NuVent Eustachian Tube Dilation Balloon

K210841 · Medtronic Xomed, Inc. · PNZ · Aug 16, 2021 · Ear, Nose, Throat

Device Facts

• Record ID: K210841
• Device Name: NuVent Eustachian Tube Dilation Balloon
• Applicant: Medtronic Xomed, Inc.
• Product Code: PNZ · Ear, Nose, Throat
• Decision Date: Aug 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4180
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The NuVent Eustachian Tube Dilation Balloon is a sterile, single-use device used to dilate the Eustachian tube canal. It consists of a handpiece with a rigid stainless steel shaft and a flexible polymer balloon section with an atraumatic tip. The device is used in a clinical setting by a physician under endoscopic guidance. The physician inserts the pre-angled balloon into the Eustachian tube canal; a blue marker band provides visual depth recognition. The balloon is inflated using a separate NuVent inflator (cleared under K132297) to expand the canal tissue and cartilage. The device provides tactile feedback during insertion. By dilating the Eustachian tube, the device aims to treat persistent dysfunction. The system is designed for manual operation and does not involve electronic processing or automated decision-making.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including mechanical performance (tensile, torsional, rigidity), usability/simulated use testing, biocompatibility per ISO 10993-1, and sterilization validation per ISO 11135.

Technological Characteristics

Materials: polymer handle, stainless steel shaft, non-compliant polymeric balloon, atraumatic polymer tip. Dimensions: 2.76 mm diameter x 95 mm long shaft; 6 mm diameter x 16 mm long balloon. Principle: manual transnasal balloon dilation. Energy: pneumatic (via external inflator). Sterilization: Ethylene Oxide (ISO 11135). Connectivity: None (mechanical).

Indications for Use

Indicated for patients 18 years and older requiring treatment for persistent Eustachian tube dysfunction. Contraindicated in patients with ipsilateral carotid artery dehiscence into the Eustachian tube lumen or history of ipsilateral patulous Eustachian tube.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the Acclarent Aera™ Eustachian Tube Balloon Dilation System is subject to the following special controls: - 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: - a. Mechanical testing, including tensile and flexural testing of catheter joints and materials. - b. Durability testing, including fatigue and burst pressure testing of the balloon materials and components. - Inflation and deflation characterization testing, including time and pressure C. measurements, and leak testing of the balloon. - d. 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: - a. Detailed instructions for use. - b. A detailed summary of the device technical parameters, including maximum allowed inflation pressure, allowable catheter geometries, and available balloon sizes. - c. A shelf life.

Predicate Devices

• XprESS ENT Dilation System (K163509)
• Aera Eustachian Tube Balloon Dilation System (K171761)

Reference Devices

• NuVent EM Sinus Balloon Dilation System (K132297)
• XprESS Multi-Sinus Dilation System (K152434)
• Acclarent Aera (DEN150056)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] E-mail: [e-mail]

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:

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.

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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.

#### 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/<br>Attribute | NuVent™ Eustachian<br>Tube Dilation Balloon<br>Subject Device | XprESS™ ENT Dilation<br>System<br>K163509<br>Primary Predicate Device | Comparison | | | | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | PNZ | PNZ, LRC | Both have PNZ product code. | | | | |
| Regulations | 21 CFR 874.4180 | 21 CFR 874.4180<br>21 CFR 874.4420 | Both are subject to 21 CFR<br>874.4180. | | | | |
| Common Name | Eustachian Tube Balloon<br>Dilation Device | Balloon Sinus Dilation System ;<br>Eustachian Tube Balloon Dilation<br>System | Both are Eustachian Tube Balloon<br>Dilation Systems. | | | | |
| Handpiece | The NuVent™ Eustachian<br>Tube Dilation Balloon<br>consists of an integrated<br>polymer handle, stainless<br>steel shaft, and flexible<br>polymer balloon section<br>with atraumatic polymer tip. | The XprESS ENT Dilation Balloons<br>consist of an integrated polymer handle,<br>stainless steel shaft and balloon section<br>with a polymer balloon mounted on a<br>polymer that slides over a stainless steel<br>tube with a rounded metal tip. | Both provide an area for the<br>surgeon to grip and manipulate the<br>handpiece for delivery of the<br>balloon into the nasal passage and<br>Eustachian Tube canal. | | | | |
| Rigid Shaft | Stainless steel<br>2.76 mm diameter x 95 mm<br>long | Stainless steel<br>3.17 mm dia x ~100 mm long | Both contain rigid shafts to support<br>manipulation of the devices for<br>directing the tips to the entrance of<br>the Eustachian Tube canal. | | | | |
| Balloon | Non-compliant polymeric<br>balloon, 6 mm diameter 16 mm<br>long | Non-compliant polymeric balloon,<br>5 mm diameter x 8 mm long<br>5 x 20 mm<br>6 x 8 mm<br>6 x 20 mm<br>7 x 20 (LoProfile) | Both offer balloons that are 6 mm<br>in diameter. | | | | |
| Description | Balloon<br>Section | Flexible polymer tube with<br>internal shaping wire | Stainless steel tube | Both have a balloon section that is<br>bent at an angle meant to support<br>insertion of the balloon into the<br>Eustachian Tube canal. The<br>Stryker device balloon sections are<br>rigid and do not have flexibility | | | |
| | Feature/<br>Attribute | NuVent™ Eustachian<br>Tube Dilation Balloon<br>Subject Device | XprESS™ ENT Dilation<br>System<br>K163509<br>Primary Predicate Device | Comparison | | | |
| | Balloon Tip | Rounded 2.6 mm diameter<br>polymer | Rounded 1.75mm diameter stainless<br>steel (LoProfile)<br>Rounded 1.50 mm diameter stainless<br>steel (Ultra) | Both systems have rounded tips.<br>The Medtronic balloon system is<br>larger and polymeric. | | | |
| | Insertion<br>Method | The flexible polymer balloon<br>section is angled to promote<br>insertion of the polymer<br>balloon section into the ET<br>canal and the balloon section is<br>inserted into the ET canal. | The rigid stainless steel balloon section<br>is bent to the ET angle with a provided<br>bending tool angled to promote insertion<br>into the ET canal and the balloon section<br>is inserted into the ET canal and the<br>polymeric balloon is advanced into the<br>ET canal over the top of the inserted SS<br>balloon section. | Both devices provide a means for<br>inserting the flexible balloon<br>sections into the Eustachian Tube<br>canal by including an angle that<br>mimics the Eustachian Tube canal<br>and both systems are inserted<br>manually as a unitized handpiece. | | | |
| | Insertion<br>Marker | Blue band at the proximal end<br>of the balloon 30mm from the<br>tip visible under direct<br>endoscopic visualization<br>provides recognition of the<br>depth of balloon insertion in<br>the ET canal aiding in<br>positioning the handpiece. | Markings on SS balloon section at 10<br>and 20 mm from tip. | Both balloon sections have<br>markings on the balloon section to<br>provide visual recognition of the<br>depth of insertion. | | | |
| | Inflator | The balloon handpiece is<br>meant to be used in<br>conjunction only with the<br>Medtronic NuVent™ inflator<br>to provide the pressure for the<br>handpiece balloon. The<br>inflator limits the pressure<br>delivered. | The balloon handpiece is meant to be<br>used in conjunction only with the<br>Entellus Inflation Syringe which limits<br>inflation pressure. | Both systems have inflators that<br>readily connect to the handpiece<br>with Luer fittings and provide<br>pressure during the procedure. | | | |
| | Intended Use | To dilate the Eustachian tube<br>canal. | To remodel or recreate the sinus outflow<br>tract and dilate the Eustachian tube by<br>transnasal balloon dilation. | Both devices are intended to dilate<br>the Eustachian Tube canal. | | | |
| | Indications for<br>Use | The NuVent Eustachian Tube<br>Dilation Balloon is indicated<br>for use in patients 18 years and<br>older who need treatment for<br>persistent Eustachian tube<br>dysfunction. | To dilate the cartilaginous portion of the<br>Eustachian tube for treating persistent<br>Eustachian tube dysfunction in patients<br>18 years and older using a transnasal<br>approach. | Both devices are indicated to treat<br>persistent Eustachian Tube<br>dysfunction in patients 18 years<br>and older. | | | |
| | Predicate Device | Acclarent Aera® - K171761<br>XprESS ENT Dilation System<br>- K163509 | XprESS Multi-Sinus Dilation System<br>(K152434)<br>Acclarent Aera® (DEN150056) | N/A | | | |
| | Contraindications | The NuVent™ Eustachian<br>Tube Dilation Balloon is<br>contraindicated for use in a<br>Eustachian tube with an<br>ipsilateral carotid artery that is<br>dehiscent into the Eustachian<br>Tube lumen or history or<br>ipsilateral patulous Eustachian<br>tube. | The XprESS device does include<br>warnings against using XprESS to dilate<br>Eustachian tubes in patients with a<br>history of patulous Eustachian tubes, to<br>review appropriate radiographic imaging<br>prior to treatment, and not to use the<br>device to treat patients with evidence of<br>internal carotid artery dehiscence. | Both devices are not intended to be<br>used in patients who have patulous<br>Eustachian Tubes or in patients<br>with evidence of internal carotid<br>artery 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/<br>Attribute | | NuVentTM Eustachian<br>Tube Dilation Balloon<br>Subject Device | Aera® Eustachian Tube<br>Balloon Dilation System<br>K171761<br>Secondary Predicate Device | Comparison | | | |
| Product Code | | PNZ | PNZ | Identical | | | |
| | Regulations<br>Common Name | 21 CFR 874.4180<br>Eustachian Tube Balloon<br>Dilation Device | 21 CFR 874.4180<br>Eustachian Tube Balloon Dilation<br>Device | Identical<br>Identical | | | |
| | | Handpiece | The NuVentTM Eustachian<br>Tube Dilation Balloon consists<br>of an integrated polymer<br>handle, stainless steel shaft,<br>and flexible polymer balloon<br>section with an atraumatic<br>polymer tip. | The ACCLARENT AERA® Eustachian<br>Tube Dilation Balloon consists of a rigid<br>Guide Catheter and a flexible polymer<br>Balloon Catheter with an atraumatic<br>polymer tip. | Both consist of a rigid shaft and<br>flexible balloon section with an<br>atraumatic polymer tip. They differ<br>in that the NuVentTM device is a<br>single handpiece, while the AeraTM<br>device uses as separate guide<br>catheter and balloon catheter. | | |
| | | Rigid<br>Shaft | Stainless steel<br>2.76 mm diameter x 95 mm<br>long | Stainless steel & rigid polymer end<br>3.83 mm dia x 83 mm long SS and 17<br>mm long polymer = ~100 mm | Both contain rigid shafts to support<br>manipulation of the devices for<br>directing the tips to the entrance of<br>the Eustachian Tube canal. | | |
| | | | Balloon | Non-compliant polymeric<br>balloon, 6 mm diameter 16 mm<br>long | Non-compliant polymeric balloon, 6 mm<br>diameter x 16 mm long | Identical | |
| | | | Balloon<br>Section | Flexible polymer tube with<br>internal shaping wire | Flexible polymer tube | Both have flexible balloon sections<br>with adequate stiffness to support<br>insertion of the balloon into the<br>Eustachian Tube canal. | |
| | | | Balloon<br>Tip | Rounded 2.6 mm diameter<br>polymer | Rounded 2.4 mm diameter polymer | Both devices have bulbous,<br>atraumatic, and polymeric tips. | |
| | | | | Insertion<br>Method | The flexible polymer balloon<br>section is angled to promote<br>insertion of the polymer<br>balloon section into the ET<br>canal and the balloon section is<br>inserted into the ET canal. | The flexible polymer balloon catheter is<br>advanced through the angled tip of the<br>guide catheter, inserting the balloon into<br>the ET canal. | Both devices provide a means for<br>inserting the flexible balloon<br>sections into the Eustachian Tube<br>canal by including an angle that<br>mimics the Eustachian Tube canal.<br>The Aera device does so by<br>following the guide catheter and<br>the Medtronic device by inclusion<br>of an angled balloon section of a<br>unitized handpiece. |
| | | Insertion<br>Marker | | Blue band at the proximal end<br>of the balloon 30mm from the<br>tip visible under direct<br>endoscopic visualization<br>provides recognition of the<br>depth of balloon insertion in<br>the ET canal aiding in<br>positioning the handpiece. | No visual markers present to estimate<br>depth of Eustachian tube insertion. The<br>device has a marker on the balloon<br>catheter to indicate when the balloon<br>section of the balloon catheter is<br>extended past the distal end of the guide<br>catheter. | Both balloon sections are 30 mm<br>long.<br>The NuVentTM balloon includes a<br>visual marker to provide easy<br>recognition of the end of the<br>flexible balloon and recognition of<br>the depth of insertion. The Aera<br>device also has a visual marker, but<br>it does not indicate the depth of<br>balloon insertion. | |
| | | Inflator | | The balloon handpiece is<br>meant to be used in<br>conjunction only with the<br>Medtronic NuVentTM inflator<br>to provide the pressure for the<br>handpiece balloon. The<br>inflator limits the pressure<br>delivered. | The balloon handpiece is compatible<br>with either the Acclarent® Balloon<br>Inflation Device or Acclarent® SE<br>Inflation Device and is instructed to not<br>exceed 12 atm pressure. | Both systems have inflators that<br>readily connect to the handpiece<br>with Luer fittings and provide<br>pressure and a way to maintain the<br>pressure during the procedure. | |
| | | | | Intended Use | To dilate the Eustachian tube<br>canal. | To dilate the Eustachian tube canal. | Identical |
| | | Description | | Indications for<br>Use | The NuVent Eustachian Tube<br>Dilation Balloon is indicated | The Acclarent Aera® Eustachian Tube | Identical |
| | | Feature/<br>Attribute | NuVent™ Eustachian<br>Tube Dilation Balloon<br>Subject Device | Aera® Eustachian Tube<br>Balloon Dilation System<br>K171761<br>Secondary Predicate Device | Comparison |…