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510(k) Data Aggregation

    K Number
    K042556
    Device Name
    SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,
    Manufacturer
    ENTER MEDICAL CORPORATION
    Date Cleared
    2005-03-11

    (172 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K002846
    Why did this record match?
    Reference Devices :

    K002846

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

    To be used in emergency situations to provide lung ventilation to individuals whose breathing is inadequate.

    Device Description

    ShineBall manual emergency resuscitator is a portable device used in life emergency situations to provide lung ventilation to individual whose breathing is inadequate. An optional ShineBall mask is recommended for use with a resuscitator to cover the patient's nose and mouth as a port to receive the patient connector of the resuscitator. A standard reservoir bag is to be used with the ventilation bag when the oxygen gas is supplied to the patient. The performances of the manual resuscitators are intended for operator-powered types. Operator-powered resuscitator device is a device by which the ventilation of the lung is produced by operator's compressing the air out of the compressible part of the device. To reach the best effect of the clinical situations, adult, child and infant sizes of the resuscitators are designed according to body mass ranges. For safety consideration the pressure limiting valve is designed optionally for those who are not so skillful to operate the device. By adding the pressure limiting valve into the setting of the device, the pressure of the lung ventilation can be controlled easily according to patient's individual requirement. To lighten the financial burden of the patient or medical facilities, the material of Silicone, which can be autoclaved, is provided for reuse. To lower the cross-infection hazard the material PVC are used for single use and disposable ones.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the ShineBall Manual Resuscitator:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission declares that the device's performance and specifications are "consistent with all requirements for this device type specified by" three international standards. It does not provide specific numerical acceptance criteria or reported device performance metrics in a tabular format within the document. Instead, it refers to the entire standard as the acceptance criteria.

    Acceptance Criteria (Reference Standard)Reported Device Performance
    ASTM 920: Standard Specification for Minimum Performance and Safety Requirements for Resusciators Intended for Use with Humans"consistent with all requirements" of ASTM 920
    ISO 8382: 1988 (E): Resuscitators Intended for Use with Humans"consistent with all requirements" of ISO 8382
    ISO 5356-1: 1987: Anesthetic and Respiratory Equipment, Conical Connectors-Part 1: Cones and Sockets"consistent with all requirements" of ISO 5356-1
    ISO 10993-5 (Cytotoxicity study)"passes"
    ISO 10993-10 (Skin irritation study)"passes"
    ISO 10993-10 (Skin sensitization study)"passes"

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

    The provided text does not specify a sample size for any test set used for performance evaluation (beyond the statement that "all" resuscitators passed biocompatibility tests). There is no mention of data provenance (e.g., country of origin, retrospective/prospective). The implication is that the performance testing was conducted internally to meet the referenced standards.

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

    This information is not provided in the document. The performance evaluation refers to compliance with international standards, rather than a clinical trial or expert-reviewed dataset which would typically involve establishing ground truth.

    4. Adjudication Method for the Test Set

    This information is not provided. As no expert-based ground truth establishment is mentioned, an adjudication method would not be applicable in the context described.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

    No MRMC comparative effectiveness study was mentioned or performed. The device is a manual resuscitator, and its evaluation focuses on meeting engineering and safety standards, not on improving the performance of human readers assisted by AI.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    This is not applicable as the ShineBall Manual Resuscitator is a physical medical device, not an algorithm or AI system.

    7. The Type of Ground Truth Used

    The "ground truth" for the device's performance is established by its compliance with the specified international engineering and safety standards (ASTM 920, ISO 8382, ISO 5356-1) and biocompatibility standards (ISO 10993-5, ISO 10993-10). No clinical outcomes data or pathology-confirmed ground truth is mentioned in this submission for performance evaluation.

    8. The Sample Size for the Training Set

    This is not applicable as the device is not an AI or algorithm that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    This is not applicable as the device is not an AI or algorithm that requires a training set.

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