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510(k) Data Aggregation

    K Number
    K992057
    Device Name
    IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
    Manufacturer
    SIMS PORTEX, INC.
    Date Cleared
    1999-09-13

    (87 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K972283
    Why did this record match?
    Reference Devices :

    K972283

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

    The 1st Response Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to patients suffering from respiratory distress. It is intended for use on patients with a body mass of 25 kg (55 lbs) or more.

    Device Description

    The 1st Response manual resuscitator is a disposable, single use emergency manual ventilator. Each device consists of a plastic compressible ventilator bag fitted with control valves at each of the two ends. The inlet valve, opposite the patient end, allows entry of fresh gas into the compressible ventilator bag. The valve blocks escape of fresh gas from the ventilator bag during its compression. Attached to this valve are one of two types of reservoirs; bag reservoir or tube reservoir. These reservoirs serve to collect an overflow of oxygen when a supplemental oxygen supply is used. The patient end of the ventilator bag is fitted with a second valve assembly. This valve consists of a 15 mm ID x 22 mm OD patient connector and exhalation port. A manometer port is optional. The device is provided with or without a facemask. Special configurations are available which include a disposable manometer, PEEP valve with adapter, or exhalation filter.

    AI/ML Overview

    The document provided is a 510(k) summary for a medical device called the "1st Response Manual Resuscitator." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a new study.

    Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training and ground truth for an AI-powered device.

    The document states:

    • "Performance and specifications of the modified device are consistent with all requirements for this device type specified by ISO 8382:1988 (E) Resuscitators intended for use with humans and ISO 5356-1: 1987 - Anaesthetic and respiratory equipment -Conical connectors - Part 1: Cones and sockets."
    • "The comparison to the predicate devices demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices."

    This indicates that the device's characteristics were compared against established standards (ISO) and existing predicate devices, rather than being subjected to a novel clinical study with explicit acceptance criteria for a new device's performance.

    In summary, this document does not support the generation of the requested table and details.

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