Predicate Devices

K791680, K802587, K822366, K822375, K823908, K823909, K823910, K830584, K923353, K943190, K955447, K963727

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a passive medical device (ventilation tubes) and does not mention any computational or analytical capabilities, let alone AI/ML.

Therapeutic

Yes
The device is described as providing a passageway for air movement and drainage, equalizing air pressures, and preventing fluid accumulation to treat conditions like otitis media. These actions are directly aimed at treating or alleviating medical conditions.

Diagnostic

No

A diagnostic device is used to identify a condition or disease. This device, a ventilation tube, is used to treat conditions like otitis media by providing a passageway for air and drainage, thus it is a therapeutic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device is a "small tubular implant" made of various biocompatible materials, indicating it is a physical hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Function: The description clearly states that this device is a ventilation tube inserted into the ear to provide a passageway for air and drainage. It is a physical implant used to treat conditions of the middle ear.
Lack of Specimen Analysis: There is no mention of this device being used to collect, prepare, or analyze any biological specimens. Its function is purely mechanical and therapeutic.

Therefore, this device falls under the category of a surgical implant or device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

Product codes (comma separated list FDA assigned to the subject device)

ETD

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Auditory canal, middle ear, tympanic membrane

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Surgeon, medical judgment and consideration of patient's medical history prior to surgical insertion in a clinical setting.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K791680, K802587, K822366, K822375, K823908, K823909, K823910, K830584, K923353, K943190, K955447, K963727

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 874.3880 Tympanostomy tube.

(a)
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.(b)
Classification. Class II.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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,
.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
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
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
Name/Classification
Name	Tympanostomy Tubes	Tympanostomy Tubes	Same	Sterilization	Ethylene Oxide	Ethylene Oxide	Same
Device 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.	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.	Same	Principle of	Surgically inserted in the tympanic	Surgically inserted in the tympanic	Same
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.	When inserted through a
myringotomy, a ventilation tube
provides a passageway for
movement of air between the
auditory canal and the middle ear.	Same	Operation	membrane following myringotomy	membrane following myringotomy
	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	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			to provide a passageway for the	to provide a passageway for the
	means of equalizing air pressures
between the outer ear and the middle
ear and continued ventilation to
prevent fluid accumulation within
the middle ear.	means of equalizing air pressures
between the outer ear and the middle
ear and continued ventilation to
prevent fluid accumulation within
the middle ear.			movement of air between the	movement of air between the
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	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	Same		auditory canal and the middle ear	auditory canal and the middle ear
Technological
Characteristics	Various Sizes (ID: 0.76-1.65; IFD:
1.09-9.80 L: 1.06-13.40 mm)	Various Sizes (ID: 0.76-1.65; IFD:
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.