RELIEVA SPIN SINUS DILATION SYSTEM

K111875 · Acclarent, Inc. · LRC · Oct 11, 2011 · Ear, Nose, Throat

Device Facts

• Record ID: K111875
• Device Name: RELIEVA SPIN SINUS DILATION SYSTEM
• Applicant: Acclarent, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Oct 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4420
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

The Relieva Spin 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 paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the Relieva Spin Sinus Dilation System is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

Device Story

Relieva Spin Sinus Dilation System is a manual surgical instrument used by physicians in clinical settings to access and dilate sinus ostia. The system consists of a handle with an integrated suction line, a sinus guide catheter tip, and a sinus balloon catheter. The device is used under direct endoscopic visualization. The physician advances the sinus balloon catheter through the guide catheter into the sinus ostium; the balloon is then inflated to dilate the space. The device includes a sinus guidewire to assist in navigation. The system is designed to provide both access and tissue expansion (dilation) in a single procedure. By dilating the sinus ostia, the device aims to improve sinus drainage and ventilation, potentially benefiting patients with chronic sinusitis or other obstructive sinus conditions.

Clinical Evidence

No clinical data was necessary. Substantial equivalence was established through bench testing, including dimensional analysis, cycle fatigue, balloon burst, and joint separation testing. Biocompatibility was confirmed. Sterilization was validated per AAMI/ANSI/ISO 11135-1:2007 (overkill approach), and packaging shelf life was validated per ASTM F1980-07, F88/F88M-09, ISTA 2A-11, and ASTM F2096-04.

Technological Characteristics

Manual surgical instrument; components include handle with suction, sinus guide catheter, and sinus balloon catheter. Balloon diameter 6mm, length 16mm, max inflation pressure 12 ATM. Materials biocompatible. Sterilization via ethylene oxide per AAMI/ANSI/ISO 11135-1:2007. Packaging shelf life per ASTM F1980-07, ASTM F88/F88M-09, ISTA 2A-11, and ASTM F2096-04.

Indications for Use

Indicated for accessing and dilating sinus ostia and paranasal sinus spaces for diagnostic/therapeutic procedures 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 Acella Sinus Balloon Catheter (K073041)
• Entellus Medical XprESS Multi-Sinus Dilation Tool (K102003)

Reference Devices

• Relieva Luma Sentry Sinus Illumination System

Submission Summary (Full Text)

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## 510(K) SUMMARY

KII1875

OCT | 1 2011

| Sponsor/Submitter: | Acclarent, Inc.<br>1525-B O'Brien Drive<br>Menlo Park, California 94025 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Keri Yen<br>Manager, Regulatory and Clinical<br>Phone: [phone]<br>Fax: [phone] |
| Date of Submission: | August 30, 2011 |
| Device Trade Name: | Relieva Spin 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 Devices: | Relieva Acella Sinus Balloon Catheter (K073041)<br>Entellus Medical XprESS Multi-Sinus Dilation Tool (K102003) |
| Device Description: | The Relieva Spins Sinus Dilation System is comprised of three<br>components: Handle System, Sinus Guide Catheter Tip, and Sinus<br>Balloon Catheter. The Handle System unites the various components<br>into one device. A suction line is embedded in the Handle System<br>which can be actuated by the user covering the suction port. The Sinu<br>Guide Catheter Tip is a sinus guide catheter that is available in three<br>shapes and attaches to the Handle System on the distal end. The Sinus<br>Balloon Catheter is a flexible catheter with a balloon on the distal tip;<br>one lumen is used for inflation of the sinus balloon and the second<br>permits passage of a sinus guidewire. A hypotube is incorporated on<br>the proximal end of the device to provide rigidity as the Sinus Balloon<br>Catheter is advanced and retracted in the Handle System. There are<br>several markers placed along the Sinus Balloon Catheter to aid in<br>positioning under direct endoscopic visualization. A sinus guidewire is<br>packaged with the Relieva Spin Sinus Dilation System. |

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- The Relieva Spin Sinus Dilation System is intended to provide a means Indications for Use: to access the sinus space and to dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the Relieva Spin Sinus Dilation System is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

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The technological characteristics of the subject device are similar to its.
Technological
Characteristics:
predicate devices.
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| Attribute | Predicate Device<br>(Relieva Acella Sinus<br>Balloon Catheter) | Predicate Device<br>(XprESS Multi-Sinus<br>Dilation Tool) | Subject Device<br>(Relieva Spin Sinus<br>Dilation System) |
|----------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| 510(k) number | K073041 | K102003 | TBD |
| Manufacturer | Acclarent | Entellus Medical | Same, Acclarent |
| Balloon<br>Diameters | 6mm | 6mm | Same, 6mm |
| Balloon Length | 12mm | 18mm | 16mm |
| Maximum<br>Inflation<br>Pressure | 14 ATM | 12 ATM | Same, 12 ATM |
| Suction<br>Incorporated | No | Yes | Same, Yes |
| Balloon Slide<br>Mechanism | No | Yes | Same, Yes |
| Technological<br>Characteristics | Combines a sinus balloon<br>catheter and a sinus<br>guidewire to access and<br>dilate sinuses. | 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 and<br>dilate sinuses. |
| Packaged<br>Devices | None | Packaged with inflation<br>device and infusion line | Packaged with Relieva<br>Luma Sentry Sinus<br>Illumination System |

## Performance Data:

Bench testing met all acceptance criteria for attributes such as dimensional, cycle fatigue, balloon burst, and joint separation. Testing also showed that Spin is biocompatible.

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".

Packaging shelf life was established per ASTM F1980-07, ASTM

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## F88/F88M-09, ISTA 2A-11, and ASTM F2096-04 requirements.

Clinical data was not necessary for Spin. The performance data demonstrates that the subject device performs as intended.

The Relieva Spin Sinus Dilation System is substantially equivalent to Summary of Substantial Equivalence: the predicate device as confirmed through relevant tests.

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

OCT 1 1 2011

Acclarent, Inc. c/o Ms. Keri Yen Manager, Regulatory and Clinical 1525-B O'Brien Drive Menlo Park. CA 94025

Re: K111875

Trade/Device Name: Relieva Spin 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: August 30, 2011 Received: August 31, 2011

Dear Ms. Yen:

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.

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Page 2 - Ms. Keri Yen

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 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,

Signature

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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Acclarent )

## APPENDIX B: INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K111875 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Relieva Spin Sinus Dilation System |
| Common Name: | Sinus Dilation System |
| Indications For Use: | The Relieva Spin 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 paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the Relieva Spin Sinus Dilation System is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic 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)

Daniel Coleman

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

(Posted November 13, 2003)

510(k) Number K111875

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