Relieva Scout Multi-Sinus Dilation System

K153341 · Acclarent, Inc. · LRC · Feb 12, 2016 · Ear, Nose, Throat

Device Facts

• Record ID: K153341
• Device Name: Relieva Scout Multi-Sinus Dilation System
• Applicant: Acclarent, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Feb 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4420
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

For patients aged 18 and older, the Relieva Scout™ Multi-Sinus Dilation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces associated with the sphenoid, frontal, and maxillary sinus cavities for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate within and transilluminate across nasal and sinus structures.

Device Story

The Relieva Scout™ Multi-Sinus Dilation System is a sterile, single-use, manually operated surgical instrument used in operating rooms or physician offices. It consists of a handle, rail, balloon catheter, and an integrated sinus illumination system with an illuminated ball tip. An angle selection tool allows the user to shape the distal end for specific sinus access (sphenoid, frontal, maxillary). The device is advanced to the target sinus space; the illumination system provides visual confirmation via transillumination. Once positioned, the balloon is inflated with sterile water or saline to dilate the sinus ostia and infundibulum. The device facilitates mechanical tissue expansion. The system is designed for single-handed operation. By enabling access and dilation of sinus outflow tracts, the device assists in restoring sinus drainage and ventilation, potentially benefiting patients with chronic sinusitis or other obstructive sinus conditions.

Clinical Evidence

Bench testing only. No clinical data was required. Performance testing included dimensional attributes, cycle fatigue, balloon burst, bond separation, and biocompatibility (ISO 10993-1). Sterilization was validated per AAMI/ANSI/ISO 11135-1 (SAL 10^-6) and EtO residuals met ISO 10993-7. Shelf life was established per ASTM F1980-07.

Technological Characteristics

Manual sinus balloon dilation system. Features: rail-based balloon catheter, angle selection tool, integrated illumination system (transillumination). Materials: patient-contacting materials commonly used in medical devices. Dimensions: 6mm balloon diameter, 24mm balloon length. Max inflation pressure: 12 ATM. Sterilization: Ethylene Oxide (EtO). Connectivity: connects to standard light source via light cable/adapter.

Indications for Use

Indicated for patients aged 18 and older requiring access to and dilation of sinus ostia and spaces associated with sphenoid, frontal, and maxillary sinus cavities for diagnostic and therapeutic procedures, including sinus illumination.

Regulatory Classification

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.

Predicate Devices

• RELIEVA SCOUT® Sinus Dilation System (K120280)
• XprESS™ Multi-Sinus Dilation Tool (K121174)
• RELIEVA® Spin Balloon Sinuplasty System (K111875)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 12, 2016

Acclarent, Inc. James Patrick Garvey Senior Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, California 94025

Re: K153341

Trade/Device Name: Relieva Scout™ Multi-Sinus Dilation System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, And Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: November 18, 2015 Received: November 19, 2015

Dear Mr. Garvey:

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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 at its toll-free number [phone] or [phone] 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 at its toll-free number [phone] or [phone] or at its Internet

address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# 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) K153341

Device Name Relieva Scout™ Multi-Sinus Dilation System

### Indications for Use (Describe)

For patients aged 18 and older, the Relieva Scout™ Multi-Sinus Dilation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces associated with the sphenoid, frontal, and maxillary sinus cavities for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate across nasal and sinus structures.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in black, except for the "ent" which is in purple. There is a purple curved line above the "ent".

Relieva Scout™ Multi-Sinus Dilation System

### APPENDIX A: 510(k) SUMMARY

| [807.92(a)(1)] Submitter Information | |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor/Submitter: | Acclarent, Inc.<br>1525-B O'Brien Drive<br>Menlo Park, California 94025 |
| Contact Person: | Patrick Garvey<br>Sr. Manager, Regulatory Affairs<br>Email: [e-mail]<br>Tel: [phone] |
| Date Summary Prepared: | February 12, 2016 |
| [807.92(a)(2)] Name of Device | |
| Device Trade Name: | Relieva ScoutTM Multi-Sinus Dilation 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 SCOUT® Sinus Dilation System (K120280)<br>XprESSTM Multi-Sinus Dilation Tool (K121174)<br>RELIEVA® Spin Balloon Sinuplasty System (K111875) |
| [807.92(a)(4)] Device Description | |

The Relieva Scout™ Multi-Sinus Dilation System is a sterile, single-use system Device Description: that is an integrated device with a handle, rail, balloon catheter, and sinus illumination system with an illuminated ball tip. The packaged device contains the sinus balloon catheter an angle selection tool to enable angular bends for multiple sinus access (sphenoid, frontal, maxillary). The device may be used to access the sinus space and the balloon inflated with sterile water or sterile or saline to dilate the sinus ostia and infandibulum. The inflation device is provided separately. The device may be used in Operating Room and physician office settings.

[807.92(a)(5)] Intended Use

#### For patients aged 18 and older, the Relieva Scout™ Multi-Sinus Dilation Indications for Use: System is intended to provide a means to access the sinus space and to dilate

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Image /page/4/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a sans-serif font, with the "ent" portion of the word in purple. A purple arc extends over the "ent" portion of the word, adding a visual element to the logo.

Relieva Scout™ Multi-Sinus Dilation System

| | the sinus ostia and spaces associated with the sphenoid, frontal, and maxillary<br>sinus cavities for diagnostic and therapeutic procedures. In addition, the<br>device is intended to illuminate within and transilluminate across nasal and<br>sinus structures. | | |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Difference in<br>Indications from<br>Predicate Device | The difference in indications for use between the subject and predicate devices<br>is supported is presented in Table 1. | | |

### [807.92(a)(6)] Technical Characteristics

The Relieva Scout™ Multi-Sinus Dilation System combines features of a rail-Technological Characteristics: based balloon catheter with the tissue expansion effect of balloon dilation. The distal end of the device may be shaped with the angle selection tool to optimize sinus access. Light from an extendable integrated illumination system can be seen via transillumination.

> See Table 1 for a comparison of the technological characteristics between the Relieva Scout and the predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in black font. There is a purple swoosh above the "ent" in Acclarent.

Relieva Scout™ Multi-Sinus Dilation System

| Attribute | Primary Predicate<br>Device:<br>RELIEVA SCOUTⓇ<br>Sinus Dilation System<br>(K120280) | Secondary Predicate<br>Device:<br>XprESS™ Multi-Sinus<br>Dilation Tool (K121174) | Predicate Device:<br>RELIEVA® Spin Sinus<br>Dilation System<br>(K111875) | Subject Device:<br>Relieva Scout ™ Multi-<br>Sinus (SMS) Dilation<br>System |
|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Acclarent, Inc. | Entellus Medical, Inc. | Acclarent, Inc. | Acclarent, Inc. |
| Common Name | Sinus Balloon Dilation<br>System | Sinus Balloon Dilation<br>System | Sinus Balloon Dilation<br>System | Sinus Balloon Dilation<br>System |
| Class | I | I | I | I |
| Product Code is LRC | LRC | LRC | LRC | LRC |
| Classification Section | 21 CFR 874.4420 | 21 CFR 874.4420 | 21 CFR 874.4420 | 21 CFR 874.4420 |
| Indications for Use | For patients aged 18 and<br>older, the Relieva Scout<br>Sinus Dilation System is<br>intended to provide a<br>means to access the frontal<br>sinus space and to dilate<br>the frontal recess, frontal<br>sinus ostia and spaces<br>within the frontal sinus<br>cavity for diagnostic and<br>therapeutic procedures. In<br>addition, the device is<br>intended to illuminate<br>within and transilluminate<br>across nasal and sinus<br>structures. | To access and treat the<br>frontal recesses, sphenoid<br>sinus ostia and maxillary<br>ostia/ethmoid<br>infundibula in adults using<br>a trans-nasal approach.<br>The bony sinus outflow<br>tracts are remodeled by<br>balloon displacement of<br>adjacent bone and<br>paranasal sinus structures. | Intended to provide a<br>means to access the sinus<br>space and to dilate the<br>sinus ostia and spaces<br>associated with the<br>paranasal sinus cavities for<br>diagnostic and therapeutic<br>procedures. For children<br>aged 17 and under, the<br>device is intended to dilate<br>sinus ostia and spaces<br>associated with the<br>maxillary sinus for<br>diagnostic and therapeutic<br>procedures. | For patients aged 18 and<br>older, the Relieva Scout<br>Multi-Sinus Dilation<br>System is intended to<br>provide a means to access<br>the sinus space and to<br>dilate the sinus ostia and<br>spaces associated with the<br>sphenoid, frontal, and<br>maxillary sinus cavities for<br>diagnostic and therapeutic<br>procedures. In addition,<br>the device is intended to<br>illuminate within and<br>transilluminate across<br>nasal and sinus structures. |
| Indicated for Children | No | No | Yes | No |
| Attribute | Primary Predicate<br>Device:<br>RELIEVA SCOUT®<br>Sinus Dilation System<br>(K120280) | Secondary Predicate<br>Device:<br>XprESS™ Multi-Sinus<br>Dilation Tool (K121174) | Predicate Device:<br>RELIEVA® Spin Sinus<br>Dilation System<br>(K111875) | Subject Device:<br>Relieva Scout TM Multi-<br>Sinus (SMS) Dilation<br>System |
| Single Patient Use | Yes | Yes | Yes | Yes |
| Direct Patient Contact | Yes | Yes | Yes | Yes |
| Labeled as Non-<br>Pyrogenic? | No | No | No | No |
| Technological<br>Characteristics | Combines features of a<br>frontal ostium seeker with<br>the tissue expansion effect<br>of balloon dilation. The<br>distal end of the device is<br>permanently curved to<br>optimize frontal ostium<br>access. Light from the<br>distal tip of the integrated<br>sinus illumination system<br>can be seen via<br>transillumination. The<br>device is connected to any<br>standard light source via a<br>light cable and an adapter. | Combines features of a<br>curved suction tip and a<br>frontal ostium seeker<br>(access) with the tissue<br>expansion effect of balloon<br>dilation (treat). The distal<br>end of the device is re-<br>shapeable. | Combines a sinus balloon<br>catheter and a sinus guide<br>catheter to access the sinus<br>space and dilate sinus<br>ostia.<br>A Sinus Illumination<br>System comes packaged<br>with the device and is pre-<br>loaded into the Spin Sinus<br>Dilation System. | Combines a sinus balloon<br>catheter with rail-based<br>balloon guidance to access<br>the sinus space and dilate<br>the sinus ostia. The<br>packaged device contains<br>an angle selection tool to<br>enable angular bends for<br>multiple sinus access.<br>Light from the distal tip of<br>the integrated sinus<br>illumination system can be<br>seen via transillumination. |
| Constructed of Materials<br>Commonly Used in Patient<br>Contacting Medical<br>Devices | Yes | Yes | Yes | Yes |
| Balloon Diameter | 6mm | 5mm to 7mm | 6mm | 6mm |
| Balloon Length | 24mm | 8-20mm | 16mm | 24mm |
| Attribute | Primary Predicate<br>Device:<br>RELIEVA SCOUT®<br>Sinus Dilation System<br>(K120280) | Secondary Predicate<br>Device:<br>XprESSTM Multi-Sinus<br>Dilation Tool (K121174) | Predicate Device:<br>RELIEVA® Spin Sinus<br>Dilation System<br>(K111875) | Subject Device:<br>Relieva Scout TM Multi-<br>Sinus (SMS) Dilation<br>System |
| Maximum Inflation<br>Pressure | 12 ATM | 12 ATM | 12 ATM | 12 ATM |
| Single-Handed Use | Yes | Yes | Yes | Yes |
| Balloon Slide Mechanism | Yes | Yes | Yes | Yes |
| Rail-Based Design | Yes, preset rail intended<br>for frontal sinus access<br>only | Yes, malleable rail | No | Yes, malleable rail |
| Handle and Slider System<br>to Facilitate Advancement<br>of a Balloon Catheter on<br>the Distal End | Yes | Yes | Yes | Yes |
| Uses a Bending Tool to<br>Achieve Target Angles for<br>Access into Targeted<br>Anatomy | No | Yes | No | Yes |
| Guidewire Capability<br>(Sinus Illumination<br>System) | Yes | Yes | Yes | Yes |
| Sinuses in which device is<br>intended for use:<br>[Sphenoid, Maxillary,<br>Frontal] | Frontal | Sphenoid, Maxillary,<br>Frontal | Sphenoid, Maxillary,<br>Frontal | Sphenoid, Maxillary,<br>Frontal |
| EtO Sterilized | Yes | Yes | Yes | Yes |
| Attribute | Primary Predicate<br>Device:<br>RELIEVA SCOUT®<br>Sinus Dilation System<br>(K120280) | Secondary Predicate<br>Device:<br>XprESSTM Multi-Sinus<br>Dilation Tool (K121174) | Predicate Device:<br>RELIEVA® Spin Sinus<br>Dilation System<br>(K111875) | Subject Device:<br>Relieva Scout TM Multi-<br>Sinus (SMS) Dilation<br>System |
| Packaging | Thermoformed tray in<br>pouch | Backer card in pouch | Backer card in pouch | Thermoformed tray in<br>pouch |
| Principles of Operation | Manually operated device.<br>Balloon inflated with<br>sterile saline or water to<br>mechanically dilate sinus<br>ostia. | Manually operated device.<br>Balloon inflated with<br>sterile saline or water to<br>mechanically dilate sinus<br>ostia. | Manually operated device.<br>Balloon inflated with<br>sterile saline or water to<br>mechanically dilate sinus<br>ostia. | Manually operated device.<br>Balloon inflated with<br>sterile saline or water to<br>mechanically dilate sinus<br>ostia. |

Table 1: Comparison of Technological Characteristics between the Relieva Scout" "Multi-Sinus Dilation System and predicate devices.

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Relieva Scout™ Multi-Sinus Dilation System

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Image /page/7/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in black font. To the right of the word is a purple design that looks like a swoosh.

Relieva Scout™ Multi-Sinus Dilation System

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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 Scout™ Multi-Sinus Dilation System

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Image /page/9/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 last part in purple. There is a purple curved line above the last part of the word.

Relieva Scout™ Multi-Sinus Dilation System

# [807.92(b) (1)] Determination of Substantial Equivalence

| Non-Clinical Performance<br>Data: | Bench testing met all acceptance criteria for attributes such as<br>dimensional attributes, cycle fatigue, balloon burst, and bond<br>separation. Testing in accordance with ISO 10993-1<br>AAMI ANSI ISO 10993-1:2009/(R) 2013 also showed that the<br>Relieva Scout™ Multi-Sinus Dilation System is biocompatible. |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The sterilization process was validated per AAMI/ANSI/ISO 11135-1:<br>2007 and demonstrated a sterility assurance level of 10-6. The method<br>used for sterilization validation was the overkill (half-cycle approach) in<br>a fixed chamber. Ethylene oxide residuals were tested and met ISO<br>10993-7:2008 requirements. The subject device is not tested nor<br>labeled as "non-pyrogenic". |
| | Packaging shelf life was established per ASTM F1980-07. |
| | The performance data demonstrated that the device performs as<br>intended. |
| [807.92(b) (2)] Determination of Substantial Equivalence | |
| Clinical Performance Data | Clinical data was not necessary for the Relieva Scout™ Multi-Sinus<br>Dilation System. The performance data demonstrated that the device<br>performs as intended. |
| [807.92(b) (3)] Conclusion | |
| Conclusion from Non-<br>Clinical and Clinical Tests | The Relieva Scout™ Multi-Sinus Dilation System is substantially<br>equivalent to the predicate devices. |