(284 days)
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.
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.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
ACCLARENT AERA™ EUSTACHIAN TUBE BALLOON DILATION SYSTEM
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details various non-clinical/bench studies and a clinical study that demonstrate the device's performance against specific criteria.
Non-Clinical/Bench Studies Acceptance Criteria and Performance:
| Test Name | Acceptance Criteria | Reported Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Acceptable per ISO 10993-5:2009 | Accepted |
| Sensitization | Acceptable per ISO 10993-10:2010 | Accepted |
| Irritation | Acceptable per ISO 10993-10:2010 | Accepted |
| Acute Systemic Toxicity | Acceptable per ISO 10993-11:2006 | Accepted |
| Sterilization & Shelf Life | ||
| Sterilization Validation | Sterility assurance level (SAL) of 10^-6 | Passed |
| Ethylene Oxide Residuals | Ethylene oxide (EO) redacted (b(4) CCI) | Passed |
| Tensile Strength | Force at break ≥ redacted (b(4) CCI) | Passed |
| Balloon Catheter Tip Test | Force at break ≥ redacted (b(4) CCI) | Passed |
| Insertion/Retraction Test | After 4 insertion/retractions without structural damage or balloon leakage | Passed |
| Fatigue Test | 8 cycles @ redacted (b(4) CCI) without failure | Passed |
| Label | Visual confirmation of correct label | Passed |
| Guide Catheter Performance | ||
| Dimensional | Per device design specifications | Passed |
| Fatigue | After 4 insertion/retraction cycles without failure | Passed |
| Materials | Visual confirmation that materials are clear/translucent for visibility | Passed |
| Torque | Torque ≥ redacted (b(4) CCI) | Passed |
| Tensile Strength | Force at break ≥ redacted (b(4) CCI) | Passed |
| Label | Visual confirmation of correct label | Passed |
Cadaver Study Acceptance Criteria and Performance:
| Test Name | Acceptance Criteria | Reported Performance |
|---|---|---|
| Simulated Use in Cadavers (Overall Performance) | 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 Acceptance Criteria and Performance:
| Endpoint | Acceptance Criteria | Reported Performance |
|---|---|---|
| Primary Efficacy | Superiority of ET balloon dilation + medical management vs. medical management alone, demonstrated by a significantly higher proportion of subjects experiencing normalization of tympanometry at 6 weeks post-treatment. | Tympanogram normalization observed in 51.8% (73/141) of investigational subjects vs. 13.9% (10/72) 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.