ACCLARENT AERA Eustachian Tube Dilation System

K230742 · Acclarent, Inc. · PNZ · Dec 13, 2023 · Ear, Nose, Throat

Device Facts

• Record ID: K230742
• Device Name: ACCLARENT AERA Eustachian Tube Dilation System
• Applicant: Acclarent, Inc.
• Product Code: PNZ · Ear, Nose, Throat
• Decision Date: Dec 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4180
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older. For patients ages 8-17 years, the ACCLARENT AERA® Eustachian Tube Balloon Dilation System, alone or in combination with adjunctive procedures, is intended to treat patients with objective signs of persistent obstructive Eustachian tube dysfunction from inflammatory pathology, resulting in chronic otitis media with effusion and are refractory to at least one surgical intervention for persistent obstructive Eustachian tube dysfunction.

Device Story

System comprises a flexible 6x16mm non-compliant balloon catheter and a guide catheter; used with an external inflation device. Physician accesses the Eustachian tube via the guide catheter; balloon is positioned under direct endoscopic visualization using an integrated marker; "blueberry" tip prevents over-advancement into the bony isthmus. Balloon is inflated to dilate the cartilaginous portion of the Eustachian tube. Used in clinical settings by physicians. Procedure aims to restore Eustachian tube function, potentially reducing chronic otitis media with effusion and the need for further surgical interventions like tympanostomy tubes.

Clinical Evidence

Evidence includes a systematic literature review (PRISMA guidelines) and real-world evidence analysis of pediatric patients (8-17 years). Study evaluated safety and effectiveness of ETBD in 20 ears with chronic otitis media with effusion. Results: 75% improvement in tympanometry; 84% failure-free rate after mean 2.7-year follow-up. Safety profile: 8.2% minor adverse event rate; no serious adverse events reported. Anatomical equivalence confirmed via CT scan reviews.

Technological Characteristics

Non-compliant nylon balloon catheter (6x16mm) with dual-lumen shaft and "blueberry" tip. Guide catheter features lubricious inner liner and hypotube for rigidity. Sterilized via ethylene oxide (AAMI/ANSI/ISO 11135-1: 2007). Biocompatible per ISO 10993-7:2008. Mechanical dilation principle; no software or electronic components.

Indications for Use

Indicated for patients ages 8 and older with persistent obstructive Eustachian tube dysfunction. Pediatric patients (8-17 years) must have objective signs of inflammatory pathology, chronic otitis media with effusion, and be refractory to at least one prior surgical intervention. Contraindicated in patients with dehiscent ipsilateral carotid artery into the ET 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

• ACCLARENT AERA® Eustachian Tube Balloon Dilation System (K171761)

Submission Summary (Full Text)

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December 13, 2023

Acclarent, Inc. Kamrie Sarnosky Senior Regulatory Specialist 31 Technology Drive Irvine. California 92618

Re: K230742

Trade/Device Name: ACCLARENT AERA Eustachian Tube Dilation System Regulation Number: 21 CFR 874.4180 Regulation Name: Eustachian tube balloon dilation system Regulatory Class: Class II Product Code: PNZ Dated: November 12, 2023 Received: November 13, 2023

Dear Kamrie Sarnosky:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

# Joyce C. Lin -S

for 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

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### Indications for Use

510(k) Number (if known) K230742

Device Name

ACCLARENT AERA® Eustachian Balloon Dilation System

Indications for Use (Describe)

The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older.

For patients ages 8-17 years, the ACCLARENT AERA® Eustachian Tube Balloon Dilation System, alone or in combination with adjunctive procedures, is intended to treat patients with objective signs of persistent obstructive Eustachian tube dysfunction from inflammatory pathology, resulting in chronic otitis media with effusion and are refractory to at least one surgical intervention for persistent obstructive 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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## K230742 - 510(k) Summary

| Sponsor/Submitter: | Acclarent, Inc.<br>31 Technology Drive<br>Irvine, CA 92618 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kamrie Sarnosky<br>Senior Program Lead, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Date of Submission: | March 16, 2023 |
| Device Trade Name: | ACCLARENT AERA® Eustachian Balloon Dilation System |
| Common Name: | Eustachian Tube Balloon Dilation Device |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 874.4180 |
| Classification Name: | Eustachian Tube Balloon Dilation System |
| Product Code: | PNZ |
| Predicate Devices: | ACCLARENT AERA® Eustachian Tube Balloon Dilation System (K171761) |
| Device Description: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System<br>includes a Eustachian Tube Balloon Catheter and Guide Catheter designed<br>specifically for use in accessing and dilating the Eustachian Tube. The system<br>is used with the following additional devices: the Acclarent® SE Inflation<br>Device (or Acclarent® Balloon Inflation Device). The Acclarent® SE Inflation<br>Device or Acclarent® Balloon Inflation Device is used to inflate the balloon.<br>All devices are provided sterile for single-patient use.<br>The ACCLARENT AERA® Eustachian Tube Balloon Dilation System<br>includes is a 6x16mm (inflated diameter x length) flexible Balloon Catheter<br>with an integrated shaft and a nylon balloon at the distal tip. The non-<br>compliant balloon is designed to dilate the cartilaginous portion of the<br>Eustachian tube. The shaft consists of dual lumen tubing with an actuator<br>component that is designed to assist in rotation and advancement of the<br>balloon catheter. The balled catheter tip (aka, “blueberry tip") on the balloon<br>catheter is designed to restrict advancement of the device into the bony portion<br>of the Eustachian tube, known as the isthmus. There is an endoscopic marker<br>placed at the proximal taper of the balloon to aid in positioning under direct<br>endoscopic visualization.<br>The AERA Guide Catheter is anatomically designed to facilitate AERA<br>Balloon Catheter access to the Eustachian tube. The AERA Guide Catheter<br>incorporates an atraumatic distal tip and distal angled tip profile that facilitates<br>access to the Eustachian tube. The Guide Catheter supplied with the<br>ACCLARENT AERA® Eustachian Tube Balloon Dilation System contains a<br>lubricious inner liner to allow smooth passage for the balloon catheter and<br>includes a hypotube for rigidity. |
| Indications for Use: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is<br>intended to dilate the Eustachian tube for treatment of persistent Eustachian<br>tube dysfunction in patients ages 18 and older.<br><br>For patients ages 8-17 years, the ACCLARENT AERA® Eustachian Tube<br>Balloon Dilation System, alone or in combination with adjunctive procedures,<br>is intended to treat patients with objective signs of persistent obstructive<br>Eustachian tube dysfunction from inflammatory pathology, resulting in chronic<br>otitis media with effusion and are refractory to at least one surgical<br>intervention for persistent obstructive Eustachian tube dysfunction. |
| Contraindications: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is<br>contraindicated for use in a Eustachian tube with an ipsilateral carotid artery<br>that is dehiscent into the ET lumen or history of ipsilateral patulous Eustachian<br>tube. |
| Technological<br>Characteristics: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is a<br>device that allows for dilation of the cartilaginous portion of the Eustachian<br>tube. Eustachian tube dilation is achieved via a noncompliant balloon located<br>on the distal end of the device. The technological characteristics of the device<br>are identical to those cleared in K171761. |
| Substantial<br>Equivalence: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System device<br>has expanded indications for use and identical fundamental scientific<br>technology as the predicate device. The AERA device is substantially<br>equivalent to the predicate device. |
| Performance Data: | Previously submitted bench testing has met all acceptance criteria for attributes<br>such as dimensional attributes, cycle fatigue, balloon burst, and bond<br>separation. Testing has shown that the ACCLARENT AERA® Eustachian<br>Tube Balloon Dilation System is biocompatible.<br><br>The sterilization process was validated per AAMI/ANSI/ISO 11135-1: 2007<br>and demonstrated a sterility assurance level of 10-6. The method used for<br>sterilization validation is the overkill (half-cycle approach) in a fixed chamber.<br><br>Testing of ethylene oxide residuals met ISO 10993-7:2008 requirements. The<br>subject device is not tested nor labeled as “non-pyrogenic”.<br><br>Packaging shelf life was established at one year via accelerated aging per<br>ASTM F1980-07.<br><br>Previously submitted performance data demonstrate that the device performs<br>as intended and no new testing was performed for this submission. |
| Clinical Data: | A systematic literature review was conducted per PRISMA guidelines to<br>assess safety and efficacy of BDET in the pediatric population inclusive of<br>both non-Acclarent and Acclarent devices.<br><br>Real-world evidence, with data from published literature and data provided by<br>established physicians, was analyzed to evaluate the safety and effectiveness o<br>the AERA Eustachian Tube Balloon Dilation System in pediatric patients. The |
| | data supported substantial equivalence for the pediatric patient population of<br>ages 8-17. Equivalence of the anatomy was demonstrated with several articles<br>which evaluated Eustachian tube anatomy in the expanded patient population.<br>Based on CT scan reviews, the anatomy of the target patient population was<br>found to be similar to that of the predicate age group with no issues of safety<br>raised. |
| | Real-world evidence was reviewed consisting of ETBD with AERA in patients<br>ages 8-17 years with objective signs of persistent obstructive Eustachian tube<br>dysfunction from inflammatory pathology, resulting in chronic otitis media<br>with effusion. This evidence supports that ETBD is comparable if not superior<br>to tympanostomy tube placement alone in the treatment of chronic otitis media<br>with effusion in the pediatric population. A review of safety data in the<br>expanded population was found to be safe with no serious adverse events<br>reported after ETBD and a minor AE rate in 8.2% of patients in the expanded<br>age group. Efficacy data in 20 ears from patients aged 8-17 years with COME<br>showed an improvement in tympanometry in 75% of procedures. A total of<br>84% of ears were failure-free after a mean of 2.7 years of follow-up (failure<br>was defined as whether further surgery was needed to treat the patient's ETD,<br>eg. tympanostomy tube insertion or revision ETBD). |
| Conclusions: | The AERA Eustachian Tube Balloon Dilation System is substantially<br>equivalent to the predicate device based on the following: (1) clinical data<br>obtained from Real-World Evidence, including a systematic literature review,<br>review of adverse events, CT studies demonstrating anatomical Eustachian<br>tube equivalence, for which data analysis showed that the BDET procedure<br>outcomes were successful to expand the indicated population to 8-17 years of<br>age with persistent otitis media with effusion due to inflammatory pathology<br>and refractory to at least one surgical intervention and (2) equivalence in terms<br>of fundamental scientific technology based on identical design and principles<br>of operations. |
| Summary of<br>Substantial<br>Equivalence: | The technological characteristics of the ACCLARENT AERA® Eustachian<br>Tube Balloon Dilation System are substantially equivalent to the predicate<br>devices for use in mechanically dilating the Eustachian tube. Previous<br>performance testing has demonstrated that the device is safe and effective.<br>Additional clinical testing was not required to demonstrate safety and efficacy<br>of the device. The ACCLARENT AERA® Eustachian Tube Balloon Dilation<br>System is substantially equivalent to the predicate. |

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