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

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.

The components of the navigation system are

1. Navigation unit with Navigation software. It has interfaces for screen, mouse and the components 2 - 4.
1. Navigation sensor (Headrest with field generator)
1. Navigation instrument

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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the "Fiagon Navigation System" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Accuracy)	Reported Device Performance (Bench Accuracy)
Position Mean: < 2mm	Mean Positional Error: < 2mm
Angular: Mean < 2°	Mean Angular Error: < 2 degrees

2. Sample Size for Test Set and Data Provenance

The document mentions "Bench testing was conducted to determine the device accuracy and the performance of the electromagnetic field distortion mechanism." However, it does not specify the sample size used for the test set (e.g., number of measurements, number of trials, or number of phantom setups).

The data provenance is from bench testing, meaning it was conducted in a controlled laboratory environment rather than on human subjects. The country of origin of the testing is not explicitly stated, but the company, Fiagon GmbH, is based in Germany. The study is a prospective test in the sense that the device was specifically designed and then tested to meet these criteria.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set. Bench testing typically relies on metrology equipment to define ground truth.

4. Adjudication Method

The document does not mention an adjudication method as it relates to expert review. For bench testing, the "adjudication" is typically the comparison of the device's output against a known, highly accurate reference measurement performed by the testing equipment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study primarily focuses on the interpretation and decision-making of human readers, which is not applicable to an image-guided navigation system's direct performance. The document focuses on the technical accuracy and precision of the device itself.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The entire "Performance Data" section describes bench tests performed on the device (the algorithm and hardware) to determine its precision and accuracy, without human interpretation or intervention in the measurement process. "Bench testing was conducted to determine the device accuracy and the performance of the electromagnetic field distortion mechanism."

7. Type of Ground Truth Used

The ground truth for the bench accuracy tests was established using technical measurements and co-ordinate measurement systems. For example, the document states: "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."

8. Sample Size for Training Set

The document does not mention a training set or its sample size. Image-guided navigation systems like the Fiagon Navigation System are typically engineered with deterministic algorithms and robust calibration methods, rather than being "trained" in the machine learning sense with large datasets. Their performance is validated through precision and accuracy testing against known physical benchmarks.

9. How Ground Truth for Training Set Was Established

Since a "training set" in the machine learning context is not mentioned or implied for this device, the question of how its ground truth was established is not applicable. The system's underlying principles are based on electromagnetic tracking and geometry, rather than data-driven learning from a labeled training set.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K151156

Device Name Fiagon Navigation System

Indications for Use (Describe)

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)

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510(k) Summary Fiagon Navigation System

1. Submitter Information

Submitter:Address:	Fiagon GmbHNeuendorfstrasse 23b16761 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.Primarypredicate	Stealth station system withsynergy cranial Software	Medtronicnavigation, Inc	K150216
2.	BrightMatter NavigationSystem V1.0	Synaptive MedicalInc.	K142024

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Device Description

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 SystemSimilar device, cleared fordifferent 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.
1. Navigation sensor (Headrest with field generator)
1. Navigation instrument

Patient reference localizer (with fixation of the localizer on the skull clamp using the adhesive pad)

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Patient reference localizer and navigation instrument are tracked within the generated field by localizer elements integrated in the devices.

Components	Grouping	Material used(if body contact)	Property
Navigation Unit	Unit	n.a.	OR EquipmentRating: 100 -240Vac 50-60 Hz, 200VA
Navigation HeadrestFlat	NavigationSensor	n.a.	OR Equipment
Navigation HeadrestMaquet	NavigationSensor	n.a.	OR Equipment
Navigation HeadrestUniversal	NavigationSensor	n.a.	OR Equipment
FlexPointer	Instrument	Stainless steelmedical grade adhesive	reusable, 10 times
FlexPointer 1.5	Instrument	Stainless steelmedical grade adhesive	reusable, 10 times
FinePointer	Instrument	Stainless steelmedical grade adhesive	reusable, 10 times
BiopsyPointer 190	Instrument	Stainless steelmedical grade adhesive	reusable, 10 times
BiopsyPointer 250	Instrument	Stainless steelmedical grade adhesive	reusable, 10 times
ShuntPointer	Instrument	Stainless steelmedical grade adhesive	reusable, 10 times
RegistrationPointer	Instrument	Stainless steelmedical grade adhesive	reusable, 10 times
Localizer AdhesivePad	Patientreferencelocalizer	n.a.	reusable
Adhesive Pad	Fixationmaterial	medical grade adhesivetape	single use

List of components/accessories

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5. Intended Use

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 NavigationSystem	Predicate 1Stealth stationsystem withsynergy cranialSoftware	Predicate 2BrightMatterNavigation SystemV1.0	Reference deviceFiagon NavigationSystem
510(k) No.	Subject ofinvestigation	K150216	K142024	K133573
Referenceimages	CT/MR/ Cone BeamCT	CT/X-Ray based,MR based NuclearMedicine based	MRI Images andDTI images of thebrain	CT/MR/ Cone BeamCT
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)ElectromagneticEither 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.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 matchingFiducial matching	Surface matchingFiducial matching	Fiducial matchingThe 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 matchingFiducial matching
Instrument verification	Instrument verified after registering of patient. User needs to confirm on anatomical landmark.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.Same needs to be done after an interval of time.
Tracker Location	Rigid instruments: handleFlexible instruments: tip	Rigid instruments: handleFlexible instruments: tip	Tip Tracking possible after calibrating the device to the navigation system.	Rigid instruments: handleFlexible instruments: tip
Mean bench accuracy as Target Registration Error (TRE) and Angular registration	Position Mean: < 2mmAngular: 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 mmSTD: 0.35 - 0.44 mmNo angular values given
Property	Fiagon NavigationSystem	Predicate 1Stealth stationsystem withsynergy cranialSoftware	Predicate 2BrightMatterNavigation SystemV1.0	Reference deviceFiagon NavigationSystem
Fielddistortiondetectingmechanism	Yes.Field distortions aredetected byredundant localizerinformation anddistorted values areexcluded fromdisplaying	YesAlgorithms monitorthe disturbances inelectromagneticfield.	Not applicable as ituses opticaltechnology	Yes.Field distortions aredetected byredundant localizerinformation anddistorted values areexcluded fromdisplaying
NavigationInstruments	• Pointing Probes	• Navigationpointer andpointing probes	• Pointing probes	• Pointing Probes
InstrumentMaterials	Instruments withbody contact arefrom stainless steel	Unknown	Unknown	Instruments withbody contact arefrom stainless steel
Safety andEMC	MeetsAAMI/ANSI ES60601-1:2005IEC 60601-1-2:2007	Meets IEC standardse.g., IEC 60601-1 formedical equipmentUL60601-1	unknown	MeetsIEC 60601-1 2nd edand 3rd ed.EN 60601-1-2:2007
Indicationsfor use	The FiagonNavigation System isintended as an aidfor precisely locatinganatomical structuresin either open orpercutaneousneurosurgicalprocedures. TheFiagon NavigationSystem is indicatedfor any medicalcondition in whichthe use ofstereotactic surgerymay be appropriate,and where referenceto a rigid anatomicalstructure in the fieldof cranial can beidentified relative toa CT or MR basedmodel of theanatomy.Example proceduresinclude, but are notlimited to:Cranial Procedures:- Skull base	The StealthStationSystem, withSynergy® Cranialsoftware, is intendedas an aid forprecisely locatinganatomical structuresin either open orpercutaneousneurosurgicalprocedures. Thesystem is indicatedfor any medicalcondition in whichreference to a rigidanatomical structurecan be identifiedrelative to images ofthe anatomy.This can include,- Cranial Biopsies- Tumor Resections- Craniotomies/Craniectomies- Skull BaseProcedures -TranssphenoidalProcedures- Thalamotomies/Pallidotomies -	BrightMatterNavigation System isintended as aplanning andintraoperativeguidance system toenable open andpercutaneouscomputer assistedsurgery. The systemis indicated formedical conditionsrequiringneurosurgical cranialprocedures where theuse of computerassisted planning andsurgery may beappropriate. Thesystem can be usedfor intra-operativeguidance where areference to a rigidanatomical structurecan be identified.The system should beoperated only bytrained personnelsuch as surgeons andother clinic staff.	The FiagonNavigation System isintended as an aidfor precisely locatinganatomicalstructures in eitheropen or percutaneousprocedures. TheFiagon NavigationSystem isindicated for anymedical condition inwhich the use ofstereotactic surgerymay beappropriate, andwhere reference to arigid anatomicalstructure in the fieldof ENT surgery,such as the paranasalsinuses, mastoidanatomy, can beidentified relative toa CT or MRbased model of theanatomy.
Property	Fiagon NavigationSystem	Predicate 1Stealth stationsystem withsynergy cranialSoftware	Predicate 2BrightMatterNavigation SystemV1.0	Reference deviceFiagon NavigationSystem
	- Craniotomies/Craniectomies(e.g.Tumorresections),- Cranial biopsies,- General catheter- Shunt placement	Pituitary TumorRemoval- CSF Leak Repair- Pediatric Catheter- Shunt Placement- General Catheter- Shunt Placement

Comparison of Fiagon Navigation System to the predicate and reference devices

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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.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).