21 CFR 874.4180 — Eustachian Tube Balloon Dilation Device
Ear, Nose, Throat (EN) · Part 874 Subpart E—Surgical Devices · § 874.4180
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.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| PNZ | Eustachian Tube Balloon Dilation Device | 2 | 9 |
Special Controls
PNZ — Eustachian Tube Balloon Dilation Device
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.
De Novo Order DEN150056
PNZ — Eustachian Tube Balloon Dilation Device
*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.
eCFR
PNZ — Eustachian Tube Balloon Dilation Device
(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.
Ecfr Llm
