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510(k) Data Aggregation

    K Number
    K211747
    Device Name
    Reusable NIBP Cuff
    Manufacturer
    Shenzhen Coreray Technology Co., Ltd.
    Date Cleared
    2021-09-23

    (108 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K173197
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Reusable NIBP Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in adult size.

    Device Description

    Reusable NIBP Cuff is a reusable accessory used in conjunction with a non-invasive blood pressure measurement system. It comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure.

    Reusable NIBP Cuff is made of PU synthetic leather (Cuff), TPU film (bladder) and TPU (Air Hose), and the PU synthetic leather is the material used to contacting with the patient's intact skin.

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a reusable NIBP (Non-Invasive Blood Pressure) cuff. It details the device's indications for use, safety and performance testing, and a comparison to a predicate device to establish substantial equivalence.

    Based on the provided text, there is no information about a study proving the device meets acceptance criteria related to a diagnostic algorithm or AI performance. The document is for a physical medical device (blood pressure cuff) and focuses on its physical characteristics, materials, and mechanical performance (e.g., durability of inflation cycles, biocompatibility) rather than a software or AI-driven diagnostic.

    Therefore, I cannot provide answers to the specific points requested (acceptance criteria table, sample size for test/training sets, expert ground truth, MRMC study, standalone performance, etc.) as they pertain to the evaluation of an AI/algorithm-based device, which is not what this document describes.

    The acceptance criteria stated for this device primarily revolve around:

    • Compliance with recognized standards: ISO 81060-1 (Non-Invasive Sphygmomanometers), ISO 10993-5 (Cytotoxicity), and ISO 10993-10 (Irritation and Skin Sensitization).
    • Biocompatibility: Demonstrated through testing for cytotoxicity, sensitization, and irritation.
    • Mechanical Durability: 10,000 inflations and 3,000 hook and loop closures.
    • Pressure Limits: 0-300mmHg.
    • Intended Use and Patient Population Matching: For adult size, non-sterile, reusability.
    • Substantial Equivalence: To a legally marketed predicate device (Orantech Inc. Reusable NIBP Cuff, K173197).

    The document explicitly states: "Clinical performance is not deemed necessary." and there is no mention of an AI/ML component in this device.

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