ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM

K103595 · Acclarent, Inc. · ETD · Apr 1, 2011 · Ear, Nose, Throat

Device Facts

• Record ID: K103595
• Device Name: ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
• Applicant: Acclarent, Inc.
• Product Code: ETD · Ear, Nose, Throat
• Decision Date: Apr 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3880
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Tympanostomy Tube Delivery System is intended to provide a means to create a myringotomy with insertion of a preloaded Paparella type tympanostomy tube. 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

Mechanical delivery system for myringotomy and tympanostomy tube insertion; preloaded with Paparella-type tube. Used in operating room under general anesthesia by physicians. Device tip registered against tympanic membrane; button-controlled activation creates incision and deploys tube. Facilitates ventilation of middle ear; treats chronic/recurrent otitis media and associated symptoms like conductive hearing loss or tinnitus. Benefits include standardized, efficient tube placement.

Clinical Evidence

Prospective, multi-center, single-arm study of 101 ears in 53 pediatric subjects. Primary endpoint: device success rate (94%). 6% non-success rate due to deployment failure (resolved with standard tools). 100% of ears received indicated treatment. 98.95% tube retention at one week. Tube occlusion rate (5%) consistent with clinical literature (7-37%).

Technological Characteristics

Mechanical delivery system; pre-loaded with Paparella-type tympanostomy tube. Manual button-controlled activation for myringotomy and tube deployment. Standalone device; no energy source or software.

Indications for Use

Indicated for pediatric patients requiring myringotomy and tympanostomy tube placement due to chronic otitis media with effusion, recurrent otitis media unresponsive to medical treatment, persistent high negative middle ear pressure, 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

• Heinz Kurz GmbH Medizintechnik Trocar Ventilation Tube (K830228)
• Acclarent Tympanostomy Tube (K082188)
• Exmoor Plastics Ltd. Myringotomy Kit (K980828)

Submission Summary (Full Text)

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Aclarent

Traditional 510(k)
Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System

APR - 1 2011

| | APPENDIX A: 510(k) SUMMARY | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Sponsor/Submitter: | Acclarent, Inc.<br>1525-B O'Brien Drive<br>Menlo Park, California 94025 | |
| Contact Person: | Gurvinder Singh Nanda<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone] | |
| Date of Submission: | January 25, 2011 | |
| Device Trade Name: | TBD | |
| Common Name: | Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery<br>System | |
| Device Classification: | Class II | |
| Regulation Number: | 21 CFR 874.3880 | |
| Classification Name: | Tube, Tympanostomy | |
| Product Code: | ETD | |
| Predicate Devices: | Heinz Kurz GmbH Medizintechnik Trocar Ventilation Tube (K830228)<br>Acclarent Tympanostomy Tube (K082188)<br>Exmoor Plastics Ltd. Myringotomy Kit (K980828) | |
| Device Description: | The Tympanostomy Tube Delivery System is a device that penetrates<br>the tympanic membrane and inserts the Acclarent Tympanostomy Tube<br>with a button controlled activation. | |
| Indications for Use: | The Tympanostomy Tube Delivery System is intended to provide a<br>means to create a myringotomy with insertion of a preloaded Paparella<br>type tympanostomy tube.<br><br>Conditions for which tympanostomy tubes are indicated include:<br><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> | |

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Aclarent

## Traditional 510(k)
Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System

| Technological<br>Characteristics: | The Tympanostomy Tube Delivery System is a mechanical device that<br>can create a myringotomy and deliver the Acclarent Tympanostomy<br>Tube. The Acclarent Tympanostomy Tube is provided pre-loaded in<br>the subject device. |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | Acclarent conducted a prospective, multi-center, single arm clinical<br>study to evaluate the performance and safety of the Acclarent TTDS<br>device for the placement of the Acclarent Tympanostomy Tube in<br>subject ears indicated for such treatment for chronic OME or recurrent<br>AOM. |
| | A total of 101 ears were enrolled in 53 pediatric subjects by 4<br>investigators at 4 study sites. All study procedures were performed<br>under general anesthesia in the operating room. The overall Device<br>Success rate of the TTDS device was 94% (95/101). The 6% device<br>non-success rate was attributable to failure of the devices to fully<br>deploy the tubes across the tympanic membranes. This anticipated<br>failure mode can occur if the device tip is not fully registered against<br>the tympanic membrane. This mode was not associated with any<br>adverse sequelae and in each case, standard otologic tools were used to<br>manually place a tympanostomy tube. 100% (101/101) of enrolled ears<br>received their indicated treatment. |
| | At the one-week post-procedure follow-up visit, retention of the<br>Acclarent Tympanostomy Tube was observed at a rate of 98.95%<br>(94/95). Consistent with the rates reported in the clinical literature, tube<br>occlusion was observed in 5% of tubes at follow-up: the incidence of<br>non-functional tympanostomy tubes caused by occlusion is relatively<br>common, ranging from 7% to 37% (Tsao, BA et al. Otolaryngol Head<br>Neck Surg, 128(6):870-874, 2001) and has been known to occur in a<br>wide variety of tubes (Weigel, MT et al. Laryngoscope, 99:252-256,<br>1989). |
| | The Tympanostomy Tube Delivery System met all the study<br>performance acceptance criteria. |
| Summary of Substantial<br>Equivalence: | The Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery<br>System is substantially equivalent to the predicate devices as confirmed<br>through dimensional attributes. |

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Acclarent, Inc. c/o Gurvinder Singh Nanda, Ph.D. Regulatory Affairs Manager 1525-B O'Brien Drive Menlo Park, CA 94025

- 1 2911 APR

Re: K103595

Trade/Device Name: Tympanostomy Tube Delivery System Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy Tube Regulatory Class: Class II Product Code: ETD Dated: February 24, 2011 Received: February 28, 2011

Dear Dr. Nanda:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Gurvinder Singh Nanda, Ph.D.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Euth Rinn for

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

Enclosure

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**Acclarent**

Traditional 510(k) Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System

| 510(k) Number (if known): | K103595 | |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Trade Name: | TBD | |
| Common Name: | Tympanostomy Tube Delivery System | |
| Indications For Use: | The Tympanostomy Tube Delivery System is intended to provide a means to create a myringotomy with insertion of a preloaded Paparella type tympanostomy tube.<br>Conditions for which tympanostomy tubes are indicated include:<br><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<br>X<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(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)

Daniel C. Clumpp
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

KID3595 510(k) Number_

(Posted November 13, 2003)