(365 days)
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.
Not Found
I am sorry. I cannot provide information about acceptance criteria and study details based on the provided text. The document is a 1997 FDA 510(k) clearance letter for a "ffrench Pocket Emergency Airway" device. It confirms the device's substantial equivalence to a predicate device and its classification.
The letter does not include:
- A table of acceptance criteria or reported device performance.
- Details about a specific study, sample sizes, data provenance, expert qualifications, or adjudication methods.
- Information on MRMC comparative effectiveness studies, standalone performance, or ground truth types and how they were established.
This document is solely an FDA clearance letter, not a clinical study report or a summary of performance data.
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Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUM. SERVICES - USA" are arranged around the top of the circle. The eagle is facing to the right, and its wings are depicted with thick, curved lines.
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 aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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. In manufac
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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
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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510(k) Number ________________________________________________________________________________________________________________________________________________________________
Device Name:ffrench 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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
To A Wictastaran
(Division Sign Off)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Nuniber_
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 868.5090 Emergency airway needle.
(a)
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.(b)
Classification. Class II (performance standards).