing on equivalence to predicate devices rather than a new clinical study with a test set of patients.
      • Data Provenance: Not applicable in the context of a clinical test set. The data presented is from bench testing and conformity to standards.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • Not applicable. There is no mention of a test set with ground truth established by experts. The determination of substantial equivalence relies on comparison to existing, legally marketed devices and specified technical performance.

    3. Adjudication method for the test set:

      • Not applicable. No test set requiring adjudication is described.

    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

      • No. This is a medical device (transducer) for measuring physiological signals, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant or mentioned.

    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

      • No. This device is an accessory transducer, not a standalone algorithm. The "performance" assessment is based on physical and technical characteristics and its ability to function as a direct replacement for predicate transducers.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • The "ground truth" in this context is the performance and specifications of the predicate devices (Corometrics, Epic, Hewlett Packard transducers) and established consensus standards (e.g., for biocompatibility, acoustic output limits). The AIV transducers aim to meet or be equivalent to these.

    7. The sample size for the training set:

      • Not applicable. This device is not an AI algorithm that requires a training set.

    8. How the ground truth for the training set was established:

      • Not applicable. As above, this device is not an AI algorithm.
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