Fiagon Navigation System

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 1, 2016 Fiagon GmbH Dr. Dirk Mucha Manager Regulatory Affairs Neuendorfstrasse 23b Hennigsdorf, Germany 16761 Re: K151156 Trade/Device Name: Fiagon Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: February 25, 2016 Received: March 02, 2016 Dear Dr. 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. 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 {1}------------------------------------------------ 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" (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 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, Carlos L. Pena -5)/Δ Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K151156 Device Name Fiagon Navigation System #### Indications for Use (Describe) The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The Fiagon Navigation System 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 cranial surgery can be identified relative to a CT or MR based model of the anatomy. Example procedures include, but are not limited to: Cranial Procedures: - Craniotomies/Craniectomies (e.g., Tumor Resection) - Skull Base Procedures - Cranial Biopsies - General Catheter Shunt Placement | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| | | | | | | X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary Fiagon Navigation System #### 1. Submitter Information | Submitter:<br>Address: | Fiagon GmbH<br>Neuendorfstrasse 23b<br>16761 Hennigsdorf, Germany | |------------------------|-------------------------------------------------------------------| | Telephone: | +49 3302 201 21 10 | | Telefax: | +49 3302 201 21 15 | | Contact: | Dr. Dirk Mucha, Manager Regulatory Affairs | | Date Prepared | 2016-02-24 | #### 2. Device Information | Trade Name: | Fiagon Navigation System | |-----------------|------------------------------| | Common Name: | Image guided surgery system | | Classification: | Class II per 21 CFR 882.4560 | | Device: | Stereotaxic Instrument | | Product Code: | HAW | #### 3. Purpose of Submission The purpose of this submission is to gain clearance for a new Image Guided Surgery System. #### Predicate Device Information 4. The Fiagon Navigation System described in this submission is substantially equivalent to the following predicates: | | Predicate Device | Manufacturer | 510(k) No. | |----------------------------|---------------------------------------------------------|------------------------------|------------| | 1.<br>Primary<br>predicate | Stealth station system with<br>synergy cranial Software | Medtronic<br>navigation, Inc | K150216 | | 2. | BrightMatter Navigation<br>System V1.0 | Synaptive Medical<br>Inc. | K142024 | {4}------------------------------------------------ ### Device Description The Fiagon Navigation System displays the position instruments in preoperative scans (e.g., CT, MRI, fluoroscopy) utilizing electromagnetic tracking technology. For cranial procedures, the use of this device is restricted to rigid fixation with a patient reference localizer attached directly to the skull clamp. The position of the instrument with integrated sensor and the patient referencing localizer (attached to the skull clamp) are localized within an electromagnetic field generated by a field generator. The principle of navigation is based on electromagnetic spatial measuring of localizer element in a generated electromagnetic field. The display of navigation information requires an image-to-patient registration procedure. During registration procedure, the navigation system determines the coordinate transformation between the intraoperative position of the patient and the position of the preoperative scan by fiducial marker, anatomical landmark or surface matching. Thereafter, the spatial position of the instrument is displayed superimposed to the image data. The navigation information is updated with a rate of 15 to 45 Hz. The device Fiagon Navigation System utilizing similar technology than the proposed device has been previously cleared for a different intended use. This device is listed as a reference device. | | Reference Device | Manufacturer | 510(k) No. | |-----|-----------------------------------------------------------------------------------|--------------|------------| | R1. | Fiagon Navigation System<br>Similar device, cleared for<br>different intended use | Fiagon GmbH | K133573 | ### Device Design The components of the navigation system are - 1. Navigation unit with Navigation software. It has interfaces for screen, mouse and the components 2 - 4. - 2. Navigation sensor (Headrest with field generator) - 3. Navigation instrument 4. Patient reference localizer (with fixation of the localizer on the skull clamp using the adhesive pad) The navigation unit is connected to a medical monitor. The unit runs the navigation software. Preoperative radiological images of the patient (DICOM CT, CBCT, MR) is imported to the system by means of CD-ROM. USB storage media or LAN network and displayed in appropriate way (defined by the software). The navigation unit compromises the spatial measuring device electronics as well. This has connections to the field generating device (navigation sensor), the patient reference localizer and the navigation instrument. {5}------------------------------------------------ Patient reference localizer and navigation instrument are tracked within the generated field by localizer elements integrated in the devices. The patient reference localizer is fixed to the skull clamp and references the patient's anatomy, while the instrument is tracked in relation to the patient reference localizer and thus to the patient's anatomy. | Components | Grouping | Material used<br>(if body contact) | Property | |----------------------------------|-----------------------------------|-------------------------------------------|-----------------------------------------------------| | Navigation Unit | Unit | n.a. | OR Equipment<br>Rating: 100 -240Vac 50-60 Hz, 200VA | | Navigation Headrest<br>Flat | Navigation<br>Sensor | n.a. | OR Equipment | | Navigation Headrest<br>Maquet | Navigation<br>Sensor | n.a. | OR Equipment | | Navigation Headrest<br>Universal | Navigation<br>Sensor | n.a. | OR Equipment | | FlexPointer | Instrument | Stainless steel<br>medical grade adhesive | reusable, 10 times | | FlexPointer 1.5 | Instrument | Stainless steel<br>medical grade adhesive | reusable, 10 times | | FinePointer | Instrument | Stainless steel<br>medical grade adhesive | reusable, 10 times | | BiopsyPointer 190 | Instrument | Stainless steel<br>medical grade adhesive | reusable, 10 times | | BiopsyPointer 250 | Instrument | Stainless steel<br>medical grade adhesive | reusable, 10 times | | ShuntPointer | Instrument | Stainless steel<br>medical grade adhesive | reusable, 10 times | | RegistrationPointer | Instrument | Stainless steel<br>medical grade adhesive | reusable, 10 times | | Localizer Adhesive<br>Pad | Patient<br>reference<br>localizer | n.a. | reusable | | Adhesive Pad | Fixation<br>material | medical grade adhesive<br>tape | single use | ### List of components/accessories {6}------------------------------------------------ # 5. Intended Use The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The Fiagon Navigation System 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 cranial surgery can be identified relative to a CT or MR based model of the anatomy. Example procedures include, but are not limited to: Cranial Procedures: - Craniotomies/Craniectomies (e.g., Tumor Resection) - - Skull Base Procedures - - Cranial Biopsies - - -General Catheter Shunt Placement # 6. Comparison of Technological Characteristics The substantial equivalence of the Fiagon Navigation System to the predicates is shown by similarity in intended use, indications for use, materials, and performance. The Fiagon Navigation System and its predicates and the reference device utilize: - Electromagnetic tracking technology for navigation in 2 cases and optical tracking in . 1 case. (For further details refer to the table below). - . Anatomical or fiducial reference points on the patient's anatomy for intraoperative registration to the image-based model of the anatomy in 2 cases (Fiagon Navigation System and Stealth station system with synergy cranial Software) and Fiducial matching in the case of BrightMatter Navigation System V1.0). - CT or MR image sets as reference images for the image-based model . The primary difference between the Fiagon Navigation System and its two predicates is that the Fiagon System includes the option of navigating flexible-tip instruments by having the instrument localizer in the tip of the instrument. Since tracking a localizer in the tip of the instrument provides similar navigation accuracy as tracking the tip of a rigid instrument via a localizer mounted to the instrument handle, this difference does not raise new issues of safety and effectiveness. | Property | Fiagon Navigation<br>System | Predicate 1<br>Stealth station<br>system with<br>synergy cranial<br>Software | Predicate 2<br>BrightMatter<br>Navigation System<br>V1.0 | Reference device<br>Fiagon Navigation<br>System | |---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | Subject of<br>investigation | K150216 | K142024 | K133573 | | Reference<br>images | CT/MR/ Cone Beam<br>CT | CT/X-Ray based,<br>MR based Nuclear<br>Medicine based | MRI Images and<br>DTI images of the<br>brain | CT/MR/ Cone Beam<br>CT | | Property | Fiagon Navigation System | Predicate 1 Stealth station system with synergy cranial Software | Predicate 2 BrightMatter Navigation System V1.0 | Reference device Fiagon Navigation System | | Tracking method | Electromagnetic | Optical (infra-red)<br>Electromagnetic<br>Either of the technologies can be selected | Optical tracking | Electromagnetic | | Field generator | Integrated into headrest or bedside mounted, Head clamp mounted | Electromagnetic tracking system can be used from its discreet location on a StealthStation System or attached to the OR bedrail | Optical Tracking Technology.<br>The surgical display and tracking camera are mounted on an Auxiliary Cart. The computer is housed in a Navigation Cart. | Integrated into headrest | | Method of registration | Surface matching<br>Fiducial matching | Surface matching<br>Fiducial matching | Fiducial matching<br>The system works with 3D cameras that know the exact location and orientation of the tools being used. It overlays the location of the tools over the 3D visualizations of the brain and uses the BrightMatter Plan system to develop a path for the instruments to take. | Surface matching<br>Fiducial matching | | Instrument verification | Instrument verified after registering of patient. User needs to confirm on anatomical landmark.<br>Same needs to be done after an interval of time. | Instrument is verified after registering to the system. User needs to confirm on anatomical landmark. | Instrument is verified after registering to the system. User needs to confirm on anatomical landmark. | Instrument verified after registering of patient. User needs to confirm on anatomical landmark.<br>Same needs to be done after an interval of time. | | Tracker Location | Rigid instruments: handle<br>Flexible instruments: tip | Rigid instruments: handle<br>Flexible instruments: tip | Tip Tracking possible after calibrating the device to the navigation system. | Rigid instruments: handle<br>Flexible instruments: tip | | Mean bench accuracy as Target Registration Error (TRE) and Angular registration | Position Mean: < 2mm<br>Angular: Mean < 2° | The System has demonstrated accuracy with a mean positional error of 2mm and mean trajectory error of 2 degrees. | Mean positional error was measured to be less than 2 mm and mean angular error was measured to be less than 2 degrees | Mean: 0.93- 1.2 mm<br>STD: 0.35 - 0.44 mm<br>No angular values given | | Property | Fiagon Navigation<br>System | Predicate 1<br>Stealth station<br>system with<br>synergy cranial<br>Software | Predicate 2<br>BrightMatter<br>Navigation System<br>V1.0 | Reference device<br>Fiagon Navigation<br>System | | Field<br>distortion<br>detecting<br>mechanism | Yes.<br>Field distortions are<br>detected by<br>redundant localizer<br>information and<br>distorted values are<br>excluded from<br>displaying | Yes<br>Algorithms monitor<br>the disturbances in<br>electromagnetic<br>field. | Not applicable as it<br>uses optical<br>technology | Yes.<br>Field distortions are<br>detected by<br>redundant localizer<br>information and<br>distorted values are<br>excluded from<br>displaying | | Navigation<br>Instruments | • Pointing Probes | • Navigation<br>pointer and<br>pointing probes | • Pointing probes | • Pointing Probes | | Instrument<br>Materials | Instruments with<br>body contact are<br>from stainless steel | Unknown | Unknown | Instruments with<br>body contact are<br>from stainless steel | | Safety and<br>EMC | Meets<br>AAMI/ANSI ES<br>60601-1:2005<br>IEC 60601-1-2:2007 | Meets IEC standards<br>e.g., IEC 60601-1 for<br>medical equipment<br>UL60601-1 | unknown | Meets<br>IEC 60601-1 2nd ed<br>and 3rd ed.<br>EN 60601-1-2:2007 | | Indications<br>for use | The Fiagon<br>Navigation System is<br>intended as an aid<br>for precisely locating<br>anatomical structures<br>in either open or<br>percutaneous<br>neurosurgical<br>procedures. The<br>Fiagon Navigation<br>System is indicated<br>for any medical<br>condition in which<br>the use of<br>stereotactic surgery<br>may be appropriate,<br>and where reference<br>to a rigid anatomical<br>structure in the field<br>of cranial can be<br>identified relative to<br>a CT or MR based<br>model of the<br>anatomy.<br>Example procedures<br>include, but are not<br>limited to:<br>Cranial Procedures:<br>- Skull base | The StealthStation<br>System, with<br>Synergy® Cranial<br>software, is intended<br>as an aid for<br>precisely locating<br>anatomical structures<br>in either open or<br>percutaneous<br>neurosurgical<br>procedures. The<br>system is indicated<br>for any medical<br>condition in which<br>reference to a rigid<br>anatomical structure<br>can be identified<br>relative to images of<br>the anatomy.<br>This can include,<br>- Cranial Biopsies<br>- Tumor Resections<br>- Craniotomies/Craniectomies<br>- Skull Base<br>Procedures -<br>Transsphenoidal<br>Procedures<br>- Thalamotomies/<br>Pallidotomies - | BrightMatter<br>Navigation System is<br>intended as a<br>planning and<br>intraoperative<br>guidance system to<br>enable open and<br>percutaneous<br>computer assisted<br>surgery. The system<br>is indicated for<br>medical conditions<br>requiring<br>neurosurgical cranial<br>procedures where the<br>use of computer<br>assisted planning and<br>surgery may be<br>appropriate. The<br>system can be used<br>for intra-operative<br>guidance where a<br>reference to a rigid<br>anatomical structure<br>can be identified.<br>The system should be<br>operated only by<br>trained personnel<br>such as surgeons and<br>other clinic staff. | The Fiagon<br>Navigation System is<br>intended as an aid<br>for precisely locating<br>anatomical<br>structures in either<br>open or percutaneous<br>procedures. The<br>Fiagon Navigation<br>System is<br>indicated for any<br>medical condition in<br>which the use of<br>stereotactic surgery<br>may be<br>appropriate, and<br>where reference to a<br>rigid anatomical<br>structure in the field<br>of ENT surgery,<br>such as the paranasal<br>sinuses, mastoid<br>anatomy, can be<br>identified relative to<br>a CT or MR<br>based model of the<br>anatomy. | | Property | Fiagon Navigation<br>System | Predicate 1<br>Stealth station<br>system with<br>synergy cranial<br>Software | Predicate 2<br>BrightMatter<br>Navigation System<br>V1.0 | Reference device<br>Fiagon Navigation<br>System | | | - Craniotomies/Cra<br>niectomies(e.g.<br>Tumor<br>resections),<br>- Cranial biopsies,<br>- General catheter<br>- Shunt placement | Pituitary Tumor<br>Removal<br>- CSF Leak Repair<br>- Pediatric Catheter<br>- Shunt Placement<br>- General Catheter<br>- Shunt Placement | | | # Comparison of Fiagon Navigation System to the predicate and reference devices {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ #### 7. Performance Data Testing was performed in order to determine device precision and accuracy and the electromagnetic field distortion detection mechanism. The following nonclinical tests were performed to determine substantial equivalence: Bench testing was conducted to determine the device accuracy and the performance of the electromagnetic field distortion mechanism. The tests performed to validate the accuracy of our navigation instruments ranged from validation of required accuracy (Positional accuracy and angular accuracy with registration) to measurement of technical accuracy with co-ordinate measurement system followed by measurement of positional and angular accuracy without registration to measure the angular accuracy of the instrument itself. The non-clinical data support the safety of the device demonstrate that the Fiagon Navigation System perform as intended in the specified use conditions. The non-clinical data demonstrate that the device performs comparably to the predicate device for the same intended use. # 8. Conclusion Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, the Fiagon Navigation System has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present any new issues of safety or effectiveness.