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510(k) Data Aggregation

    K Number
    K013434
    Device Name
    VP-2000/1000
    Manufacturer
    COLIN CORP.
    Date Cleared
    2002-07-09

    (266 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K973637,K973562,K922668,K990809
    Why did this record match?
    Device Name :

    VP-2000/1000

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

    VP-2000/1000 is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. It has a capability of measuring; non-invasive blood pressures, heart rate, pulse wave, and heart sound. It also has a capability of calculating ABI (Ankle Brachial Index), Pulse Wave Velocity, and Augmentation Index. The instrument is used in a vascular laboratory, clinic, hospital, doctor's office, and other medical facilities where the non-invasive peripheral vascular test is conducted. It is used on adult patients only.

    Device Description

    The BP-203 RPE II Series VP-1000 and VP-2000 monitor is a prescriptive device intended for use only by health care professionals. The monitors are designed to assist in the detection of peripheral vascular diseases and have been designed and tested to automate published clinical diagnostic test methods. The device is capable of measuring noninvasive blood pressure (NIBP), ECG (lead I), non-invasive pulse waveforms, and heart sounds. In addition, the monitors are also capable of calculating specific clinically recognized indices such as ABI (Ankle-Brachial Index) and PWV (Pulse Wave Velocity).

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called VP-2000/1000. It describes the device, its intended use, and states that performance testing was conducted. However, it does not provide specific details about acceptance criteria, the results of the performance study, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance using the provided input. The document only generally states that "Clinical tests were performed and confirmed the performance of VP-2000/1000 met the product requirements." It does not elaborate on what those specific requirements or the results were.

    To answer your request, I would need more detailed information, typically found in a clinical study report rather than a 510(k) summary.

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