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 Description

The ACCLARENT AERA® Eustachian Tube Balloon Dilation System includes a Eustachian Tube Balloon Catheter and Guide Catheter designed specifically for use in accessing and dilating the Eustachian Tube. The system is used with the following additional devices: the Acclarent® SE Inflation Device (or Acclarent® Balloon Inflation Device). The Acclarent® SE Inflation Device or Acclarent® Balloon Inflation Device is used to inflate the balloon. All devices are provided sterile for single-patient use. The ACCLARENT AERA® Eustachian Tube Balloon Dilation System includes is a 6x16mm (inflated diameter x length) flexible Balloon Catheter with an integrated shaft and a nylon balloon at the distal tip. The non-compliant balloon is designed to dilate the cartilaginous portion of the Eustachian tube. The shaft consists of dual lumen tubing with an actuator component that is designed to assist in rotation and advancement of the balloon catheter. The balled catheter tip (aka, “blueberry tip") on the balloon catheter is designed to restrict advancement of the device into the bony portion of the Eustachian tube, known as the isthmus. There is an endoscopic marker placed at the proximal taper of the balloon to aid in positioning under direct endoscopic visualization. The AERA Guide Catheter is anatomically designed to facilitate AERA Balloon Catheter access to the Eustachian tube. The AERA Guide Catheter incorporates an atraumatic distal tip and distal angled tip profile that facilitates access to the Eustachian tube. The Guide Catheter supplied with the ACCLARENT AERA® Eustachian Tube Balloon Dilation System contains a lubricious inner liner to allow smooth passage for the balloon catheter and includes a hypotube for rigidity.

AI/ML Overview

The Acclarent AERA Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for the treatment of persistent Eustachian tube dysfunction. The expanded indication covers patients aged 8-17 years with objective signs of persistent obstructive Eustachian tube dysfunction from inflammatory pathology, resulting in chronic otitis media with effusion and refractory to at least one surgical intervention.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance and Validation
Mechanical Performance	Dimensional attributes, cycle fatigue, balloon burst, bond separation.	Previously submitted bench testing met all acceptance criteria for these attributes. No new testing for mechanical characteristics was performed for this submission as the technological characteristics of the device are identical to the predicate device.
Biocompatibility	Device materials are biocompatible.	Testing has shown that the ACCLARENT AERA® Eustachian Tube Balloon Dilation System is biocompatible.
Sterilization	Sterility assurance level (SAL) of 10^-6.	The sterilization process was validated per AAMI/ANSI/ISO 11135-1: 2007, using the overkill (half-cycle approach) in a fixed chamber, and demonstrated a sterility assurance level of 10^-6.
Ethylene Oxide Residuals	Meet ISO 10993-7:2008 requirements.	Testing of ethylene oxide residuals met ISO 10993-7:2008 requirements.
Packaging Shelf Life	One-year shelf life.	Packaging shelf life was established at one year via accelerated aging per ASTM F1980-07.
Safety (Pediatric)	Acceptable adverse event rate in pediatric patients (8-17 years old) with persistent obstructive Eustachian tube dysfunction from inflammatory pathology, resulting in chronic otitis media with effusion, and refractory to at least one surgical intervention.	A review of safety data in the expanded pediatric population (8-17 years) found the device to be safe with no serious adverse events reported after ETBD. A minor AE rate of 8.2% of patients in this expanded age group was observed. This evidence was derived from real-world evidence, including published literature and data provided by established physicians.
Efficacy (Pediatric)	Improvement in tympanometry and failure-free rate in pediatric patients (8-17 years old) with persistent obstructive Eustachian tube dysfunction from inflammatory pathology, resulting in chronic otitis media with effusion, and refractory to at least one surgical intervention.	Efficacy data from 20 ears in patients aged 8-17 years with Chronic Otitis Media with Effusion (COME) showed an improvement in tympanometry in 75% of procedures. A total of 84% of ears were failure-free after a mean of 2.7 years of follow-up (failure defined as requiring further surgery for ETD, e.g., tympanostomy tube insertion or revision ETBD). This evidence was derived from real-world evidence, including published literature and data provided by established physicians, and supports that ETBD is comparable, if not superior, to tympanostomy tube placement alone in the treatment of chronic otitis media with effusion in the pediatric population.
Anatomical Equivalence	Eustachian tube anatomy in the expanded patient population (8-17 years) to be similar to the predicate age group (18+ years).	Equivalence of anatomy was demonstrated through a systematic literature review including several articles evaluating Eustachian tube anatomy. Based on CT scan reviews, the anatomy of the target pediatric patient population (8-17 years) was found to be similar to that of the predicate adult age group (18+) with no issues of safety raised.

2. Sample Sizes and Data Provenance:

Test Set (for pediatric expansion):
- Clinical Data: Efficacy data was reported from 20 ears of patients aged 8-17 years with Chronic Otitis Media with Effusion. Safety data encompassed a broader analysis across the expanded pediatric age group (8-17 years), without a specific patient count provided for the 8.2% minor AE rate, but it was derived from real-world evidence.
- Anatomical Equivalence: "Several articles" based on CT scan reviews were used. No specific number of patients or scans are provided for this.
- Provenance: "Real-world evidence, with data from published literature and data provided by established physicians" was analyzed. It is retrospective in nature, as it relies on existing published literature and real-world clinical experience. The country of origin of the data is not specified but is generally understood to be diverse given the nature of a systematic literature review and physician-provided data.
Training Set: The document does not explicitly describe a separate "training set" in the context of an AI/ML algorithm requiring such a set. The performance data for the device (mechanical, biocompatibility, sterilization, etc.) relies on previously submitted bench testing and validations, which are not typically referred to as training sets. The clinical data for the pediatric expansion relies on real-world evidence and a systematic literature review, which also does not fit the typical definition of a training set for an AI/ML model.

3. Number of Experts and Qualifications for Ground Truth:

For Clinical Data (Pediatric Expansion): The document mentions "data provided by established physicians." It does not specify the number or specific qualifications (e.g., years of experience) of these individual physicians, nor does it detail the experts involved in conducting the systematic literature review.
For Anatomical Equivalence: Similarly, the CT scan reviews were used as evidence for anatomical equivalence, based on "several articles." The experts performing these CT scan reviews or evaluating the articles are not explicitly identified or qualified.

4. Adjudication Method for the Test Set:

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1) for the clinical data or anatomical equivalence evaluations for the pediatric expansion. The data from published literature and physician-provided data likely reflect outcomes as recorded and reported in their respective studies or practices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is a physical medical device for dilation, not an AI or imaging diagnostic software that would typically involve human readers interpreting cases with and without AI assistance. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone (algorithm only) performance study was not done. As noted above, this device is a physical medical device (balloon dilation system), not a software algorithm that would have standalone performance.

7. Type of Ground Truth Used:

For the pediatric efficacy data, the ground truth was based on:
- Clinical Outcomes/Measurements: Improvement in tympanometry (an objective measure of middle ear function).
- Failure-Free Rate: Defined as not requiring further surgery for ETD (e.g., tympanostomy tube insertion or revision ETBD), which is an outcome-based measure.
For the pediatric safety data, the ground truth was based on:
- Reported Adverse Events: Classification of events as serious or minor, as observed in real-world clinical practice and literature.
For anatomical equivalence, the ground truth was based on:
- CT Scan Reviews: Morphometric analysis of Eustachian tube anatomy as reported in published studies.

8. Sample Size for the Training Set:

As mentioned in section 2, the document does not describe a "training set" in the context of AI/ML. All referred performance data are either previously established bench tests for the device itself or real-world clinical evidence/literature reviews for the expanded indication.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as a conventional "training set" with established ground truth for an AI/ML model is not described in this submission. The "ground truth" for the device's functional and safety characteristics was established through standard engineering bench testing and clinical data collection/review methodologies relevant to medical devices.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.

Type of Use (Select one or both, as applicable)
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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.31 Technology DriveIrvine, CA 92618
Contact Person:	Kamrie SarnoskySenior Program Lead, Regulatory AffairsPhone: 931-551-5023Fax: (949) 450-6886
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 Systemincludes a Eustachian Tube Balloon Catheter and Guide Catheter designedspecifically for use in accessing and dilating the Eustachian Tube. The systemis used with the following additional devices: the Acclarent® SE InflationDevice (or Acclarent® Balloon Inflation Device). The Acclarent® SE InflationDevice or Acclarent® Balloon Inflation Device is used to inflate the balloon.All devices are provided sterile for single-patient use.The ACCLARENT AERA® Eustachian Tube Balloon Dilation Systemincludes is a 6x16mm (inflated diameter x length) flexible Balloon Catheterwith an integrated shaft and a nylon balloon at the distal tip. The non-compliant balloon is designed to dilate the cartilaginous portion of theEustachian tube. The shaft consists of dual lumen tubing with an actuatorcomponent that is designed to assist in rotation and advancement of theballoon catheter. The balled catheter tip (aka, “blueberry tip") on the ballooncatheter is designed to restrict advancement of the device into the bony portionof the Eustachian tube, known as the isthmus. There is an endoscopic markerplaced at the proximal taper of the balloon to aid in positioning under directendoscopic visualization.The AERA Guide Catheter is anatomically designed to facilitate AERABalloon Catheter access to the Eustachian tube. The AERA Guide Catheterincorporates an atraumatic distal tip and distal angled tip profile that facilitatesaccess to the Eustachian tube. The Guide Catheter supplied with theACCLARENT AERA® Eustachian Tube Balloon Dilation System contains alubricious inner liner to allow smooth passage for the balloon catheter andincludes a hypotube for rigidity.
Indications for Use:	The ACCLARENT AERA® Eustachian Tube Balloon Dilation System isintended to dilate the Eustachian tube for treatment of persistent Eustachiantube dysfunction in patients ages 18 and older.For patients ages 8-17 years, the ACCLARENT AERA® Eustachian TubeBalloon Dilation System, alone or in combination with adjunctive procedures,is intended to treat patients with objective signs of persistent obstructiveEustachian tube dysfunction from inflammatory pathology, resulting in chronicotitis media with effusion and are refractory to at least one surgicalintervention for persistent obstructive Eustachian tube dysfunction.
Contraindications:	The ACCLARENT AERA® Eustachian Tube Balloon Dilation System iscontraindicated for use in a Eustachian tube with an ipsilateral carotid arterythat is dehiscent into the ET lumen or history of ipsilateral patulous Eustachiantube.
TechnologicalCharacteristics:	The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is adevice that allows for dilation of the cartilaginous portion of the Eustachiantube. Eustachian tube dilation is achieved via a noncompliant balloon locatedon the distal end of the device. The technological characteristics of the deviceare identical to those cleared in K171761.
SubstantialEquivalence:	The ACCLARENT AERA® Eustachian Tube Balloon Dilation System devicehas expanded indications for use and identical fundamental scientifictechnology as the predicate device. The AERA device is substantiallyequivalent to the predicate device.
Performance Data:	Previously submitted bench testing has met all acceptance criteria for attributessuch as dimensional attributes, cycle fatigue, balloon burst, and bondseparation. Testing has shown that the ACCLARENT AERA® EustachianTube Balloon Dilation System is biocompatible.The sterilization process was validated per AAMI/ANSI/ISO 11135-1: 2007and demonstrated a sterility assurance level of 10-6. The method used forsterilization validation is the overkill (half-cycle approach) in a fixed chamber.Testing of ethylene oxide residuals met ISO 10993-7:2008 requirements. Thesubject device is not tested nor labeled as “non-pyrogenic”.Packaging shelf life was established at one year via accelerated aging perASTM F1980-07.Previously submitted performance data demonstrate that the device performsas intended and no new testing was performed for this submission.
Clinical Data:	A systematic literature review was conducted per PRISMA guidelines toassess safety and efficacy of BDET in the pediatric population inclusive ofboth non-Acclarent and Acclarent devices.Real-world evidence, with data from published literature and data provided byestablished physicians, was analyzed to evaluate the safety and effectiveness othe AERA Eustachian Tube Balloon Dilation System in pediatric patients. The
	data supported substantial equivalence for the pediatric patient population ofages 8-17. Equivalence of the anatomy was demonstrated with several articleswhich evaluated Eustachian tube anatomy in the expanded patient population.Based on CT scan reviews, the anatomy of the target patient population wasfound to be similar to that of the predicate age group with no issues of safetyraised.
	Real-world evidence was reviewed consisting of ETBD with AERA in patientsages 8-17 years with objective signs of persistent obstructive Eustachian tubedysfunction from inflammatory pathology, resulting in chronic otitis mediawith effusion. This evidence supports that ETBD is comparable if not superiorto tympanostomy tube placement alone in the treatment of chronic otitis mediawith effusion in the pediatric population. A review of safety data in theexpanded population was found to be safe with no serious adverse eventsreported after ETBD and a minor AE rate in 8.2% of patients in the expandedage group. Efficacy data in 20 ears from patients aged 8-17 years with COMEshowed an improvement in tympanometry in 75% of procedures. A total of84% of ears were failure-free after a mean of 2.7 years of follow-up (failurewas defined as whether further surgery was needed to treat the patient's ETD,eg. tympanostomy tube insertion or revision ETBD).
Conclusions:	The AERA Eustachian Tube Balloon Dilation System is substantiallyequivalent to the predicate device based on the following: (1) clinical dataobtained from Real-World Evidence, including a systematic literature review,review of adverse events, CT studies demonstrating anatomical Eustachiantube equivalence, for which data analysis showed that the BDET procedureoutcomes were successful to expand the indicated population to 8-17 years ofage with persistent otitis media with effusion due to inflammatory pathologyand refractory to at least one surgical intervention and (2) equivalence in termsof fundamental scientific technology based on identical design and principlesof operations.
Summary ofSubstantialEquivalence:	The technological characteristics of the ACCLARENT AERA® EustachianTube Balloon Dilation System are substantially equivalent to the predicatedevices for use in mechanically dilating the Eustachian tube. Previousperformance testing has demonstrated that the device is safe and effective.Additional clinical testing was not required to demonstrate safety and efficacyof the device. The ACCLARENT AERA® Eustachian Tube Balloon DilationSystem is substantially equivalent to the predicate.

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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.