Fiagon Navigation System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other. The faces are facing to the right and are connected by a flowing line. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 14, 2017 Fiagon Gmbh % Yarmela Pavlovic Regulatory Counsel Hogan Lovells US LLP 3 Embarcadero Center, Suite 1500 San Francisco, California 94111 Re: K163209 Trade/Device Name: Fiagon Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: August 15, 2017 Received: August 15, 2017 Dear Ms. Pavlovic: 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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 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. # Michaelリ. Hoffmann -S for 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) K163209 Device Name Fiagon Navigation System #### Indications for Use (Describe) The Fiagon Navigation System is intended as an aid for 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 - Pediatric Catheter Shunt Placement The user should consult the "Bench Accuracy" section of the User Manual to assess whether the accuracy of the system is suitable for their needs. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------------|--| | <div style="display:flex; align-items:center;"><span style="font-size:16px;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | | | <div style="display:flex; align-items:center;"><span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | | #### 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 ### 510(k) Summary Fiagon Navigation System # Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared | Submitter: | Fiagon GmbH | |----------------|----------------------------------------------------| | Address: | Neuendorfstrasse 23b<br>16761 Hennigsdorf, Germany | | Telephone: | +49 3302 201 21 10 | | Telefax: | +49 3302 201 21 15 | | Contact: | Dr. Dirk Mucha, CTO | | Date Prepared: | 2017-9-11 | #### Name of Device and Name/Address of Sponsor | 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 | # Predicate Devices - . Fiagon Navigation System, Fiagon GmbH (K151156 - Primary Predicate) - StealthStation System with Synergy Cranial Software, Medtronic Navigation, Inc. (K150216) and Skull Mounted Patient Tracker (K141833) #### Intended Use / Indications for Use The Fiagon Navigation System is intended as an aid for 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: {4}------------------------------------------------ - Craniotomies/Craniectomies (e.g., Tumor Resection) - Skull Base Procedures - Cranial Biopsies - General Catheter Shunt Placement - Pediatric Catheter Shunt Placement The user should consult the "Bench Accuracy" part of the User Manual to assess if the accuracy of the system is suitable for their needs. # Device Description The Fiagon Navigation System displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy) utilizing electromagnetic tracking technology. The instrument with integrated sensor and the patient equipped with 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 is updated with a rate of 15 to 45 Hz. The components of the navigation system are 1. Navigation unit with Navigation software. It has interfaces for screen, mouse and the components 2 – 4 below. - 2. Navigation sensor (Headrest with field generator) - 3. Navigation instrument (ShuntPointer, BiopsyPointer190 and BiopsyPointer 250) 4. Patient reference localizer (Localizer Set Bone Anchor and Localizer 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) are 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 includes the spatial measuring device electronics as well. This has connections to the field generating device (navigation sensor), the patient localizer and the navigation instrument. The patient reference localizer and navigation instrument are tracked within the generated field by localizer elements integrated in the devices. {5}------------------------------------------------ The patient reference localizer is fixed to the patient's anatomy and references it, while the instrument is tracked in relation to the patient localizer and thus to the patient's anatomy. The components and accessories of the system are listed in the table below: | Components | Grouping | Material used (if body contact) | Property | Previously cleared in | |---------------------------|-----------------------------|----------------------------------------|---------------------------------------------------|----------------------------| | Navigation Unit | Unit | n.a. | OR Equipment Rating: 110 - 240Vac 50-60 Hz, 200VA | Cleared in K151156/K133573 | | BiopsyPointer 190 | Instrument | Stainless steel medical grade adhesive | reusable, 10 times | Cleared in K151156 | | BiopsyPointer 250 | Instrument | Stainless steel medical grade adhesive | reusable, 10 times | Cleared in K151156 | | ShuntPointer | Instrument | Stainless steel medical grade adhesive | reusable, 10 times | Cleared in K151156 | | Localizer Set Bone Anchor | Patient reference localizer | n.a. | reusable | Part of this submission | | Localizer Adhesive Pad | Patient reference localizer | n.a. | reusable | Cleared in K151156/K133573 | # Comparison of Technology Characteristics The Fiagon Navigation System has the same intended use and similar indications for use as the predicate devices. Specifically, the intended use of the Fiagon Navigation System is identical to the predicate devices, which is use in locating anatomical structures in either open or percutaneous neurosurgical procedures. Although the modified device features an additional indication (pediatric shunt placement) compared to the predicate Fiagon device, that indication is also included in the StealthStation predicate (K150216). The device remains technologically unchanged compared to the Fiagon device cleared in K151156 with the single exception of the addition of a pinless fixation method for the localizer, which is similar to Medtronic's skull mounted patient tracker predicate (K141833) used with the predicate StealthStation. The minor differences in technological characteristics do not raise any different questions of safety or effectiveness. All three devices use electromagnetic tracking technology, and utilize anatomical or fiducial reference points on the patient's anatomy for intraoperative registration to the imagebased model of the anatomy. Performance data demonstrate that the Fiagon navigation system performs in a manner that is substantially equivalent to the predicate devices. In addition, sterilization, electrical safety/EMC and biocompatibility testing has been conducted to further support the device performance. {6}------------------------------------------------ Therefore, the device is substantially equivalent to its predicates. | Property | Fiagon Navigation System | Fiagon Navigation System | StealthStation System with<br>Synergy Cranial Software | |-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | Subject Device | K151156 | K150216, K141833 | | Indications for use | The Fiagon Navigation<br>System is intended as an aid<br>for locating anatomical<br>structures in either open or<br>percutaneous neurosurgical<br>procedures. The Fiagon<br>Navigation System is<br>indicated for any medical<br>condition in which the use of<br>stereotactic surgery may be<br>appropriate, and where<br>reference to a rigid anatomical<br>structure in the field of cranial<br>surgery can be identified<br>relative to a CT or MR based<br>model of the anatomy. | The Fiagon Navigation<br>System is intended as an aid<br>for precisely locating<br>anatomical structures in either<br>open or percutaneous<br>neurosurgical procedures. The<br>Fiagon Navigation System is<br>indicated for any medical<br>condition in which the use of<br>stereotactic surgery may be<br>appropriate, and where<br>reference to a rigid anatomical<br>structure in the field of cranial<br>surgery can be identified<br>relative to a CT or MR based<br>model of the anatomy. | The StealthStation System,<br>with Synergy® Cranial<br>software, is intended as an aid<br>for precisely locating<br>anatomical structures in either<br>open or percutaneous<br>neurosurgical procedures. The<br>system is indicated for any<br>medical condition in which<br>reference to a rigid anatomical<br>structure can be identified<br>relative to images of the<br>anatomy.<br><br>This can include,<br>- Cranial Biopsies<br>- Tumor Resections<br>- Craniotomies/Craniectomies<br>- Skull Base Procedures -<br>Transsphenoidal Procedures<br><br>Thalamotomies/Pallidotomies<br>- Pituitary Tumor Removal<br>- CSF Leak Repair<br>- Pediatric Catheter Shunt<br>Placement<br>- General Catheter Shunt<br>Placement | | | Example procedures include,<br>but are not limited to:<br>Cranial Procedures:<br>- Craniotomies/Craniec<br>tomies ( Eg: Tumor<br>resection)<br>- Skull Base<br>Procedures<br>- Cranial Biopsies<br>- General Catheter<br>Shunt Placement<br>- Pediatric Catheter<br>Shunt Placement | Example procedures include,<br>but are not limited to:<br>Cranial Procedures:<br>- Craniotomies/Craniec<br>tomies ( Eg: Tumor<br>resection)<br>- Skull Base<br>Procedures<br>- Cranial Biopsies<br>- General Catheter<br>Shunt Placement | | | Reference images | CT/ MR/ Cone Beam CT | CT/ MR/ Cone Beam CT | CT/X-Ray based, MR based<br>Nuclear Medicine based | | Tracking method | Electromagnetic | Electromagnetic | Optical (infra-red)<br>Electromagnetic<br>Either of the technologies can<br>be selected | | Field generator | Integrated into headrest or<br>bedside mounted, Head clamp<br>mounted | Integrated into headrest or<br>bedside mounted, Head clamp<br>mounted | Electromagnetic tracking<br>system can be used from its<br>discreet location on a<br>StealthStation System or<br>attached to the OR bedrail | | Method of<br>registration | Surface matching<br>Fiducial matching | Surface matching<br>Fiducial matching | Surface matching<br>Fiducial matching | | Instrument<br>verification | Instrument verified after<br>registering of patient. User<br>needs to confirm on | Instrument verified after<br>registering of patient. User<br>needs to confirm on | Instrument is verified after<br>registering to the system. User<br>needs to confirm on | | Property | Fiagon Navigation System | Fiagon Navigation System | StealthStation System with<br>Synergy Cranial Software | | anatomical landmark.<br>Same needs to be done after<br>an interval of time. | anatomical landmark.<br>Same needs to be done after<br>an interval of time. | anatomical landmark.<br>Same needs to be done after<br>an interval of time. | anatomical landmark. | | Tracker Location | Rigid instruments: handle<br>instruments: tip | Rigid instruments: handle<br>Flexible instruments: tip | Rigid instruments: handle<br>Flexible instruments: tip | | Mean bench<br>accuracy | Position Mean: < 2mm<br>Angular: Mean: < 2º | Position Mean: < 2mm<br>Angular: Mean: < 2º | Position Mean: < 2mm<br>Angular: Mean: < 2º | | Field distortion<br>detecting<br>mechanism | Yes.<br>Field distortions are detected<br>by redundant localizer<br>information and distorted<br>values are excluded from<br>displaying | Yes.<br>Field distortions are detected<br>by redundant localizer<br>information and distorted<br>values are excluded from<br>displaying | Yes<br>Algorithms monitor the<br>disturbances in<br>electromagnetic field. | | Navigation<br>Instruments | Pointing Probes, Stylet,<br>patient tracker (non-invasive<br>and Skull mounted) | Pointing Probes, Stylet,<br>patient tracker (non-invasive) | Navigation pointer and<br>pointing probes<br>Patient tracker (non-invasive<br>and skull mounted) | | Safety and EMC | Meets<br>AAMI/ANSI ES 60601-<br>1:2005<br>IEC 60601-1-2:2007 | Meets<br>AAMI/ANSI ES 60601-<br>1:2005<br>IEC 60601-1-2:2007 | Meets IEC standards e.g., IEC<br>60601-1 for medical<br>equipment UL60601-1 | | Sterilization | Reusable, validated cleaning<br>and sterilization procedure | Reusable, validated cleaning<br>and sterilization procedure | Reusable, validated cleaning<br>and sterilization procedure | # Comparison of Fiagon Navigation System to the predicate devices {7}------------------------------------------------ # Performance Testing Bench testing was conducted to determine the device accuracy of the Fiagon Navigation System with Localizer Set Bone Anchor as the fixation method in neurosurgical procedures when using three instruments (BiopsyPointer 190, BiopsyPointer 250, and the ShuntPointer). The assessments included measuring the registration and application error related to the trajectory (from the entry point down to the final target) by comparing preoperative surgical planning for instrument insertion with the actual instrument location in the postoperative images. The measurement phantom was a model of the human skull with half cranium and an imbedded structure that mimics part of the brain. Rods with a touch point and tubes were placed in this structure to facilitate the measurement of the trajectory of the surgical tube and the target registration measurements. The phantom was scanned with computer tomography (CT) prior to the testing. The axial CT slices had a resolution of 0.45 mm (512 x 512 pixels) in each layer and 0.75 mm layer distance. The positions of the reference points were measured using a Coordinate Measurement Machine (CMM) with an accuracy of 0.018 mm. The coordinate system of the CMM was then registered with the coordinate system of the CT images. {8}------------------------------------------------ During the course of the evaluation, the Localizer Set Bone Anchor is attached to the phantom head in a similar fashion as the real patient treatment scenario. Each rod is touched at the corresponding approach path with the navigation point of the instrument, which was guided in alignment to the planned interventional trajectory until the target point was reached. The position and orientation of the pointer in the coordinate system of the previously registered images were then recorded. The results showed that the average Target Registration Error (TRE) for the device with Localizer Set Bone Anchor was 1.17 mm (99% Cl upper bound: 2.47 mm) and the average Angular Registration Error (ARE) was 1.45° (99% CI upper bound: 2.8°), which were similar to the accuracy of the predicate devices. Similar testing was conducted for the Localizer Adhesive Pads. The results showed that the average Target Registration Error (TRE) for the device with Localizer Adhesive Pads was 1.42 mm (99% CI upper bound: 2.42 mm) and the average Angular Registration Error (ARE) was 1.46° (99% CI upper bound: 2.9°), which were also similar to the accuracy of the predicate devices. Therefore, the non-clinical data demonstrate that the device performs comparably to the predicates device for the same intended use. In addition, the Localizer Set Bone Anchor was subjected to biocompatibility assessments for cytotoxicity, irritation, sensitization, and acute systemic toxicity, and material mediated pyrogenicity. The testing results showed that the Localizer Set Bone Anchor is biocompatible. # Conclusions 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 different issues of safety or effectiveness. The results from the bench testing demonstrate that the device performs similarly to the predicate devices.