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510(k) Data Aggregation

    K Number
    K181699
    Date Cleared
    2018-07-26

    (29 days)

    Product Code
    Regulation Number
    870.5900
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    Level 1 Convective Warmer

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

    The Level 1® Convective Warmer is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warmer can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Level 1® Convective Warmer can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments.

    Device Description

    The Level 1® Convective Warmer, is a forced air thermal regulating systems which includes a connection hose to attach to the Snuggle Warm® Convective Warming Blankets for patients requiring body temperature requlation in clinical environments which are provided non-sterile and intended to be reused. In order to accommodate various clinical environments, the Level 1® Convective Warmer is able to be placed on the floor, placed on a floor cart, or mounted on an I.V. pole to allow flexible portability. The Level 1® Convective Warmer is used with the Snuggle Warm® Convective Warming Blankets.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device, specifically a convective warmer. It is not about an AI/ML medical device. Therefore, the information requested about acceptance criteria, study details, expert involvement, and ground truth for an AI/ML model is not available in this document.

    The document focuses on establishing substantial equivalence for a physical medical device (Level 1® Convective Warmer) to a predicate device (Equator® Convective Warmer), particularly noting the introduction of a microprocessor control system in the new device where the predicate used analog circuitry. The "performance testing" described refers to engineering and safety tests for the physical device, not a performance study of an AI model's diagnostic accuracy.

    Therefore, I cannot provide a response that directly answers the detailed questions about AI/ML acceptance criteria and study particulars based on the provided text. The prompt's assumptions (e.g., test sets, ground truth establishment, MRMC studies) are applicable to AI/ML device submissions, but not to this specific medical device submission.

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