(212 days)
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Not Found
No
The summary describes a physical medical device (tracheal tube) and contains no mention of AI, ML, or software-based image processing or analysis.
No
The T-Wall™ Uncuffed Tracheal Tube is used for intubation and airway management, which are procedures, not therapies.
No
Explanation: The device is a tracheal tube used for intubation and airway management, which are therapeutic and management procedures, not diagnostic ones.
No
The device description clearly identifies it as a "Tracheal Tube," which is a physical hardware device used for intubation. There is no mention of software as the primary component or function.
Based on the provided information, the T-Wall™ Uncuffed Tracheal Tube is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "tracheal intubation and airway management." This describes a medical device used in vivo (within the body) for a procedural purpose, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description is of a physical tube used for airway management.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Reagents or test kits
Therefore, the T-Wall™ Uncuffed Tracheal Tube is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The T-Wall™ Uncuffed Tracheal Tube is indicated for tracheal intubation and airway management.
Product codes
73 BTR
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
tracheal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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.
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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 (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
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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.
. m. Pn C
(Division Sign-Off) Division of Cardiovascut and Neurological Devis 510(k) Number
prescription use $\checkmark$