FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM

• 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

Intended Use

- 1. To establish a patent airway to provide ventilation to a patient who has undergone cardiac* and/or pulmonary arrest. - 2. 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. * - 4. To establish a patent airway where a rescuer is unable to ventilate the unconscious patient with conventional methods. * - 5. This device is particularly indicated where standard tracheal tube intubation may be difficult or not possible. - 6. Where either tracheal or esophageal obturator airway is indicated. - 7. Applicable to larger children, small adult or adult depending on sizes of our product available, with applied clinical judgement required. - 8. 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

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical airway management device and does not mention any software, algorithms, or AI/ML capabilities.

Therapeutic

No
The device is used to establish and maintain an airway, which is a supportive function to enable ventilation, rather than directly treating a disease or condition. Its purpose is to facilitate other medical interventions rather than directly providing therapy.

Diagnostic

No
The provided text describes the device's use for establishing a patent airway for ventilation or to protect a compromised airway, which are therapeutic interventions rather than diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly indicates a "Trachea1/Esophagea1 Airway System," which is a physical medical device used for airway management, not a software-only product.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential donors and recipients, or to monitor therapeutic measures.
• Device Function: The description of the "FastTrach Single-Pass Trachea1/Esophagea1 Airway System" clearly indicates it is a device used to establish and maintain an airway within a patient's body. It is a physical device used for ventilation and airway management.
• Intended Use: The intended uses all relate to directly interacting with a patient's airway to facilitate breathing, not to analyze biological specimens.

Therefore, this device falls under the category of a medical device used for direct patient care, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Indications For Use:

• 1. To establish a patent airway to provide ventilation to a patient who has undergone cardiac* and/or pulmonary arrest.
• 2. 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. *
• 4. To establish a patent airway where a rescuer is unable to ventilate the unconscious patient with conventional methods. *
• 5. This device is particularly indicated where standard tracheal tube intubation may be difficult or not possible.
• 6. Where either tracheal or esophageal obturator airway is indicated.
• 7. Applicable to larger children, small adult or adult depending on sizes of our product available, with applied clinical judgement required.
• 8. For use by a person trained and experienced in airway management and the use of this device.

*Note: These four indications are modified from "Indications for Endotracheal Intubation" from the Textbook of Advanced Life Support published by the American heart Association, copyright 1994 (ISBN 0-87493-626-8) p2-3.

Product codes

73 CAO

Device Description

FastTrach™ Single-Pass Tracheal/Esophageal Airway System

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

airway, tracheal, esophageal

Indicated Patient Age Range

larger children, small adult or adult

Intended User / Care Setting

a person trained and experienced in airway management and the use of this device.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 1998

Mr. Donald R. Gorsuch President GreenField Medical Products, Inc. 910 Boston Turnpike Shrewsbury, MA 01545

Re : K971348 FastTrach™ Single-Pass Tracheal/Esophageal Airway System Requlatory Class: II (Two) Product Code: 73 CAO Dated: December 4, 1997 December 9, 1997 Received:

Dear Mr. Gorsuch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

1

Page 2 - Mr. Donald R. Gorsuch

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of -1-

510(k) Number (if known): K971348

Device Name: FastTrach Single-Pass Trachea1/Esophagea1 Airway System

Indications For Use:

• 1. To establish a patent airway to provide ventilation to a patient who has undergone cardiac* and/or pulmonary arrest.
• 2. 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. *
• 4. To establish a patent airway where a rescuer is unable to ventilate the unconscious patient with conventional methods. *
• 5. This device is particularly indicated where standard tracheal tube intubation may be difficult or not possible.
• 6. Where either tracheal or esophageal obturator airway is indicated.
• 7. Applicable to larger children, small adult or adult depending on sizes of our product available, with applied clinical judgement required.
• 8. For use by a person trained and experienced in airway management and the use of this device.

*Note: These four indications are modified from "Indications for Endotracheal Intubation" from the Textbook of Advanced Life Support published by the American heart Association, copyright 1994 (ISBN 0-87493-626-8) p2-3.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Rugg

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_K971348

Prescription Use (Per 2.1 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)