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.

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

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Ventilation (Tympanostomy) Tubes" by Medtronic Xomed, Inc. This submission is for consolidating previously cleared and preamendment ventilation tubes and claims substantial equivalence to predicate devices. As such, it does not contain information about a study to prove acceptance criteria for a new device or algorithm performance.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this document. This submission relies on the existing clearance and established performance of the predicate devices.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Not Applicable. This submission is for devices that have already been cleared or were preamendment devices, meaning their performance and safety were established previously. No new performance acceptance criteria or study results are presented in this document. The document asserts "same" for all comparative characteristics with existing predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No new test set or data provenance is mentioned as no new performance testing was conducted for this 510(k). The document states, "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."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No test set or ground truth establishment relevant to the performance of a new device is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set or related adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI device, and no MRMC study was conducted or referenced for this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an AI/algorithm device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No new ground truth for performance evaluation is mentioned. The clearance is based on substantial equivalence to predicate devices.

8. The sample size for the training set

Not Applicable. This is not an AI/algorithm device and thus has no training set.

9. How the ground truth for the training set was established

Not Applicable. This is not an AI/algorithm device and thus has no training set or associated ground truth establishment.

Summary of Relevant Information from the Document:

The document focuses on demonstrating substantial equivalence to existing predicate devices. The key argument is that the proposed Ventilation (Tympanostomy) Tubes are identical in intended use, indications for use, technological characteristics, and principle of operation to 12 previously cleared predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Based on the document, the "acceptance criteria" appear to be meeting the characteristics of the predicate devices, thereby establishing substantial equivalence. The reported "performance" is implicitly that these devices function identically to the legally marketed predicates.

Feature / Criterion	Subject Device (Medtronic Xomed Ventilation (Tympanostomy) Tubes)	Predicate Devices	Comparison / Outcome
Intended Use	Provides a passageway for air movement between the auditory canal and middle ear; allows drainage of fluids from otitis media; equalizes air pressures and prevents fluid accumulation.	Same as Subject Device	Same (Substantially Equivalent)
Indications for Use	Chronic otitis media with effusion (serous, mucoid, purulent); Recurrent acute otitis media failing alternative therapies; Persistent high negative middle ear pressure (with conductive hearing loss, otalgia, vertigo, tinnitus); Atelectasis from tympanic membrane retraction pocket or eustachian tube dysfunction. The surgeon must use medical judgment.	Same as Subject Device	Same (Substantially Equivalent)
Technological Characteristics (Materials)	Silicone elastomer, fluoroplastic, C-FLEX® TPE, stainless steel, titanium. Some fitted with semi-permeable membranes.	Various Materials: Silicone, Teflon, Titanium Stainless Steel, C-Flex, Silicone/Microgel, FEP, Fluoroplastic, Hydroxylapatite Coating from 12 listed predicate devices.	Same (Substantially Equivalent, encompassing the full range of materials already on market)
Technological Characteristics (Design/Sizes)	Small tubular implants, numerous designs and sizes available with single or multiple flanges. (ID: 0.76-1.65 mm; IFD: 1.09-9.80 mm; 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 (Substantially Equivalent, covering the range of previously cleared sizes)
Sterilization	Ethylene Oxide	Ethylene Oxide	Same (Substantially Equivalent)
Principle of Operation	Surgically inserted in the tympanic membrane following myringotomy to provide a passageway for air movement between the auditory canal and the middle ear.	Surgically inserted in the tympanic membrane following myringotomy to provide a passageway for the movement of air between the auditory canal and the middle ear.	Same (Substantially Equivalent)
Performance Testing (Clinical, Bench, Animal)	"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." (Details of literature review not provided in the excerpt.)	Previously established performance and safety based on prior 510(k) clearances (listed in Section X) and preamendment status of predicate devices. Implied long-term successful use and safety profiles of the predicate devices.	The device meets the acceptance criteria by demonstrating substantial equivalence in all key characteristics to legally marketed predicate devices, negating the need for new performance studies. The prior clearances and post-market surveillance data of predicates serve as evidence of acceptable performance.

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.

· 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:

VIII. Intended Use:

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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:

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/ HydrogelCoating	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	NotApplicable		Silicone/Microgel, FEP	Silicone/Microgel, FEP
Product Code	ETD	ETD	Same		Fluoroplastic, Hydroxylapatite	Fluoroplastic, Hydroxylapatite
Classification	Class II	Class II	Same		Coating	Coating
CommonName/ClassificationName	Tympanostomy Tubes	Tympanostomy Tubes	Same	Sterilization	Ethylene Oxide	Ethylene Oxide	Same
Device Description	Medtronic® Xomed® Ventilation(tympanostomy) Tubes are smalltubular implants available in avariety of biocompatible materialsincluding silicone elastomer,fluoroplastic, C-FLEX® TPE,stainless steel and titanium.Numerous designs and sizes areavailable with single or multipleflanges to satisfy various surgicaltechniques for insertion and tofacilitate short or long-termcommunication of the auditory canalwith the middle ear. Some tubes arefitted with semi-permeablemembranes intended to allow freepassage of air while preventingmovement of fluids into the middleear.	Medtronic® Xomed® Ventilation(tympanostomy) Tubes are smalltubular implants available in avariety of biocompatible materialsincluding silicone elastomer,fluoroplastic, C-FLEX® TPE,stainless steel and titanium.Numerous designs and sizes areavailable with single or multipleflanges to satisfy various surgicaltechniques for insertion and tofacilitate short or long-termcommunication of the auditory canalwith the middle ear. Some tubes arefitted with semi-permeablemembranes intended to allow freepassage of air while preventingmovement of fluids into the middleear.	Same	Principle of	Surgically inserted in the tympanic	Surgically inserted in the tympanic	Same
Intended Use	When inserted through amyringotomy, a ventilation tubeprovides a passageway formovement of air between theauditory canal and the middle ear.	When inserted through amyringotomy, a ventilation tubeprovides a passageway formovement of air between theauditory canal and the middle ear.	Same	Operation	membrane following myringotomy	membrane following myringotomy
	The unobstructed passageway mayalso allow a means of drainage offluids resulting from acute orchronic otitis media from the middleear into the auditory canal. Inaddition, surgical placement ofventilation tubes also provides a	The unobstructed passageway mayalso allow a means of drainage offluids resulting from acute orchronic otitis media from the middleear into the auditory canal. Inaddition, surgical placement ofventilation tubes also provides a			to provide a passageway for the	to provide a passageway for the
	means of equalizing air pressuresbetween the outer ear and the middleear and continued ventilation toprevent fluid accumulation withinthe middle ear.	means of equalizing air pressuresbetween the outer ear and the middleear and continued ventilation toprevent fluid accumulation withinthe middle ear.			movement of air between the	movement of air between the
Indications forUse	The surgeon must usemedical judgment andconsider the patient'smedical history prior to adecision to surgically insert aventilation tube. Pathologicconditions for whichventilation tubes areindicated include but notlimited to:Chronic otitis mediawith effusioncharacterized asserous, mucoid, orpurulent Recurrent acute otitismedia which fails torespond satisfactorilyto alternativetherapies A patient with ahistory of persistenthigh negative middleear pressure whichmay be associatedwith conductivehearing loss, otalgia,vertigo and/ortinnitus Atelectasis resultingfrom retractionpocket of thetympanic membraneor eustachian tubedysfunction	The surgeon must usemedical judgment andconsider the patient'smedical history prior to adecision to surgically insert aventilation tube. Pathologicconditions for whichventilation tubes areindicated include but notlimited to:Chronic otitis mediawith effusioncharacterized asserous, mucoid, orpurulent Recurrent acute otitismedia which fails torespond satisfactorilyto alternativetherapies A patient with ahistory of persistenthigh negative middleear pressure whichmay be associatedwith conductivehearing loss, otalgia,vertigo and/ortinnitus Atelectasis resultingfrom retractionpocket of thetympanic membraneor eustachian tubedysfunction	Same		auditory canal and the middle ear	auditory canal and the middle ear
TechnologicalCharacteristics	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.

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.