MYRINGOTOMY TUBE - BOBBIN WITH TAB

K972400 · Mednet Locator, Inc. · ETD · Jul 23, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972400
• Device Name: MYRINGOTOMY TUBE - BOBBIN WITH TAB
• Applicant: Mednet Locator, Inc.
• Product Code: ETD · Ear, Nose, Throat
• Decision Date: Jul 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MedNet Locator, INC., bobbin with tab 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 Story

Myringotomy tube (bobbin with tab) designed for surgical insertion into eardrum; used by ENT physicians to treat mild to chronic otitis media; facilitates ventilation and drainage of middle ear; relieves earache and discomfort; mechanical device; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bobbin-shaped myringotomy tube with tab; mechanical ventilation/drainage device; class II per 21 CFR 874.3880.

Indications for Use

Indicated for patients with mild to chronic otitis media requiring ventilation or drainage of the middle ear via myringotomy tube insertion.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Judy S. Chandler MedNet Locator, Inc. 7000 Shadow Oaks Memphis, TN 38125

Re: K972400 Myringotomy Tube - Bobbin with Tab Dated: May 20, 1997 Received: June 5, 1997 Regulatory class: II 21 CFR 874.3880/Procode: 77 ETD

JUL 2 3 1997

Dear Ms. Chandler:

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 intentions for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to 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 prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (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 Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 predicate device results in 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 vitry diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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 under 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.

h.Jliau Ym
Lillian Yim, Ph.D.

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

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K972400 510(k) Number (if known):

Device Name:_ Myringotomy Tube - Bobbin with Tab

Indications For Use:

The MedNet Locator, INC., bobbin with tab 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices |
|---------------|----------------------------------------------------------------------------------------------------|
| 510(k) Number | |

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | |

(Optional Format 1-2-96)