The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous 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 ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to:

ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures

Device Description

The Fiagon Navigation System displays the position instruments in preoperative scans (e.g., CT, MRI, fluoroscopy) utilizing electromagnetic tracking technology. The position of the instrument with integrated sensor and the patient equipped with localizers 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 components of the navigation system are

Navigation unit with Navigation software. It has interfaces for screen, mouse and the components 2 - 4.
Navigation sensor (Headrest with field generator)
Navigation instrument,
Patient reference localizer (with fixation material) :

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 as well the spatial measuring device electronics. This has connections to the field generating device (navigation sensor), the patient 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 patients 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

Here's a summary of the acceptance criteria and study details for the Fiagon Navigation System, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Predicate Bench/Clinical Accuracy)	Reported Device Performance (Fiagon Navigation System)
Bench Accuracy: 0.8 mm to 1.0 mm	Bench Accuracy: 0.9 mm (SD 0.34 mm)
Field Distortion Detection: 1.0 mm	Field Distortion Detection: < 0.9 mm
Clinical Accuracy: 1.64 mm to 2.8 mm	Clinical Accuracy: 1.79 mm (SD 0.4 mm)

Study Details

Sample Size used for the test set and data provenance:
- Sample Size: Not explicitly stated in terms of number of cases or patients. The document refers to "bench accuracy" and "clinical accuracy" without providing the sample size for these measurements.
- Data Provenance: Not explicitly stated. The study appears to be part of the regulatory submission from Fiagon GmbH, a German company, so it's likely the testing occurred in Germany, but this is not confirmed. The document only mentions "Bench testing was conducted" and "Reported mean clinical accuracy," implying these were done by the manufacturer. Retrospective or prospective nature is not specified, but typically performance testing for regulatory submission is prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here relates to physical measurements of accuracy and distortion, not expert consensus on medical images or diagnoses.
Adjudication method for the test set: Not applicable, as the data are objective measurements of physical accuracy.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI/ML-driven diagnostic tool involving human readers; it's an image-guided surgery system. The "AI" in "AI vs without AI assistance" does not apply to this context.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Yes, a standalone performance assessment was done. The "bench testing" and "mean clinical accuracy" reported refer to the inherent accuracy of the device itself in localizing instruments, rather than its performance integrated with human interpretations or decision-making.
The type of ground truth used:
- For bench accuracy, the ground truth would be precise, metrological measurements of known physical locations from a reference standard.
- For field distortion detection, the ground truth would be controlled induction of electromagnetic field distortions and measurement of when the device detects them.
- For clinical accuracy, the ground truth would be precise measurements of instrument tip positions relative to anatomical structures, likely through comparison with highly accurate imaging or fiducial markers.
The sample size for the training set: Not applicable. This device is an image-guided surgery system based on electromagnetic tracking technology, not a machine learning model that requires a "training set."
How the ground truth for the training set was established: Not applicable, as there is no training set mentioned for this type of device.

Summary

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APR 3 0 2014 K133573

510(k) Summary Fiagon Navigation System

1. Submitter Information

Submitter:	Fiagon GmbH
Address:	Neuendorfstrasse 23b
	16761 Hennigsdorf, Germany
Telephone:	+49 3302 201 21 10
Telefax:	+49 3302 201 21 15
Contact:	Mr. Dirk Mucha, Manager Regulatory Affairs
Date Prepared:	2013-11-15 (original), 2014-03-26 (revision)

2. Device Information

Trade Name:	Fiagon Navigation System.
Common Name:	Image guided surgery system
Classification:	Class II per 21 CFR 882.4560
Device:	Ear, Nose, and Throat Stereotaxic Instrument
Product Code:	PGW

3. Purpose of Submission

The purpose of this submission is to gain clearance for a 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	StealthStation® SystemGoldenEye™ Micro MagneticTracking System	Medtronic SurgicalNavigationTechnologies	K001284
2	InstaTrak®(InstaTrak 3000)	VisualizationTechnology, Inc.	K960330(K983529)
3	Regulus™ Navigator	COMPASSInternational Inc.	K964229

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5. 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.

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,
1. Patient reference localizer (with fixation material) :

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 patients anatomy and references it, while the instrument is tracked in relation to the patient localizer and thus to the patient's anatomy.

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List of components/ accessories

and the comments of the comments of

: .

Components	Grouping	Material used(if body contact)	Property
Navigation Unit	Unit	n.a.	OR EquipmentRating: 110-240Vac50-60 Hz, 200VA
Navigation Headrest Flat	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
FinePointer	Instrument	Stainless steelmedical grade adhesive	reusable, 10 times
Localizer Headband	Patientreferencelocalizer	n.a.	reusable
Localizer Adhesive Pad	Patientreferencelocalizer	n.a.	reusable
Headband	Fixationmaterial	medical grade adhesivetape	single use
Adhesive Pad	Fixationmaterial	medical grade adhesivetape	single use

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6. Intended Use

Example procedures include, but are not limited to:

7. 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 utilize:

. Electromagnetic tracking technology for navigation
Anatomical or fiducial reference points on the patient's anatomy for intraoperative . registration to the image-based model of the anatomy
. CT or MR image sets as reference images for the image-based model

The primary difference between the Fiagon Navigation System and its predicates is that the Fiagon System includes the option of navigating flexible-tip instruments by mounting 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.

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8. 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.

A mean bench accuracy of 0.9 mm (Standard deviation 0.34 mm) was measured which compares to the values 0.8 mm to 1.0 mm reported for the predicate devices.

Results showed that the device detected field distortions under normal conditions before the induced error became larger than 0.9 mm which compares to a value of 1.0 mm reported for the predicate device.

Reported mean clinical accuracy was 1.79 mm (Standard deviation 0.4 mm) which compares to the reported mean clinical accuracy of the predicate devices in the range of 1.64 mm to 2.8 mm.

The results supports the claim of substantial equivalence to the predicate devices.

9. 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.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W()66-G609 Silver Spring, MD 20993-0002

April 30, 2014

Fiagon GmbH Dr. Dirk Mucha Manager. Regulatory Alfairs Neuendorfstrasse 23b Hennigsdorf. Germany 16761

Re: K133573

Trade/Device Name: Fiagon Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: April 2, 2014 Received: April 2. 2014

Dear Dr. Mucha:

We have reviewed vour 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 10 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. Iisting 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.

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Page 2 - Dr. Dirk Mucha

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 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,

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K133573

Device Name: Fiagon Navigation System

Indications for Use:

The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or perculaneous 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 ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to:

Prescription Use _ X_ (Part 21 CFR 801 Subpart D)

And / Or

Over-The-Counter-Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sageev George -S 2014.04.30 12:13:18 -04'00'

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).