Ventilation (Tympanostomy) Tubes

K151067 · Medtronic Xomed, Inc. · ETD · Jul 22, 2015 · Ear, Nose, Throat

Device Facts

• Record ID: K151067
• Device Name: Ventilation (Tympanostomy) Tubes
• Applicant: Medtronic Xomed, Inc.
• Product Code: ETD · Ear, Nose, Throat
• Decision Date: Jul 22, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3880
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

When inserted through a myringotomy, a ventilation tube provides a passageway for movement of air between the auditory canal and the middle ear. The unobstructed passageway may also allow a means of drainage of fluids resulting from acute or chronic otitis media from the middle ear into the auditory canal. In addition, surgical placement of ventilation tubes also provides a means of equalizing air pressures between the outer ear and the middle ear and continued ventilation to prevent fluid accumulation within the middle ear.

Device Story

Small tubular implants; inserted surgically through myringotomy into tympanic membrane; provide passageway between auditory canal and middle ear. Function: equalize air pressure; facilitate drainage of middle ear fluids; prevent fluid accumulation. Materials: silicone elastomer, fluoroplastic, C-FLEX TPE, stainless steel, titanium. Designs: single or multiple flanges; some include semi-permeable membranes to allow air passage while blocking fluid. Used by surgeons in clinical settings. Benefits: resolution of otitis media symptoms; prevention of conductive hearing loss and atelectasis.

Clinical Evidence

No clinical data or new bench testing performed. Substantial equivalence is based on the consolidation of previously cleared devices and a literature review of post-market surveillance data.

Technological Characteristics

Tubular implants; materials include silicone elastomer, fluoroplastic, C-FLEX TPE, stainless steel, titanium. Features single/multiple flanges; some include semi-permeable membranes. Dimensions: ID 0.76-1.65 mm, IFD 1.09-9.80 mm, Length 1.06-13.40 mm. Sterilization: Ethylene Oxide.

Indications for Use

Indicated for patients with chronic otitis media with effusion (serous, mucoid, or purulent); recurrent acute otitis media unresponsive to alternative therapies; persistent high negative middle ear pressure associated with conductive hearing loss, otalgia, vertigo, or tinnitus; and atelectasis resulting from tympanic membrane retraction pockets or eustachian tube dysfunction.

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

• Pope Umbrella Tube (K791680)
• Otological Ventilation Tubes (K802587)
• Tytan Grommet Vent Tube, .040 (K822366)
• Armstrong V Vent Tube (K822375)
• Grommet Vent Tube (K823908)
• T-Tube Vent Tube (K823909)
• Donaldson Vent Tubes (K823910)
• Soileau Tytan Bobbin Vent Tube (K830584)
• Ventilation Tubes w/ Hydrogel Coating (K923353)
• C-Flex Vent Tubes (K943190)
• Tympanostomy Tube (K955447)
• Hoffman H/A Coated Long-Term Ventilation Tube with Liner (K963727)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with a symbol resembling a caduceus above them.

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

July 22, 2015

Medtronic Xomed, Inc. Ms. Michelle Hughes Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216

Re: K151067

Trade/Device Name: Ventilation (Tympanostomy) Tubes Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy Tube Regulatory Class: Class II Product Code: ETD Dated: April 20, 2015 Received: April 21, 2015

Dear Ms. Hughes:

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.

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.

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for 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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# Indications for Use

510(k) Number (if known)

Device Name Ventilation (Tympanostomy) Tubes

Indications for Use (Describe) Intended Use/ Indications for Use:

When inserted through a myringotomy, a ventilation tube provides a passageway for movement of air between the auditory canal and the middle ear. The unobstructed passageway may also allow a means of fluids resulting from acute or chronic otitis media from the middle ear into the auditory canal. In addition, surgical placement of ventilation tubes also provides a means of equalizing air pressures between the outer ear and continued ventilation to prevent fluid accumulation within the middle ear.

The surgeon must use medical judgment and consider the patient's medical history prior to a decision to surgically insert a ventilation tube. Pathologic conditions for which ventilation tubes are indicated include but not limited to:

- · Chronic otitis media with effusion characterized as serous, mucoid, or purulent
- · Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies

· A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus

- · Atelectasis resulting from retraction pocket of the tympanic membrane or eustachian tube dysfunction

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

# April 20, 2015

- I. Company: Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, Florida 32216 USA Telephone Number: 904-332-2489 Fax Number: 904-296-2386
- Michelle Hughes Contact: Regulatory Affairs Specialist

Proprietary Trade Name: Ventilation (Tympanostomy) Tubes

- II. Common Name: Tympanostomy Tubes
- III. Classification Name: Tympanostomy Tubes (21 CFR 874.3880)
- IV. Classification: Class II (21 CFR 874.3880)
- V. Product Code: ETD

#### VI. Introduction:

Medtronic® Xomed®, Inc. is requesting clearance for Ventilation (Tympanostomy) Tubes that include both the 12 previously cleared premarket notifications and preamendment status devices. Medtronic® Xomed®, Inc. will use the 12 previously cleared premarket notifications as predicate devices.

#### VII. Product Description:

Medtronic® Xomed® Ventilation (tympanostomy) Tubes are small tubular implants available in a variety of biocompatible materials including silicone elastomer, fluoroplastic. C-FLEX® TPE. stainless steel and titanium. Numerous designs and sizes are available with single or multiple flanges to satisfy various surgical techniques for insertion and to facilitate short or long-term communication of the auditory canal with the middle ear. Some tubes are fitted with semi-permeable membranes intended to allow free passage of air while preventing movement of fluids into the middle ear.

#### VIII. Intended Use:

When inserted through a myringotomy, a ventilation tube provides a passageway for movement of air between the auditory canal and the middle ear. The unobstructed passageway may also allow a means of drainage of fluids resulting from acute or chronic

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otitis media from the middle ear into the auditory canal. In addition, surgical placement of ventilation tubes also provides a means of equalizing air pressures between the outer ear and the middle ear and continued ventilation to prevent fluid accumulation within the middle ear.

### IX. Indications for Use:

The surgeon must use medical judgment and consider the patient's medical history prior to a decision to surgically insert a ventilation tube. Pathologic conditions for which ventilation tubes are indicated include but not limited to:

- Chronic otitis media with effusion characterized as serous, mucoid, or purulent ●
- Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies
- . A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus
- . Atelectasis resulting from retraction pocket of the tympanic membrane or eustachian tube dysfunction

### X. Identification of Legally Marketed Devices (Predicate Devices)

Ventilation (Tympanostomy) Tubes are substantially equivalent in intended use and performance characteristics to the following 12 previously cleared premarket notifications:

| Description | 510(k) Number | Clearance Date |
|------------------------------------------|---------------|----------------|
| Pope Umbrella Tube | K791680 | 11/13/1979 |
| Otological Ventilation Tubes | K802587 | 11/12/1980 |
| Tytan® Grommet Vent Tube,<br>.040 | K822366 | 09/02/1982 |
| Armstrong V Vent Tube | K822375 | 09/09/1982 |
| Grommet Vent Tube | K823908 | 01/28/1983 |
| T-Tube Vent Tube | K823909 | 03/17/1983 |
| Donaldson Vent Tubes | K823910 | 11/22/1983 |
| Soileau Tytan Bobbin Vent Tube | K830584 | 06/02/1983 |
| Ventilation Tubes w/ Hydrogel<br>Coating | K923353 | 05/18/1993 |
| C-Flex Vent Tubes | K943190 | 08/24/1994 |
| Tympanostomy Tube | K955447 | 12/21/1995 |

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| Hoffman H/A Coated Long-Term Ventilation Tube with Liner | K963727 | 02/11/1997 |
|----------------------------------------------------------|---------|------------|
|----------------------------------------------------------|---------|------------|

### XI. Comparison of the Technological Characteristics:

| Feature | Subject Device | Predicates | Comparison | | Various Materials: Silicone, Teflon, | Various Materials: Silicone, Teflon, | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---------------|--------------------------------------|--------------------------------------|------|
| Product | Ventilation (Tympanostomy) Tubes | See Section IX | Same | | Titanium Stainless Steel, C-Flex, | Titanium Stainless Steel, C-Flex, | |
| 510(k) Number | Proposed | See Section IX | Not<br>Applicable | | Silicone/Microgel, FEP | Silicone/Microgel, FEP | |
| Product Code | ETD | ETD | Same | | Fluoroplastic, Hydroxylapatite | Fluoroplastic, Hydroxylapatite | |
| Classification | Class II | Class II | Same | | Coating | Coating | |
| Common<br>Name/Classification<br>Name | Tympanostomy Tubes | Tympanostomy Tubes | Same | Sterilization | Ethylene Oxide | Ethylene Oxide | Same |
| Device Description | Medtronic® Xomed® Ventilation<br>(tympanostomy) Tubes are small<br>tubular implants available in a<br>variety of biocompatible materials<br>including silicone elastomer,<br>fluoroplastic, C-FLEX® TPE,<br>stainless steel and titanium.<br>Numerous designs and sizes are<br>available with single or multiple<br>flanges to satisfy various surgical<br>techniques for insertion and to<br>facilitate short or long-term<br>communication of the auditory canal<br>with the middle ear. Some tubes are<br>fitted with semi-permeable<br>membranes intended to allow free<br>passage of air while preventing<br>movement of fluids into the middle<br>ear. | Medtronic® Xomed® Ventilation<br>(tympanostomy) Tubes are small<br>tubular implants available in a<br>variety of biocompatible materials<br>including silicone elastomer,<br>fluoroplastic, C-FLEX® TPE,<br>stainless steel and titanium.<br>Numerous designs and sizes are<br>available with single or multiple<br>flanges to satisfy various surgical<br>techniques for insertion and to<br>facilitate short or long-term<br>communication of the auditory canal<br>with the middle ear. Some tubes are<br>fitted with semi-permeable<br>membranes intended to allow free<br>passage of air while preventing<br>movement of fluids into the middle<br>ear. | Same | Principle of | Surgically inserted in the tympanic | Surgically inserted in the tympanic | Same |
| Intended Use | When inserted through a<br>myringotomy, a ventilation tube<br>provides a passageway for<br>movement of air between the<br>auditory canal and the middle ear. | When inserted through a<br>myringotomy, a ventilation tube<br>provides a passageway for<br>movement of air between the<br>auditory canal and the middle ear. | Same | Operation | membrane following myringotomy | membrane following myringotomy | |
| | The unobstructed passageway may<br>also allow a means of drainage of<br>fluids resulting from acute or<br>chronic otitis media from the middle<br>ear into the auditory canal. In<br>addition, surgical placement of<br>ventilation tubes also provides a | The unobstructed passageway may<br>also allow a means of drainage of<br>fluids resulting from acute or<br>chronic otitis media from the middle<br>ear into the auditory canal. In<br>addition, surgical placement of<br>ventilation tubes also provides a | | | to provide a passageway for the | to provide a passageway for the | |
| | means of equalizing air pressures<br>between the outer ear and the middle<br>ear and continued ventilation to<br>prevent fluid accumulation within<br>the middle ear. | means of equalizing air pressures<br>between the outer ear and the middle<br>ear and continued ventilation to<br>prevent fluid accumulation within<br>the middle ear. | | | movement of air between the | movement of air between the | |
| Indications for<br>Use | The surgeon must use<br>medical judgment and<br>consider the patient's<br>medical history prior to a<br>decision to surgically insert a<br>ventilation tube. Pathologic<br>conditions for which<br>ventilation tubes are<br>indicated include but not<br>limited to:<br>Chronic otitis media<br>with effusion<br>characterized as<br>serous, mucoid, or<br>purulent Recurrent acute otitis<br>media which fails to<br>respond satisfactorily<br>to alternative<br>therapies A patient with a<br>history of persistent<br>high negative middle<br>ear pressure which<br>may be associated<br>with conductive<br>hearing loss, otalgia,<br>vertigo and/or<br>tinnitus Atelectasis resulting<br>from retraction<br>pocket of the<br>tympanic membrane<br>or eustachian tube<br>dysfunction | The surgeon must use<br>medical judgment and<br>consider the patient's<br>medical history prior to a<br>decision to surgically insert a<br>ventilation tube. Pathologic<br>conditions for which<br>ventilation tubes are<br>indicated include but not<br>limited to:<br>Chronic otitis media<br>with effusion<br>characterized as<br>serous, mucoid, or<br>purulent Recurrent acute otitis<br>media which fails to<br>respond satisfactorily<br>to alternative<br>therapies A patient with a<br>history of persistent<br>high negative middle<br>ear pressure which<br>may be associated<br>with conductive<br>hearing loss, otalgia,<br>vertigo and/or<br>tinnitus Atelectasis resulting<br>from retraction<br>pocket of the<br>tympanic membrane<br>or eustachian tube<br>dysfunction | Same | | auditory canal and the middle ear | auditory canal and the middle ear | |
| Technological<br>Characteristics | Various Sizes (ID: 0.76-1.65; IFD:<br>1.09-9.80 L: 1.06-13.40 mm) | Various Sizes (ID: 0.76-1.65; IFD:<br>1.09-9.80 L: 1.06-13.40 mm) | Same | | | | |

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#### XII. Discussion of the Performance Testing

The Ventilation (Tympanostomy) Tubes did not undergo any design changes as a result of this submission. Therefore no additional bench, animal or clinical testing is required. A Literature Review is provided with post market surveillance data for these Ventilation Tubes.

#### XIII. Conclusions

A comparison of key characteristics demonstrates that the proposed submission consolidates previously cleared and preamendment Ventilation Tubes that have the same intended use/indications for use, technological characteristics and principle of operations. Based on this, Medtronic Xomed claims substantial equivalence to the predicate devices.