(90 days)
No
The description focuses on mechanical components and electromagnetic navigation, with no mention of AI or ML capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "therapeutic procedures."
No
The device is primarily a therapeutic device (balloon sinuplasty system) used for dilating sinus ostia. While it "facilitates diagnostic procedures" and can be used for "diagnostic and therapeutic procedures," its core function is not to diagnose. The device assists in accessing and irrigating the sinus space, which in turn might aid in diagnostic procedures, but it does not independently perform a diagnostic function.
No
The device description clearly details physical components such as a handle, balloon catheter, guidewire, and guide catheter tips, indicating it is a hardware device. While it interfaces with a navigation system (which likely includes software), the core device itself is not software-only.
Based on the provided information, the Relieva SpinPlus Nav™ Balloon Sinuplasty System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for surgical procedures (accessing, dilating, and irrigating sinus spaces). IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical instrument with a balloon catheter, guidewire, and features for manipulation and navigation within the nasal and sinus structures. This is consistent with a surgical device, not a device for analyzing biological samples.
- Anatomical Site: The device is used directly on anatomical sites within the body (nasal and sinus structures).
- Performance Studies: The performance studies focus on the physical and functional performance of the device itself (burst pressure, tensile strength, navigation accuracy) and its use in simulated surgical procedures. There is no mention of analyzing biological samples or diagnostic accuracy metrics like sensitivity, specificity, PPV, or NPV in the context of a diagnostic test. While sensitivity is mentioned under "Key Metrics," it's in the context of navigation accuracy, not diagnostic test performance.
In summary, the Relieva SpinPlus Nav™ Balloon Sinuplasty System is a surgical device used for therapeutic and diagnostic procedures within the body, not a device used to perform tests on biological samples outside the body.
N/A
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
Product codes
LRC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT- or MR-based model, or digitized landmarks based on CT-imaging
Anatomical Site
sinus space, nasal and sinus structures, paranasal sinus cavities, maxillary sinus
Indicated Patient Age Range
For children aged 17 and under, and general use.
Intended User / Care Setting
ENT surgeons, surgical guidance in either open or percutaneous procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: The RELIEVA SPINPLUS Nav™ Balloon Sinuplasty System met all performance acceptance criteria including dimensional specifications; balloon burst pressure, joint separation force, deflation time, and balloon cycle fatigue. Additional testing to demonstrated that wire stiffness, tensile strength and irrigation testing were also performed to demonstrate that the device met performance specifications. Packaging shelf life was established through accelerated aging via ASTM F1980-07, ASTM F88/F88M-09, and ASTM F2096-04 requirements and confirmed to meet a shelf life of three months. Biocompatibility testing successfully completed to determine that the RELIEVA SPINPLUS® NAV Balloon Sinuplasty System is biocompatible. The sterilization process has been validated per AAMI/ANSI/ISO 11135:2014 and demonstrated a sterility assurance level of 10-6. The method used for sterilization validation was the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals were tested and met ISO 10993-7:2008 requirements. The subject device is not tested nor labeled as "non-pyrogenic”. Simulated use testing was performed with ENT surgeons performing balloon dilation of the paranasal sinuses utilizing the RELIEVA SPINPLUS® NAV Balloon Sinuplasty System and the ACCLARENT ENT™ Navigation System. The testing demonstrated that the RELIEVA SPINPLUS® NAV Balloon Sinuplasty System and the ACCLARENT ENT™ Navigation System could effectively access the paranasal sinuses. Clinical data was not necessary for the RELIEVA SPINPLUS® NAV Balloon Sinuplasty System. Testing was performed to verify the navigation accuracy of the device when used with the Acclarent ENT Navigation System (K161701). Testing included sensitivity and connection verification. The performance data demonstrated that the device performs as intended.
Clinical Performance Data: Clinical data was not necessary for the RELIEVA SPINPLUS Nav™ Balloon Sinuplasty System. The performance data demonstrated that the device performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RELIEVA SPINPLUS® Balloon Sinuplasty System, (K143541)
Reference Device(s)
ACCLARENT® NAVWIRE™ Sinus Navigation System, (K161697), Medtronic NuVent™ EM Sinus Dilation System, (K152121)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Drive | |
| Irvine, CA 92618 | |
| Contact Person: | Patrick Garvey |
| Associate Director, Regulatory Affairs | |
| Email: pgarvey@its.jnj.com | |
| Tel: 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 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 |
4
Image /page/4/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" is in purple. There is a purple swoosh above the "ent" part of the word.
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 in | |
| Indications from | |
| Predicate Device | The difference in indications for use between the subject and predicate devices is supported is presented in Table 1 of this summary. |
5
Image /page/5/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a sans-serif font, with the first part of the word in black and the "ent" portion in purple. A purple curved line extends over the "ent" portion of the word, adding a visual element to the logo.
RELIEVA SPINPLUS® NAV Balloon Sinuplasty System
[807.92(a)(6)] Technical Characteristics
| Technological
Characteristics: | The RELIEVA SPINPLUS® NAV Balloon Sinuplasty System combines a
Sinus Guide Catheter and Handle Assembly (integrated with Sinus Balloon
Catheter, Sinus Irrigation and Electromagnetically-trackable Guidewire) into a
single device. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | See Table 1 for a comparison of the technological characteristics between the
RELIEVA SPINPLUS® NAV Balloon Sinuplasty System and the predicate
devices. |
6
Image /page/6/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a sans-serif font, with the first part of the word in black and the second part in purple. A purple curved line extends over the top of the word, ending in a point to the right.
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 Dilation
System) | Subject Device
(RELIEVA SPINPLUS® NAV
Balloon Sinuplasty System) |
|------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------------------|
| 510(k) number | K143541 | K161697 | K152121 | TBD |
| Manufacturer | Acclarent | Acclarent | Medtronic | Acclarent |
| Trade Name | RELIEVA SPINPLUS® Sinus
Dilation System | ACCLARENT NAVWIRE™
Sinus Navigation Guidewire | NuVent™ EM Sinus Dilation
System | RELIEVA SPINPLUS® NAV
Balloon 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 |
7
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.
8
Image /page/8/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" is in purple. There is a purple curved line above the "ent" portion of the word.
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 Dilation
System) | Subject Device
(RELIEVA SPINPLUS® NAV
Balloon 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 |
| Technological
Characteristics | Combines a Sinus Guide
Catheter and Handle Assembly
(integrated with Sinus Balloon
Catheter, Sinus Irrigation and
Sinus Illumination System) into
a single device. The device is
connected to any standard light
source via accessory light cable
and adapter. | The ACCLARENT®
NAVWIRE™ Sinus Navigation
Guidewire utilizes
electromagnetic image-guided
sinus surgery and is used in
conjunction with a compatible
surgical navigation system
which consists of computer-
aided software, CT-imaging,
patient tracker, registration
probe, and various instruments
used in sinus surgery.
ACCLARENT® NAVWIRETM
Sinus Navigation Guidewire
provides real-time tracking at
the distal tip of the guidewire in
the nasal anatomy. | Combines a Sinus Guide
Catheter and Handle Assembly
(integrated with Sinus Balloon
Catheter and Sinus Navigation
System) into a single device.
The device is connected to the
Medtronic Fusion Navigation
System to provide location
information via EM navigation
relative to a pre-loaded scan. | Combines a Sinus Guide
Catheter and Handle Assembly
(integrated with Sinus Balloon
Catheter, Sinus Irrigation and
Sinus Navigation System) into a
single device. The device is
connected to the Acclarent ENT
Navigation System to provide
location information via EM
navigation relative to a pre-
loaded scan. |
| Balloon Length | 16 mm | N/A | 17 mm | 16 mm |
| Guidewire
Diameter | 0.035 inches | 0.035 inches | N/A | 0.035 inches |
| Maximum
Inflation Pressure | 12 ATM | N/A | Unknown | 12 ATM |
| Flexible Balloon
Catheter | 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 Dilation
System) | Subject Device
(RELIEVA SPINPLUS® NAV
Balloon Sinuplasty System) |
| Balloon
Radiopaque
Marker Bands | No | N/A | EM-Navigation | No |
| Suction
Incorporated | Yes | No | No | Yes |
| Irrigation
Incorporated | Yes | No | No | Yes |
| Balloon Slide
Mechanism | Yes | No | No | Yes |
| Indicated for
Children | Yes, maxillary | Yes, maxillary1 | No | Yes, maxillary |
| Compatible with
ACCLARENT®
ENT Navigation
System | No | Yes | No
(Compatible with
Medtronic Fusion® ENT
Navigation System) | Yes |
| Principles of
Operation | Manually operated device.
Balloon inflated with sterile
saline or water to mechanically
dilate sinus ostia. | Manually operated device.
Balloon inflated with sterile
saline or water to mechanically
dilate sinus ostia. | Manually operated device.
Balloon inflated with sterile
saline or water to mechanically
dilate sinus ostia. | Manually operated device.
Balloon inflated with sterile
saline or water to mechanically
dilate sinus ostia. |
| Flexible | Yes – flexible sinus balloon
catheter and guidewire. | Yes – Flexible guidewire | No- fixed, rigid instrument not
designed to bend. | Yes – flexible balloon sinus
catheter and guidewire. |
9
Image /page/9/Picture/0 description: The image shows the word "Acclarent" in black font. The last part of the word, "rent" is in purple font. There is a curved line above the "rent" part of the word.
RELIEVA SPINPLUS® NAV Balloon Sinuplasty System
1 Based upon use with Relieva UlttirraNav Sinus Balloon Catheter, cleared on K161698
10
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 Performance
Data: | The RELIEVA SPINPLUS Nav™ Balloon Sinuplasty System met all
performance acceptance criteria including dimensional specifications;
balloon burst pressure, joint separation force, deflation time, and
balloon cycle fatigue. Additional testing to demonstrated that wire
stiffness, tensile strength and irrigation testing were also performed to
demonstrate that the device met performance specifications.
Packaging shelf life was established through accelerated aging via
ASTM F1980-07, ASTM F88/F88M-09, and ASTM F2096-04
requirements and confirmed to meet a shelf life of three months.
Biocompatibility testing successfully completed to determine that the
RELIEVA SPINPLUS® NAV Balloon Sinuplasty System is
biocompatible.
The sterilization process has been validated per AAMI/ANSI/ISO
11135:2014 and demonstrated a sterility assurance level of 10-6. The
method used for sterilization validation was the overkill (half-cycle
approach) in a fixed chamber. Ethylene oxide residuals were tested and
met ISO 10993-7:2008 requirements. The subject device is not tested
nor labeled as "non-pyrogenic”.
Simulated use testing was performed with ENT surgeons performing
balloon dilation of the paranasal sinuses utilizing the RELIEVA
SPINPLUS® NAV Balloon Sinuplasty System and the ACCLARENT
ENT™ Navigation System. The testing demonstrated that the
RELIEVA SPINPLUS® NAV Balloon Sinuplasty System and the
ACCLARENT ENT™ Navigation System could effectively access the
paranasal sinuses. Clinical data was not necessary for the RELIEVA
SPINPLUS® NAV Balloon Sinuplasty System.
Testing was performed to verify the navigation accuracy of the device
when used with the Acclarent ENT Navigation System (K161701).
Testing included sensitivity and connection verification.
The performance data demonstrated that the device performs as
intended. |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| [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 that
the device performs as intended. |
11
Image /page/11/Picture/1 description: The image shows the word "Acclarent" in a stylized font. The first part of the word, "Acclar" is in black, while the "ent" is in purple. There is a purple arc above the word that extends from the "e" to the right side of the word.
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.