(271 days)
ACCLARENT AERA® Eustachian Tube Balloon Dilation System (K171761)
Not Found
No
The device description and performance studies focus on the mechanical aspects of the balloon dilation system and clinical outcomes, with no mention of AI or ML.
Yes
The device is described as a "Eustachian Tube Balloon Dilation System" intended to "dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction," which directly indicates its use for treating a medical condition.
No.
The device is intended to dilate the Eustachian tube for treatment purposes, not for diagnosis.
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 information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used 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 description details a physical system (catheter, guide catheter, inflation device) designed for mechanical dilation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical tool used for a therapeutic intervention.
N/A
Intended Use / Indications for Use
The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is intended to dilute 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.
Product codes (comma separated list FDA assigned to the subject device)
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
18 and older; 8-17 years
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)
Previously submitted 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 was validated per AAMI/ANSI/ISO 11135-1: 2007 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.
Previously submitted performance data demonstrate that the device performs as intended and no new testing was performed for this submission.
A systematic literature review was conducted per PRISMA guidelines to assess safety and efficacy of BDET in the pediatric population inclusive of both non-Acclarent and Acclarent devices.
Real-world evidence, with data from published literature and data provided by established physicians, was analyzed to evaluate the safety and effectiveness of the AERA Eustachian Tube Balloon Dilation System in pediatric patients. The data supported substantial equivalence for the pediatric patient population of ages 8-17. Equivalence of the anatomy was demonstrated with several articles which evaluated Eustachian tube anatomy in the expanded patient population.
Based on CT scan reviews, the anatomy of the target patient population was found to be similar to that of the predicate age group with no issues of safety raised.
Real-world evidence was reviewed consisting of ETBD with AERA in patients ages 8-17 years with objective signs of persistent obstructive Eustachian tube dysfunction from inflammatory pathology, resulting in chronic otitis media with effusion. This evidence 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. A review of safety data in the expanded population was found to be safe with no serious adverse events reported after ETBD and a minor AE rate in 8.2% of patients in the expanded age group. Efficacy data in 20 ears from patients aged 8-17 years with 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 was defined as whether further surgery was needed to treat the patient's ETD, eg. tympanostomy tube insertion or revision ETBD).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ACCLARENT AERA® Eustachian Tube Balloon Dilation System (K171761)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
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.
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.
| 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)
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K230742 - 510(k) Summary
| Sponsor/Submitter: | Acclarent, Inc.
31 Technology Drive
Irvine, CA 92618 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kamrie Sarnosky
Senior Program Lead, Regulatory Affairs
Phone: 931-551-5023
Fax: (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 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.
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. |
| 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. The technological characteristics of the device
are identical to those cleared in K171761. |
| Substantial
Equivalence: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System device
has expanded indications for use and identical fundamental scientific
technology as the predicate device. The AERA device is substantially
equivalent to the predicate device. |
| Performance Data: | Previously submitted 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 was validated per AAMI/ANSI/ISO 11135-1: 2007
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.
Previously submitted performance data demonstrate that the device performs
as intended and no new testing was performed for this submission. |
| Clinical Data: | A systematic literature review was conducted per PRISMA guidelines to
assess safety and efficacy of BDET in the pediatric population inclusive of
both non-Acclarent and Acclarent devices.
Real-world evidence, with data from published literature and data provided by
established physicians, was analyzed to evaluate the safety and effectiveness o
the AERA Eustachian Tube Balloon Dilation System in pediatric patients. The |
| | data supported substantial equivalence for the pediatric patient population of
ages 8-17. Equivalence of the anatomy was demonstrated with several articles
which evaluated Eustachian tube anatomy in the expanded patient population.
Based on CT scan reviews, the anatomy of the target patient population was
found to be similar to that of the predicate age group with no issues of safety
raised. |
| | Real-world evidence was reviewed consisting of ETBD with AERA in patients
ages 8-17 years with objective signs of persistent obstructive Eustachian tube
dysfunction from inflammatory pathology, resulting in chronic otitis media
with effusion. This evidence 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. A review of safety data in the
expanded population was found to be safe with no serious adverse events
reported after ETBD and a minor AE rate in 8.2% of patients in the expanded
age group. Efficacy data in 20 ears from patients aged 8-17 years with 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
was 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 substantially
equivalent to the predicate device based on the following: (1) clinical data
obtained from Real-World Evidence, including a systematic literature review,
review of adverse events, CT studies demonstrating anatomical Eustachian
tube equivalence, for which data analysis showed that the BDET procedure
outcomes were successful to expand the indicated population to 8-17 years of
age with persistent otitis media with effusion due to inflammatory pathology
and refractory to at least one surgical intervention and (2) equivalence in terms
of fundamental scientific technology based on identical design and principles
of operations. |
| Summary of
Substantial
Equivalence: | The technological characteristics of the ACCLARENT AERA® Eustachian
Tube Balloon Dilation System are substantially equivalent to the predicate
devices for use in mechanically dilating the Eustachian tube. Previous
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 predicate. |
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