The Nu Vent Eustachian Tube Dilation Balloon is indicated for use in patients 18 years and older who need treatment for persistent Eustachian tube dysfunction.

Device Description

The NuVent™ Eustachian Tube Dilation Balloon is composed of a sterile, single use balloon handpiece and stopcock valve. The balloon is used in conjunction with the NuVent™ inflator, which is packaged with extension tubing to connect the inflator to the stopcock valve. The NuVent™ Inflator was cleared as a part of the NuVent™ EM Sinus Balloon Dilation System, 510(k) cleared under K132297.

A pre-angled flexible balloon section promotes easy access and insertion into the Eustachian tube from the nasal opening with the aid of endoscopic guidance. An atraumatic tip at the distal end of the flexible balloon section is meant to reduce the potential for risk of injury to the Eustachian tube and surrounding tissues during insertion. The rigid shaft and handle extending to the flexible balloon section provides stability and tactile feedback when moving the balloon through the nasal passages and into the Eustachian tube canal.

Mounted near the distal end of the balloon handpiece is a flexible balloon section. Once the balloon section is advanced into the target Eustachian tube the 6mm diameter/16 mm long rigid balloon is inflated using the separate NuVent™ inflator, expanding the Eustachian tube canal tissue and cartilage.

AI/ML Overview

The provided text is a 510(k) Summary for the NuVent Eustachian Tube Dilation Balloon. This type of document is submitted to the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. The information supplied in this document focuses on mechanical and functional performance testing to prove substantial equivalence, rather than a clinical study evaluating the device's impact on human readers or clinical outcomes in the way a diagnostic AI device might be.

Therefore, many of the requested items (e.g., number of experts for ground truth, MRMC study, effect size of human improvement with AI, standalone performance, training set details) are not applicable to this type of device and the information provided in this 510(k) summary.

However, I can extract the acceptance criteria and performance data for the mechanical and functional tests that were performed to support the device's substantial equivalence.

Here's the information based on the provided text:

Acceptance Criteria and Reported Device Performance

The document states that "All samples passed testing and met acceptance criteria." While the specific numerical acceptance criteria for each test are not explicitly detailed (e.g., "tensile strength must be > X N"), the general statement indicates that the device met pre-defined requirements for these performance characteristics. The table below lists the performance tests conducted, implying that the acceptance criterion for each was successful completion without failure, demonstrating performance comparable to or better than the predicate devices and ensuring safety and effectiveness.

Performance Test Category	Reported Device Performance (Acceptance Criteria Met)
Mechanical/Functional Testing
Wire dislodgement	Passed (met acceptance criteria)
Balloon inflation	Passed (met acceptance criteria)
Balloon deflation	Passed (met acceptance criteria)
Stopcock holding pressure without leaking	Passed (met acceptance criteria)
Pressure indicator button functionality	Passed (met acceptance criteria)
System does not leak or burst under use conditions in cyclic testing	Passed (met acceptance criteria)
Handpiece does not leak at the rated burst pressure in cyclic testing	Passed (met acceptance criteria)
Tensile strength of balloon, balloon bonds and tip	Passed (met acceptance criteria)
Torsional testing of balloon system	Passed (met acceptance criteria)
Usability testing, including simulated use	Passed (met acceptance criteria)
Flexibility testing (comparing subject and predicate devices under axial, angular, and torsional loading of balloon sections)	Passed (met acceptance criteria), demonstrating that the NuVent device is as safe and effective as the primary and secondary predicates.
Biocompatibility	Complies with ISO 10993-1 and FDA guidance (met requirements for intended use)
Sterilization	Achieved minimum sterility assurance level (SAL) of 10^-6 (validated to ISO 11135, ISO 11138-2, ISO 11737-1, ISO 11737-2)
Shelf Life Testing	All samples passed testing and met acceptance criteria of design inputs for device and packaging system following accelerated aging. Real-time aging is ongoing.

Study Information Specifics:

Sample Size Used for the Test Set and Data Provenance:
- The document states "All samples passed testing," but does not specify the sample size (N) used for each of the performance tests.
- The data provenance is from non-clinical tests conducted by Medtronic Xomed, Inc. This testing is typically done in a lab setting, not on human subjects.
- The data is prospective in the sense that the tests were designed and executed to evaluate the new device.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- N/A. This device's testing involves mechanical and functional performance, not diagnostic interpretation requiring expert ground truth in the context of a medical imaging or AI study. The ground truth for these tests is based on engineering specifications and physical measurements/observations of device performance against predefined criteria.
Adjudication Method for the Test Set:
- N/A. Since this involves mechanical/functional tests against engineering specifications, there is no "adjudication" in the sense of reconciling human expert opinions. Test results are objectively measured or observed.
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:
- N/A. This device (Eustachian Tube Dilation Balloon) is not an AI-powered diagnostic tool, nor does it assist human readers in interpreting medical images. It is a surgical device.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not have an "algorithm-only" performance component. It is a physical medical device.
The Type of Ground Truth Used:
- The ground truth used for this type of device relies on engineering specifications, physical measurements, and adherence to established performance standards (e.g., ISO, ASTM, internal Medtronic criteria). For example, a "passed" result for tensile strength means it met a minimum force before breaking, or "passed" for inflation means it inflated to the specified dimensions without bursting within a given pressure range.
The Sample Size for the Training Set:
- N/A. There is no "training set" in the context of this device's mechanical and functional testing, as it is not an AI/machine learning model.
How the Ground Truth for the Training Set was Established:
- N/A. This question pertains to AI/machine learning model development, which is not relevant to the type of device and testing described in this 510(k) summary.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 16, 2021

Medtronic Xomed, Inc. Matthew Harmon Principal Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216

Re: K210841

Trade/Device Name: NuVent Eustachian Tube Dilation Balloon Regulation Number: 21 CFR 874.4180 Regulation Name: Eustachian Tube Balloon Dilation System Regulatory Class: Class II Product Code: PNZ Dated: July 20, 2021 Received: July 21, 2021

Dear Matthew Harmon:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210841

Device Name NuVent Eustachian Tube Dilation Balloon

Indications for Use (Describe)

The Nu Vent Eustachian Tube Dilation Balloon is indicated for use in patients 18 years and older who need treatment for persistent Eustachian tube dysfunction.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

K210841

Company: Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, Florida 32216 USA Telephone Number: 904-332-8186 Fax Number: 904-296-2386
Contact: Matthew Harmon Principal Regulatory Affairs Specialist Phone: (904) 332-6704 E-mail: matthew.harmon@medtronic.com

Date Prepared: August 12, 2021

Device Trade name: NuVent Eustachian Tube Dilation Balloon

Common Name: Eustachian Tube Balloon Dilation System

Classification Name: Eustachian Tube Balloon Device (21 CFR 874.4180)

Classification: Class II (21 CFR 874.4180)

Product Code: PNZ

Primary Predicate Device: XprESS ENT Dilation System K163509

Secondary Predicate Device: Aera®Eustachian Tube Balloon Dilation System K171761

Device Description:

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Indications for Use:

The NuVent™ Eustachian Tube Dilation Balloon is indicated for use in patients 18 years and older who need treatment for persistent Eustachian tube dysfunction.

Technological Characteristics:

The NuVent™ device has the same intended use, same indications for use, same principle of operation, function, biocompatibility, and sterilization as well as similar design and materials to the primary predicate XprESS™ device and the secondary predicate Aera® device.

Please find a comparison of the subject NuVent™and the primary predicate XprESS™ device in Table 1, and a comparison of the subject NuVent™ and secondary predicate Aera® device in Table 2, below.

Feature/Attribute	NuVent™ EustachianTube Dilation BalloonSubject Device	XprESS™ ENT DilationSystemK163509Primary Predicate Device	Comparison
Product Code	PNZ	PNZ, LRC	Both have PNZ product code.
Regulations	21 CFR 874.4180	21 CFR 874.418021 CFR 874.4420	Both are subject to 21 CFR874.4180.
Common Name	Eustachian Tube BalloonDilation Device	Balloon Sinus Dilation System ;Eustachian Tube Balloon DilationSystem	Both are Eustachian Tube BalloonDilation Systems.
Handpiece	The NuVent™ EustachianTube Dilation Balloonconsists of an integratedpolymer handle, stainlesssteel shaft, and flexiblepolymer balloon sectionwith atraumatic polymer tip.	The XprESS ENT Dilation Balloonsconsist of an integrated polymer handle,stainless steel shaft and balloon sectionwith a polymer balloon mounted on apolymer that slides over a stainless steeltube with a rounded metal tip.	Both provide an area for thesurgeon to grip and manipulate thehandpiece for delivery of theballoon into the nasal passage andEustachian Tube canal.
Rigid Shaft	Stainless steel2.76 mm diameter x 95 mmlong	Stainless steel3.17 mm dia x ~100 mm long	Both contain rigid shafts to supportmanipulation of the devices fordirecting the tips to the entrance ofthe Eustachian Tube canal.
Balloon	Non-compliant polymericballoon, 6 mm diameter 16 mmlong	Non-compliant polymeric balloon,5 mm diameter x 8 mm long5 x 20 mm6 x 8 mm6 x 20 mm7 x 20 (LoProfile)	Both offer balloons that are 6 mmin diameter.
Description	BalloonSection	Flexible polymer tube withinternal shaping wire	Stainless steel tube	Both have a balloon section that isbent at an angle meant to supportinsertion of the balloon into theEustachian Tube canal. TheStryker device balloon sections arerigid and do not have flexibility
	Feature/Attribute	NuVent™ EustachianTube Dilation BalloonSubject Device	XprESS™ ENT DilationSystemK163509Primary Predicate Device	Comparison
	Balloon Tip	Rounded 2.6 mm diameterpolymer	Rounded 1.75mm diameter stainlesssteel (LoProfile)Rounded 1.50 mm diameter stainlesssteel (Ultra)	Both systems have rounded tips.The Medtronic balloon system islarger and polymeric.
	InsertionMethod	The flexible polymer balloonsection is angled to promoteinsertion of the polymerballoon section into the ETcanal and the balloon section isinserted into the ET canal.	The rigid stainless steel balloon sectionis bent to the ET angle with a providedbending tool angled to promote insertioninto the ET canal and the balloon sectionis inserted into the ET canal and thepolymeric balloon is advanced into theET canal over the top of the inserted SSballoon section.	Both devices provide a means forinserting the flexible balloonsections into the Eustachian Tubecanal by including an angle thatmimics the Eustachian Tube canaland both systems are insertedmanually as a unitized handpiece.
	InsertionMarker	Blue band at the proximal endof the balloon 30mm from thetip visible under directendoscopic visualizationprovides recognition of thedepth of balloon insertion inthe ET canal aiding inpositioning the handpiece.	Markings on SS balloon section at 10and 20 mm from tip.	Both balloon sections havemarkings on the balloon section toprovide visual recognition of thedepth of insertion.
	Inflator	The balloon handpiece ismeant to be used inconjunction only with theMedtronic NuVent™ inflatorto provide the pressure for thehandpiece balloon. Theinflator limits the pressuredelivered.	The balloon handpiece is meant to beused in conjunction only with theEntellus Inflation Syringe which limitsinflation pressure.	Both systems have inflators thatreadily connect to the handpiecewith Luer fittings and providepressure during the procedure.
	Intended Use	To dilate the Eustachian tubecanal.	To remodel or recreate the sinus outflowtract and dilate the Eustachian tube bytransnasal balloon dilation.	Both devices are intended to dilatethe Eustachian Tube canal.
	Indications forUse	The NuVent Eustachian TubeDilation Balloon is indicatedfor use in patients 18 years andolder who need treatment forpersistent Eustachian tubedysfunction.	To dilate the cartilaginous portion of theEustachian tube for treating persistentEustachian tube dysfunction in patients18 years and older using a transnasalapproach.	Both devices are indicated to treatpersistent Eustachian Tubedysfunction in patients 18 yearsand older.
	Predicate Device	Acclarent Aera® - K171761XprESS ENT Dilation System- K163509	XprESS Multi-Sinus Dilation System(K152434)Acclarent Aera® (DEN150056)	N/A
	Contraindications	The NuVent™ EustachianTube Dilation Balloon iscontraindicated for use in aEustachian tube with anipsilateral carotid artery that isdehiscent into the EustachianTube lumen or history oripsilateral patulous Eustachiantube.	The XprESS device does includewarnings against using XprESS to dilateEustachian tubes in patients with ahistory of patulous Eustachian tubes, toreview appropriate radiographic imagingprior to treatment, and not to use thedevice to treat patients with evidence ofinternal carotid artery dehiscence.	Both devices are not intended to beused in patients who have patulousEustachian Tubes or in patientswith evidence of internal carotidartery dehiscence.
	Contact Time	Limited (≤ 24 hours)	Limited (≤ 24 hours)	Identical
	Sterility	Ethylene Oxide	Ethylene Oxide	Identical
	Biocompatibility	ISO 10993-1	ISO 10993-1	Identical
Feature/Attribute		NuVentTM EustachianTube Dilation BalloonSubject Device	Aera® Eustachian TubeBalloon Dilation SystemK171761Secondary Predicate Device	Comparison
Product Code		PNZ	PNZ	Identical
	RegulationsCommon Name	21 CFR 874.4180Eustachian Tube BalloonDilation Device	21 CFR 874.4180Eustachian Tube Balloon DilationDevice	IdenticalIdentical
		Handpiece	The NuVentTM EustachianTube Dilation Balloon consistsof an integrated polymerhandle, stainless steel shaft,and flexible polymer balloonsection with an atraumaticpolymer tip.	The ACCLARENT AERA® EustachianTube Dilation Balloon consists of a rigidGuide Catheter and a flexible polymerBalloon Catheter with an atraumaticpolymer tip.	Both consist of a rigid shaft andflexible balloon section with anatraumatic polymer tip. They differin that the NuVentTM device is asingle handpiece, while the AeraTMdevice uses as separate guidecatheter and balloon catheter.
		RigidShaft	Stainless steel2.76 mm diameter x 95 mmlong	Stainless steel & rigid polymer end3.83 mm dia x 83 mm long SS and 17mm long polymer = ~100 mm	Both contain rigid shafts to supportmanipulation of the devices fordirecting the tips to the entrance ofthe Eustachian Tube canal.
			Balloon	Non-compliant polymericballoon, 6 mm diameter 16 mmlong	Non-compliant polymeric balloon, 6 mmdiameter x 16 mm long	Identical
			BalloonSection	Flexible polymer tube withinternal shaping wire	Flexible polymer tube	Both have flexible balloon sectionswith adequate stiffness to supportinsertion of the balloon into theEustachian Tube canal.
			BalloonTip	Rounded 2.6 mm diameterpolymer	Rounded 2.4 mm diameter polymer	Both devices have bulbous,atraumatic, and polymeric tips.
				InsertionMethod	The flexible polymer balloonsection is angled to promoteinsertion of the polymerballoon section into the ETcanal and the balloon section isinserted into the ET canal.	The flexible polymer balloon catheter isadvanced through the angled tip of theguide catheter, inserting the balloon intothe ET canal.	Both devices provide a means forinserting the flexible balloonsections into the Eustachian Tubecanal by including an angle thatmimics the Eustachian Tube canal.The Aera device does so byfollowing the guide catheter andthe Medtronic device by inclusionof an angled balloon section of aunitized handpiece.
		InsertionMarker		Blue band at the proximal endof the balloon 30mm from thetip visible under directendoscopic visualizationprovides recognition of thedepth of balloon insertion inthe ET canal aiding inpositioning the handpiece.	No visual markers present to estimatedepth of Eustachian tube insertion. Thedevice has a marker on the ballooncatheter to indicate when the balloonsection of the balloon catheter isextended past the distal end of the guidecatheter.	Both balloon sections are 30 mmlong.The NuVentTM balloon includes avisual marker to provide easyrecognition of the end of theflexible balloon and recognition ofthe depth of insertion. The Aeradevice also has a visual marker, butit does not indicate the depth ofballoon insertion.
		Inflator		The balloon handpiece ismeant to be used inconjunction only with theMedtronic NuVentTM inflatorto provide the pressure for thehandpiece balloon. Theinflator limits the pressuredelivered.	The balloon handpiece is compatiblewith either the Acclarent® BalloonInflation Device or Acclarent® SEInflation Device and is instructed to notexceed 12 atm pressure.	Both systems have inflators thatreadily connect to the handpiecewith Luer fittings and providepressure and a way to maintain thepressure during the procedure.
				Intended Use	To dilate the Eustachian tubecanal.	To dilate the Eustachian tube canal.	Identical
		Description		Indications forUse	The NuVent Eustachian TubeDilation Balloon is indicated	The Acclarent Aera® Eustachian Tube	Identical
		Feature/Attribute	NuVent™ EustachianTube Dilation BalloonSubject Device	Aera® Eustachian TubeBalloon Dilation SystemK171761Secondary Predicate Device	Comparison
			for use in patients 18 years andolder who need treatment forpersistent Eustachian tubedysfunction.	dilate the Eustachian tube for treatmentof persistent Eustachian tube dysfunctionin patients 18 years and older.
Predicate Device		Acclarent Aera® - K171761XprESS ENT Dilation System- K163509	Acclarent Aera® (DEN150056)Entellus XprESS ENT Dilation System(K163509)	N/A
Contraindications	The NuVent™ EustachianTube Dilation Balloon iscontraindicated for use in aEustachian tube with anipsilateral carotid artery that isdehiscent into the EustachianTube lumen or history oripsilateral patulous Eustachiantube.	The Acclarent Aera® Eustachian TubeBalloon Dilation System iscontraindicated for use in a Eustachiantube with an ipsilateral carotid artery thatis dehiscent into the ET lumen or historyof ipsilateral patulous Eustachian tube.	Identical
Contact Time	Limited (≤ 24 hours)	Limited (≤ 24 hours)	Identical
Sterility	Ethylene Oxide	Ethylene Oxide	Identical
Biocompatibility	ISO 10993-1	ISO 10993-1	Identical

Table 1: Device Comparison - NuVent™ and XprESS™ Devices

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Table 2: Device Comparison – NuVent™ and Aera® Devices

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Substantial Equivalence:

The NuVent™ Eustachian Tube Dilation Balloon has the same intended use, indications for use, and similar scientific technology as the primary predicate XprESS device (K163509) and the secondary predicate Aera® device (K171761). In support of this determination Medtronic conducted non-clinical tests to demonstrate compliance with the special controls applicable to this device, as set out in 21 CFR 874.4180, including tensile and flexural testing, durability testing, inflation and deflation testing, verification testing of the safety features on both the NuVent device and the NuVent inflator, biocompatibility testing, and sterility testing. The NuVent device met all acceptance criteria for this testing.

Medtronic conducted usability and validation testing on the NuVent device. In addition, to show equivalence to the predicate devices, Medtronic conducted comparison testing between the subject NuVent, primary predicate XprESS, and secondary predicate Aera to assess balloon characteristics by performing flexibility, torsional, and axial rigidity tests to demonstrate the NuVent device is as safe and effective as the primary and secondary predicates.

A comparison of the devices' dimensions, materials, design, power source, insertion methods, and instructions for use, as shown in Table 1 and Table 2, above, does not indicate any differences in the potential risks for each device and does not raise different questions of safety or effectiveness than the predicate Aera and XprESS devices. Therefore, the NuVent™ Eustachian Tube Dilation Balloon is substantially equivalent to the primary predicate XprESS device and the secondary predicate Aera device.

Biocompatibility:

Biocompatibility testing was performed using ISO 10993 Biological Evaluation of Medical Devices and FDA guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," issued June 16, 2016. The

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NuVent™ Eustachian Tube Dilation Balloon complies with the biocompatibility requirements for its intended use.

Sterilization:

Sterilization is accomplished via ethylene oxide to deliver a minimum sterility assurance level (SAL) of 10 6. The sterilization method was validated in compliance to:

. ISO 11135:2014 – Sterilization of Health Care Products – Ethylene Oxide – Requirements for development, validation, and routine control of a sterilization process for medical devices.
ISO 11138-2: 2017 - Sterilization of health care products: Biological Indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11737-1:2018 – Sterilization of Health Care Products - Microbiological Methods – Part 1: Determination of the Population of Microorganisms on Product
ISO 11737-2: 2019 - Sterilization of Health Care Products - Microbiological Methods – Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process.

Performance Testing:

Performance testing consisted of testing to support the substantial equivalence of the NuVent™ device to the predicate Aera® and XprESS™ devices, and to support the safety and effectiveness of the NuVent™ device. All testing was conducted on the sterile final product, and followed the appropriate standards and guidance documents, with appropriate modifications following risk assessment. Testing plans were based upon FDA guidance documents and international standards. Testing was performed on baseline (non-aged) and aged products.

Testing included:

Wire dislodgement
. Balloon inflation
. Balloon deflation
Stopcock holding pressure without leaking
. Pressure indicator button functionality
System does not leak or burst under use conditions in cyclic testing
Handpiece does not leak at the rated burst pressure in cyclic testing
. Tensile strength of balloon, balloon bonds and tip
Torsional testing of balloon system
Usability testing, including simulated use
Flexibility testing comparing the flexibility and rigidity of the subject and predicate devices under the conditions of axial, angular, and torsional loading of the balloon sections.

All samples passed testing and met acceptance criteria. This testing demonstrates that the subject NuVent™ device is as safe, as effective, and performs as well as the predicate Aera® and XprESS™ devices.

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Shelf Life Testing:

Shelf life testing was performed on the sterile final product and its packaging according to the applicable standards and guidance documents. The sterile final product and packaging were subjected to accelerated aging per ASTM F1980 – 2016. Real-time aging for the accelerated aging equivalent time is ongoing.

All samples passed testing and met the acceptance criteria of the design inputs for the device and packaging system following accelerated aging.

Conclusion:

Utilizing FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated 510(k)s" issued on September 13, 2019, a comparison of key characteristics demonstrates that the proposed device NuVent™ Eustachian Tube Dilation Balloon is substantially equivalent to the predicate device(s) in terms of performance characteristics. The NuVent™ Eustachian Tube Dilation Balloon is as safe, as effective, and performs as well as the predicate device(s).

Regulation Number and Section

§ 874.4180 Eustachian tube balloon dilation system.

(a)
Identification. A Eustachian tube balloon dilation system is a prescription device that includes a flexible catheter attached to an inflatable balloon. The system is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
(i) Mechanical testing, including tensile and flexural testing of catheter joints and materials.
(ii) Durability testing, including fatigue and burst pressure testing of the balloon materials and components.
(iii) Inflation and deflation characterization testing, including time and pressure measurements, and leak testing of the balloon.
(iv) Verification testing of safety features built into the device must be performed, including the characterization of catheter geometries and distal tip insertion limitation mechanisms.
(2) Simulated use testing in a clinically relevant model must demonstrate the reliability of the device to remain mechanically functional throughout the anticipated conditions of use, and validate that the design features limit access to only the cartilaginous portion of the Eustachian tube.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device.
(5) Performance data must support shelf life by demonstrating continued sterility of the device, package integrity, and device functionality over the identified shelf life.
(6) Training must include simulated use on cadavers to ensure users can follow the instructions for use to allow safe use of the device.
(7) Labeling must include:
(i) Detailed instructions for use.
(ii) A detailed summary of the device technical parameters, including maximum allowed inflation pressure, allowable catheter geometries, and available balloon sizes.
(iii) A shelf life.