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510(k) Data Aggregation

    K Number
    K152115
    Device Name
    Renew NCP-5 External Counterpulsation System
    Manufacturer
    Stage 2 Innovations
    Date Cleared
    2015-12-17

    (141 days)

    Product Code
    DRN
    Regulation Number
    870.5225
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K042413
    Why did this record match?
    Applicant Name (Manufacturer) :

    Stage 2 Innovations

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

    The Renew NCP-5 External Counterpulsation System is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, increased VO2, and increased blood flow. It is intended for use under the oversight of a healthcare professional.

    Device Description

    The Renew"" NCP-5 External Counterpulsation System (ECS) is comprised of the following major components, a switch panel, laptop PC computer, a foldable treatment bed, main unit, and a set of patient cuffs. The device is a microprocessor-controlled system that sequentially inflates then deflates three pairs of air cuffs, which compress vascular beds in the muscles of the calves, thighs, and buttocks in synchrony with the heart cycle to achieve the desired therapy.

    AI/ML Overview

    This document describes a 510(k) premarket notification for the Renew™ NCP-5 External Counterpulsation System. Unfortunately, the provided text does not contain details about acceptance criteria, a specific study proving the device meets those criteria, or information relevant to an AI/ML-based device evaluation.

    The document focuses on:

    • The FDA's 510(k) clearance for the Renew™ NCP-5 External Counterpulsation System.
    • The device's intended use and technological characteristics (external counterpulsation).
    • Biocompatibility, electrical safety, EMC compatibility, and software/firmware validation.
    • A "literature review regarding the use of external counterpulsation in healthy patients" to support an additional indication.
    • The conclusion of substantial equivalence to its predicate device (ACS Model NCP-2 External Counterpulsation Device).

    There is no mention of an AI/ML component in the Renew™ NCP-5 External Counterpulsation System. Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device cannot be extracted from this text.

    To answer your specific questions, I would need a different document that details the validation of an AI/ML medical device.

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