RELIEVA SOLO ELITE SINUS BALLOON CATHETER

K111254 · Acclarent, Inc. · LRC · Aug 22, 2011 · Ear, Nose, Throat

Device Facts

• Record ID: K111254
• Device Name: RELIEVA SOLO ELITE SINUS BALLOON CATHETER
• Applicant: Acclarent, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Aug 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4420
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

The Relieva Solo Elite Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures. For children aged 17 and under, the Relieva Solo Elite Sinus Balloon Catheter is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.

Device Story

Flexible catheter with non-compliant distal balloon; hypotube proximal shaft for rigidity. Used by physicians to dilate sinus ostia and irrigate paranasal sinus cavities. Facilitates access via sinus guidewire or illumination system. Device inserted through sinus guide catheter. Irrigation performed via distal tip and three side holes. Benefits include minimally invasive access to sinus spaces for diagnostic and therapeutic purposes.

Clinical Evidence

Bench testing only. Performance criteria met for dimensional specs, balloon burst pressure, joint separation force, deflation time, irrigation flow rate, and balloon cycle fatigue. Sterilization validated per AAMI/ANSI/ISO 11135-1:2007; shelf life established per ASTM F1980-07, ASTM F88/F88M-09, ISTA 2A-11, and ASTM F2096-04.

Technological Characteristics

Non-compliant balloon catheter; hypotube proximal shaft. Sterilized via ethylene oxide (AAMI/ANSI/ISO 11135-1:2007). Shelf life testing per ASTM F1980-07, ASTM F88/F88M-09, ISTA 2A-11, and ASTM F2096-04. Ethylene oxide residuals meet ISO 10993-7:2008.

Indications for Use

Indicated for dilation of sinus ostia and paranasal sinus spaces for diagnostic/therapeutic procedures and irrigation in adults and children (aged 17 and under, maxillary sinus only).

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 Sinus Balloon Catheter (K073041)
• Xpress Multi-Sinus Dilation Tool (K102003)

Submission Summary (Full Text)

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111254

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AUG 2 2 2011

## 510(k) SUMMARY

| Sponsor/Submitter: | Acclarent, Inc.<br>1525-B O'Brien Drive<br>Menlo Park, California 94025 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kim Ky<br>Sr. Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Date of Submission: | August 11, 2011 |
| Device Trade Name: | Relieva Solo Elite Sinus Balloon Catheter |
| Common Name: | Sinus Balloon Catheter |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 874.4420 |
| Classification Name: | Ear, nose, and throat manual surgical instrument |
| Product Code: | LRC |
| Predicate Devices: | Relieva Sinus Balloon Catheter (K073041)<br>Xpress Multi-Sinus Dilation Tool (K102003) |
| Device Description: | The Relieva Solo Elite Sinus Balloon Catheter is a flexible<br>catheter that is intended to dilate sinus ostia. The shaft allows<br>for inflation of the sinus balloon and permits the passage of a<br>sinus guidewire or sinus illumination system to facilitate<br>access to the target sinus ostia. A hypotube is incorporated on<br>the proximal end to provide rigidity during insertion through a<br>sinus guide catheter. The subject device also has the capability<br>to irrigate the sinus through the distal tip and three side holes<br>on the distal end. |
| Indications for Use: | The Relieva Solo Elite Sinus Balloon Catheter is an<br>instrument intended to dilate sinus ostia and spaces within the<br>paranasal sinus cavities for diagnostic and therapeutic<br>procedures. It is also intended to irrigate from within a target<br>sinus for therapeutic procedure and to facilitate diagnostic<br>procedures.<br><br>For children aged 17 and under, the Relieva Solo Elite Sinus<br>Balloon Catheter is intended to dilate sinus ostia and spaces<br>associated with the maxillary sinus for diagnostic and<br>therapeutic procedures. It is also intended to irrigate from<br>within a target sinus for therapeutic procedures and to |

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Technological Characteristics:

Performance Data:

Summary of Substantial Equivalence:

facilitate diagnostic procedures.

The Relieva Solo Elite Sinus Balloon Catheter is a device that allows for dilation of sinus ostia with the added capability to irrigate. Dilation is achieved via a non-compliant balloon located on the distal end of the device.

The Relieva Solo Elite Sinus Balloon Catheter met all performance acceptance criteria including dimensional specifications; balloon burst pressure, joint separation force, deflation time, irrigation flow rate, and balloon cycle fatigue.

The sterilization process is validated per AAMI/ANSI/ISO 11135-1: 2007 and demonstrated a sterility assurance level of 10 . The method used for sterilization validation is the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals were tested and meet ISO 10993-7:2008 requirements. The subject device is not tested or labeled as "non-pyrogenic".

Shelf life was established per ASTM F1980-07 ASTM F88/F88M-09, ISTA 2A-11, and ASTM F2096-04 requirements.

The Relieva Solo Elite Sinus Balloon Catheter is substantially equivalent to predicate device as confirmed through relevant tests.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

Acclarent, Inc. Ms. Kim Ky Manager, Regulatory & Clinical 1525-B O'Brien Dr Menlo Park, CA 94025

AUG 2 2 2011

Re: K111254

Trade/Device Name: Relieva Solo Elite Sinus Balloon Catheter Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose, and throat manual surgical instrument Regulatory Class: I Product Code: LRC Dated: July 18, 2011 Received: July 19, 2011

Dear Ms. Ky,

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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Evelin Mz. Jr.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K111254 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Relieva Solo Elite Sinus Balloon Catheter |
| Common Name: | Sinus Balloon Catheter |
| Indications For Use: | The Relieva Solo Elite Sinus Balloon Catheter is an instrument<br>intended to dilate sinus ostia and spaces within the paranasal<br>sinus cavities for diagnostic and therapeutic procedures. It is<br>also intended to irrigate from within a target sinus for therapeutic<br>procedures and to facilitate diagnostic procedures.<br><br>For children aged 17 and under, the Relieva Solo Elite Sinus<br>Balloon Catheter is intended to dilate sinus ostia and spaces<br>associated with the maxillary sinus for diagnostic and therapeutic<br>procedures. It is also intended to irrigate from within a target<br>sinus for therapeutic procedures and to facilitate diagnostic<br>procedures. |

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Anatolur

(Division Sign-Off) (Division Sign-Orr)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K111254.

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(Posted November 13, 2003)