Next Generation Balloon Dilation System

K201115 · Acclarent, Inc. · LRC · Aug 27, 2020 · Ear, Nose, Throat

Device Facts

• Record ID: K201115
• Device Name: Next Generation Balloon Dilation System
• Applicant: Acclarent, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Aug 27, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4420
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

The NGB Balloon Dilation System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; irrigate from within a target sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures. For children aged 17 and under, the NGB Balloon Dilation System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; irrigate from within the maxillary sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures. The NGB Balloon Dilation System is intended to dilate the cartilaginous Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older. The NGB Balloon Dilation System with the navigation guidewire may be utilized in conjunction with the TruDi™ Navigation System, to help direct access to nasal and paranasal spaces, and to confirm placement in the targeted anatomy. NGB may be utilized in conjunction with the TruDi™ NAV Wire to confirm placement of the balloon in the Eustachian tube. The NGB Balloon Dilation System with the illumination guidewire may be utilized to illuminate within and provide transcutaneous illumination across nasal and sinus structures.

Device Story

Handheld integrated balloon sinuplasty and Eustachian tube dilation device; features adjustable grip, directable guide tip with four preset positions (Sphenoid, Eustachian tube, Frontal, Maxillary), wire slider, spinner, and balloon slider. Inputs include manual manipulation by physician; device supports optional TruDi Navigation System for EM tracking and illumination guidewire for transcutaneous visualization. Device provides mechanical dilation of sinus ostia or Eustachian tube; enables irrigation and suction. Used in clinical settings by physicians to treat sinus/Eustachian tube dysfunction. Benefits include minimally invasive access, real-time placement confirmation, and combined therapeutic/diagnostic capability.

Clinical Evidence

No clinical data provided; substantial equivalence determined via non-clinical bench testing including simulated use, dimensional attributes, cycle fatigue, balloon burst, bond separation, irrigation flow rate, and device accuracy.

Technological Characteristics

Handheld catheter with non-compliant balloon; materials include Pebax, PET, PEEK, stainless steel, polycarbonate, nylon, PTFE, silicone, and nitinol. Features EM navigation and illumination compatibility. Sterilized via Ethylene Oxide (EtO) per ISO 11135-1. Packaging per ASTM F1980-07.

Indications for Use

Indicated for sinus ostia/space dilation and irrigation/suction in paranasal sinus cavities (all ages) and maxillary sinus (children 17 and under); also indicated for dilation of the cartilaginous Eustachian tube in patients 18 and older with persistent Eustachian tube dysfunction.

Regulatory Classification

Identification

An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.

Predicate Devices

• Acclarent AERA® Eustachian Tube Balloon Dilation System (K171761)
• Relieva SpinPlus® Nav Balloon Sinuplasty System (K171687)
• Relieva SpinPlus® Balloon Sinuplasty System (K143541)

Reference Devices

• Acclarent TruDi NAV Wire (K190532)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 27, 2020

Acclarent Inc. David Locke Manager, Regulatory Affairs 31 Technology Dr., Suite 200 Irvine, California 92618

Re: K201115

Trade/Device Name: Next Generation Balloon Dilation System Regulation Number: 21 CFR 874.4180 Regulation Name: Eustachian Tube Balloon Dilation System Regulatory Class: Class II Product Code: PNZ, PGW, LRC Dated: July 25, 2020 Received: July 28, 2020

Dear David Locke:

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.

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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 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 (OS) 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 medical devices and radiation-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.

for Malvina B. Eydelman, M.D. Director 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) K201115

Device Name Next Generation Balloon Dilation System

#### Indications for Use (Describe)

The NGB Balloon Dilation System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnoutic procedures; irrigate from within a target sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures.

For children aged 17 and under, the NGB Balloon System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; irrigate from within the maxillary sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures.

The NGB Balloon Dilation System is intended to dilate the cartilaginous Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older.

The NGB Balloon Dilation System with the navigation guidewire may be utilized in conjunction with the TruDi™ Navigation System, to help direct access to nasal and paranasal spaces, and to confirm placement in the targeted anatomy. NGB may be utilized in conjunction with the TruDi™ NAV Wire to confirm placement of the balloon in the Eustachian tube.

The NGB Balloon Dilation System with the illumination guidewire may be utilized to illuminate within and provide transcutaneous illumination across nasal and sinus structures.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image displays the Acclarent logo, with the company name in bold, followed by a curved line above the 'ent'. Below the logo, the text "Next Generation Balloon Dilation System" is present. The text is in a smaller font size compared to the logo.

# K201115 - 510(K) SUMMARY

#### [807.92(a)(1)] Submitter Information

| Applicant: | Acclarent Inc.<br>31 Technology Drive, Suite 200<br>Irvine, CA 92618, USA<br>Tel.: [phone]<br>Fax: [phone] |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David Locke<br>Manager, Regulatory Affairs<br>Acclarent Inc.<br>Phone: [phone]<br>Dlocke1 @its.jnj.com |
| Authored by: | David Locke<br>Manager, Regulatory Affairs<br>Acclarent Inc.<br>Phone: [phone] |
| Date Summary Prepared: | Aug 26, 2020 |
| [807.92(a)(2)] Name of Device | |
| Device Trade Name:<br>Device Common Name:<br>Classification Name: | Next Generation Balloon - Balloon Dilation System<br>Next Generation Balloon Dilation System<br>Eustachian tube balloon dilation system (21 CFR 874.4180) |
| Device Classification: | Class II |
| Product Code:<br>Secondary Codes:<br>Review Panel: | PNZ<br>PGW, LRC<br>Ear, Nose and Throat |
| [807.92(a)(3)] Legally Marketed Devices | |
| Primary Predicate Device: | Acclarent AERA® Eustachian Tube Balloon Dilation System<br>(K171761) |
| Secondary Predicate<br>Devices: | Relieva SpinPlus® Nav Balloon Sinuplasty System (K171687)<br>Relieva SpinPlus® Balloon Sinuplasty System (K143541) |
| Reference Device: | Acclarent TruDi NAV Wire (K190532) |
| Device Description: | The Next Generation Balloon Dilation System (NGB) is an integrated<br>balloon sinuplasty (BSP) and Eustachian tube (ET) dilation device, that<br>will be available in light fiber and navigation guidewire configurations for<br>compatibility with illumination and navigation technology. The system<br>includes a handle with several integrated features to allow for single-<br>handed use. The adjustable gripping feature allows for ergonomic<br>handling. The directable guide tip enables access (i.e.<br>manipulating/separating/dividing tissue) and placement near the targeted<br>anatomy. There are four preset approximate positions: Sphenoid<br>(straight), Eustachian tube (55°), Frontal (70°), Maxillary (110°). The<br>directable guide knob allows for positioning of the balloon tip towards the<br>target anatomy. The wire slider and spinner are used to advance, retract,<br>and rotate the guidewire. The balloon slider is used advance and retract<br>the balloon. The Next Generation Balloon Dilation System also allows for<br>suction and irrigation in and around the target anatomy. |

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## [807.92(a)(4)] Device Description

## [807.92(a)(5)] Intended Use and Predicate Device Comparison

| Indications for Use: |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The NGB Balloon Dilation System is intended to provide a means to<br>access the sinus space within and across nasal and sinus structures; dilate<br>the sinus ostia and spaces associated with the paranasal sinus cavities for<br>diagnostic and therapeutic procedures; irrigate from within a target sinus;<br>suction throughout therapeutic procedures and to facilitate diagnostic<br>procedures. |
| For children aged 17 and under, the NGB Balloon Dilation System is<br>intended to provide a means to access the sinus space within and across<br>nasal and sinus structures; dilate sinus ostia and spaces associated with the<br>maxillary sinus for diagnostic and therapeutic procedures; irrigate from<br>within the maxillary sinus; suction throughout therapeutic procedures and<br>to facilitate diagnostic procedures. |
| The NGB Balloon Dilation System is intended to dilate the cartilaginous<br>Eustachian tube for treatment of persistent Eustachian tube dysfunction in<br>patients ages 18 and older. |
| The NGB Balloon Dilation System with the navigation guidewire may be<br>utilized in conjunction with the TruDiTM Navigation System, to help direct<br>access to nasal and paranasal spaces, and to confirm placement in the<br>targeted anatomy. NGB may be utilized in conjunction with the TruDiTM<br>NAV Wire to confirm placement of the balloon in the Eustachian tube. |
| The NGB Balloon Dilation System with the illumination guidewire may<br>be utilized to illuminate within and provide transcutaneous illumination<br>across nasal and sinus structures. |

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Image /page/5/Picture/0 description: The image shows the word "Acclarent" in bold, with a purple arc over the last few letters. Below that, the text "Next Generation Balloon Dilation System" is written in a smaller font. The word "Next" is capitalized, and the rest of the words are in lowercase.

# [807.92(a)(6)] Technical Characteristics

| Technological<br>Characteristics: | The Next Generation Balloon Dilation System combines Sinuplasty and<br>Eustachian Tube Dilation into a single handheld device. The device also<br>allows for the use of the Acclarent TruDiTM NAV Wire for real-time<br>tracking within nasal and Eustachian tube anatomy as well as an<br>illumination wire for transcutaneous illumination across, nasal and sinus<br>structures. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-clinical Performance<br>Data: | The Next Generation Balloon was tested to ensure that it functions in<br>accordance with the device design specifications related to substantial<br>equivalence in terms of device safety and effectiveness.<br>The following nonclinical tests were performed:<br><br>1. Bench testing has been performed and met all acceptance criteria for<br>attributes such as simulated use testing, dimensional attributes, cycle<br>fatigue, balloon burst, bond separation, irrigation flow rate and device<br>accuracy. Moreover, testing also showed that the Next Generation<br>Balloon Dilation System is biocompatible.<br><br>2. The sterilization process has been validated per AAMI/ANSI/ISO<br>11135-1: 2007 and demonstrated a sterility assurance level of 10-6.<br>The method used for sterilization validation is the overkill (half-cycle<br>approach) in a fixed chamber. Ethylene oxide residuals have been<br>tested and meet ISO 10993-7:2008 requirements. The subject device<br>is not tested nor labeled as “non-pyrogenic”.<br><br>3. Packaging shelf life has been established to be 3 months per ASTM<br>F1980-07.<br><br>4. Mechanical testing was performed, including tensile and flexural<br>testing of catheter joints and materials.<br><br>5. Durability testing was performed, including fatigue and burst pressure<br>testing of the balloon materials and components.<br><br>6. Inflation and deflation characterization testing was performed,<br>including time and pressure measurements, and leak testing of the<br>balloon.<br><br>7. Verification testing of safety features built into the device was<br>performed, including the characterization of catheter geometries and<br>distal tip insertion limitation mechanisms.<br><br>8. Simulated use testing in a clinically relevant model demonstrated the<br>reliability of the device to remain mechanically functional throughout<br>the anticipated conditions of use, and that the design features limit<br>access to only the cartilaginous portion of the Eustachian tube.<br><br>9. The Next Generation Balloon Dilation System passed all tests in<br>accordance with appropriate test criteria and standards, and the<br>modified device did not raise new questions of safety or effectiveness. |

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Image /page/6/Picture/0 description: The image shows the Acclarent logo, with the company name in bold black letters and a purple curved line above the "ent" portion of the name. Below the logo, the text "Next Generation Balloon Dilation System" is displayed in a smaller, non-bold font. The text is left-aligned and positioned directly beneath the Acclarent logo.

| Clinical Data: | Clinical data was not necessary to determine that the subject Next<br>Generation Balloon Dilation System performs as intended. |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The modified Next Generation Balloon Dilation System device is<br>substantially equivalent to the currently cleared Acclarent AERA®<br>Eustachian Tube Balloon Dilation System and the secondary predicate<br>devices based on the completion of non-clinical bench testing as well as<br>similar principles of design, operation and indications for use. |

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Image /page/7/Picture/0 description: The image shows the word "Acclarent" in black font. The "ent" portion of the word is in purple font. There is a purple arc above the "ent" portion of the word.

# Substantial Equivalence Table

| Attribute | Primary Predicate<br>Device:<br>ACCLARENT<br>AERA®<br>Eustachian Tube<br>Balloon Dilation<br>System | Secondary<br>Predicate<br>Device:<br>RELIEVA<br>SPINPLUS®<br>NAV Balloon<br>Sinuplasty<br>System | Secondary<br>Predicate<br>Device:<br>RELIEVA<br>SPINPLUS®<br>Balloon<br>Sinuplasty<br>System | Reference<br>Device:<br>TruDi™ NAV<br>Wire® | Subject<br>Device:<br>Next<br>Generation<br>Balloon<br>Dilation<br>System | Substantial<br>Equivalence<br>Rationale |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>number | K171761 | K171687 | K143541 | K190532 | K201115 | N/A |
| Manufacturer | Acclarent | Acclarent | Acclarent | Acclarent | Acclarent | N/A |
| Trade Name | ACCLARENT<br>AERA®<br>Eustachian<br>Balloon<br>Dilation<br>System | RELIEVA<br>SPINPLUS®<br>NAV<br>Balloon<br>Sinuplasty<br>System | Relieva<br>SpinPlus<br>Balloon<br>Sinuplasty<br>System | TruDi™ NAV Wire | Next<br>Generation<br>Balloon<br>Dilation<br>System | N/A |
| Common<br>Name | Eustachian<br>Tube Balloon<br>Dilation<br>Device | Sinus<br>Dilation<br>System | Sinus<br>Dilation<br>System | Image Guided<br>Surgery<br>System | Eustachian<br>Tube<br>Balloon<br>Dilation<br>Device | N/A |
| Class | II | I | I | II | II | Same as the<br>higher<br>classification<br>devices |
| Attribute | Primary Predicate<br>Device:<br>ACCLARENT<br>AERA®<br>Eustachian Tube<br>Balloon Dilation<br>System | Secondary<br>Predicate<br>Device:<br>RELIEVA<br>SPINPLUS®<br>NAV Balloon<br>Sinuplasty<br>System | Secondary<br>Predicate<br>Device:<br>RELIEVA<br>SPINPLUS®<br>Balloon<br>Sinuplasty<br>System | Reference<br>Device:<br>TruDi™ NAV<br>Wire® | Subject<br>Device:<br>Next<br>Generation<br>Balloon<br>Dilation<br>System | Substantial<br>Equivalence<br>Rationale |
| Classification<br>Product Code | PNZ | LRC | LRC | PGW | PNZ | Same as<br>primary<br>predicate<br>device |
| Subsequent<br>Product Code | N/A | PGW | N/A | N/A | PGW,<br>LRC | N/A |
| Classification<br>Section | 874.4180 | 874.4420 | 874.4420 | 882.4560 | 874.4180 | Same as<br>primary<br>predicate<br>device |
| Indications<br>for Use | The ACCLARENT<br>AERA® Eustachian<br>Tube Balloon Dilation<br>System is intended to<br>dilate the Eustachian<br>tube for treatment of<br>persistent Eustachian<br>tube dysfunction in<br>patients ages 18 and<br>older. | The RELIEVA<br>SPINPLUS® NAV<br>Balloon Sinuplasty<br>System is intended to<br>provide a means to<br>access the sinus space,<br>within and across<br>nasal and sinus<br>structures; dilate the<br>sinus ostia and spaces<br>associated with the<br>paranasal sinus<br>cavities for diagnostic<br>and therapeutic<br>procedures; and<br>irrigate from within a<br>target sinus for<br>therapeu…