RELIEVA SCOUT SINUS DILATION SYSTEM

K140160 · Acclarent, Inc. · LRC · Feb 20, 2014 · Ear, Nose, Throat

Device Facts

• Record ID: K140160
• Device Name: RELIEVA SCOUT SINUS DILATION SYSTEM
• Applicant: Acclarent, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Feb 20, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4420
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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

Device Story

Relieva Scout Sinus Dilation System is an integrated manual surgical instrument for frontal sinus procedures. Device features low-profile rail, balloon catheter, illuminated ball tip, and ergonomic handle. Operates by inserting device into frontal sinus space; light source provides transillumination for navigation; balloon is manually inflated to dilate frontal recess and ostia. Used by physicians in clinical settings. Provides navigational assistance via manual wire adjustment and visual feedback through transillumination. Benefits include minimally invasive access and dilation of sinus structures to facilitate therapeutic or diagnostic interventions.

Clinical Evidence

Bench testing only. Testing included dimensional attributes, cycle fatigue, balloon burst, bond separation, and biocompatibility. Sterilization validated per AAMI/ANSI/ISO 11135-1:2007 (SAL 10^-6). Ethylene oxide residuals met ISO 10993-7:2008. Shelf life established at one year via accelerated aging per ASTM F1980-07.

Technological Characteristics

Manual surgical instrument; integrated balloon catheter, low-profile rail, and illumination system with ball tip. Features permanent distal curve for frontal ostium access and manual wire adjustment. Sterilized via ethylene oxide (AAMI/ANSI/ISO 11135-1:2007). Biocompatible per ISO 10993-7:2008. Shelf life validated per ASTM F1980-07.

Indications for Use

Indicated for patients aged 18 and older requiring access to the frontal sinus space and dilation of the frontal recess, frontal sinus ostia, and frontal sinus cavity spaces for diagnostic or therapeutic procedures; also indicated for illumination and transillumination of nasal and sinus structures.

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 Seeker Balloon Sinuplasty System (K120280)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The logo consists of the word "Acclarent" in a bold, sans-serif font, with a curved line above the letters "ent". Below the logo is the text "Modified Sinus Dilation System" in a smaller, sans-serif font. The text indicates that Acclarent specializes in products related to sinus dilation.

K140160

FEB 2 0 2014 Special 510(k)

## APPENDIX A: 510(K) SUMMARY

| Sponsor/Submitter: | Acclarent, Inc.<br>1525-B O'Brien Drive<br>Menlo Park, California 94025 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Patrick Garvey II<br>Senior Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Date of Submission: | January 17, 2014 |
| Device Trade Name: | Relieva Scout ™ Sinus Dilation System |
| Common Name: | Sinus Dilation System |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 874.4420 |
| Classification Name: | Ear, Nose, and Throat Manual Surgical Instrument |
| Product Code: | LRC |
| Predicate Device: | Relieva Seeker Balloon Sinuplasty System (K120280) |
| Device Description: | The Relieva Scout Sinus Dilation System is an integrated device with a<br>low-profile rail, balloon catheter, sinus illumination system with an<br>illuminated ball tip, and an ergonomic handle. The sinus balloon may<br>be inflated to dilate the frontal recess, frontal sinus ostia, and spaces<br>within the frontal sinus cavity. |
| Indications for Use: | For patients aged 18 and older, the Relieva Scout ™ Sinus Dilation<br>System is intended to provide a means to access the frontal sinus space<br>and to dilate the frontal recess, frontal sinus ostia and spaces within the<br>frontal sinus cavity for diagnostic and therapeutic procedures. In<br>addition, the device is intended to illuminate within and transilluminate<br>across nasal and sinus structures. |

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Modified Sinus Dilation System

| Technological<br>Characteristics: | The Scout Balloon Sinuplasty System combines features of a frontal<br>ostium seeker with the tissue expansion effect of balloon dilation. The<br>distal end of the device is permanently curved to optimize frontal<br>ostium access. Light from an extendable integrated illumination system<br>can be seen via transillumination. Additionally, the Scout Balloon<br>Sinuplasty System allows for the manual wire adjustment to provide<br>balloon navigational assistance. |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | Bench testing met all acceptance criteria for attributes such as<br>dimensional attributes, cycle fatigue, balloon burst, and bond<br>separation. Testing also showed that the Scout Balloon Sinuplasty<br>System is biocompatible.<br><br>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 will be the overkill (half-cycle<br>approach) in a fixed chamber. Testing of ethylene oxide residuals met<br>ISO 10993-7:2008 requirements. The subject device is not tested nor<br>labeled as "non-pyrogenic".<br><br>Packaging shelf life was established at one year via accelerated aging<br>per ASTM F1980-07.<br><br>The performance data demonstrate that the device performs as intended. |
| Summary of Substantial<br>Equivalence: | The Relieva Scout Sinus Dilation System is substantially equivalent to<br>the predicate device. |

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

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

February 20, 2014

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

Re: K140160

Trade/Device Name: Relieva Scout 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: January 22, 2014 Received: January 22, 2014

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 - Mr. James Patrick Garvey II

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k)

### APPENDIX B: INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K140160 |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Relieva Scout™ Balloon Dilation System |
| Common Name: | Sinus Dilation System |
| Indications For Use: | For patients aged 18 and older, the Relieva Scout Sinus Dilation System is intended to provide a means to access the frontal sinus space and to dilate the frontal recess, frontal sinus ostia and spaces within the frontal sinus cavity for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate within and transilluminate across nasal and sinus structures. |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
| | AND/OR |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Sageev George -S 2014.02.20 15:23:02 -05'00'

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