T-WALL UNCUFFED TRACHEAL TUBE

K970196 · Vital Signs, Inc. · BTR · Aug 21, 1997 · Anesthesiology

Device Facts

• Record ID: K970196
• Device Name: T-WALL UNCUFFED TRACHEAL TUBE
• Applicant: Vital Signs, Inc.
• Product Code: BTR · Anesthesiology
• Decision Date: Aug 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The T-Wall™ Uncuffed Tracheal Tube is indicated for tracheal intubation and airway management.

Device Story

T-Wall™ Uncuffed Tracheal Tube is a medical device used for tracheal intubation and airway management. It is inserted into the trachea to maintain an open airway for ventilation. Used in clinical settings such as hospitals or emergency care by trained healthcare professionals (physicians, anesthesiologists, or respiratory therapists). The device facilitates gas exchange by providing a conduit for air/oxygen delivery to the lungs. It is a passive mechanical device; no electronic or software components are involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Uncuffed tracheal tube; mechanical airway management device. No electronic components, software, or energy sources. Materials and construction consistent with standard tracheal tube specifications.

Indications for Use

Indicated for tracheal intubation and airway management in patients requiring an artificial airway.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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
Regulatory 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 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 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 GMF 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. 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 [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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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.


prescription use ☑