(90 days)
The Relieva SpinPlus Nav™ Balloon Sinuplasty 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 diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.
For children aged 17 and under, the Relieva SpinPlus Nav™ Balloon Sinuplasty 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; and irrigate from within the maxillary sinus for therapeutic procedures and to facilitate diagnostic procedures.
The Relieva SpinPlus Nav™ Balloon Sinuplasty System may be utilized in conjunction with the ACCLARENT® ENT Navigation System, to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy
The RELIEVA SPINPLUS® NAV Balloon Sinuplasty System is packaged with a handle with integrated flexible balloon catheter and Sinus Navigation Guidewire, and three RELIEVA® Spin Sinus Guide Catheter Tips. The system features a handle with an integrated flexible balloon catheter. Features of the handle include a sinus guide tip release button, a suction system, a balloon guard, and several gripping features to grip the device. The guide tip release button must be depressed to separate the sinus guide catheter tip from the handle system. The suction system consists of a suction line and a suction port. Suction may be used to clear the field of fluids and/or blood. The suction line is attached to the proximal end of the handle system and may be removed if desired. The suction port may be covered by the user's finger to increase the suction flow rate. A clear balloon guard is connected to the distal end of the handle system and protects the sinus balloon during sinus guide catheter tip exchanges. The Handle features a wire slider, wire spinner, balloon slider, sinus balloon, handle markers, and proximal connections. The wire slider allows the user to advance, retract and spin the sinus navigation guidewire with a single hand while simultaneously supporting the handle. The balloon slider allows the user to advance and retract the sinus balloon catheter to the target sinus ostia and outflow tract, to enable dilation. The integrated connector enables the device to be interfaced to the ACCLARENT ENT™ Navigation System to facilitate EM navigation. The RELIEVA SPINPLUS® NAV Balloon Sinuplasty System may be utilized in conjunction with the ACCLARENT ENT™ Navigation System to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy via electromagnetic navigation.
This document describes the RELIEVA SPINPLUS® NAV Balloon Sinuplasty System. The information provided focuses on technical characteristics and non-clinical performance data to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating its performance against specific acceptance criteria in patient outcomes. Therefore, some of the requested information, specifically regarding sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and ground truth establishment for training, is not available from the provided text.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Tests Performed | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Dimensional specifications | Met all performance acceptance criteria. |
| Balloon burst pressure | Met all performance acceptance criteria. | |
| Joint separation force | Met all performance acceptance criteria. | |
| Deflation time | Met all performance acceptance criteria. | |
| Balloon cycle fatigue | Met all performance acceptance criteria. | |
| Wire stiffness | Met performance specifications. | |
| Tensile strength | Met performance specifications. | |
| Irrigation testing | Met performance specifications. | |
| Shelf Life | Packaging shelf life established via accelerated aging (ASTM F1980-07, ASTM F88/F88M-09, and ASTM F2096-04) | Confirmed to meet a shelf life of three months. |
| Biocompatibility | Biocompatibility testing | Successfully completed, device is biocompatible. |
| Sterilization | Sterilization process validated per AAMI/ANSI/ISO 11135:2014, Method: overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals tested against ISO 10993-7:2008. | Demonstrated a sterility assurance level of 10-6. Ethylene oxide residuals met ISO 10993-7:2008 requirements. (Note: Device is not tested or labeled as "non-pyrogenic"). |
| Simulated Use | ENT surgeons performing balloon dilation of paranasal sinuses utilizing the device and ACCLARENT ENT™ Navigation System. | Demonstrated that the RELIEVA SPINPLUS® NAV Balloon Sinuplasty System and the ACCLARENT ENT™ Navigation System could effectively access the paranasal sinuses. |
| Navigation Accuracy | Verification of navigation accuracy when used with the Acclarent ENT Navigation System (K161701). Testing included sensitivity and connection verification. | Performance data demonstrated that the device performs as intended when used with the Acclarent ENT Navigation System. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" in terms of a patient cohort. The performance evaluation relies on non-clinical bench testing and simulated use testing with ENT surgeons. The number of instances or items tested for each bench test is not provided (e.g., how many balloons were burst tested, how many times was the device used in simulated use).
- Data Provenance: The data is primarily from non-clinical, laboratory-based testing (bench tests, accelerated aging, biocompatibility, sterilization validation) and simulated use testing performed with ENT surgeons. There is no mention of data from human patients or a specific country of origin in the context of a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: For the "simulated use testing," ENT surgeons were involved. The exact "number of experts" is not specified (e.g., "ENT surgeons" could imply more than one, but no specific count is given).
- Qualifications of Experts: The experts are identified as "ENT surgeons," indicating their medical specialty relevant to the device's use. No further details on their experience (e.g., "10 years of experience") are provided.
- Ground Truth: In the context of simulated use, the "ground truth" would be the successful procedural outcome as observed and judged by these ENT surgeons in a simulated environment (i.e., effective access and dilation).
4. Adjudication Method for the Test Set
- The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the simulated use testing or any other part of the performance evaluation. The results are presented as having "demonstrated" specific outcomes.
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 conducted. The document states, "Clinical data was not necessary for the RELIEVA SPINPLUS™ NAV Balloon Sinuplasty System." The evaluation was based on non-clinical performance and simulated use data to establish substantial equivalence. Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This device is a physical medical instrument (a balloon sinuplasty system) and does not involve an "algorithm" or AI in the traditional sense of image analysis or decision support for diagnostics. It is used in conjunction with an "ACCLARENT ENT™ Navigation System," which is a separate system (K161701 for its navigation accuracy testing). The performance reviewed here is an instrument that aids surgeons, not a standalone AI algorithm. While navigation accuracy was tested for the combined system, it's not an "algorithm only" performance evaluation.
7. The Type of Ground Truth Used
- The "ground truth" for the various non-clinical tests was based on engineering specifications, industry standards, and established metrics for material properties, mechanical integrity, and biological safety (e.g., burst pressure limits, sterility assurance levels, biocompatibility standards).
- For the simulated use testing, the "ground truth" was established by expert observation and judgment of ENT surgeons regarding the device's ability to effectively access and dilate paranasal sinuses in a simulated environment.
8. The Sample Size for the Training Set
- The document describes a device approval process based on substantial equivalence to predicate devices through non-clinical and simulated use testing. It does not mention a "training set" as would be relevant for machine learning algorithms or for establishing a new clinical efficacy profile.
9. How the Ground Truth for the Training Set Was Established
- As no "training set" for an algorithm or new clinical efficacy was described, this information is not applicable and not present in the document.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 13, 2017
Acclarent. Inc. James Patrick Garvey II Associate Director. Regulatory Affairs 33 Technology Drive Irvine, California 92618
Re: K171687
Trade/Device Name: Relieva SpinPlus® Nav Balloon Sinuplasty System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, and Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: June 6, 2017 Received: June 7, 2017
Dear James Patrick Garvey:
This letter corrects our substantially equivalent letter of September 5, 2017.
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.
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
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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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Eric A. Mann -S
for Malvina 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) K171687
Device Name
RELIEVA SPINPLUS NAV Balloon Sinuplasty System
Indications for Use (Describe)
The Relieva SpinPlus Nav™ Balloon Sinuplasty 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 diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.
For children aged 17 and under, the Relieva SpinPlus Nav™ Balloon Sinuplasty 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; and irrigate from within the maxillary sinus for therapeutic procedures and to facilitate diagnostic procedures.
The Relieva SpinPlus Nav™ Balloon Sinuplasty System may be utilized in conjunction with the ACCLARENT® ENT Navigation System, to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy
Type of Use (Select one or both, as applicable)
| ☑ 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 shows the word "Acclarent" in a stylized font. The first part of the word, "Acclar" is in black, while the "ent" portion is in purple. There is a purple curved line above the "ent" portion of the word.
| 510(K) SUMMARY | |
|---|---|
| 510(k) Number: | K171687 |
| [807.92(a)(1)] Submitter Information | |
| Sponsor/Submitter: | Acclarent, Inc.33 Technology DriveIrvine, CA 92618 |
| Contact Person: | Patrick GarveyAssociate Director, Regulatory AffairsEmail: pgarvey@its.jnj.comTel: 949-789-8505 Fax: 650-687-5899 |
| Date Summary Prepared: | August 28, 2017 |
| [807.92(a)(2)] Name of Device | |
| Device Trade Name: | RELIEVA SPINPLUS® NAV Balloon Sinuplasty System |
| Common Name: | Sinus Balloon Catheter |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 874.4420 |
| Classification Name: | Ear, Nose, and Throat Manual Surgical Instrument (21 CFR 874.4420) |
| Product Code: | LRC |
| [807.92(a)(3)] Legally Marketed Devices | |
| Predicate Devices: | RELIEVA SPINPLUS® Balloon Sinuplasty System, (K143541) |
| Reference Devices | ACCLARENT® NAVWIRE™ Sinus Navigation System, (K161697)Medtronic NuVent™ EM Sinus Dilation System, (K152121) |
| [807.92(a)(4)] Device Description | |
| Device Description: | The RELIEVA SPINPLUS® NAV Balloon Sinuplasty System is packagedwith a handle with integrated flexible balloon catheter and Sinus NavigationGuidewire, and three RELIEVA® Spin Sinus Guide Catheter Tips. The systemfeatures a handle with an integrated flexible balloon catheter. Features of thehandle include a sinus guide tip release button, a suction system, a balloonguard, and several gripping features to grip the device. The guide tip releasebutton must be depressed to separate the sinus guide catheter tip from thehandle system. The suction system consists of a suction line and a suctionport. Suction may be used to clear the field of fluids and/or blood. The suctionline is attached to the proximal end of the handle system and may be removed |
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RELIEVA SPINPLUS® NAV Balloon Sinuplasty System
| if desired. The suction port may be covered by the user's finger to increase the suction flow rate. A clear balloon guard is connected to the distal end of the handle system and protects the sinus balloon during sinus guide catheter tip exchanges. The Handle features a wire slider, wire spinner, balloon slider, sinus balloon, handle markers, and proximal connections. The wire slider allows the user to advance, retract and spin the sinus navigation guidewire with a single hand while simultaneously supporting the handle. The balloon slider allows the user to advance and retract the sinus balloon catheter to the target sinus ostia and outflow tract, to enable dilation. The integrated connector enables the device to be interfaced to the ACCLARENT ENT™ Navigation System to facilitate EM navigation The RELIEVA SPINPLUS® NAV Balloon Sinuplasty System may be utilized in conjunction with the ACCLARENT ENT™ Navigation System to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy via electromagnetic navigation. | |
|---|---|
| [807.92(a)(5)] Intended Use | |
| Indications for Use: | The RELIEVA SPINPLUS® NAV Balloon Sinuplasty 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 diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures. |
| For children aged 17 and under, the RELIEVA SPINPLUS® NAV Balloon Sinuplasty 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; and irrigate from within the maxillary sinus for therapeutic procedures and to facilitate diagnostic procedures.” | |
| The RELIEVA SPINPLUS® NAV Balloon Sinuplasty System may be utilized in conjunction with the Acclarent ENT Navigation System, to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy. | |
| Difference inIndications fromPredicate Device | The difference in indications for use between the subject and predicate devices is supported is presented in Table 1 of this summary. |
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RELIEVA SPINPLUS® NAV Balloon Sinuplasty System
[807.92(a)(6)] Technical Characteristics
| TechnologicalCharacteristics: | The RELIEVA SPINPLUS® NAV Balloon Sinuplasty System combines aSinus Guide Catheter and Handle Assembly (integrated with Sinus BalloonCatheter, Sinus Irrigation and Electromagnetically-trackable Guidewire) into asingle device. |
|---|---|
| See Table 1 for a comparison of the technological characteristics between theRELIEVA SPINPLUS® NAV Balloon Sinuplasty System and the predicatedevices. |
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RELIEVA SPINPLUS® NAV Balloon Sinuplasty System
Table 1: Comparison of Technological Characteristics between the RELIEVA SPINPLUS® NA V Balloon Sinuplasty System and predicate and reference devices.
| Attribute | Primary Predicate Device(RELIEVA SPINPLUS®Balloon Sinuplasty System) | Reference Device(ACCLARENT NAVWIRE™Sinus Navigation Guidewire) | Reference Device(NuVent EM Sinus DilationSystem) | Subject Device(RELIEVA SPINPLUS® NAVBalloon Sinuplasty System) |
|---|---|---|---|---|
| 510(k) number | K143541 | K161697 | K152121 | TBD |
| Manufacturer | Acclarent | Acclarent | Medtronic | Acclarent |
| Trade Name | RELIEVA SPINPLUS® SinusDilation System | ACCLARENT NAVWIRE™Sinus Navigation Guidewire | NuVent™ EM Sinus DilationSystem | RELIEVA SPINPLUS® NAVBalloon Sinuplasty System |
| Common Name | Sinus Dilation System | Sinus Balloon Catheter | Sinus Balloon Catheter | Sinus Dilation System |
| Class | I | II | I | I |
| Product Code | LRC | PGW | LRC | LRC |
| Classification Section | 21 CFR 874.4420 | 21 CFR 882.4560 | 21 CFR 874.4420 | 21 CFR 874.4420 |
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Balloon Sinuplasty System
Traditional 510(k) Premarket Notification RELIEVA SPINPLUS® NAV
The RELIEVA SPINPLUS™ The ACCLARENT® NAVWIRE™ The EM Sinus Dilation System is The RELIEVA SPINPLUS™ Nav Indications for Balloon Sinuplasty System is Sinus Navigation Guidewire is intended for use in conjunction Balloon Sinuplasty System is Use intended to: provide a means to intended for use as a navigable with the Medtronic Computer intended to provide a means to access the sinus space and guidewire to provide access to Assisted Surgery System during access the sinus space, within and sinus procedures when surgical across nasal and sinus structures; illuminate within and nasal and sinus spaces, and transilluminate across nasal and confirmation of placement in the navigation or image-guided surgery dilate the sinus ostia and spaces sinus structures; dilate the sinus accessed anatomy. The Acclarent may be necessary. When used associated with the paranasal sinus ostia and spaces associated with the NavWire is designed for use during concomitantly, these systems may cavities for diagnostic and paranasal sinus cavities for procedures where reference to a be used to locate and move tissue, therapeutic procedures; and irrigate diagnostic and therapeutic rigid anatomical structure in the bone or cartilaginous tissue from within a target sinus for procedures; and irrigate from field of ENT surgery, such as the surrounding the drainage pathways therapeutic procedures and to within a target sinus for therapeutic paranasal sinuses, can be identified of frontal, maxillary, and sphenoid facilitate diagnostic procedures. procedures and to facilitate relative to a CT-based model of the sinuses to facilitate dilation of the diagnostic procedures. anatomy. sinus ostia: or locate and move For children aged 17 and under, the RELIEVA SPINPLUS™ Nav tissue, bone or cartilaginous tissue For children aged 17 and under, the surrounding the drainage pathways Balloon Sinuplasty System is RELIEVA SPINPLUS™ Balloon of frontal, maxillary, and sphenoid intended to provide a means to Sinuplasty System is intended to: sinuses that is scarred, granulated access the sinus space, within and or previously surgically altered to provide a means to access the sinus across nasal and sinus structures: space and illuminate within and facilitate dilation of the sinus ostia. dilate sinus ostia and spaces associated with the maxillary sinus transilluminate across nasal and The Medtronic computer-assisted sinus structures; dilate sinus ostia surgery system and its associated for diagnostic and therapeutic and spaces associated with the applications are intended as an aid procedures; and irrigate from maxillary sinus for diagnostic and for precisely locating anatomical within the maxillary sinus for therapeutic procedures; and irrigate structures in either open or therapeutic procedures and to from within the maxillary sinus for percutaneous procedures. Their use facilitate diagnostic procedures. therapeutic procedures and to is indicated for any medical facilitate diagnostic procedures. condition in which the use of The RELIEVA SPINPLUS™ Nav stereotactic surgery may be Balloon Sinuplasty System may be appropriate, and where reference to utilized in conjunction with the a rigid anatomical structure, such as ACCLARENT® ENT Navigation System, to provide access to nasal the skull, can be identified relative to a CT- or MR-based model, or and sinus spaces, and to confirm digitized landmarks of the placement in the accessed anatomy. The system and its anatomy." associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.
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RELIEVA SPINPLUS® NAV
Balloon Sinuplasty System
| Attribute | Primary Predicate Device(RELIEVA SPINPLUS®Sinus Dilation System) | Reference Device(ACCLARENT NAVWIRE™Sinus Navigation Guidewire) | Reference Device(NuVent EM Sinus DilationSystem) | Subject Device(RELIEVA SPINPLUS® NAVBalloon Sinuplasty System) |
|---|---|---|---|---|
| Sterilization | EtO | EtO | EtO | EtO |
| Packaging | Thermoformed tray in pouch | Thermoformed tray in pouch | Unknown | Thermoformed tray in pouch |
| Single Use | Yes | Yes | Yes | Yes |
| Patient Contact | Direct | Direct | Direct | Direct |
| Labeled as Non-Pyrogenic? | No | No | No | No |
| TechnologicalCharacteristics | Combines a Sinus GuideCatheter and Handle Assembly(integrated with Sinus BalloonCatheter, Sinus Irrigation andSinus Illumination System) intoa single device. The device isconnected to any standard lightsource via accessory light cableand adapter. | The ACCLARENT®NAVWIRE™ Sinus NavigationGuidewire utilizeselectromagnetic image-guidedsinus surgery and is used inconjunction with a compatiblesurgical navigation systemwhich consists of computer-aided software, CT-imaging,patient tracker, registrationprobe, and various instrumentsused in sinus surgery.ACCLARENT® NAVWIRETMSinus Navigation Guidewireprovides real-time tracking atthe distal tip of the guidewire inthe nasal anatomy. | Combines a Sinus GuideCatheter and Handle Assembly(integrated with Sinus BalloonCatheter and Sinus NavigationSystem) into a single device.The device is connected to theMedtronic Fusion NavigationSystem to provide locationinformation via EM navigationrelative to a pre-loaded scan. | Combines a Sinus GuideCatheter and Handle Assembly(integrated with Sinus BalloonCatheter, Sinus Irrigation andSinus Navigation System) into asingle device. The device isconnected to the Acclarent ENTNavigation System to providelocation information via EMnavigation relative to a pre-loaded scan. |
| Balloon Length | 16 mm | N/A | 17 mm | 16 mm |
| GuidewireDiameter | 0.035 inches | 0.035 inches | N/A | 0.035 inches |
| MaximumInflation Pressure | 12 ATM | N/A | Unknown | 12 ATM |
| Flexible BalloonCatheter | Yes | N/A | N/A | Yes |
| Attribute | Primary Predicate Device(RELIEVA SPINPLUS®Sinus Dilation System) | Reference Device(ACCLARENT NAVWIRE™Sinus Navigation Guidewire) | Reference Device(NuVent EM Sinus DilationSystem) | Subject Device(RELIEVA SPINPLUS® NAVBalloon Sinuplasty System) |
| BalloonRadiopaqueMarker Bands | No | N/A | EM-Navigation | No |
| SuctionIncorporated | Yes | No | No | Yes |
| IrrigationIncorporated | Yes | No | No | Yes |
| Balloon SlideMechanism | Yes | No | No | Yes |
| Indicated forChildren | Yes, maxillary | Yes, maxillary1 | No | Yes, maxillary |
| Compatible withACCLARENT®ENT NavigationSystem | No | Yes | No(Compatible withMedtronic Fusion® ENTNavigation System) | Yes |
| Principles ofOperation | Manually operated device.Balloon inflated with sterilesaline or water to mechanicallydilate sinus ostia. | Manually operated device.Balloon inflated with sterilesaline or water to mechanicallydilate sinus ostia. | Manually operated device.Balloon inflated with sterilesaline or water to mechanicallydilate sinus ostia. | Manually operated device.Balloon inflated with sterilesaline or water to mechanicallydilate sinus ostia. |
| Flexible | Yes – flexible sinus ballooncatheter and guidewire. | Yes – Flexible guidewire | No- fixed, rigid instrument notdesigned to bend. | Yes – flexible balloon sinuscatheter and guidewire. |
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RELIEVA SPINPLUS® NAV Balloon Sinuplasty System
1 Based upon use with Relieva UlttirraNav Sinus Balloon Catheter, cleared on K161698
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Image /page/10/Picture/0 description: The image shows the logo for Acclarent. The text "Acclarent" is in black font. There is a purple arc above the text.
[807.92(b) (1)] Determination of Substantial Equivalence
| Non-Clinical PerformanceData: | The RELIEVA SPINPLUS Nav™ Balloon Sinuplasty System met allperformance acceptance criteria including dimensional specifications;balloon burst pressure, joint separation force, deflation time, andballoon cycle fatigue. Additional testing to demonstrated that wirestiffness, tensile strength and irrigation testing were also performed todemonstrate that the device met performance specifications.Packaging shelf life was established through accelerated aging viaASTM F1980-07, ASTM F88/F88M-09, and ASTM F2096-04requirements and confirmed to meet a shelf life of three months.Biocompatibility testing successfully completed to determine that theRELIEVA SPINPLUS® NAV Balloon Sinuplasty System isbiocompatible.The sterilization process has been validated per AAMI/ANSI/ISO11135:2014 and demonstrated a sterility assurance level of 10-6. Themethod used for sterilization validation was the overkill (half-cycleapproach) in a fixed chamber. Ethylene oxide residuals were tested andmet ISO 10993-7:2008 requirements. The subject device is not testednor labeled as "non-pyrogenic”.Simulated use testing was performed with ENT surgeons performingballoon dilation of the paranasal sinuses utilizing the RELIEVASPINPLUS® NAV Balloon Sinuplasty System and the ACCLARENTENT™ Navigation System. The testing demonstrated that theRELIEVA SPINPLUS® NAV Balloon Sinuplasty System and theACCLARENT ENT™ Navigation System could effectively access theparanasal sinuses. Clinical data was not necessary for the RELIEVASPINPLUS® NAV Balloon Sinuplasty System.Testing was performed to verify the navigation accuracy of the devicewhen used with the Acclarent ENT Navigation System (K161701).Testing included sensitivity and connection verification.The performance data demonstrated that the device performs asintended. |
|---|---|
| [807.92(b) (2)] Determination of Substantial Equivalence | |
| Clinical Performance Data | Clinical data was not necessary for the RELIEVA SPINPLUS Nav™Balloon Sinuplasty System. The performance data demonstrated thatthe device performs as intended. |
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RELIEVA SPINPLUS® NAV Balloon Sinuplasty System
[807.92(b) (3)] Conclusion The RELIEVA SPINPLUS Nav™ Balloon Sinuplasty System is Conclusion from Non-Clinical and Clinical Tests substantially equivalent to the predicate devices.
§ 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.