TYMPANOSTOMY TUBE

K082188 · Acclarent, Inc. · ETD · Sep 19, 2008 · Ear, Nose, Throat

Device Facts

• Record ID: K082188
• Device Name: TYMPANOSTOMY TUBE
• Applicant: Acclarent, Inc.
• Product Code: ETD · Ear, Nose, Throat
• Decision Date: Sep 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Conditions for which tympanostomy tubes are indicated include: Chronic otitis media with effusion (serous, mucoid, or purulent) Recurrent otitis media that fails to respond to conventional medical treatment A history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus. Retraction pocket of the tympanic membrane.

Device Story

Tympanostomy tube; silicone material; inserted through tympanic membrane. Provides ventilation and drainage to middle ear. Used by clinicians to treat chronic/recurrent otitis media and negative middle ear pressure. Benefits patient by resolving fluid buildup and pressure-related symptoms.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Silicone tympanostomy tube; available in Donaldson and Paparella styles; designed for insertion through the tympanic membrane to facilitate middle ear ventilation and fluid drainage.

Indications for Use

Indicated for patients with chronic otitis media with effusion, recurrent otitis media unresponsive to medical treatment, persistent high negative middle ear pressure (associated with conductive hearing loss, otalgia, vertigo, or tinnitus), or tympanic membrane retraction pockets.

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.

Predicate Devices

• MicroMedics Otological Ventilation Tube (K830228)
• Xomed Activent Ventilation Tube (K941407)
• Exmoor Plastics Ltd. Donaldson Vent-Mini Tube (K911580)

Submission Summary (Full Text)

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SEP 1 9 2008

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| | APPENDIX A: 510(k) SUMMARY |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor/Submitter: | Acclarent, Inc.<br>1525-B O'Brien Drive<br>Menlo Park, California 94025 |
| Contact Person: | Keri Yen<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Date of Submission: | August 1, 2008 |
| Device Trade Name: | TBD |
| Common Name: | Tympanostomy Tube |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 874.3880 |
| Classification Name: | Tube, Tympanostomy |
| Product Code: | ETD |
| Predicate Devices: | MicroMedics Otological Ventilation Tube (K830228)<br>Xomed Activent Ventilation Tube (K941407)<br>Exmoor Plastics Ltd. Donaldson Vent-Mini Tube (K911580) |
| Device Description: | The Tympanostomy Tube is a silicone tube that is intended to<br>provide ventilation and/or drainage to the middle ear. The<br>Tympanostomy Tube is available in two types: Donaldson and<br>Paparella. |
| Indications for Use: | Conditions for which tympanostomy tubes are indicated include:<br>○ Chronic otitis media with effusion (serous, mucoid, or purulent)<br>○ Recurrent otitis media that fails to respond to conventional medical treatment<br>○ A history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus.<br>○ Retraction pocket of the tympanic membrane. |
| Technological<br>Characteristics: | The Tympanostomy Tube, when inserted through the tympanic membrane, is intended to ventilate the middle ear. It also allows for drainage of fluid resulting from otitis media. |
| Performance Data: | The Tympanostomy Tube met all performance acceptance<br>criteria. |
| Summary of Substantial<br>Equivalence: | The Tympanostomy Tube is substantially equivalent to the<br>predicate devices as confirmed through relevant tests. |

Acclarent)

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**Acclarent**

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human profiles, represented by curved lines. The profiles are arranged in a way that suggests a sense of unity and collaboration.

SEP 1 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Acclarent, Inc. c/o Keri Yen 1525-B O'Brien Drive Menlo Park, CA 94025

Re: K082188

Trade/Device Name: Tympanostomy Tube Regulation Number: 21 CFR 874.3880 Regulation Name: Tube, tympanostomy Regulatory Class: II Product Code: ETD Dated: August 1, 2008 Received: August 4, 2008

Dear Ms. Yen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 --Keri Yen

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mahina B. Esguerra, M.D.

Malvina B. Eydelman, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## APPENDIX B: INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K082188 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | TBD |
| Common Name: | Tympanostomy Tube |
| Indications For Use: | Conditions for which tympanostomy tubes are indicated include: <ul><li>Chronic otitis media with effusion (serous, mucoid, or purulent)</li><li>Recurrent otitis media that fails to respond to conventional medical treatment</li><li>A history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus.</li><li>Retraction pocket of the tympanic membrane.</li></ul> |

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Karen A. Baker

Sign-Off) ാivision of Ophthalmic Ear, Nose and Throat Devises

KO82188 510(k) Number _

(Posted November 13, 2003)

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