(216 days)
Not Found
No
The description focuses on the mechanical components and function of a balloon dilation system and inflation device. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended to treat persistent Eustachian tube dysfunction by dilating the Eustachian tube, directly addressing a medical condition.
No
The device is described as a "Balloon Dilation System" intended to "dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction." This indicates a therapeutic, not a diagnostic, function.
No
The device description clearly outlines physical components like a balloon catheter, guide catheter, and inflation device, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to dilate the Eustachian tube for treatment of a medical condition (persistent Eustachian tube dysfunction). This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical system (catheter, balloon, inflation device) designed for a surgical/interventional procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information for diagnosis. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the ACCLARENT AERA® Eustachian Tube Balloon Dilation System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
PNZ
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.
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
patients ages 18 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 testing has met all acceptance criteria for attributes such as dimensional attributes, cycle fatigue, balloon burst, and bond separation. Testing has shown that the ACCLARENT AERA® Eustachian Tube Balloon Dilation System is biocompatible.
The sterilization process has been validated per AAMI/ANSI/ISO 11135: 2014 and demonstrated a sterility assurance level of 10-6. The method used for sterilization validation is the overkill (half-cycle approach) in a fixed chamber. Testing of ethylene oxide residuals met ISO 10993-7:2008 requirements. The subject device is not tested nor labeled as “non-pyrogenic”.
Packaging shelf life was established at one year via accelerated aging per ASTM F1980-07.
Real-world clinical data was collected from 25 patients from two sites.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ACCLARENT AERA® Eustachian Tube Balloon Dilation System (DEN150056), Entellus XprESS ENT Dilation System (K163509)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 16, 2018
Acclarent, Inc. James Garvey II Associate Director 33 Technology Drive Irvine, CA 92618
Re: K171761
Trade/Device Name: ACCLARENT AERA® Eustachian Tube Balloon Dilation System Regulation Number: 21 CFR 874.4180 Regulation Name: Eustachian Tube Balloon Dilation System Regulatory Class: Class II Product Code: PNZ Dated: December 14, 2017 Received: December 15, 2017
Dear James Garvey II:
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 (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. 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.
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm_for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171761
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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The word "Acclarent" is written in a bold, sans-serif font, with the first half in black and the second half in purple. Above the word "Acclarent" is a purple arc. Below the word "Acclarent" is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".
ACCLARENT AERA® Eustachian Balloon Dilation System
510(K) SUMMARY
K171761
| Sponsor/Submitter: | Acclarent, Inc.
33 Technology Drive
Irvine, California 92618 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Patrick Garvey II
Associate Director, Regulatory Affairs
Phone: 949-789-8505
Fax: (650) 687-4449 |
| Date of Submission: | June 12, 2017 |
| 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 |
| Establishment Registration Number | 3005172759 |
| Predicate Devices: | ACCLARENT AERA® Eustachian Tube Balloon Dilation System
(DEN150056)
Entellus XprESS ENT Dilation System (K163509) |
| 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. | |
| Indications for 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. |
| Contraindications: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System 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. |
| Technological
Characteristics: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is a
device that allows for dilation of the cartilaginous portion of the Eustachian
tube. Eustachian tube dilation is achieved via a noncompliant balloon located
on the distal end of the device which is inflated with sterile saline or sterile
water. |
| Substantial
Equivalence: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System device
has expanded indications for use, identical intended use, and identical
fundamental scientific technology as the predicate device. The AERA device is
substantially equivalent to the predicate devices. |
| Performance Data: | Bench testing has met all acceptance criteria for attributes such as dimensional
attributes, cycle fatigue, balloon burst, and bond separation. Testing has
shown that the ACCLARENT AERA® Eustachian Tube Balloon Dilation
System is biocompatible. |
| The sterilization process has been validated per AAMI/ANSI/ISO 11135: 2014
and demonstrated a sterility assurance level of 10-6. The method used for
sterilization validation is the overkill (half-cycle approach) in a fixed chamber.
Testing of ethylene oxide residuals met ISO 10993-7:2008 requirements. The
subject device is not tested nor labeled as “non-pyrogenic”. | |
| Packaging shelf life was established at one year via accelerated aging per
ASTM F1980-07. | |
4
Image /page/4/Picture/0 description: The image shows the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. The word "Acclarent" is written in a combination of black and purple font, with a purple arc above the "ent" portion of the word. Below the logo, the text "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" is written in a smaller font size.
ACCLARENT AERA® Eustachian Balloon Dilation System
5
Image /page/5/Picture/0 description: The image shows the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. The word "Acclarent" is written in a bold, sans-serif font, with the first part of the word in black and the last part in purple. Above the word "Acclarent" is a purple arc. Below the word "Acclarent" is the text "PART OF THE Johnson-Johnson FAMILY OF COMPANIES".
ACCLARENT AERA® Eustachian Balloon Dilation System
The performance data demonstrate that the device performs as intended.
Although use of AERA device under local anesthesia alone has not been studied in a randomized controlled trial, evidence of its use under topical/local anesthesia along with sedation and analgesia is available in the literature. 1
In addition, real-world clinical data collected from 25 patients from two sites supports the use of AERA device under local/topical anesthetic with appropriate patient preparation which may include supplemental medication for patient management.
The technological characteristics of the ACCLARENT AERA® Eustachian Conclusion: Tube Balloon Dilation System are substantially equivalent to the predicate devices for use in mechanically dilating the Eustachian tube. Performance testing has demonstrated that the device is safe and effective. Additional clinical testing was not required to demonstrate safety and efficacy of the device. The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is substantially equivalent to the predicates.
² Luukkainen V, Kivekäs I, Hammarén-Malmi S, Rautiainen M, Pöyhönen L, Aarnisalo AA, Jero J, Sinkkonen ST. Balloon Eustachian tuboplasty under local anesthesia: Is it feasible? Laryngoscope. 2017 Feb 03. doi:10.1002/lary.26488