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K Number
K992222
Device Name
FLUOROPLASTIC VENTILATION TUBES
Manufacturer
GYRUS ENT L.L.C.
Date Cleared
1999-08-26

(56 days)

Product Code
ETD
Regulation Number
874.3880
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Chronic otitis media with effusion (serous, mucoid, or purulent) .
  • Recurrent episodes of acute otitis media despite conventional medical treatment .
  • A record of persistent high negative middle ear pressure associated with one or more of the . following system:
      1. Conductive hearing loss that is symptomatic
      1. Persistent or recurrent otalgia
      1. Persistent or recurrent vertigo, tinnitus, or both
  • Retraction pocket of the tympanic membrane .
Device Description

The Fluoroplastic Ventilation Tubes are substantially equivalent to the current fluoroplastic tubes marketed by Smith & Nephew, Inc., ENT Division, and the fluoroplastic tubes marketed by Xomed.

AI/ML Overview

The provided text is a 510(k) summary for Fluoroplastic Ventilation Tubes. This type of document is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with statistical endpoints.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training sets is not available in the provided document.

The document states:

  • "The Fluoroplastic Ventilation Tubes are substantially equivalent to the current fluoroplastic tubes marketed by Smith & Nephew, Inc., ENT Division, and the fluoroplastic tubes marketed by Xomed."
  • "Differences between the Fluoroplastic Ventilation Tubes and the predicate devices should not affect the safety or effectiveness."

This indicates that the main "proof" presented is the assertion of substantial equivalence based on manufacturing materials and intended use, not a clinical study demonstrating performance against a specific set of acceptance criteria.

§ 874.3880 Tympanostomy tube.

(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.