TYMPANOSTOMY VENTILATION TUBE

K971454 · Ikonos Corp. · ETD · May 29, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K971454
• Device Name: TYMPANOSTOMY VENTILATION TUBE
• Applicant: Ikonos Corp.
• Product Code: ETD · Ear, Nose, Throat
• Decision Date: May 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ventilation tubes are indicated where cases of enstachian tube dysfunction fails to respond conventional therapy. This includes : · Chronic otitis Media with effusion (serous , mucoid, or pur ulent). Recurrent acute ofitis Media . persistent high negative A record of with associated middle ear pressure, hearing conductive Symptomatic otalgia, vertige and for timmitas brangia, version of the tympanic membraine.

Device Story

Tympanostomy ventilation tube (TVT 800) is a passive implantable device; inserted into tympanic membrane by otolaryngologist; facilitates middle ear ventilation and drainage; treats chronic/recurrent otitis media and associated symptoms (hearing loss, otalgia, vertigo, tinnitus); provides pressure equalization; non-electronic; no software or algorithm.

Clinical Evidence

No clinical data provided; device is a passive implantable ventilation tube.

Technological Characteristics

Passive implantable ventilation tube; dimensions/materials not specified in document; non-electronic; no software; no energy source.

Indications for Use

Indicated for patients with eustachian tube dysfunction unresponsive to conventional therapy, including chronic otitis media with effusion (serous, mucoid, or purulent), recurrent acute otitis media, persistent high negative middle ear pressure with associated conductive hearing loss, symptomatic otalgia, vertigo, and tinnitus.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized human figure with three lines representing the body, arms, and legs. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

MAY 2 9 1997

Robert E. Ellis Vice President, Operations Ikonos Corporation 320 Southwest Sixth Avenue Second Floor Portland, Oregon 97204-1749 Re: K971454

Tympanotomy Ventilation Tube-TVT 800 Dated: April 17, 1997 Received: April 21, 1997 Regulatory class: II 21 CFR 874.3880/Procode: 77 ETD

Dear Mr. Ellis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions against misbranion.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51. through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations:

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed production a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] for Radiology devices, or 594-4613 for Eac, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities water the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K971454 510(k) Number (if known): Device Name: Tympanostomy Ventilation Tube - TVT 800 Indications For Use: Ventilation tubes are indicated where cases of enstachian tube dysfunction fails to respond conventional therapy. This includes : · Chronic otitis Media with effusion (serous , mucoid, or pur ulent). Recurrent acute ofitis Media . persistent high negative A record of with associated middle ear pressure, hearing conductive Symptomatic otalgia, vertige and for timmitas brangia, version of the tympanic membraine.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Gerrit A. Lykken
(Division Sign-Off)

Division of Reproductive, Abdominal, El and Radiological Devices V4710 0(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)