ACCLARENT AERA Eustachian Tube Balloon Dilation System
K171761 · Acclarent, Inc. · PNZ · Jan 16, 2018 · Ear, Nose, Throat
Device Facts
Record ID
K171761
Device Name
ACCLARENT AERA Eustachian Tube Balloon Dilation System
Applicant
Acclarent, Inc.
Product Code
PNZ · Ear, Nose, Throat
Decision Date
Jan 16, 2018
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 874.4180
Device Class
Class 2
Attributes
Therapeutic, Real-World Evidence
Real-World Evidence
Submission
Device
Sponsor
RWD Sources
RWE Use Summary
Key Tags
K171761 · Jan 16, 2018
ACCLARENT AERA Eustachian Tube Balloon Dilation System
Acclarent, Inc.
Real-world clinical data (patient records/clinical site data)
Real-world clinical data from 25 patients at two sites was used to support the safety and feasibility of using the AERA device under local/topical anesthesia.
Local anesthesia; Clinical site data; Eustachian tube dysfunction
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
Retrospective/Observational clinical data collection
Patients undergoing Eustachian tube dilation; Sample Size: 25; Number of Sites: 2
Not applicable for this study
Feasibility of device use under local/topical anesthesia
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.
Device Story
System comprises Eustachian Tube Balloon Catheter, Guide Catheter, and inflation device. Catheter features 6x16mm non-compliant nylon balloon, dual-lumen shaft with actuator for rotation/advancement, and 'blueberry' tip to prevent isthmus advancement. Guide catheter includes lubricious liner and hypotube for rigidity. Used by physicians under endoscopic visualization to access and dilate cartilaginous Eustachian tube. Inflation achieved via sterile saline/water using external inflation device. Procedure aims to restore Eustachian tube function; benefits include mechanical dilation of persistent dysfunction. Used in clinical settings; may be performed under local/topical anesthesia with sedation/analgesia.
Clinical Evidence
Bench testing confirmed dimensional attributes, cycle fatigue, balloon burst, bond separation, and biocompatibility. Sterilization validated per AAMI/ANSI/ISO 11135:2014 (SAL 10^-6). Shelf life established at one year via ASTM F1980-07. Real-world clinical data from 25 patients and literature review (Luukkainen et al., 2017) support use under local/topical anesthesia.
Technological Characteristics
Non-compliant nylon balloon; dual-lumen catheter shaft; guide catheter with lubricious liner and hypotube. Sterilized via ethylene oxide (AAMI/ANSI/ISO 11135:2014). Biocompatibility per ISO 10993-7:2008. Shelf life 1 year (ASTM F1980-07). Mechanical dilation principle.
Indications for Use
Indicated for dilation of the Eustachian tube to treat persistent Eustachian tube dysfunction in patients aged 18 and older. Contraindicated in patients with ipsilateral carotid artery dehiscence into the ET lumen or history of ipsilateral patulous Eustachian tube.
Regulatory Classification
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.
Special Controls
*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.
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.
Predicate Devices
ACCLARENT AERA® Eustachian Tube Balloon Dilation System (DEN150056)
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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.
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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
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### 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)
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## ACCLARENT AERA® Eustachian Balloon Dilation System
# 510(K) SUMMARY
## K171761
| Sponsor/Submitter: | Acclarent, Inc.<br>33 Technology Drive<br>Irvine, California 92618 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Patrick Garvey II<br>Associate Director, Regulatory Affairs<br>Phone: 949-789-8505<br>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<br>(DEN150056)<br>Entellus XprESS ENT Dilation System (K163509) |
| Device Description: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System<br>includes a Eustachian Tube Balloon Catheter and Guide Catheter designed<br>specifically for use in accessing and dilating the Eustachian Tube. The system<br>is used with the following additional devices: the ACCLARENT® SE Inflation<br>Device (or ACCLARENT® Balloon Inflation Device). The ACCLARENT® SE<br>Inflation Device or ACCLARENT® Balloon Inflation Device is used to inflate<br>the balloon. All devices are provided sterile for single-patient use.<br><br>The ACCLARENT AERA® Eustachian Tube Balloon Dilation System<br>includes is a 6x16mm (inflated diameter x length) flexible Balloon Catheter<br>with an integrated shaft and a nylon balloon at the distal tip. The non-<br>compliant balloon is designed to dilate the cartilaginous portion of the |
| Eustachian tube. The shaft consists of dual lumen tubing with an actuator<br>component that is designed to assist in rotation and advancement of the<br>balloon catheter. The balled catheter tip (aka, “blueberry tip") on the balloon<br>catheter is designed to restrict advancement of the device into the bony portion<br>of the Eustachian tube, known as the isthmus. There is an endoscopic marker<br>placed at the proximal taper of the balloon to aid in positioning under direct<br>endoscopic visualization. | |
| The AERA Guide Catheter is anatomically designed to facilitate AERA<br>Balloon Catheter access to the Eustachian tube. The AERA Guide Catheter<br>incorporates an atraumatic distal tip and distal angled tip profile that facilitates<br>access to the Eustachian tube. The Guide Catheter supplied with the<br>ACCLARENT AERA® Eustachian Tube Balloon Dilation System contains a<br>lubricious inner liner to allow smooth passage for the balloon catheter and<br>includes a hypotube for rigidity. | |
| Indications for Use: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is<br>intended to dilate the Eustachian tube for treatment of persistent<br>Eustachian tube dysfunction in patients ages 18 and older. |
| Contraindications: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is<br>contraindicated for use in a Eustachian tube with an ipsilateral carotid artery<br>that is dehiscent into the ET lumen or history of ipsilateral patulous Eustachian<br>tube. |
| Technological<br>Characteristics: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is a<br>device that allows for dilation of the cartilaginous portion of the Eustachian<br>tube. Eustachian tube dilation is achieved via a noncompliant balloon located<br>on the distal end of the device which is inflated with sterile saline or sterile<br>water. |
| Substantial<br>Equivalence: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System device<br>has expanded indications for use, identical intended use, and identical<br>fundamental scientific technology as the predicate device. The AERA device is<br>substantially equivalent to the predicate devices. |
| Performance Data: | Bench testing has met all acceptance criteria for attributes such as dimensional<br>attributes, cycle fatigue, balloon burst, and bond separation. Testing has<br>shown that the ACCLARENT AERA® Eustachian Tube Balloon Dilation<br>System is biocompatible. |
| The sterilization process has been validated per AAMI/ANSI/ISO 11135: 2014<br>and demonstrated a sterility assurance level of 10-6. The method used for<br>sterilization validation is the overkill (half-cycle approach) in a fixed chamber.<br>Testing of ethylene oxide residuals met ISO 10993-7:2008 requirements. The<br>subject device is not tested nor labeled as “non-pyrogenic”. | |
| Packaging shelf life was established at one year via accelerated aging per<br>ASTM F1980-07. | |
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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
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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
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
