(284 days)
No
The device description focuses on mechanical components and their function. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies describe clinical trial results and bench testing, not the evaluation of an AI/ML model.
Yes
The device is described as "intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction," which directly indicates a therapeutic purpose.
No
Explanation: The device is described as a system for dilating the Eustachian tube to treat Eustachian tube dysfunction. Its purpose is therapeutic (treatment), not diagnostic (identifying a condition).
No
The device description explicitly lists hardware components such as a balloon catheter, guide catheter, inflation device, and extension tubing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a physical system (catheter, balloon, inflation device) used for a surgical/interventional procedure.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such testing on specimens.
The device is a medical device used for a therapeutic intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The ACCLARENT AERATM Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in adults ages 22 and older.
Product codes
PNZ
Device Description
The ACCLARENT® AERA™ Eustachian Tube Balloon Dilation System includes the Eustachian Tube Balloon Catheter (ETBC) and the Eustachian Tube Guide Catheter (ETGC). The system is provided with the following additional devices: the Acclarent SE Inflation Device (or Acclarent Balloon Inflation Device) and Relieva Extension Tubing. The Acclarent SE Inflation Device (or Acclarent Balloon Inflation Device) is used to inflate the ETBC. The Acclarent SE Inflation Device and Acclarent Balloon Inflation Device are FDA cleared devices (K150172 and K052198, respectively). The Relieva Extension Tubing may be used to connect the Balloon Catheters and the Inflation Device when additional tubing length is required. The Relieva Extension Tubing is a Class I exempt device under 21 CFR 874.4420. All devices are provided sterile for single-patient use.
The ETBC is a 6x16mm (inflated diameter x length) flexible Balloon Catheter (Figure 1) 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 (ET). The shaft consists of dual lumen tubing with an actuator component that is designed to assist in rotation and advancement of the ETBC. The balled catheter tip (aka, "blueberry tip") on the ETBC is designed to restrict advancement of the device into the bony portion of the ET, 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 ETGC (Figure 2) is designed to facilitate ETBC access to the ET. The ETGC incorporates an atraumatic distal tip and distal angled tip profile that facilitates access to the ET. The ETGC contains a lubricious inner liner to allow smooth passage for the ETBC and includes a hypotube for rigidity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eustachian tube
Indicated Patient Age Range
adults ages 22 and older.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Studies:
The ACCLARENT® AERA™ Eustachian Tube Balloon Dilation System was tested to ensure that it functions according to the design specifications, passing nonclinical tests for biocompatibility, shelf life, sterility, and performance.
- Biocompatibility: Materials are well known and commonly used. Patient-contacting materials were evaluated per ISO 10993-1 and FDA Bluebook Memorandum G95-1 for cytotoxicity, sensitization, and acute systemic toxicity, all found acceptable.
- Shelf Life/Sterility: Sterilization process complies with ISO 11135:2014, achieving SAL of 10^-6. Proposed 2-year shelf life validated using accelerated aging (ASTM F1980-07). Packaging integrity tests (ASTM F1886/F1886M, ASTM F2096-11, ASTM F88-09) were passed. Transit testing performed per ISO 2233:2000 and ASTM D4169:2009.
- Performance Testing (Bench): Functional testing performed on ETBC and ETGC after sterilization, environmental conditioning, transit simulations, and accelerated aging. Devices passed all functional testing, including dimensional checks, balloon deflation time, burst pressure, tensile strength, tip bond strength, insertion/retraction, fatigue, and label verification.
- Balloon Catheter tests: Deflation time (b(4) CCI), Burst Pressure (> b(4) CCI), Tensile Strength (Force at break b(4) CCI), Balloon Catheter Tip Test (Force at break b(4) CCI), Insertion/Retraction Test (After 4 insertion/retractions), Fatigue Test (8 cycles @ b(4) CCI).
- Guide Catheter tests: Fatigue (After 4 insertion/retraction cycles), Torque (Torque >= b(4) CCI), Tensile Strength (Force at break >= b(4) CCI).
Cadaver Study:
- Study Type: Simulated use testing in cadavers.
- Sample Size: Not explicitly stated for number of cadavers, but each evaluator used device to dilate left and right ET of same specimen.
- Key Results: ENT physicians assessed various attributes (e.g., device placement, attachment, movement, single-hand operation, avoiding trauma, functionality). Acceptance criteria: clinically acceptable rating of "2" or higher on a 1-4 point scale (4=excellent, 1=clinically unacceptable). All ratings from each evaluator were above "2". The lowest average rating for any requirement was 3.3, and the highest was 3.7 (out of 4). System performed as intended with no safety issues.
Clinical Study:
- Study Type: Prospective, multi-center, randomized controlled trial.
- Study Objectives: Evaluate efficacy and safety of ET balloon dilation with ETBC plus medical management (investigational arm) vs. medical management alone (control arm) for ETD.
- Primary Efficacy Endpoint: Proportion of subjects with normalization of tympanometry at 6 weeks post-treatment (investigational) vs. 6 weeks post-randomization (control).
- Secondary Efficacy Endpoint: Proportion of subjects achieving at least a minimally important difference (MID) level improvement of 0.5 points for ETDQ-7 score at 6 weeks.
- Safety Evaluation: Occurrence of anticipated or unanticipated adverse events.
- Study Methodology: 2:1 randomization (ETBC:MM). Group sequential design with 3 planned looks. Second-look cohort used for evidence. Independent tympanogram evaluator blinded to arm assignment.
- Number of Subjects: Second interim analysis cohort: 72 MM, 141 ETBC, 81 Lead-In subjects. Safety analysis included 299 subjects (80 lead-in + 149 randomized ETBC + 70 MM cross-overs).
- Efficacy Results:
- Technical Success: 298/299 (99.7%) of targeted ETs successfully accessed and dilated.
- Primary Endpoint: Tympanogram normalization: 51.8% (73/141) in investigational arm vs. 13.9% (10/72) in controls (p
§ 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.
0
DE NOVO CLASSIFICATION REQUEST FOR ACCLARENT AERA™ EUSTACHIAN TUBE BALLOON DILATION SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Eustachian Tube Balloon Dilation System. 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.
NEW REGULATION NUMBER: 874.4180
CLASSIFICATION: CLASS II
PRODUCT CODE: PNZ
BACKGROUND
DEVICE NAME: ACCLARENT AERA™ EUSTACHIAN TUBE BALLOON DILATION SYSTEM
SUBMISSION NUMBER: DEN150056
DATE OF DE NOVO: DECEMBER 4, 2015
CONTACT: ACCLARENT, INC. 33 TECHNOLOGY DRIVE IRVINE, CA 92618
INDICATIONS FOR USE
The ACCLARENT AERATM Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in adults ages 22 and older.
LIMITATIONS
The sale, distribution, and use of the ACCLARENT AERA™ Eustachian Tube Balloon Dilation System are restricted to prescription use in accordance with 21 CFR 801.109.
Limitations on device use are also achieved through the following contraindications. warnings, and precautions included in the Instructions for Use:
1
CONTRAINDICATIONS
The ACCLARENT AERA™ Eustachian Tube Balloon Catheter is contraindicated for use in a Eustachian tube with an ipsilateral carotid artery that is dehiscent into the ET lumen or history of ipsilateral patulous Eustachian tube.
WARNINGS
- Intended for single patient use only. DO NOT REUSE. ●
- . Patients with a history of skull base surgery, prior ear surgery, skull fracture, or anatomic abnormalities may have elevated risk of complications and should be radiographically screened for eligibility before treatment.
- DO NOT use product if the integrity of the sterile packaging has been ● compromised or if the device appears damaged.
- DO NOT use the ACCLARENT AERA™ Eustachian Tube Balloon Catheter if ● the device becomes damaged or touches a non-sterile object outside of the operating field.
- Never advance or retract the device against unknown resistance, as this could . cause tissue trauma or device damage.
- . Advancing the Eustachian Tube Balloon Catheter into the Eustachian tube against resistance may cause injury.
- DO NOT exceed the recommended maximum balloon inflation pressure of 12 ● atmospheres (ATM).
- Use only sterile saline or sterile water for inflation. DO NOT inflate with air. ●
- . The safety of the device as used under local anesthesia has not been evaluated.
PRECAUTIONS
- DO NOT move the balloon while it is inflated. Ensure balloon is fully deflated ● during insertion and withdrawal.
- Radiographic assessment of the targeted Eustachian tube is recommended prior to ● any procedure involving balloon tuboplasty.
- Certain nasal anatomy such as a deviated nasal septum may preclude access to the . Eustachian tube/s resulting in failure to treat the target anatomy.
- DO NOT inflate the Eustachian Tube Balloon Catheter until it has exited the . ACCLARENT AERA™ Eustachian Tube Guide Catheter.
- DO NOT bend the Guide Catheter shaft. .
DEVICE DESCRIPTION
The ACCLARENT® AERA™ Eustachian Tube Balloon Dilation System includes the Eustachian Tube Balloon Catheter (ETBC) and the Eustachian Tube Guide Catheter (ETGC). The system is provided with the following additional devices: the Acclarent SE Inflation Device (or Acclarent Balloon Inflation Device) and Relieva Extension Tubing. The Acclarent SE Inflation Device (or Acclarent Balloon Inflation Device) is used to inflate the ETBC. The Acclarent SE Inflation Device and Acclarent Balloon Inflation Device are FDA cleared devices (K150172 and K052198, respectively). The Relieva Extension Tubing may be used to connect the Balloon Catheters and the Inflation Device when additional tubing length is required. The
De Novo Summary (DEN150056)
2
Relieva Extension Tubing is a Class I exempt device under 21 CFR 874.4420. All devices are provided sterile for single-patient use.
The ETBC is a 6x16mm (inflated diameter x length) flexible Balloon Catheter (Figure 1) 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 (ET). The shaft consists of dual lumen tubing with an actuator component that is designed to assist in rotation and advancement of the ETBC. The balled catheter tip (aka, "blueberry tip") on the ETBC is designed to restrict advancement of the device into the bony portion of the ET, 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.
Image /page/2/Figure/2 description: The image shows a diagram of a medical device, specifically a catheter. The diagram labels several key components of the catheter, including the vent cap, luer, inflation port, actuator, proximal marker, catheter shaft, endoscopic marker, balloon, and catheter tip. The diagram provides a detailed view of the catheter's structure and features.
Figure 1: Illustration of the Eustachian Tube Balloon Catheter
The ETGC (Figure 2) is designed to facilitate ETBC access to the ET. The ETGC incorporates an atraumatic distal tip and distal angled tip profile that facilitates access to the ET. The ETGC contains a lubricious inner liner to allow smooth passage for the ETBC and includes a hypotube for rigidity.
Image /page/2/Figure/5 description: The image shows a medical instrument with several labeled parts. The instrument has a proximal handle/hub, a rigid shaft, a tip angle, and an atraumatic tip. The handle is blue, and the shaft is black.
Figure 2: Diagram of Eustachian Tube Guide Catheter
3
SUMMARY OF NONCLINICAL/BENCH STUDIES
The ACCLARENT® AERA™ Eustachian Tube Balloon Dilation System was tested to ensure that it functions according to the design specifications. The device passed the following nonclinical tests as described below.
BIOCOMPATIBILITY/MATERIALS
The materials used in the ACCLARENT® AERA™ Eustachian Tube Balloon Dilation System are well known and commonly used in the medical device industry, and are appropriate for ethylene oxide (EO) sterilization.
Both the Balloon Catheter and Guide Catheter are considered surface-contacting devices that contact breached or compromised surfaces for limited duration (less than 24 hours) according to ISO 10993-1: 2009/Corr 1:2010. The patient contacting materials including the adhesives were evaluated for cytotoxicity, sensitization, and acute systemic toxicity per ISO 10993-1, and FDA Bluebook Memorandum G95-1 entitled "Required Biocompatibility Training and Testing Profiles for Evaluation of Medical Devices," as listed in Table 1: Biocompatibility TestingTable 1. The results of these tests were found to be acceptable.
| Test Name | Test Method | Results |
|---|---|---|
| Biocompatibility – Balloon Catheter and Guide Catheter | ||
| Cytotoxicity | ISO 10993-5:2009 Biological Evaluation of Medical | |
| Devices: Tests for Cytotoxicity: in vitro; MEM | ||
| Elution method | Acceptable | |
| Sensitization | ISO 10993-10:2010: Biological Evaluation of Medical | |
| Devices: Tests for Irritation and Delayed Type | ||
| Hypersensitivity: Guinea Pig Maximization | ||
| Sensitization method | Acceptable | |
| Irritation | ISO 10993-10:2010: Biological Evaluation of Medical | |
| Devices: Tests for Irritation and Sensitization: Rabbit | ||
| Intracutaneous method | Acceptable | |
| Acute Systemic | ||
| Toxicity | ISO 10993-11:2006: Biological Evaluation of Medical | |
| Devices: Tests for Systemic Toxicity | Acceptable |
Table 1: Biocompatibility Testing
SHELF LIFE/STERILITY
Packaging, shelf life and sterilization testing is summarized in Table 2. The ETBC and the ETGC are packaged together on a b(4) CCI backer card in a b(4) CCI pouch. The pouches are then placed into cartons and sterilized using ethylene oxide (EO). The validation of this sterilization process complies with ISO 11135:2014-"Sterilization of Health Care Products-Ethylene Oxide: Requirements for Development. Validation, and Routine Control of a Sterilization Process for Medical Devices". The sterilization method achieves a sterilization assurance level (SAL) of 106
4
The proposed shelf life of 2 years has been validated using accelerated aging. The accelerated aging testing was conducted according to ASTM F1980-07; followed by testing on the packaging configuration and functional performance. Seal strength testing was conducted according to ASTM F88-09, and whole package integrity was conducted according to ASTM F2096-11. Real time aging for 2 years has been initiated and will be followed by the same testing on the packaging configuration and functional performance to confirm the proposed shelf life.
Transit testing was performed on the ACCLARENT® AERATM Eustachian Tube Balloon Dilation System after EO sterilization, climate conditioning per ISO 2233:2000 and transit simulations (compression, initial random vibrations, impact, and final random vibration) per ASTM D4169:2009.
| Test Name | Test Method | Acceptance Criteria | Results |
|---|---|---|---|
| Sterilization - Balloon Catheter and Guide Catheter | |||
| Sterilization | |||
| Validation | ISO 11135:2014: | ||
| Sterilization of health- | |||
| care products - | |||
| Ethylene oxide - | |||
| Requirements for the | |||
| development, | |||
| validation and routine | |||
| control of a | |||
| sterilization process for | |||
| medical devices | Sterility assurance level | ||
| (SAL) of 10-6 | Passed | ||
| Ethylene Oxide | |||
| Residuals | ISO 10993-7:2008: | ||
| Biological Evaluation | |||
| of Medical Devices: | |||
| Ethylene oxide | |||
| sterilization residuals | Ethylene oxide (EO)b(4) | ||
| CCLb(4) device and Ethylene | |||
| chlorohydrin (ECH)b(4) | |||
| CCLmg/device | Passed | ||
| Shelf Life and Packaging – Balloon Catheter and Guide Catheter | |||
| Environmental | |||
| Conditioning | ISO 2233:2000: | ||
| Packaging - Complete, | |||
| filled transport | |||
| packages and unit | |||
| loads - Conditioning | |||
| for testing | N/A | Completed | |
| Transportation | |||
| Simulation | ASTM D4169:2014: | ||
| Standard Practice for | |||
| Performance Testing | |||
| of Shipping Containers | |||
| and Systems | Testing performed for | ||
| compression, initial random | |||
| vibrations, impact, and final | |||
| random vibration | Completed |
Table 2: Sterilization, Shelf Life and Packaging Testing
5
| Test Name | Test Method | Acceptance Criteria | Results |
|---|---|---|---|
| Accelerated Aging | ASTM F1980-07: | ||
| Standard Guide for | |||
| Accelerated Aging of | |||
| Sterile Barrier Systems | |||
| for Medical Devices | Testing to simulate shelf | ||
| life of 2 years | Completed | ||
| Package Integrity | |||
| (Visual) | ASTM | ||
| F1886/F1886M: | |||
| Standard Test Method | |||
| for Determining | |||
| Integrity of Seals for | |||
| Flexible Packaging by | |||
| Visual Inspection | • No damage to package | ||
| (pouch or box) that could | |||
| affect product performance, | |||
| marketability, or sterility | |||
| after compression, vibration, | |||
| and drop challenges. | |||
| • Package shall have no | |||
| damage, defects/smudges to | |||
| the pouch labeling. | |||
| • The device shall stay in the | |||
| intended place during | |||
| compression, vibration, and | |||
| drop challenges. | |||
| • Minimum seal width of ¼" | Passed | ||
| Gross Leak | |||
| Detection | ASTM F2096-11: | ||
| Standard Test Method | |||
| for Detecting Gross | |||
| Leaks in Packaging by | |||
| Internal Pressurization | |||
| (Bubble Test) | No gross leak | Passed | |
| Seal Strength | ASTM F88-09: | ||
| Standard Test Method | |||
| for Seal Strength of | |||
| Flexible Barrier | |||
| Materials | b(4) CCI minimum for | ||
| individual value and b(4) CCI | |||
| b(4) CCI minimum for the | |||
| average value | Passed | ||
| Test Name | Test Method | Acceptance Criteria | Results |
| Performance Testing - Balloon Catheter | |||
| Dimensional | Measure the dimensions | ||
| of the catheter, balloon, | |||
| location and dimensions | |||
| of the yellow endoscopic | |||
| marker, proximal shaft | |||
| marker, flexible length of | |||
| the balloon catheter, | |||
| balloon bond, tip and | |||
| venting lumen | Per device design | ||
| specifications | Passed | ||
| Deflation time | Verify the time to deflate | ||
| the balloon | Deflation time b(4) CCI | Passed | |
| Balloon Burst | |||
| Pressure | Evaluate that the balloon | ||
| does not burst when | |||
| subjected to the maximum | |||
| rated pressure | Pressure > b(4) CCI | Passed | |
| Tensile Strength | Evaluate the tensile | ||
| strength of all joints | Force at break b(4) CCI | Passed | |
| Balloon Catheter | |||
| Tip Test | Ensure that balloon | ||
| catheter tip is bonded | |||
| securely by evaluating its | |||
| tensile strength | Force at break b(4) CCI | Passed | |
| Insertion/Retraction | |||
| Test | Ensure that balloon | ||
| catheter can withstand | |||
| multiple | |||
| insertion/retraction cycles | |||
| through the Guide | |||
| Catheter without | |||
| structural damage or | |||
| balloon leakage | After 4 | ||
| insertion/retractions | Passed | ||
| Fatigue Test | Ensure that the balloon | ||
| can withstand multiple | |||
| inflation/deflation cycles | |||
| at the maximum rated | |||
| pressure | 8 cycles @ b(4) CCI | Passed | |
| Label | Visually verify that | ||
| correct label is applied to | |||
| the balloon and balloon | |||
| inflation port label | Visual confirmation | Passed | |
| Performance Testing - Guide Catheter | |||
| Dimensional | Measure the dimensions | ||
| of the catheter, distal tip, | |||
| and transition bond | Per device design | ||
| specifications | Passed | ||
| Test Name | Test Method | Acceptance Criteria | Results |
| Fatigue | Ensure that the catheter | ||
| can withstand multiple | |||
| insertion/retraction cycles | |||
| of the balloon catheter | |||
| through it | After 4 | ||
| insertion/retraction | |||
| cycles | Passed | ||
| Materials | Ensure that the materials | ||
| used to construct distal | |||
| shaft are clear/ translucent | |||
| so that balloon catheter tip | |||
| and yellow endoscopic | |||
| marker are visible in the | |||
| guide distal shaft during | |||
| insertion | Visual confirmation | Passed | |
| Torque | Test the torque resistance | ||
| to ensure no material or | |||
| joint failure | Torque $\geq$ b(4) CCI | Passed | |
| Tensile Strength | Evaluate the tensile | ||
| strength of all joints | Force at break $\geq$ b(4) CCI | Passed | |
| Label | Visually verify that the | ||
| correct label is applied on | |||
| the guide handle | Visual confirmation | Passed |
PERFORMANCE TESTING – BENCH
Functional testing was performed on both the ETBC and the ETGC, as summarized in Table 3Error! Reference source not found.. The testing was performed on devices after EO sterilization, environmental conditioning, transit simulations, and accelerated aging, to simulate worst-case conditions. All testing was performed with a compatible inflation device. The devices passed all functional testing.
6
Table 3: Performance Testing
7
PERFORMANCE TESTING - CADAVER
The ACCLARENT® AERA™ Eustachian Tube Balloon Dilation System was evaluated in cadavers to ensure that it functions in accordance with its design specifications and intended use. This simulated use testing was conducted by ENT physicians using cadaveric specimens.
Each evaluator used the same device to dilate a left and a right ET of the same specimen. Evaluators were asked to assess various attributes such as device placement without excessive advancement to the bony portion of the ET, ability to attach the compatible inflation device or extension tubing to the ETBC, ETBC movement through the ETGC, ability to position and operate the system with one hand, ability to avoid unacceptable trauma to mucosa or anatomical structures, and ability to maintain device functionality throughout treatment. The acceptance criteria for this study were a clinically acceptable rating of "2" or higher on a 1-4 point scale, with 4 defined as "excellent" performance and 1 defined as "clinically unacceptable" performance.
All ratings from each evaluator were above "2". Therefore all performance requirements met the acceptance criteria. The lowest average rating for each requirement was 3.3, while the highest average rating was 3.7 out of a possible rating of 4. The system performed as intended and no safety issues were observed.
8
SUMMARY OF CLINICAL INFORMATION
Introduction: Acclarent designed and executed a randomized controlled study evaluating the safety and efficacy of the subject device with the goal of providing sufficient evidence to support a reasonable assurance of safety and efficacy.
Study Objectives: To evaluate efficacy and safety of ET balloon dilation with the Eustachian Tube Balloon Catheter (ETBC) in conjunction with medical management (investigational arm) compared to medical management alone to treat Eustachian tube dysfunction (ETD) in adult patients (control arm).
- . Primary efficacy endpoint evaluation consists of comparison of the proportion of subjects experiencing normalization of tympanometry at 6 weeks post-treatment in the investigational arm versus the proportion of subjects experiencing normalization of tympanometry at 6 weeks post-randomization in the control arm.
- . Secondary efficacy endpoint evaluation employs the Eustachian Tube Dysfunction Questionnaire (ETDO-7) to compare the proportion of subjects achieving at least a minimally important difference (MID) level improvement of 0.5 points at 6 weeks posttreatment in the investigational arm versus the proportion of subjects achieving at least a MID level improvement of 0.5 points at 6 weeks post-randomization in the control arm.
- . Safety evaluation includes occurrence of all anticipated or unanticipated adverse events in both treatment arms.
Study Methodology: The study was a prospective, multi-center, randomized controlled trial to demonstrate superiority of the ET balloon dilation with ETBC in conjunction with medical management (investigational arm) compared to medical management (MM) alone (control arm) to treat ETD. Study population includes subjects age 22 and older with ETD refractory to medical therapy. Each investigator was required to perform 3 successful ETBC procedures in non-randomized Lead-In subjects. MM consists of treatment with triamcinolone acetonide (TA) nasal steroid spray (such as Nasacort® AQ Nasal Spray (NAQ) or equivalent). All enrolled study subjects in both the lead-in and randomized phase are required to adhere to the recommended TA labeling dosage and frequency through the 6 week follow-up visit. All ETBC procedures were performed under general anesthesia in the operating room.
The randomized cohort is conducted in a 2:1 ratio with two subjects randomized to ETBC for every one MM subject. The study is a group sequential design with 3 planned looks (2 interim and 1 final) at 54:27, 108:54, and 162:81 evaluable subjects. The clinical evidence being presented in this summary is supported by the second-look cohort.
The primary endpoint was graded by both the investigator as well as an independent evaluator with appropriate expertise unaffiliated with study patient care. The independent tympanogram evaluator was blinded to subjects' arm assignment and had no knowledge of the outcome of the investigators' tympanogram results.
Each subject was enrolled individually and served as the unit of analysis, regardless of indication for unilateral or bilateral ETD. Subjects had five follow-up visits. Follow-up visits occurred at 2
9
weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks following either randomization (control arm) or the ETBC procedure (investigational arm). MM subjects may cross over to receive an ETBC procedure after the 6 week follow-up visit and are subsequently followed for 12 weeks postprocedure.
Number of Subjects (planned and analyzed): The second interim analysis cohort consisted of 72 MM, 141 ETBC and 81 enrolled Lead-In subjects. Twenty-one (70) MM subjects crossed over to receive an ET dilation procedure and are included in the safety analysis of 299 subjects (80 lead-in + 149 randomized ETBC + 70 MM cross-overs).
Diagnosis and Main Criteria for Inclusion: The study includes adult males or females aged 22 years and older diagnosed with persistent ETD. Persistent ETD is defined by patient-reported symptoms of ETD (including pressure and/or pain and/or clogged and/or muffled sensation in the affected ear(s)) and documented evidence that the subject has experienced persistent ETD symptoms for 12 weeks or greater prior to enrollment. Patients must have failed appropriate medical management consisting of either a minimum of 4 weeks of continuous daily usage of any intranasal steroid spray (INS) or a minimum of one completed course of an oral steroid. The failed medical management may occur any time within 90 days prior to study enrollment. In addition, all patients are required to have a computed tomography (CT) scan taken to confirm absence of internal carotid artery (ICA) dehiscence into the Eustachian tube (ET) lumen bilaterally.
All patients must present with abnormal tympanometry (type B or type C) after failed MM and within 14 days prior to study enrollment. In addition, all included patients must have demonstrated symptomatic dysfunction as documented through a validated quality of life instruments (the ETDQ-7) with a score ≥ 2.1 after failed MM.
Females who are pregnant or lactating were excluded. In addition subjects were excluded if they had (1) anatomy that required an adjunctive surgical procedure on the same day as ETBC surgery to allow balloon catheter access to the ET, or (2) concomitant nasal, sinus or ear procedures planned on the same day as ETBC surgery or any time during study participation. This criterion did not apply to Lead-In subjects. In addition, patients were excluded if they have a history of major surgery of the head or neck within four (4) months prior to randomization, patulous ET in either ear, fluctuating sensorineural hearing loss, active chronic or acute otitis media (AOM), tympanic membrane perforation or presence of a tympanostomy tube in either ear, tympanosclerosis, acute upper respiratory infection, active temporomandibular joint disorder (TMJ), cleft palate or history of cleft palate repair, craniofacial syndrome, cystic fibrosis, ciliary dysmotility syndrome, systemic mucosal diseases or immunodeficiency disorders, intolerance of protocol-defined medication regimen, prior surgical intervention on ET, or absence of dilatory muscular contractions.
EFFICACY RESULTS:
Technical success was high with 298/299 (99.7%) of all targeted ETs successfully accessed and dilated. The one (1) failure was due to anatomical constraint undetected prior to procedure, resulting from angiofibroma surgery 31 years prior which prevented appropriate balloon access
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and positioning. Several events considered as device malfunctions were reported. Two (2) ETBC were reported to have leaked saline upon inflation; of these, one (1) device was disposed following the procedure and was not returned to the company for testing; one (1) device was returned for testing which indicated a functional balloon (i.e., the leak was not confirmed). One (1) ETBC was bent during approach into the ET. No adverse events were associated with the malfunctions.
Primary efficacy results demonstrated superiority of the investigational device plus MM compared to MM alone. Tympanogram normalization was observed in 51.8% (73/141) of investigational subjects compared to 13.9% (10/72) controls (p