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510(k) Data Aggregation

    K Number
    K112163
    Device Name
    MONICA IF24
    Manufacturer
    MONICA HEALTHCARE
    Date Cleared
    2011-08-30

    (34 days)

    Product Code
    OSP,HGM
    Regulation Number
    884.2720
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K101801,K023931
    Why did this record match?
    Device Name :

    MONICA IF24

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

    The Monica IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal monitor. The Monica IF24 CTG Interface Device enables signals collected by the Monica AN24 to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. The device is intended for use by healthcare professionals in a clinical setting.

    Device Description

    The Monica IF24 CTG Interface Device is an interface device that allows an AN24 to send data to a standard Fetal Monitor. The Monica AN24™ is a small, battery-powered device for L&D surveillance of fetal well-being. The AN24™ is designed to passively monitor Fetal Heart Rate (FHR) from the fetal electrocardiogram (fECG) and Uterine Activity (UA) from the Electrohysterogram (EHG) during pregnancy and can be used at any time from > 36 completed weeks gestation in laboring patients. The AN24™ is suitable for singleton pregnancies only.

    The Monica IF24 CTG Interface Device is a small, low-voltage device that receives the monitored parameters from the Monica AN24 Fetal Monitor and converts the wireless digital signal to analogue for inputting into a CTG Monitor. It has a touch screen for:

    • Selection of the appropriate CTG monitor
    • Calibration with the CTG Monitor
    • Display AN24 battery power
    • Display Bluetooth connectivity between the AN24 & IF24
    AI/ML Overview

    The Monica IF24 CTG Interface Device is an accessory designed to interface the wireless output of the Monica AN24 Fetal Monitor with a standard CTG (Cardiotocography) Fetal monitor. This allows signals collected by the AN24 to be displayed, printed, and potentially sent to a central network via the CTG monitor.

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

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document primarily focuses on non-clinical testing and substantial equivalence rather than explicit performance metrics with acceptance criteria for clinical efficacy. The acceptance criteria are broadly implied as compliance with relevant voluntary standards and accurate data reception/transmission.

    Acceptance Criteria (Implied)Reported Device Performance
    Electrical Safety (Compliance with EN60601-1)"The Monica IF24 CTG Interface Device and Accessories comply with voluntary standards. The standards were employed in the following areas: Electrical Safety." "The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were EN60601-1 electrical safety."
    EMC (Electromagnetic Compatibility) (Compliance with EN60601-1-2, FCC CFR47)"The Monica IF24 CTG Interface Device and Accessories comply with voluntary standards. The standards were employed in the following areas: EMC." "The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were EN60601-1-2 EMC, FCC CFR47 EMC."
    Material Safety/Biocompatibility (Compliance with ISO10993)"The Monica IF24 CTG Interface Device and Accessories comply with voluntary standards. The standards were employed in the following areas: Material Safety." "The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were ISO10993 Biocompatibility."
    Software Validation (Compliance with EN 62304)"The Monica IF24 CTG Interface Device and Accessories comply with voluntary standards. The standards were employed in the following areas: Software Validation." "The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were EN 62304 Software."
    Usability (Compliance with IEC 62366)"The Monica IF24 CTG Interface Device and Accessories comply with voluntary standards. The standards were employed in the following areas: Usability." "The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were IEC 62366 Usability."
    Quality Management System (Compliance with ISO13485)"The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were ISO13485 QMS."
    Accurate data reception and transmission"The Monica IF24 CTG Interface Device accurately receives and transmits the correct data." (Demonstrated through "software validation and performance bench testing").
    Substantial Equivalence to predicate devices"The conclusions drawn from the nonclinical tests, performance tests and the validation demonstrate that the Monica IF24 CTG Interface Device is substantially equivalent to the legally marketed predicate device."

    2. Sample Size Used for the Test Set and Data Provenance:

    The document does not explicitly state a "test set" in the context of clinical data for the IF24 device. The regulatory submission is primarily based on non-clinical tests (electrical safety, EMC, material safety, software validation, usability, and performance bench testing) to demonstrate substantial equivalence to predicate devices (Monica AN24, Philips Avalon CTS).

    • Sample Size for Test Set: Not applicable or not specified in terms of patient data. The testing involves engineering and software validation tests.
    • Data Provenance: Not applicable in terms of patient data. The testing is described as non-clinical and performance bench testing, likely conducted in a laboratory or engineering environment. The manufacturer is Monica Healthcare Ltd, based in Nottingham, UK.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

    This information is not provided in the document. Given the non-clinical nature of the testing described, it's unlikely that "experts" (e.g., radiologists) in the typical sense for medical image interpretation were used for establishing ground truth for a clinical test set. The experts involved would likely be engineers, software testers, and regulatory compliance specialists responsible for executing and evaluating the non-clinical tests.

    4. Adjudication Method for the Test Set:

    Not applicable. There is no mention of an adjudication method for a clinical test set because the provided information focuses on non-clinical and bench testing.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

    No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence through non-clinical testing of the interface device itself, not on comparing human reader performance with or without AI assistance.

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

    The concept of "standalone performance" as typically applied to an AI algorithm making a diagnosis or performing a task without human intervention doesn't directly apply here. The Monica IF24 is an interface device; its "performance" is in accurately receiving and transmitting data, not in making clinical interpretations. The "algorithm" in this context refers to the software controlling the device's functionality (e.g., conversion of wireless digital signal to analog), which was validated through "software validation and performance bench testing" to ensure accurate data handling.

    7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

    For the non-clinical tests, the "ground truth" would be established by:

    • Compliance with published standards: For electrical safety, EMC, material safety, software, usability, and QMS, the ground truth is simply adherence to the requirements outlined in the specified standards (e.g., EN60601-1, IEC 62366).
    • Expected data values/behavior: For "accurate data reception and transmission," the ground truth would be the known input data values from the AN24 and the expected output values and waveform fidelity on the CTG monitor, verified through performance bench testing.

    8. The Sample Size for the Training Set:

    Not applicable. The Monica IF24 is an interface device, not an AI model that requires a training set in the conventional sense of machine learning for classification or prediction tasks. The software involved handles data conversion and communication, which is validated, not "trained."

    9. How the Ground Truth for the Training Set was Established:

    Not applicable, as there is no mention of a training set for an AI model.

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