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K Number
K232059
Device Name
Tympanostomy Tubes
Manufacturer
Grace Medical, Inc.
Date Cleared
2023-11-24

(136 days)

Product Code
ETD
Regulation Number
874.3880
Type
Traditional
Panel
EN
Reference & Predicate Devices
K062385,K830228
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • 1 ) Chronic otitis media with effusion characterize as either serous, mucoid, or purulent.
    1. Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies.
    1. A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss that is symptomatic, persistent or recurrent otalgia, persistent or recurrent vertigo and/or timitus.
    1. Atelectasis recurrent form retraction pocket of the tympanic membrane or eustachian tube dysfunction.
Device Description

The Grace Medical, Inc. ETFE (Fluoroplastic) Ventilation Tubes are intended to ventilate the middle ear subsequent to otitis media. The placement of the tympanic membrane provides the means for any fluid buildup in the middle ear while creating an avenue of the passage of air to equalize pressure on either side of the drum. These ventilation tubes will be made from ETFE (fluoroplastic). ETFE has been used as a material for ventilation tubes and other middle ear application for many years.

AI/ML Overview

This document describes an FDA 510(k) premarket notification for a medical device, specifically a Tympanostomy Tube. The submission aims to demonstrate "substantial equivalence" to previously cleared devices rather than providing clinical performance data with acceptance criteria for a new AI application.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance for an AI device is not applicable to this document.

This document focuses on:

  • Device: Grace Medical, Inc. ETFE Tympanostomy Tube (K232059)
  • Predicate Devices: Grace Medical, Inc. PTFE Tympanostomy Tube (K062385) and Micromedic, Inc. ETFE Tympanostomy Tube (K830228)
  • Primary Change: Material change from PTFE to ETFE for the Grace Medical device.
  • Demonstration of Substantial Equivalence: By comparing technological characteristics, indications for use, and presenting non-clinical bench testing, biocompatibility, sterility, and packaging testing data.

There is no mention of an AI component or software in this document.

§ 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.