GuideWire

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized image of three human profiles facing to the right, stacked on top of each other, creating a sense of depth and unity. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 10, 2016 Fiagon Gmbh Mr. Dirk Mucha, CTO Neuendorfstr. 23 B Hennigsdorf DE 16761 Brandenburg Re: K160369 Trade/Device Name: Guidewire Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: January 15, 2016 Received: February 10, 2016 Dear Mr. Mucha: 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. {1}------------------------------------------------ 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 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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. Kesia Alexander for 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known): K160369 Device Name: Fiagon Navigation - GuideWire 0.6 Indications for Use: The GuideWire 0.6 is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. It is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy. Example procedures include, but are not limited to: ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures. Prescription Use (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 IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE) {3}------------------------------------------------ # 510(k) Summary ## January 15, 2016 #### 1. Submitter Information/ 510(k) Holder | Submitter: | Fiagon GmbH | |------------|----------------------------------------------------| | Address: | Neuendorfstrasse 23b<br>16761 Hennigsdorf, Germany | | Telephone: | +49 3302 201 21 10 | |------------|--------------------| | Telefax: | +49 3302 201 21 15 | Mr. Dirk Mucha, CTO Contact: #### 2. Device Information | Trade Name: | Fiagon Navigation – GuideWire 0.6 | |-----------------|----------------------------------------------| | Common Name: | Image guided surgery system | | Classification: | Class II per 21 CFR 882.4560 | | Device: | Ear, Nose, and Throat Stereotaxic Instrument | | Product Code: | PGW | #### 3. Purpose of Submission The purpose of this submission is to gain clearance for a geometrically modified instrument for the Image Guided Surgery Instruments, Fiagon Navigation extended instrument Set ENT (K141456). #### Predicate Device Information 4. The device described in this submission is substantially equivalent to the following comparable unmodified devices: | | Predicate Device / legally<br>marketed device | Manufacturer | 510(k) No. | |---|-----------------------------------------------------------------------------------------------|--------------|------------| | 1 | Fiagon Navigation Extended<br>Instrument Set ENT<br>Component<br>GuideWire and VenteraPointer | Fiagon GmbH | K141456 | {4}------------------------------------------------ #### ട്. Device Description The Fiagon Navigation - FlexPointer 1.5 is a reusable instrument intended to be used with the Fiagon Navigation system. The instrument is an electromagnetically navigated devices that is - a. Navigated pointing devices (maleable, sensor within the tip) Each device incorporates a sensor device, which is tracked by the navigation system with in the low-energy magnetic field of a field generator (part of the navigation system) The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy) #### 6. Intended Use The GuideWire 0.6 is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. It is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery. such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy. Example procedures include, but are not limited to: ENT Procedures: Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures. #### 7. Comparison of Technological Characteristics The substantial equivalence of the GuideWire 0.6 to the unmodified devices GuideWire and VenteraPointer is shown by similarity in intended use, indications for use, materials, and performance. All devices utilize: - · Electromagnetic tracking technology for navigation included in surgical instruments - flexible instruments enabled for image guidance - · Instruments with tracking sensor at the instrument tip, precalibrated - · Compatible to use in combination with verified cannulated instruments {5}------------------------------------------------ The primary difference between the unmodified devices and the new device is geometrical change of the outer construction of the device (diameter and length). This different does not raise new issues of safety and effectiveness. #### 8. Performance Data Testing was performed in order to determine device precision and accuracy. The following nonclinical tests were performed to determine substantial equivalence: A mean bench accuracy of 1.27 mm (Standard deviation 0.4 mm) was measured for the new device. which compares to the values mean 1.24 mm (Standard deviation 0.44 mm) in an identical test setup. The results supports the claim of substantial equivalence to the unmodified devices. Testing was completed to ensure functionality and compatibility with the Fiagon Navigation system. #### 9. Conclusion Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, the GuideWire 0.6 has been shown to be substantially equivalent to the comparable devices GuideWire and VenteraPointer, and does not present any new issues of safety or effectiveness.