ENTELLUS MEDICAL SINUS GUIDEWIRE

{0}------------------------------------------------ # k110739 Entellus Medical JUN 1 4 2011 Image /page/0/Picture/3 description: The image shows the logo for "entellus MEDICAL". To the left of the text is a circular graphic made up of curved lines. The text "entellus" is in a sans-serif font, and below it is the word "MEDICAL" in a smaller font. 510(k) Summary Date Prepared: Submitter Information: Establishment Registration: Contact Information: June 13, 2011 Entellus Medical, Inc. 6705 Wedgwood Court, North Maple Grove, MN 55311 3006345872 Karen E. Peterson Vice President Clinical, Regulatory and Quality (763) 463-7066 kpeterson@entellusmedical.com Device Information: Trade Name: Common Name: Classification Regulation: Classification Name: Classification Panel: Device Classification: Product Code: Entellus Medical Sinus Guidewire Sinus Guidewire 21 CFR 874.4420 ENT Manual Surgical Instrument ENT Class I LRC ### Predicate Devices: NeoMetrics Selectiva™ SB Guidewire [K033321, K013024] Relieva Vigor™ Sinus Guidewire ## Device Description: Entellus Medical Sinus Guidewire is a 0.035" – compatible guidewire with a flexible angled radiopaque distal tip. It is constructed of nickel titanium alloys, stainless steel, and features a polymer coating. #### Indication for Use To provide a means to access the frontal, sphenoid and maxillary sinuses, for diagnostic and therapeutic procedures in adults aged 18 and over. ### Contraindications: None #### Technological Characteristics: The device has the same technological characteristics (i.e., design, function, materials, biocompatibility, packaging and sterilization) as the predicate device [K033321, K013024]. The device has the same technological characteristics (i.e., design, function, principle of operation, and biocompatibility) as the predicate device (Relieva Vigor Sinus Guidewire). The subject and {1}------------------------------------------------ predicate devices are all sterilized using Ethylene Oxide (EtO), validated per ISO 11135-1, and have a Sterility Assurance Level (SAL) of 10°. All devices are for single use only and are biocompatible per ISO 10993-1. #### Substantial Equivalence: The intended use and indications for use of the subject device is the same as the predicate device (Relieva Vigor Sinus Guidewire). The technological characteristics of the subject device are the same as the predicate devices, [K033321, K013024] and/or Relieva Vigor Sinus Guidewire, including: design, function, principle of operation, materials, biocompatibility, packaging and sterilization. #### Performance Data: Performance testing of the Entellus Medical Sinus Guidewire consisted of design verification testing and a cadaver study. Design verification testing included simulated use and compatibility testing. A cadaver study was conducted to support the utility of this device in the sinus spaces. Biocompatibility, sterilization, packaging, shelf life testing, animal and clinical data were not submitted. Performance testing showed that the device meets design specifications and performed as intended. #### Conclusion In conclusion, the device is substantially equivalent based on a comparison of intended use, indications for use, and technological characteristics. The device is safe and effective for its intended use. {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 stylized depiction of a human figure with three flowing lines extending from the head, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JUN 1 4 2011 Entellus Medical, Inc. c/o Karen E. Peterson Vice President, Clinical, Regulatory and Quality 705 Wedgwood Court North Maple Grove, MN 55311 USA Re: K110739 Trade/Device Name: Entellus Medical Sinus Guidewire Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose and Throat manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: March 16, 2011 Received: March 17, 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. 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 {3}------------------------------------------------ device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.html 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, Q.h.hm.b Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known): __ K110739 Device Name: Entellus Medical Sinus Guidewire ## Indications for Use To provide a means to access the frontal, sphenoid and maxillary sinuses, for diagnostic and therapeutic procedures in adults aged 18 and over. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Prescription Use OR/AND Susan Rudy CRNP (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices KI10739 510(k) Number_ Over-the-Counter Use