LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K102625
    Device Name
    VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03
    Manufacturer
    VEGA TECHNOLOGIES, INC.
    Date Cleared
    2011-06-10

    (270 days)

    Product Code
    BZD,BTT
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K010263
    Why did this record match?
    Device Name :

    VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03

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

    The VEGA CPAP System/Heated Humidifier, models CP-03 delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only. The device is intended for use in the home or hospital/institutional environment on adult patients.

    Device Description

    The VEGA CPAP System/Heated Humidifier, models CP-03 is a smaller and lighter AC -powered, micro processor-controlled, and blower-based system that generates positive airway pressure from 3 to 20 cm H2O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface(mask). The CPAP device may also be used with VEGA Heated Humidifier that has been designed to be compatible with the CPAP and controlled from the CPAP. The basic functional and performance characteristics of the VEGA CPAP System/Heated Humidifier are completely similar to the predicate device, the Respironics REMstar Plus CPAP System/REMstar Heated Humidifier(K010263).

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria in the context of a medical device's performance characteristics or clinical outcomes. Instead, it describes a 510(k) summary for a CPAP system and heated humidifier, focusing on its substantial equivalence to a predicate device, technical specifications, and non-clinical verification activities.

    Specifically:

    • The document mentions "Performance Compliance Test for CPAP according to ISO 17510-1" and "Performance Compliance Test for heated humidifier according to ISO 17510-1" as non-clinical tests conducted by the manufacturer. However, it does not specify what the acceptance criteria for these tests were (e.g., specific pressure accuracy ranges, flow rate tolerances, temperature stability) nor does it report the device's performance against any such criteria.
    • It explicitly states: "No any Clinical Test is conducted for the VEGA CPAP System/Heated Humidifier." This means there is no clinical study to demonstrate effectiveness or patient outcomes, which would typically be associated with acceptance criteria for device performance in a clinical setting.
    • The document primarily relies on "substantial equivalence" to a predicate device (Respironics REMstar Plus CPAP System/REMstar Heated Humidifier, K010263) based on similar intended use and technological characteristics, and verification/validation tests for electrical safety and EMC.

    Therefore, I cannot provide the requested table or answer most of the questions because the necessary information (acceptance criteria, reported performance against those criteria, details of a performance study, sample sizes, ground truth, expert qualifications, etc.) is not present in the provided 510(k) summary.

    In summary, the document does not describe a study that proves the device meets specific acceptance criteria in the way a clinical trial or a detailed performance validation report would.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1