(216 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the ACCLARENT AERA® Eustachian Tube Balloon Dilation System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document focuses on the substantial equivalence of the device and does not explicitly list specific numerical acceptance criteria for clinical performance (e.g., target success rates, symptom improvement percentages). Instead, the performance data section describes meeting acceptance criteria for various bench tests related to device integrity and safety.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing | |
| Dimensional Attributes | Met all acceptance criteria |
| Cycle Fatigue | Met all acceptance criteria |
| Balloon Burst | Met all acceptance criteria |
| Bond Separation | Met all acceptance criteria |
| Biocompatibility | Testing has shown the device is biocompatible |
| Sterilization | Validated per AAMI/ANSI/ISO 11135:2014, achieving a sterility assurance level of 10^-6 |
| Ethylene Oxide Residuals | Met ISO 10993-7:2008 requirements |
| Packaging Shelf Life | Established at one year via accelerated aging per ASTM F1980-07 |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Data):
- The document references "real-world clinical data collected from 25 patients from two sites."
- Data Provenance: The document cites a publication by Luukkainen et al. (2017) regarding the feasibility of balloon Eustachian tuboplasty under local anesthesia. One of the authors, Rautiainen M, is from Finland (based on a quick search for the publication reference, not explicitly stated in the provided text). It's likely this smaller clinical data set is retrospective or a case series/pilot observational study, given the description as "real-world clinical data" supporting use under local/topical anesthetic. The document does not describe a formal, large-scale clinical trial used as a "test set" for the purpose of establishing primary effectiveness or safety endpoints in a randomized controlled manner.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The document does not specify the number of experts used or their qualifications for establishing ground truth for the 25-patient clinical data set. The clinical data appears to be observational and intended to support the feasibility of the device under certain anesthetic conditions rather than being a formal "test set" with pre-defined ground truth established by experts for performance evaluation.
4. Adjudication Method for the Test Set
- No adjudication method is described for the 25-patient clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided document. The device is a medical device for dilation, not an imaging or diagnostic AI tool where MRMC studies are typically performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is a physical medical device, not an algorithm or AI system. Its performance is evaluated through bench testing, biocompatibility, sterilization, and then clinical use with human operators.
7. The Type of Ground Truth Used
- For Bench Testing: The "ground truth" for bench testing would be predefined engineering specifications, material properties, and regulatory standards (e.g., dimensional tolerances, burst pressure limits, sterilization efficacy, biocompatibility assay results).
- For Clinical Data (25 patients): The clinical data from the 25 patients likely relied on clinical endpoints, such as resolution of Eustachian tube dysfunction symptoms, patency of the Eustachian tube, or patient satisfaction, as assessed by the treating physicians. The document does not detail how "ground truth" was established for these clinical outcomes in this specific dataset.
8. The Sample Size for the Training Set
- This question is not applicable as the ACCLARENT AERA® Eustachian Tube Balloon Dilation System is a physical medical device, not an AI model requiring a "training set" in the computational sense.
- The document mentions that the device has "expanded indications for use" and that "additional clinical testing was not required to demonstrate safety and efficacy of the device" because it is substantially equivalent to predicate devices. This indicates that prior clinical data from the predicate devices and existing literature inform its use, rather than a new "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable for the reasons stated in point 8.
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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.33 Technology DriveIrvine, California 92618 |
|---|---|
| Contact Person: | James Patrick Garvey IIAssociate Director, Regulatory AffairsPhone: 949-789-8505Fax: (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 Systemincludes a Eustachian Tube Balloon Catheter and Guide Catheter designedspecifically for use in accessing and dilating the Eustachian Tube. The systemis used with the following additional devices: the ACCLARENT® SE InflationDevice (or ACCLARENT® Balloon Inflation Device). The ACCLARENT® SEInflation Device or ACCLARENT® Balloon Inflation Device is used to inflatethe balloon. All devices are provided sterile for single-patient use.The ACCLARENT AERA® Eustachian Tube Balloon Dilation Systemincludes is a 6x16mm (inflated diameter x length) flexible Balloon Catheterwith 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 actuatorcomponent that is designed to assist in rotation and advancement of theballoon catheter. The balled catheter tip (aka, “blueberry tip") on the ballooncatheter is designed to restrict advancement of the device into the bony portionof the Eustachian tube, known as the isthmus. There is an endoscopic markerplaced at the proximal taper of the balloon to aid in positioning under directendoscopic visualization. | |
| The AERA Guide Catheter is anatomically designed to facilitate AERABalloon Catheter access to the Eustachian tube. The AERA Guide Catheterincorporates an atraumatic distal tip and distal angled tip profile that facilitatesaccess to the Eustachian tube. The Guide Catheter supplied with theACCLARENT AERA® Eustachian Tube Balloon Dilation System contains alubricious inner liner to allow smooth passage for the balloon catheter andincludes a hypotube for rigidity. | |
| Indications for Use: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System isintended to dilate the Eustachian tube for treatment of persistentEustachian tube dysfunction in patients ages 18 and older. |
| Contraindications: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System iscontraindicated for use in a Eustachian tube with an ipsilateral carotid arterythat is dehiscent into the ET lumen or history of ipsilateral patulous Eustachiantube. |
| TechnologicalCharacteristics: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is adevice that allows for dilation of the cartilaginous portion of the Eustachiantube. Eustachian tube dilation is achieved via a noncompliant balloon locatedon the distal end of the device which is inflated with sterile saline or sterilewater. |
| SubstantialEquivalence: | The ACCLARENT AERA® Eustachian Tube Balloon Dilation System devicehas expanded indications for use, identical intended use, and identicalfundamental scientific technology as the predicate device. The AERA device issubstantially equivalent to the predicate devices. |
| Performance Data: | Bench testing has met all acceptance criteria for attributes such as dimensionalattributes, cycle fatigue, balloon burst, and bond separation. Testing hasshown that the ACCLARENT AERA® Eustachian Tube Balloon DilationSystem is biocompatible. |
| The sterilization process has been validated per AAMI/ANSI/ISO 11135: 2014and demonstrated a sterility assurance level of 10-6. The method used forsterilization validation is the overkill (half-cycle approach) in a fixed chamber.Testing of ethylene oxide residuals met ISO 10993-7:2008 requirements. Thesubject device is not tested nor labeled as “non-pyrogenic”. | |
| Packaging shelf life was established at one year via accelerated aging perASTM F1980-07. |
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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
§ 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.