KEY CHAIN EMERGENCY AIRWAY

K962312 · Ffrench Pocket Emergency Airway, Inc. · BWC · Jun 17, 1997 · Anesthesiology

Device Facts

• Record ID: K962312
• Device Name: KEY CHAIN EMERGENCY AIRWAY
• Applicant: Ffrench Pocket Emergency Airway, Inc.
• Product Code: BWC · Anesthesiology
• Decision Date: Jun 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5090
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for emergency airway obstruction in a non-clinical environment. The device is intended to be used for less than 24 hours.

Device Story

The Key Chain Emergency Airway is a portable, temporary device designed for use in non-clinical environments to address emergency airway obstruction. It is intended for short-term use, specifically less than 24 hours. The device is operated by individuals in emergency situations to maintain an open airway. It functions as a mechanical aid to assist breathing during acute obstruction events. The device is provided for prescription use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical airway device; portable form factor; intended for temporary, short-term use (<24 hours).

Indications for Use

Indicated for emergency airway obstruction management in non-clinical settings for patients requiring temporary airway support for less than 24 hours.

Regulatory Classification

Identification

An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 17 1997

Mr. H. Clay Wilson, P.E.
ffrench Pocket Emergency Airway, Inc.
1705 Calhoun Street
New Orleans, Louisiana 70118

Re: K962312
Key Chain Emergency Airway
Regulatory Class: II (two)
Product Code: 73 BWC
Dated: May 29, 1997
Received: May 30, 1997

Dear Mr. Wilson:

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 2 - 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.

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Page 2 - Mr. H. Clay Wilson, P.E.

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, 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 13 of 14

510(k) Number K962312

Device Name: french Pocket Emergency Airway

Indications For Use:

The device is intended for emergency airway obstruction in a non-clinical environment.

The device is intended to be used for less than 24 hours.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jo A Wicdaw

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

Prescription Use ☑

(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)