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510(k) Data Aggregation

    K Number
    K040490
    Device Name
    WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE
    Manufacturer
    WELCH ALLYN, INC.
    Date Cleared
    2004-08-18

    (174 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Abbreviated
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K002530,K024005
    Why did this record match?
    Device Name :

    WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE

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

    The Spot Vital Signs Ultra automatically measures systolic and diastolic pressure, Mean Arterial Pressure (MAP), pulse rate, temperature (oral, adult axillary, pediatric axillary, rectal, and ear), and pulse oximetry (SpO2) of adult and pediatric patients. Furthermore, Spot Vital Signs Ultra allows the manual entry of height, weight, respiration, and pain level. Spot Ultra also calculates Body Mass Index (BMI) following height and weight entry. The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.

    Device Description

    The Welch Allyn Spot Ultra Vital Signs Device utilizes an Oscillometric BP Algorithm and temperature technology, similar to Spot Vital Signs and utilizes the same SpO2 OEM as the Welch Allyn Spot Vital Signs. The new Spot Ultra Vital Signs will incorporate a new temperature module (Braun 4000) and a new SpO2 OEM module the Masimo SET as options.

    AI/ML Overview

    Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Welch Allyn Spot Ultra Vital Signs device:

    Welch Allyn Spot Ultra Vital Signs Device: Acceptance Criteria and Study Information

    This 510(k) summary describes the Welch Allyn Spot Ultra Vital Signs device, which measures blood pressure, pulse rate, temperature, and pulse oximetry. The summary establishes substantial equivalence to existing predicate devices (Welch Allyn Spot Vital Signs) by comparing technological characteristics and adherence to relevant standards.

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria (Standard / Predicate)Reported Device Performance
    Blood Pressure Measurement AccuracyAAMI SP10-1992 (Predicate Device)AAMI SP10-2002 (Spot Ultra Vital Signs Device)
    Cuff Pressure: +/- 3 mmHg
    Systolic: 60-250 mmHg
    Diastolic: 30-160 mmHg
    Heart Rate (Oscillometric): +/- 5% (35-199 bpm)
    Nellcor® OEM SpO2 Measurement AccuracySpO2: 70-100% +/- 3% (
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