(122 days)
The NGB Balloon Dilation System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnoutic procedures; irrigate from within a target sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures.
For children aged 17 and under, the NGB Balloon System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; irrigate from within the maxillary sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures.
The NGB Balloon Dilation System is intended to dilate the cartilaginous Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older.
The NGB Balloon Dilation System with the navigation guidewire may be utilized in conjunction with the TruDi™ Navigation System, to help direct access to nasal and paranasal spaces, and to confirm placement in the targeted anatomy. NGB may be utilized in conjunction with the TruDi™ NAV Wire to confirm placement of the balloon in the Eustachian tube.
The NGB Balloon Dilation System with the illumination guidewire may be utilized to illuminate within and provide transcutaneous illumination across nasal and sinus structures.
The Next Generation Balloon Dilation System (NGB) is an integrated balloon sinuplasty (BSP) and Eustachian tube (ET) dilation device, that will be available in light fiber and navigation guidewire configurations for compatibility with illumination and navigation technology. The system includes a handle with several integrated features to allow for single-handed use. The adjustable gripping feature allows for ergonomic handling. The directable guide tip enables access (i.e. manipulating/separating/dividing tissue) and placement near the targeted anatomy. There are four preset approximate positions: Sphenoid (straight), Eustachian tube (55°), Frontal (70°), Maxillary (110°). The directable guide knob allows for positioning of the balloon tip towards the target anatomy. The wire slider and spinner are used to advance, retract, and rotate the guidewire. The balloon slider is used advance and retract the balloon. The Next Generation Balloon Dilation System also allows for suction and irrigation in and around the target anatomy.
Here's a breakdown of the acceptance criteria and the study information for the Acclarent Next Generation Balloon Dilation System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Therefore, rather than specific acceptance criteria in terms of performance metrics with pre-defined thresholds, the document outlines the types of non-clinical tests performed and states that the device "met all acceptance criteria" and "passed all tests in accordance with appropriate test criteria and standards."
| Acceptance Criteria Category (Derived from Testing) | Reported Device Performance |
|---|---|
| Functional Performance | Met all acceptance criteria for attributes such as: |
| - Simulated Use Testing | Reliability to remain mechanically functional throughout anticipated conditions of use. Design features limit access to only the cartilaginous portion of the Eustachian tube. |
| - Dimensional Attributes | Met all acceptance criteria. |
| - Cycle Fatigue | Met all acceptance criteria. |
| - Balloon Burst | Met all acceptance criteria. |
| - Bond Separation | Met all acceptance criteria. |
| - Irrigation Flow Rate | Met all acceptance criteria. |
| - Device Accuracy | Met all acceptance criteria. |
| - Inflation and Deflation Characterization | Performed, including time and pressure measurements, and leak testing of the balloon. |
| - Durability (fatigue and burst pressure) | Performed. |
| - Verification of Safety Features | Performed, including characterization of catheter geometries and distal tip insertion limitation mechanisms. |
| Biocompatibility | Biocompatible. |
| Sterilization | Validated per AAMI/ANSI/ISO 11135-1: 2007 (sterility assurance level of 10-6 via overkill (half-cycle approach) in a fixed chamber). Ethylene oxide residuals meet ISO 10993-7:2008. Not tested/labeled as “non-pyrogenic.” |
| Packaging Shelf Life | Established to be 3 months per ASTM F1980-07. |
| Mechanical Testing | Performed, including tensile and flexural testing of catheter joints and materials. |
2. Sample Size for Test Set and Data Provenance
The document explicitly states: "Clinical data was not necessary to determine that the subject Next Generation Balloon Dilation System performs as intended." This indicates that no clinical "test set" was used as part of this submission for performance evaluation against specific clinical acceptance criteria. The performance data is derived solely from non-clinical bench testing. The provenance of this data is therefore internal laboratory testing rather than patient data from a specific country or retrospective/prospective study.
3. Number of Experts and Qualifications to Establish Ground Truth for Test Set
Not applicable, as no clinical test set was used to establish ground truth with expert review.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission is based on demonstrating substantial equivalence through non-clinical testing.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical medical device, not an algorithm, and its performance is evaluated in relation to its physical and functional characteristics.
7. Type of Ground Truth Used
For the non-clinical testing, the "ground truth" would be the engineering specifications, industry standards (e.g., AAMI/ANSI/ISO for sterilization, ASTM for shelf life), and validated internal test methods that define acceptable performance.
8. Sample Size for the Training Set
Not applicable, as this is a physical medical device and not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a device effectively comes from its design and manufacturing processes, guided by engineering principles and regulatory standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 27, 2020
Acclarent Inc. David Locke Manager, Regulatory Affairs 31 Technology Dr., Suite 200 Irvine, California 92618
Re: K201115
Trade/Device Name: Next Generation Balloon Dilation System Regulation Number: 21 CFR 874.4180 Regulation Name: Eustachian Tube Balloon Dilation System Regulatory Class: Class II Product Code: PNZ, PGW, LRC Dated: July 25, 2020 Received: July 28, 2020
Dear David Locke:
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. 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 located 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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.
for Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201115
Device Name Next Generation Balloon Dilation System
Indications for Use (Describe)
The NGB Balloon Dilation System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnoutic procedures; irrigate from within a target sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures.
For children aged 17 and under, the NGB Balloon System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; irrigate from within the maxillary sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures.
The NGB Balloon Dilation System is intended to dilate the cartilaginous Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older.
The NGB Balloon Dilation System with the navigation guidewire may be utilized in conjunction with the TruDi™ Navigation System, to help direct access to nasal and paranasal spaces, and to confirm placement in the targeted anatomy. NGB may be utilized in conjunction with the TruDi™ NAV Wire to confirm placement of the balloon in the Eustachian tube.
The NGB Balloon Dilation System with the illumination guidewire may be utilized to illuminate within and provide transcutaneous illumination across nasal and sinus structures.
| 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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Image /page/3/Picture/0 description: The image displays the Acclarent logo, with the company name in bold, followed by a curved line above the 'ent'. Below the logo, the text "Next Generation Balloon Dilation System" is present. The text is in a smaller font size compared to the logo.
K201115 - 510(K) SUMMARY
[807.92(a)(1)] Submitter Information
| Applicant: | Acclarent Inc.31 Technology Drive, Suite 200Irvine, CA 92618, USATel.: 419-233-2611Fax: 949-450-6886 |
|---|---|
| Contact Person: | David LockeManager, Regulatory AffairsAcclarent Inc.Phone: 419-233-2611Dlocke1 @its.jnj.com |
| Authored by: | David LockeManager, Regulatory AffairsAcclarent Inc.Phone: 419-233-2611 |
| Date Summary Prepared: | Aug 26, 2020 |
| [807.92(a)(2)] Name of Device | |
| Device Trade Name:Device Common Name:Classification Name: | Next Generation Balloon - Balloon Dilation SystemNext Generation Balloon Dilation SystemEustachian tube balloon dilation system (21 CFR 874.4180) |
| Device Classification: | Class II |
| Product Code:Secondary Codes:Review Panel: | PNZPGW, LRCEar, Nose and Throat |
| [807.92(a)(3)] Legally Marketed Devices | |
| Primary Predicate Device: | Acclarent AERA® Eustachian Tube Balloon Dilation System(K171761) |
| Secondary PredicateDevices: | Relieva SpinPlus® Nav Balloon Sinuplasty System (K171687)Relieva SpinPlus® Balloon Sinuplasty System (K143541) |
| Reference Device: | Acclarent TruDi NAV Wire (K190532) |
| Device Description: | The Next Generation Balloon Dilation System (NGB) is an integratedballoon sinuplasty (BSP) and Eustachian tube (ET) dilation device, thatwill be available in light fiber and navigation guidewire configurations forcompatibility with illumination and navigation technology. The systemincludes a handle with several integrated features to allow for single-handed use. The adjustable gripping feature allows for ergonomichandling. The directable guide tip enables access (i.e.manipulating/separating/dividing tissue) and placement near the targetedanatomy. There are four preset approximate positions: Sphenoid(straight), Eustachian tube (55°), Frontal (70°), Maxillary (110°). Thedirectable guide knob allows for positioning of the balloon tip towards thetarget anatomy. The wire slider and spinner are used to advance, retract,and rotate the guidewire. The balloon slider is used advance and retractthe balloon. The Next Generation Balloon Dilation System also allows forsuction and irrigation in and around the target anatomy. |
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[807.92(a)(4)] Device Description
[807.92(a)(5)] Intended Use and Predicate Device Comparison
| Indications for Use: |
|---|
| The NGB Balloon Dilation System is intended to provide a means toaccess the sinus space within and across nasal and sinus structures; dilatethe sinus ostia and spaces associated with the paranasal sinus cavities fordiagnostic and therapeutic procedures; irrigate from within a target sinus;suction throughout therapeutic procedures and to facilitate diagnosticprocedures. |
| For children aged 17 and under, the NGB Balloon Dilation System isintended to provide a means to access the sinus space within and acrossnasal and sinus structures; dilate sinus ostia and spaces associated with themaxillary sinus for diagnostic and therapeutic procedures; irrigate fromwithin the maxillary sinus; suction throughout therapeutic procedures andto facilitate diagnostic procedures. |
| The NGB Balloon Dilation System is intended to dilate the cartilaginousEustachian tube for treatment of persistent Eustachian tube dysfunction inpatients ages 18 and older. |
| The NGB Balloon Dilation System with the navigation guidewire may beutilized in conjunction with the TruDiTM Navigation System, to help directaccess to nasal and paranasal spaces, and to confirm placement in thetargeted anatomy. NGB may be utilized in conjunction with the TruDiTMNAV Wire to confirm placement of the balloon in the Eustachian tube. |
| The NGB Balloon Dilation System with the illumination guidewire maybe utilized to illuminate within and provide transcutaneous illuminationacross nasal and sinus structures. |
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Image /page/5/Picture/0 description: The image shows the word "Acclarent" in bold, with a purple arc over the last few letters. Below that, the text "Next Generation Balloon Dilation System" is written in a smaller font. The word "Next" is capitalized, and the rest of the words are in lowercase.
[807.92(a)(6)] Technical Characteristics
| TechnologicalCharacteristics: | The Next Generation Balloon Dilation System combines Sinuplasty andEustachian Tube Dilation into a single handheld device. The device alsoallows for the use of the Acclarent TruDiTM NAV Wire for real-timetracking within nasal and Eustachian tube anatomy as well as anillumination wire for transcutaneous illumination across, nasal and sinusstructures. |
|---|---|
| Non-clinical PerformanceData: | The Next Generation Balloon was tested to ensure that it functions inaccordance with the device design specifications related to substantialequivalence in terms of device safety and effectiveness.The following nonclinical tests were performed:1. Bench testing has been performed and met all acceptance criteria forattributes such as simulated use testing, dimensional attributes, cyclefatigue, balloon burst, bond separation, irrigation flow rate and deviceaccuracy. Moreover, testing also showed that the Next GenerationBalloon Dilation System is biocompatible.2. The sterilization process has been validated per AAMI/ANSI/ISO11135-1: 2007 and demonstrated a sterility assurance level of 10-6.The method used for sterilization validation is the overkill (half-cycleapproach) in a fixed chamber. Ethylene oxide residuals have beentested and meet ISO 10993-7:2008 requirements. The subject deviceis not tested nor labeled as “non-pyrogenic”.3. Packaging shelf life has been established to be 3 months per ASTMF1980-07.4. Mechanical testing was performed, including tensile and flexuraltesting of catheter joints and materials.5. Durability testing was performed, including fatigue and burst pressuretesting of the balloon materials and components.6. Inflation and deflation characterization testing was performed,including time and pressure measurements, and leak testing of theballoon.7. Verification testing of safety features built into the device wasperformed, including the characterization of catheter geometries anddistal tip insertion limitation mechanisms.8. Simulated use testing in a clinically relevant model demonstrated thereliability of the device to remain mechanically functional throughoutthe anticipated conditions of use, and that the design features limitaccess to only the cartilaginous portion of the Eustachian tube.9. The Next Generation Balloon Dilation System passed all tests inaccordance with appropriate test criteria and standards, and themodified device did not raise new questions of safety or effectiveness. |
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Image /page/6/Picture/0 description: The image shows the Acclarent logo, with the company name in bold black letters and a purple curved line above the "ent" portion of the name. Below the logo, the text "Next Generation Balloon Dilation System" is displayed in a smaller, non-bold font. The text is left-aligned and positioned directly beneath the Acclarent logo.
| Clinical Data: | Clinical data was not necessary to determine that the subject NextGeneration Balloon Dilation System performs as intended. |
|---|---|
| Conclusion: | The modified Next Generation Balloon Dilation System device issubstantially equivalent to the currently cleared Acclarent AERA®Eustachian Tube Balloon Dilation System and the secondary predicatedevices based on the completion of non-clinical bench testing as well assimilar principles of design, operation and indications for use. |
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Substantial Equivalence Table
| Attribute | Primary PredicateDevice:ACCLARENTAERA®Eustachian TubeBalloon DilationSystem | SecondaryPredicateDevice:RELIEVASPINPLUS®NAV BalloonSinuplastySystem | SecondaryPredicateDevice:RELIEVASPINPLUS®BalloonSinuplastySystem | ReferenceDevice:TruDi™ NAVWire® | SubjectDevice:NextGenerationBalloonDilationSystem | SubstantialEquivalenceRationale |
|---|---|---|---|---|---|---|
| 510(k)number | K171761 | K171687 | K143541 | K190532 | K201115 | N/A |
| Manufacturer | Acclarent | Acclarent | Acclarent | Acclarent | Acclarent | N/A |
| Trade Name | ACCLARENTAERA®EustachianBalloonDilationSystem | RELIEVASPINPLUS®NAVBalloonSinuplastySystem | RelievaSpinPlusBalloonSinuplastySystem | TruDi™ NAV Wire | NextGenerationBalloonDilationSystem | N/A |
| CommonName | EustachianTube BalloonDilationDevice | SinusDilationSystem | SinusDilationSystem | Image GuidedSurgerySystem | EustachianTubeBalloonDilationDevice | N/A |
| Class | II | I | I | II | II | Same as thehigherclassificationdevices |
| Attribute | Primary PredicateDevice:ACCLARENTAERA®Eustachian TubeBalloon DilationSystem | SecondaryPredicateDevice:RELIEVASPINPLUS®NAV BalloonSinuplastySystem | SecondaryPredicateDevice:RELIEVASPINPLUS®BalloonSinuplastySystem | ReferenceDevice:TruDi™ NAVWire® | SubjectDevice:NextGenerationBalloonDilationSystem | SubstantialEquivalenceRationale |
| ClassificationProduct Code | PNZ | LRC | LRC | PGW | PNZ | Same asprimarypredicatedevice |
| SubsequentProduct Code | N/A | PGW | N/A | N/A | PGW,LRC | N/A |
| ClassificationSection | 874.4180 | 874.4420 | 874.4420 | 882.4560 | 874.4180 | Same asprimarypredicatedevice |
| Indicationsfor Use | The ACCLARENTAERA® EustachianTube Balloon DilationSystem is intended todilate the Eustachiantube for treatment ofpersistent Eustachiantube dysfunction inpatients ages 18 andolder. | The RELIEVASPINPLUS® NAVBalloon SinuplastySystem is intended toprovide a means toaccess the sinus space,within and acrossnasal and sinusstructures; dilate thesinus ostia and spacesassociated with theparanasal sinuscavities for diagnosticand therapeuticprocedures; andirrigate from within atarget sinus fortherapeutic proceduresand to facilitatediagnostic procedures.For children aged 17and under, theRELIEVASPINPLUS® NAVBalloon SinuplastySystem is intended toprovide a means toaccess the sinus space,within and acrossnasal and sinusstructures; dilate sinusostia and spacesassociated with themaxillary sinus fordiagnostic andtherapeuticprocedures; andirrigate from withinthe maxillary sinus fortherapeutic proceduresand to facilitatediagnostic procedures.The RELIEVASPINPLUS® NAVBalloon Sinuplasty | The RELIEVASPINPLUS™Balloon SinuplastySystem is intendedto: provide a meansto access thesinus space andilluminate withinand transilluminateacross nasal andsinus structures;dilate the sinusostia and spacesassociated with theparanasal sinuscavities fordiagnostic andtherapeuticprocedures;and irrigate fromwithin a target sinusfor therapeuticprocedures and tofacilitate diagnosticprocedures.For children aged 17and under, theRELIEVASPINPLUS™Balloon SinuplastySystem is intendedto:provide a means toaccess the sinusspace and illuminatewithin andtransilluminateacross nasal andsinus structures;dilate sinus ostia andspaces associatedwith the maxillarysinus for diagnosticand therapeuticprocedures; andirrigate from withinthe maxillary sinus | The TruDi™ NAVWire is intendedfor use as anelectromagneticallynavigableguidewire toprovide access andconfirmation ofplacement in thepatient anatomy.The device isintended for useduring ENTprocedures wherereference to a rigidanatomicalstructure can beidentified relativeto a CT-basedmodel of theanatomy. | The NGB BalloonDilation System isintended to providea means to accessthe sinus spacewithin and acrossnasal and sinusstructures; dilatethe sinus ostia andspaces associatedwith the paranasalsinus cavities;irrigate fromwithin a targetsinus; suctionthroughouttherapeuticprocedures and tofacilitate diagnosticprocedures.For children aged17 and under, theNGB BalloonDilation System isintended to providea means to accessthe sinus spacewithin and acrossnasal and sinusstructures; dilatesinus ostia andspaces associatedwith the maxillarysinus for diagnosticand therapeuticprocedures; irrigatefrom within themaxillary sinus;suction throughouttherapeuticprocedures and tofacilitate diagnosticprocedures.The NGB BalloonDilation System isintended to dilate | The IFU andIndications of thesubject NextGenerationBalloon DilationSystem is alignedwith thepredicate devices.The merging oftechnologieswithin theindications doesnot bring aboutany new concernswith respect tosubstantialequivalence, andthe safety andeffectiveness ofthe subject deviceis supported bycompleted devicetesting. |
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Traditional 510(k) Premarket Notification
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Image /page/10/Picture/0 description: The image shows the word "Acclarent" in black font. There is a purple arc over the last few letters of the word. The arc starts above the "r" and ends above the "t".
| utilized in conjunctionwith theACCLARENT® ENTNavigation System, toprovide access tonasal and sinusspaces, and to confirmplacement in theaccessed anatomy." | for therapeuticprocedures and tofacilitate diagnosticprocedures. | the cartilaginousEustachian tube fortreatment ofpersistentEustachian tubedysfunction inpatients ages 18and older.The NGB BalloonDilation Systemwith the navigationguidewire may beutilized inconjunction withthe TruDi™NavigationSystem, to helpdirect access tonasal and paranasalspaces, and toconfirm placementin the targetedanatomy. NGBmay be utilized inconjunction withthe TruDi™ NAVWire to confirmplacement of theballoon in theEustachian tube.The NGB BalloonDilation Systemwith theilluminationguidewire may beutilized toilluminate withinand providetranscutaneousillumination acrossnasal and sinusstructures. | ||
|---|---|---|---|---|
| -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
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Image /page/11/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in black, with the "ent" portion of the word in purple. Above the "ent" is a purple curved line.
| Attribute | PrimaryPredicateDevice:ACCLARENTAERA®Eustachian TubeBalloon DilationSystem | SecondaryPredicateDevice:RELIEVASPINPLUS®NAVBalloonSinuplastySystem | SecondaryPredicateDevice:RELIEVASPINPLUS®BalloonSinuplastySystem | ReferenceDevice:TruDi™ NAVWire®Sinus NavigationGuidewire | SubjectDevice:Next GenerationBalloon DilationSystem | SubstantialEquivalenceRationale |
|---|---|---|---|---|---|---|
| Sterilization | EtO | EtO | EtO | EtO | EtO | Same |
| Packaging | PETGthermoformedtray inTyvek/Nylonpouch | PETGthermoformedd tray inTyvek/Nylonpouch | PETGthermoformedtray inTyvek/Nylonpouch | Backer-card inTyvek/Nylonpouch | PETGthermoformedtray inTyvek/Nylonpouch | Same |
| Single Use | Yes | Yes | Yes | Yes | Yes | Same |
| Patient Contact | Direct | Direct | Direct | Direct | Direct | Same |
| Labeled as Non-Pyrogenic? | No | No | No | No | No | Same |
| TechnologicalCharacteristics | The ACCLARENTAERA® EustachianTube BalloonDilation System isa device thatallows for dilationof the cartilaginous | TheRELIEVASPINPLUS®NAV BalloonSinuplastySystemcombines a | The RELIEVASPINPLUS®BalloonSinuplastySystem combinesa Sinus Guide | The TruDi™NAV Wireutilizeselectromagneticimage-guidedsinus surgery | The NEXTGENERATIONBALLOONDILATIONSYSTEMcombines | The technologicalcharacteristicshave been testedthrough non-clinical testingand they do not |
| portion of theEustachian tube.Eustachian tubedilation is achievedvia a noncompliantballoon located onthe distal end ofthe device. | Sinus GuideCatheter andHandleAssembly(integratedwith SinusBalloonCatheter,SinusIrrigation andSinusNavigationSystem) into asingle device.The device isconnected tothe AcclarentENTNavigationSystem toprovidelocationinformationvia EMnavigationrelative to apre-loadedscan. | Catheter andHandle Assembly(integrated withSinus BalloonCatheter, SinusIrrigation andSinusIlluminationSystem) into asingle device.The device isconnected to anystandard lightsource viaaccessory lightcable and adapter. | and is used inconjunctionwith acompatiblesurgicalnavigationsystem whichconsists ofcomputer-aidedsoftware, CT-imaging, patienttracker,registrationprobe, andvariousinstrumentsused in sinussurgery.TruDi® NAVWire providesreal-timetracking at thedistal tip of theguidewire in thenasal anatomy. | Sinuplasty andEustachian TubeDilation into asingle handhelddevice. Thedevice also allowsfor the use of theAcclarent TruDiNav Wire forreal-time trackingwithin nasal andEustachian tubeanatomy as wellas an illuminationwire fortranscutaneousilluminationacross, nasal andsinus structures. | impact substantialequivalence.Moreover, theminortechnologicaldifferences do notraise any newconcerns withrespect to safetyand effectiveness. | |
| Material | PTFE,Polycarbonate,Nylon, Pebax,Grilamid Ely,Barium, Pebax, BlueNylon, Barium,Marabu TPU ink,Stainless Steel. | Pebax, PET,Loctite, Padprinting,Stainless steel,PEEK,Polycarbonate,Nylon, PTFE,Polyester. | Pebax, PET,Loctite, Padprinting, Stainlesssteel, PEEK,Polycarbonate,Nylon, PTFE,Polyester, Siliconerubber. | PolycarbonatePebaxEthylCyanoacrylateAdhesive, SilverPlated Copper,PTFE, Silver | Pebax, PET,Loctite, Padprinting, Stainlesssteel, PEEK,Polycarbonate,Nylon, PTFE,Polyester, Silicone | The materialsused are thosecommonly used inmedical devicesand have beentested via |
| Polyolefin, Loctite4014, Loctite 4011,Dymax 204CTH,Loctite 745,Platinum, 10%Iridium, Loctite 408,Loctite 7451,Dymax 1191 | Silicone rubber,Polypropylene,Silicone, Tygon,Parylene,Polyurethane,Silver PlatedCopper,AntioxidantNickel-Iron-MolybdenumAlloy, fiberglassinsulation,RoHS-compliantPCB Assembly,Adhesive SilverPlated Copper | Polypropylene,Silicone, Tygon,Parylene.Polyurethane | FilledPolycarbonate/ABSRoHS-compliantPCB AssemblyPolypropylene,HydrocarbonResin, Styrene-ButadienePolymer, ParaffinWax.Polyethylene,Antioxidant.Nickel-Iron-MolybdenumAlloy, StainlessSteel, Silicone | rubber,Polypropylene,Silicone, Tygon,Parylene,Polyurethane,Silver PlatedCopper.AntioxidantNickel-Iron-MolybdenumAlloy, fiberglassinsulation, RoHS-compliant PCBAssembly,Adhesive SilverPlated CopperSE508 Nitinol | biocompatibility.The materials usein the subjectdevice are thesame as thepredicate devices.There are no newconcerns withrespect to safetyand effectivenessand the materialsused in the subjectdevice aresubstantiallyequivalent to thepredicate devices. | |
| BalloonMaterial | PET | Nylon | PET | N/A | Nylon | The balloonmaterial isequivalent to thatof the currentlymarketed primarypredicate device. |
| Balloon Length | 16 mm | 16 mm | 16 mm | N/A | 16 mm | Same |
| GuidewireDiameter | N/A | 0.035 inches | N/A | 0.035 inches | 0.035 inches | Same as comparedto applicabledevices |
| Deflation Time | <5 seconds | <5 seconds | <5 seconds | N/A | <5 seconds | Same |
| MaximumInflationPressure | 12 ATM | 12 ATM | 12 ATM | N/A | 12 ATM | Same |
| Flexible BalloonCatheter | Yes | Yes | Yes | N/A | Yes | Same |
| BalloonRadiopaqueMarker Bands | No | No | No | N/A | No | Same |
| SuctionIncorporated | No | Yes | Yes | No | Yes | Same as comparedto applicabledevices |
| IrrigationIncorporated | No | Yes | Yes | No | Yes | Same as comparedto applicabledevices |
| Balloon SlideMechanism | No | Yes | Yes | No | Yes | Same as comparedto applicabledevices |
| Indicated forChildren | Yes - Eustachiantube dilation for18 years old andgreater | Yes, maxillarysinus forchildren 17and under | Yes, maxillarysinus forchildren 17 andunder | Yes, maxillarysinus forchildren 17and under | Yes, maxillarysinus forchildren 17 andunderYes -Eustachian tubedilation for 18years old andgreater | Same:Sinus Dilation -maxillary sinusfor children 17and under.Eustachian TubeDilation - 18 yearsand greater. |
| Compatible withACCLARENT® ENTNavigationSystem | No | Yes | No | Yes | Yes | Same with respectto those devicesthat connect to theTruDi NavigationSystem. |
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Image /page/12/Picture/0 description: The image shows the word "Acclarent" in black font. There is a purple arc over the "ent" portion of the word. The arc starts above the "r" and ends above the "t".
Traditional 510(k) Premarket Notification
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Image /page/13/Picture/0 description: The image shows the word "Acclarent" in black font. The "larent" portion of the word is in purple font. There is a purple arc above the word.
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Image /page/14/Picture/0 description: The image shows the word "Acclarent" in black font. There is a purple arc above the word that starts at the "r" and ends at the "t". The font is sans-serif and the word is slightly bolded.
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Image /page/15/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a bold, sans-serif font. The "ent" portion of the word is in purple, and there is a purple arc above the letters.
Traditional 510(k) Premarket Notification
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.