XPRESS MULTI-SINUS DILATION TOOL

{0}------------------------------------------------ k112506 DEC 2 1 2011 Image /page/0/Picture/2 description: The image shows the logo for "entellus MEDICAL". The logo consists of a circular design on the left, made up of several curved lines that create a sense of rotation or movement. To the right of the circular design is the word "entellus" in a lowercase, sans-serif font. Below "entellus" is the word "MEDICAL" in smaller, uppercase letters. # 510(k) Summary Date Prepared: Submitter Information: November 4, 2011 Entellus Medical, Inc. 6705 Wedgwood Court, North Maple Grove, MN 55311 XprESS Multi-Sinus Dilation Tool ENT Manual Surgical Instrument Sinus Balloon Dilation System Class I, 21 CFR 874.4420 Establishment Registration: Contact Information: 3006345872 Karen E. Peterson Vice President Clinical, Regulatory and Quality (763) 463-7066 kpeterson@entellusmedical.com Device Information: Trade Name: Common Name: Classification Name: Product Code: Regulation Number: Predicate Device: XprESS Multi-Sinus Dilation Tool [K102003] #### Device Description: 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 seeker 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. XprESS is offered in three balloon sizes: 5mm, 6mm and 7mm diameter balloons. LRC The XprESS Multi-Sinus Dilation Tool has been tested to withstand multiple inflations and device tip manipulations (up to 25) in a surgical case wherein all 6 sinus ostia are being dilated. The XprESS device curved suction tip has a 2 mm atraumatic ball tip with a 1 mm inside diameter. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Infusion 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. {1}------------------------------------------------ Image /page/1/Figure/0 description: The image shows a diagram of a medical device with several labeled parts. The device has a long, thin body with a curved suction tip at one end. The other end has a proximal barbed facing and a balloon inflation luer. The diagram also labels the balloon slide mechanism and the suction vent. XprESS Multi-Sinus Dilation Tool The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only. The items packaged with the Xpress Multi-Sinus Dilation Tool include the Inflation Device and Infusion Line. ### Indication 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. ### Contraindications: - Do not use this XprESS device in patients who are allergic to nickel or barium sulfate. . - Do not attach the XprESS device directly to the CT Image Guidance systems. This may . result in inaccurate device positioning. ### Technological Characteristics: The XprESS device has the same indications for use and fundamental scientific technology as the predicate device [K102003]. The device has the same technological characteristics (i.e., basic design, function, mode of operation, packaging, shelf life and sterilization) as the predicate device. Both devices are sterilized using Ethylene Oxide (EtO) and are not labeled as nonpyrogenic. Both devices are for single use only. Both devices are biocompatible per ISO 10993l . ### Substantial Equivalence: The XprESS device was modified to provide additional balloon sizes, a suction vent, and the device handle was modified to improve ergonomics. The XprESS device has the same indications for use and fundamental scientific technology as the predicate device [K 102003]. The XprESS device is substantially equivalent to the predicate device. ## Performance Data: Performance testing of the XprESS device consisted of biocompatibility, design verification and simulated use in a cadaver model. Design verification included dimensional, functional and simulated use testing. Animal and clinical data was not submitted. Performance testing showed that the device meets design specifications and performed as intended. ### Conclusion: In conclusion, the indications for use and technological characteristics are the same as or equivalent to the predicate device. Performance testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of flowing lines. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Entellus Medical c/o Ms. Karen Peterson VP Clinical, Regulatory and Quality 6705 Wedgewood Rd. Maple Grove, MN 55311 DEC 2 1 2011 Re: K112506 Trade/Device Name: XprESS Multi-sinus Dilation Tool Regulation Number: 21 CFR 874.4420 Regulation Name: ENT manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: November 4, 2011 Received: November 7, 2011 Dear Ms. Peterson: 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. {3}------------------------------------------------ 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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Debra Falls 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 {4}------------------------------------------------ ### Indications for Use 510(k) Number (if known): K12506 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 X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Rudy, CRNP (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number k112506 Page 1 of _ 1