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.

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

Navigation unit with Navigation software. It has interfaces for screen, mouse and the components 2 – 4 below.

1. Navigation sensor (Headrest with field generator)
1. Navigation instrument (ShuntPointer, BiopsyPointer190 and BiopsyPointer 250)

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.

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.

AI/ML Overview

The provided text describes the Fiagon Navigation System, a stereotaxic instrument used as an aid for locating anatomical structures in neurosurgical procedures. The document focuses on demonstrating the substantial equivalence of this device to existing predicate devices, rather than a standalone AI-driven diagnostic system. As such, many of the requested elements pertaining to AI model validation, such as training set details, multi-reader multi-case studies, and expert consensus for ground truth, are not applicable to this type of medical device submission.

The document primarily details bench testing to assess the accuracy of the navigation system.

Here's an breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device appear to be implicitly defined by demonstrating accuracy similar to predicate devices. The key performance metrics are Target Registration Error (TRE) and Angular Registration Error (ARE).

Performance Metric	Acceptance Criteria (Implied: similar to predicate)	Reported Device Performance (Localizer Set Bone Anchor)	Reported Device Performance (Localizer Adhesive Pads)
Target Registration Error (TRE)	< 2mm (based on predicate)	1.17 mm (99% CI upper bound: 2.47 mm)	1.42 mm (99% CI upper bound: 2.42 mm)
Angular Registration Error (ARE)	< 2º (based on predicate)	1.45° (99% CI upper bound: 2.8°)	1.46° (99% CI upper bound: 2.9°)

The document states, "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." A similar statement is made for the Adhesive Pads. The predicate devices are listed with "Mean bench accuracy: Position Mean: < 2mm; Angular: Mean: < 2º", which serves as the implicit acceptance threshold.

Details of the Study Proving Device Meets Acceptance Criteria

Sample Size Used for the Test Set and Data Provenance:
- The document describes a bench test using a phantom model. It does not refer to a "test set" in the context of patient data or a dataset of medical images for an AI.
- The sample size for the bench testing (e.g., number of measurements taken) is not explicitly stated.
- Data Provenance: The data is generated from a physical phantom model and CT scans of that phantom. It is a prospective test conducted specifically for this submission, not retrospective patient data. There is no country of origin for the "data" as it's a bench test, not clinical data from patients.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This is not applicable for this type of device and study. The "ground truth" for the bench test was established by a Coordinate Measurement Machine (CMM) with an accuracy of 0.018 mm and the CT scans of the phantom with known reference points. This is a physical, measurable ground truth, not one established by human experts or clinical outcomes for an AI system.
Adjudication Method for the Test Set:
- Not applicable. There was no human interpretation or adjudication involved in establishing the "ground truth" for the performance metrics. The accuracy was measured physically against known points on the phantom.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is typically performed for diagnostic or AI-assisted devices where human interpretation is a key component. This device is a navigation system used during surgery, and its evaluation focuses on its physical accuracy, not its impact on human reader performance in interpreting medical images.
If a Standalone Performance Study (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, the bench testing is a standalone performance study. The accuracy of the navigation system itself (the "algorithm" in a broad sense, though it's a physical tracking system) was measured independently of surgeons using it in a live setting. The measurements captured the system's ability to accurately register and track instruments against a known physical model.
The Type of Ground Truth Used:
- Physical/Measured Ground Truth: The ground truth was established by precise measurements of target points on a phantom using a Coordinate Measurement Machine (CMM) and the known geometry derived from CT scans of the phantom. This is objective, physical data, not expert consensus or pathological findings.
The Sample Size for the Training Set:
- Not applicable. This document describes a medical device (navigation system) with electromagnetic tracking, not a machine learning or artificial intelligence algorithm that requires a "training set." The system's functionality is based on established physical principles and engineering, not on learning from a dataset.
How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no "training set" for this device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K163209

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
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)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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 23b16761 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

Example procedures include, but are not limited to:

Cranial Procedures:

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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 components of the navigation system are

Navigation unit with Navigation software. It has interfaces for screen, mouse and the components 2 – 4 below.

1. Navigation sensor (Headrest with field generator)
1. Navigation instrument (ShuntPointer, BiopsyPointer190 and BiopsyPointer 250)

Patient reference localizer (Localizer Set Bone Anchor and Localizer Adhesive Pad)

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

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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.

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Therefore, the device is substantially equivalent to its predicates.

Comparison of Fiagon Navigation System to the predicate devices

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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.

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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.

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).

Property	Fiagon Navigation System	Fiagon Navigation System	StealthStation System withSynergy Cranial Software
510(k) No.	Subject Device	K151156	K150216, K141833
Indications for use	The Fiagon NavigationSystem is intended as an aidfor locating anatomicalstructures in either open orpercutaneous neurosurgicalprocedures. The FiagonNavigation System isindicated for any medicalcondition in which the use ofstereotactic surgery may beappropriate, and wherereference to a rigid anatomicalstructure in the field of cranialsurgery can be identifiedrelative to a CT or MR basedmodel of the anatomy.	The Fiagon NavigationSystem is intended as an aidfor precisely locatinganatomical structures in eitheropen or percutaneousneurosurgical procedures. TheFiagon Navigation System isindicated for any medicalcondition in which the use ofstereotactic surgery may beappropriate, and wherereference to a rigid anatomicalstructure in the field of cranialsurgery can be identifiedrelative to a CT or MR basedmodel of the anatomy.	The StealthStation System,with Synergy® Cranialsoftware, is intended as an aidfor precisely locatinganatomical structures in eitheropen or percutaneousneurosurgical procedures. Thesystem is indicated for anymedical condition in whichreference to a rigid anatomicalstructure can be identifiedrelative to images of theanatomy.This can include,- Cranial Biopsies- Tumor Resections- Craniotomies/Craniectomies- Skull Base Procedures -Transsphenoidal ProceduresThalamotomies/Pallidotomies- Pituitary Tumor Removal- CSF Leak Repair- Pediatric Catheter ShuntPlacement- General Catheter ShuntPlacement
	Example procedures include,but are not limited to:Cranial Procedures:- Craniotomies/Craniectomies ( Eg: Tumorresection)- Skull BaseProcedures- Cranial Biopsies- General CatheterShunt Placement- Pediatric CatheterShunt Placement	Example procedures include,but are not limited to:Cranial Procedures:- Craniotomies/Craniectomies ( Eg: Tumorresection)- Skull BaseProcedures- Cranial Biopsies- General CatheterShunt Placement
Reference images	CT/ MR/ Cone Beam CT	CT/ MR/ Cone Beam CT	CT/X-Ray based, MR basedNuclear Medicine based
Tracking method	Electromagnetic	Electromagnetic	Optical (infra-red)ElectromagneticEither of the technologies canbe selected
Field generator	Integrated into headrest orbedside mounted, Head clampmounted	Integrated into headrest orbedside mounted, Head clampmounted	Electromagnetic trackingsystem can be used from itsdiscreet location on aStealthStation System orattached to the OR bedrail
Method ofregistration	Surface matchingFiducial matching	Surface matchingFiducial matching	Surface matchingFiducial matching
Instrumentverification	Instrument verified afterregistering of patient. Userneeds to confirm on	Instrument verified afterregistering of patient. Userneeds to confirm on	Instrument is verified afterregistering to the system. Userneeds to confirm on
Property	Fiagon Navigation System	Fiagon Navigation System	StealthStation System withSynergy Cranial Software
anatomical landmark.Same needs to be done afteran interval of time.	anatomical landmark.Same needs to be done afteran interval of time.	anatomical landmark.Same needs to be done afteran interval of time.	anatomical landmark.
Tracker Location	Rigid instruments: handleinstruments: tip	Rigid instruments: handleFlexible instruments: tip	Rigid instruments: handleFlexible instruments: tip
Mean benchaccuracy	Position Mean: < 2mmAngular: Mean: < 2º	Position Mean: < 2mmAngular: Mean: < 2º	Position Mean: < 2mmAngular: Mean: < 2º
Field distortiondetectingmechanism	Yes.Field distortions are detectedby redundant localizerinformation and distortedvalues are excluded fromdisplaying	Yes.Field distortions are detectedby redundant localizerinformation and distortedvalues are excluded fromdisplaying	YesAlgorithms monitor thedisturbances inelectromagnetic field.
NavigationInstruments	Pointing Probes, Stylet,patient tracker (non-invasiveand Skull mounted)	Pointing Probes, Stylet,patient tracker (non-invasive)	Navigation pointer andpointing probesPatient tracker (non-invasiveand skull mounted)
Safety and EMC	MeetsAAMI/ANSI ES 60601-1:2005IEC 60601-1-2:2007	MeetsAAMI/ANSI ES 60601-1:2005IEC 60601-1-2:2007	Meets IEC standards e.g., IEC60601-1 for medicalequipment UL60601-1
Sterilization	Reusable, validated cleaningand sterilization procedure	Reusable, validated cleaningand sterilization procedure	Reusable, validated cleaningand sterilization procedure