SILICONE TRACHEAL T-TUBES

• K Number: K013321
• Device Name: SILICONE TRACHEAL T-TUBES
• Manufacturer: TECHNICAL PRODUCTS, INC.
• Date Cleared: 2002-06-04 ( 242 days)
• Product Code: BTR
• Regulation Number: 868.5730
• Type: Traditional
• Panel: Anesthesiology
• Reference & Predicate Devices: N/A
• Predicate For: K120079

Intended Use

1. As a stent to aid in the rehabilitation of tracheal stenosis
2. As a stent to temporarily aid in laryngotracheal injuries
3. To support a Reconstituted Trachea
4. As a stent to provide an airway for a cervical trachea that cannot be repaired

Device Description

Not Found

AI/ML Overview

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called "Silicone Tracheal T-Tube." This document focuses on the regulatory approval process based on substantial equivalence to a predicate device, rather than a study detailing acceptance criteria and device performance as a standalone product.

Therefore, the information required to answer your request (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text. The document is a regulatory approval letter, not a scientific study report.

Specifically, it doesn't contain:

1. A table of acceptance criteria and reported device performance.
2. Details about a test set, its sample size, or data provenance.
3. Information on experts, their qualifications, or ground truth establishment.
4. Adjudication methods.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone performance study results.
7. Type of ground truth used.
8. Information about a training set or how its ground truth was established.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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..." This means the device's market approval is based on its similarity to an already approved device, not necessarily on a new, comprehensive performance study meeting specific acceptance criteria in the way you've outlined.

Summary

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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 [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" (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 [phone] or [phone] 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:

1. As a stent to aid in the rehabilitation of tracheal stenosis

2. As a stent to temporarily aid in laryngotracheal injuries

3. To support a Reconstituted Trachea

4. 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

Regulation Number and Section

§ 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).