(242 days)
Not Found
Not Found
No
The summary describes a physical medical device (a stent) and contains no mention of AI, ML, image processing, or data analysis related to AI/ML model training or performance.
Yes
The device is described as a stent used to aid in the rehabilitation of tracheal stenosis, temporarily aid in laryngotracheal injuries, support a reconstituted trachea, and provide an airway for a cervical trachea, all of which are therapeutic interventions.
No
The device is described as a stent for rehabilitation, temporary aid, and support of the trachea, which are all therapeutic functions. There is no mention of it being used to detect, diagnose, or monitor a disease or condition.
No
The intended use describes a physical stent, which is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to providing structural support and maintaining an airway within the trachea. These are therapeutic or supportive functions performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not involve the examination of specimens.
- Device Description: While the device description is "Not Found," the intended uses clearly point to a physical implant or support structure.
- Other Information: The lack of mentions of image processing, AI/ML, input imaging modality, training/test sets, performance studies, and key metrics further supports that this is not an IVD, as these are common elements for devices that analyze data or images.
Therefore, based on the provided details, this device is a medical device used for direct patient treatment/support, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- As a stent to aid in the rehabilitation of tracheal stenosis
- As a stent to temporarily aid in laryngotracheal injuries
- To support a Reconstituted Trachea
- As a stent to provide an airway for a cervical trachea that cannot be repaired
Product codes
BTR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tracheal/Thoracic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard . Rockville MD 20850
Technical Products, Inc. c/o Norbert Thomson, President 2416 Park Central Boulevard Decatur. Georgia 30035
Re: K013321
Trade/Device Name: Silicone Tracheal T-Tube Regulation Number: 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: May 9, 2002 Received: May 10, 2002
Dear Mr. Thomson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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.
JUN 0 4 2002
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Norbert Thomson, President
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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510 (k) Number (if known):
K 013321
Tracheal/Thoracic T-Tube Device Name:
Indications for Use:
-
As a stent to aid in the rehabilitation of tracheal stenosis
-
As a stent to temporarily aid in laryngotracheal injuries
-
To support a Reconstituted Trachea
-
As a stent to provide an airway for a cervical trachea that cannot be repaired
Prescription Use (Per 21 CFR 801.109)
Anatolut
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
KO133. 510(k) Number