LogoFDA 510(k) Search
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
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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.

§ 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).