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K Number
K971348
Device Name
FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM
Manufacturer
GREEN FIELD MEDICAL SOURCING, INC.
Date Cleared
1998-02-27

(323 days)

Product Code
CAO
Regulation Number
868.5650
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
    1. To establish a patent airway to provide ventilation to a patient who has undergone cardiac* and/or pulmonary arrest.
    1. To establish a protected airway where a compromised or obstructed airway exists in an unconscious patient. *
  • To establish a patent airway in a conscious patient who is unable to ventilate 3. adequately. *
    1. To establish a patent airway where a rescuer is unable to ventilate the unconscious patient with conventional methods. *
    1. This device is particularly indicated where standard tracheal tube intubation may be difficult or not possible.
    1. Where either tracheal or esophageal obturator airway is indicated.
    1. Applicable to larger children, small adult or adult depending on sizes of our product available, with applied clinical judgement required.
    1. For use by a person trained and experienced in airway management and the use of this device.
Device Description

FastTrach Single-Pass Trachea1/Esophagea1 Airway System

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for the FastTrach™ Single-Pass Tracheal/Esophageal Airway System. It states that the device is substantially equivalent to legally marketed predicate devices.

This document does NOT contain information regarding:

  • Acceptance criteria or reported device performance metrics.
  • A clinical study design, sample sizes, data provenance, expert qualifications, or adjudication methods.
  • Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
  • The type or establishment of ground truth for training or test sets.

Therefore, I cannot extract the requested information from the provided text.

§ 868.5650 Esophageal obturator.

(a)
Identification. An esophageal obturator is a device inserted through a patient's mouth to aid ventilation of the patient during emergency resuscitation by occluding (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea. The device consists of a closed-end semirigid esophageal tube that is attached to a face mask.(b)
Classification. Class II (performance standards).