(212 days)
The T-Wall™ Uncuffed Tracheal Tube is indicated for tracheal intubation and airway management.
T-Wall™ Uncuffed Tracheal Tube
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (T-Wall™ Uncuffed Tracheal Tube). This type of document primarily confirms that a device has been found substantially equivalent to a predicate device and allows it to be marketed.
It does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria, study design, expert qualifications, or AI-related metrics. The letter focuses on regulatory approval rather than a scientific study report.
Therefore, I cannot provide the requested table and information based solely on the text you provided.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Anthony P. Martino Vital Signs, Inc. 20 Campus Road --Totowa, New Jersey 07512
AUG 21 1997 :
Re: K970196 T-Wall™ Uncuffed Tracheal Tube Requlatory Class: II (two) Product Code: 73 BTR Dated: July 2, 1997 Received: July 3, 1997
Dear Mr. Martino:
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 misbrandinq 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 cbligation 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. Anthony P. Martino
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 (301) 594-4648. 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
{2}------------------------------------------------
REF:510(K) Number K970196 Submitted by: Vital Signs Inc. Product: T-Wall™ Uncuffed Tracheal Tube
"Indication For Use"
The T-Wall™ Uncuffed Tracheal Tube is indicated for tracheal intubation and airway management.
. m. Pn C
(Division Sign-Off) Division of Cardiovascut and Neurological Devis 510(k) Number
prescription use $\checkmark$
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).