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K Number
K972126
Device Name
MYRINGOTOMY TUBE
Manufacturer
MEDNET LOCATOR, INC.
Date Cleared
1997-07-29

(54 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

The MedNet LOCATOR, INC., pediatric myringotomy tube is to be used by ear, nose and throat physicians for insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient.

Device Description

Myringotomy Tube - Pediatric

AI/ML Overview

This letter is a 510(k) clearance for a Myringotomy Tube - Pediatric device and does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document states:

  • The device is a "Myringotomy Tube - Pediatric" (K972126).
  • It is for "insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient."
  • The FDA has determined the device to be "substantially equivalent" to devices marketed prior to May 28, 1976. This means it has met the regulatory requirements for clearance based on its similarity to an already approved device, rather than through a direct study demonstrating its performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from this document. It does not include:

  • A table of acceptance criteria or reported device performance.
  • Sample sizes for test sets or data provenance.
  • Information on experts for ground truth establishment or adjudication methods.
  • Details on MRMC comparative effectiveness studies or standalone algorithm performance.
  • Specific types of ground truth used.
  • Sample sizes for training sets or how ground truth for training sets was established.

§ 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.