XPRESS MULTI-SINUS DILATION TOOL

K132440 · Entellus Medical, Inc. · LRC · Oct 4, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K132440
• Device Name: XPRESS MULTI-SINUS DILATION TOOL
• Applicant: Entellus Medical, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Oct 4, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4420
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

To access and treat the frontal recesses. sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

Device Story

XprESS Multi-Sinus Dilation Tool; trans-nasal balloon dilation system for sinus outflow tract remodeling. Device features curved suction tip, frontal ostium seeker, and inflatable balloon. Physician tracks device to sinus ostium using endoscopic visualization; distal end is re-shapeable for multi-sinus use. Proximal barbed fitting allows connection to suction or irrigation syringe. Sterile, single-use device. Benefits include minimally invasive access and treatment of sinus ostia/recesses via bone displacement.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Manual surgical instrument; trans-nasal balloon dilation system. Features re-shapeable distal end, suction tip, and irrigation port. Sterile, single-use. No electronic components, software, or energy sources.

Indications for Use

Indicated for adults requiring access and treatment of frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula via trans-nasal approach for remodeling of bony sinus outflow tracts.

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

• XprESS Multi-Sinus Dilation Tool (K121943)

Submission Summary (Full Text)

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Entellus Medical

Image /page/0/Picture/1 description: The image contains a handwritten sequence of characters. The sequence appears to be "K13240". The characters are written in a simple, somewhat stylized manner, with varying stroke thicknesses. The image is in black and white.

OCT 0 4 2013

510(k) Summary

Date Prepared: Submitter Information:

Establishment Registration:

Contact Information:

August 5. 2013 Entellus Medical. Inc. 3600 Holly Lane North. Suite 40 Plymouth, MN 55447

3006345872

Karen E. Peterson Vice President Clinical. Regulatory and Quality [phone] [e-mail]

Device Information: Trade Name: Common Name: Classification Name: Product Code: Regulation Number:

XprESS Multi-Sinus Dilation Tool Sinus Balloon Dilation System ENT Manual Surgical Instrument LRC Class 1, 21 CFR 874.4420

XprESS Multi-Sinus Dilation Tool [K 121943]

## Device Description:

Predicate Device:

The XprESS Multi-Sinus Dilation Tool is intended to remodel or recreate the sinus outflow tract via trans-nasal balloon dilation. The XprESS device combines features of a curved suction tip and a frontal ostium secker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device to the sinus ostium using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient.

Image /page/0/Figure/20 description: The image shows a diagram of a system with several components. On the left side, there is a "Flow activation box". In the middle, there is a "Pressure Regulator". On the right side, there is a "Pressure Threshold Box" and a "Pressure Indicator Line".

XprESS Multi-Sinus Dilation Tool

The XprESS curved suction tip has an atraumatic ball tip. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Extension Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation.

The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only.

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Image /page/1/Figure/0 description: The image shows proposed labeling for medical devices, specifically needle guide inserts. There are two labels displayed, one for "Needle Guide Marker Insert centered - Sterile for US" with REF 4876US and LOT 1010, and another for "Needle Guide Insert 19G. Sterile for US" with REF 5989Q19US and LOT 1010. The document is labeled with "Proposed Labeling 510(k) Number: K131433" and "PD/B18". Both labels include the SYS Medizintechnik GmbH logo and various symbols related to sterilization and usage.

| Doc No: PD 75 11543 | | Revision 01 from: 03.06.2013 | | 6/116 |
|---------------------|--------------------|------------------------------|------------|----------------|
| Created by: | Approved by: | Invalid since: | Source: | Approval Date: |
| Oliver Spitz | Dr. Michael Vogele | | FO 42 1996 | 06.06.2011 |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Go09 Silver Spring, MI) 20993-0002

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three lines representing its wings, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

October 4, 2013

Entellus Medical, Inc. % Karen E. Peterson Vice President Clinical, Regulatory and Quality 3600 Holly Lane North, Suite 40 Plymouth, MN 55447

Re: K132440

Trade/Device Name: XprESS™ Multi-Sinus Dilation Tool Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose, and throat manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: September 4, 2013 Received: September 5, 2013

Dear Ms. Peterson:

We have reviewed your Scction 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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Page 2 - Ms. Karen E. Peterson

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Eric A. Mann -S

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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## Indications for Use

| Applicant: | Entellus |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K132440 |
| Device Name: | XprESS Multi-Sinus Dilation Tool |
| Indications for Use | To access and treat the frontal recesses. sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures. |
| Prescription Use (Part 21 CFR 801 Subpart D) | X OR/AND Over-the-Counter Use (21 CFR 801 Subpart C) |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |

Sageev George -S 2013.10.02 15:00:52 -04'00'

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