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K Number
K061058
Device Name
NEOZOLINE VENTILATION TUBES
Manufacturer
ADEPT MEDICAL LTD
Date Cleared
2006-07-12

(86 days)

Product Code
ETD
Regulation Number
874.3880
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The largest patient population are children between 4 months and 6 years of age (but not exclusively). Otological ventilation tubes are indicated for patients with:

  • Chronic or recurrent otitis media with persistent effusion (OME).
  • Recurrent acute otitis media.
  • Acute otitis media with complications.
  • Eustachian tube dysfunction resulting in one or more of the following: significant and symptomatic hearing loss, otalgia, vertigo, and tinnitus.
  • Hearing loss resulting from bilateral chronic middle ear effusion.
Device Description

Neozoline Ventilation Tubes

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the "Neozoline Ventilation Tubes" and does not contain information regarding detailed acceptance criteria, device performance studies, or ground truth establishment relevant to AI/ML device evaluation. It is a regulatory document stating that the device is substantially equivalent to a predicate device for its indicated uses.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on:

  • Device Name: Neozoline Ventilation Tubes
  • Regulation Number/Name: 21 CFR 874.3880, Tympanostomy Tubes
  • Regulatory Class: Class II
  • Product Code: ETD
  • Indications for Use: Chronic or recurrent otitis media with persistent effusion (OME), Recurrent acute otitis media, Acute otitis media with complications, Eustachian tube dysfunction (resulting in hearing loss, otalgia, vertigo, tinnitus), and Hearing loss from bilateral chronic middle ear effusion.
  • Target Population: Largest patient population are children between 4 months and 6 years of age (but not exclusively).

To answer your questions about acceptance criteria and device performance studies, a different type of document (e.g., a clinical study report, a comprehensive technical report, or a detailed submission summary that includes performance data) would be required.

§ 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.