The Fiagon Navigation – Extended Instrument Set ENT is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The Fiagon Navigation - Extended Instrument Set ENT 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. Skull base procedures for ENT access.

Device Description

The Fiagon Navigation - Extended Instrument Set ENT are reusable instruments intended to be used with the Fiagon Navigation system. The instruments in the Set are electromagnetically navigated devices that are

Navigated suction instruments (malleable, designed to be bendable by hand, sensor a. within the tip, attachable to standard surgical vacuum suction systems)
b. Navigated pointing devices (flexible, sensor within the tip)
c. Registration probe (designed for non.sterile patient registration)
d. Instrument adaptors (designed for mechanical connection to cylindric schaped surgical instruments of different diameters)

Each device incorporates a sensor device which is tracked by the navigation system with in the low-energy magnetic field of a field generator (part of the navigation system)

The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy)

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Fiagon Navigation - Extended Instrument Set ENT, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state formal "acceptance criteria" in a numerical target format (e.g., "accuracy must be less than X mm"). Instead, it compares the device's performance to that of its predicate devices. The implied acceptance criterion is that the new device's accuracy should be comparable to or better than the predicate devices, specifically remaining under 2mm at the 95% confidence level.

Acceptance Criterion (Implied)	Reported Device Performance
Navigational Accuracy (95% Confidence Level) < 2 mm (based on predicate performance)	< 2 mm (All 95% confidence levels for different instruments)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "different instruments" were tested, but doesn't quantify how many instances or repetitions were performed per instrument or for the entire set.
Data Provenance: The study was "Bench testing," indicating it was conducted in a laboratory setting. The location of the testing is not specified, but the applicant is based in Germany. The data is retrospective in the sense that it's a post-design performance evaluation, but not observational or collected from real-world clinical patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. This was bench testing against a known, controlled physical target, not a subjective interpretation task requiring expert consensus.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The "ground truth" was established by the physical setup of the bench test (e.g., precise measurement of actual position vs. navigated position), not through expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC study was not done. This device is a surgical navigation instrument, and the performance assessment described is related to its mechanical and electromagnetic tracking accuracy, not a diagnostic imaging interpretation task requiring human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Yes, the described "Bench testing" is a form of standalone performance evaluation. It assesses the device's inherent accuracy in tracking and displaying positions without direct human surgical intervention in a real patient. The navigation system's software and hardware (including instruments) performance are tested in a controlled environment.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth was established by precise physical measurements in a controlled bench test environment. This likely involved highly accurate measurement tools to determine the true position of the instrument's tip, which was then compared to the position reported by the navigation system.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is a navigation device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a system involves calibration and internal algorithms, which are developed and refined by the manufacturer, but not typically referred to as a "training set" in the context of regulatory submissions like this unless it's a new AI algorithm component.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a traditional training set for an AI algorithm. The device's internal calibration and algorithmic parameters would have been established during its development and manufacturing processes using engineering principles and testing against known physical standards.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 8, 2014

Fiagon GmbH % Dr. Dirk Mucha Manager, Regulatory Affairs Neuendorfstrasse 23b 16761 Hennigsdorf, Germany

Re: K141456

Trade/Device Name: Fiagon Navigation - Extended Instrument Set ENT Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: September 5, 2014 Received: September 10, 2014

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.

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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/Resourcesfor You/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

510(k) Number (if known): K141456

Device Name: Fiagon Navigation – Extended Instrument Set ENT

Indications for Use:

Example procedures include, but are not limited to:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

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510(k) Summary

May 28, 2014

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

Device Information 2.

Trade Name:	Fiagon Navigation - Extended Instrument Set ENT
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 set of instruments for the Image Guided Surgery System, Fiagon Navigation system (K133573).

4. Predicate Device Information

The Fiagon Navigation System described in this submission is substantially equivalent to the following predicates:

	Predicate Device	Manufacturer	510(k) No.
1	Fiagon Navigation System	Fiagon GmbH	K133573
2	Malleable Suction™ Instruments	MedtronicNavigation, Inc.	K133665
3	Instatrak®	VisualizationTechnology, Inc.	K960330

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5. Device Description

Navigated suction instruments (malleable, designed to be bendable by hand, sensor a. within the tip, attachable to standard surgical vacuum suction systems)
b. Navigated pointing devices (flexible, sensor within the tip)
c. Registration probe (designed for non.sterile patient registration)
d. Instrument adaptors (designed for mechanical connection to cylindric schaped surgical instruments of different diameters)

Each device incorporates a sensor device which is tracked by the navigation system with in the low-energy magnetic field of a field generator (part of the navigation system)

The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy)

Components	Grouping	Sterility State	Patient contact
FlexTube 3 mm	Suction and navigationInstrument	user sterilized, reusable, delivered in non steril state	limited duration (<24h) External communicating Tissue/bone/dentin
FlexTube 4 mm	Suction and navigationInstrument	user sterilized, reusable, delivered in non steril state	limited duration (<24h) External communicating Tissue/bone/dentin
PointerTubeStraight	Suction and navigationInstrument	user sterilized, reusable delivered in non steril state	limited duration External communicating Tissue/bone/dentin
PointerTubeStammberger	Suction and navigationInstrument	user sterilized, reusable delivered in non steril state	limited duration External communicating Tissue/bone/dentin
PointerTube SinusFrontalis	Suction and navigationInstrument	user sterilized, reusable delivered in non steril state	limited duration External communicating Tissue/bone/dentin
RegistrationPointer	Pointing Instrumentfor patient registrationonly, ball tip	reusable not to be sterilized outside sterile field	limited duration Surface communicating Skin

List of components

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Components	Grouping	Sterility State	Patient contact
VenteraPointer	Pointing Instrument	• user sterilized,• reusable,• delivered in non sterilstate	• limited duration(< 24h)• External communicating• Tissue/bone/dentin
GuideWire	Pointing Instrument	• user sterilized,• reusable,• delivered in non sterilstate	• limited duration(< 24h)• External communicating• Tissue/bone/dentin
PointerShell 4 mm	Instrument adapter	• user sterilized,• reusable,• delivered in non sterilstate	• limited duration• Surface communicating• Skin
PointerShell 5 mm	Instrument adapter	• user sterilized,• reusable,• delivered in non sterilstate	• limited duration• Surface communicating• Skin
PointerShell 3 mm	Instrument adapter	• user sterilized,• reusable,• delivered in non sterilstate	• limited duration• Surface communicating• Skin

6. Intended Use

The Fiagon Navigation - Extended Instrument Set ENT is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The Fiagon Navigation - Extended Instrument Set ENT 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 can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to:

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7. Comparison of Technological Characteristics

The substantial equivalence of the Fiagon Navigation – Extended Instrument Set ENT 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 attached or included in surgical ● instruments (all predicates)
Malleable suction instruments enabled for image guidance (Predicate 2)
Adapters for Instruments for enabling image guidance (Predicate 3)
. Instruments with tracking sensor at the instrument tip, precalibrated (Predicate 1 and 2)

The primary difference between the Fiagon Navigation - Extended Instrument Set ENT and it predicates Fiagon Navigation System is that the Fiagon Navigation - Extended Instrument Set ENT provides electromagnetic tracking of the same kind in instruments of different geometry. This different does not raise new issues of safety and effectiveness, with respect to the following:

Cannulated instruments have been demonstrated by predicate 2. Therefore, the suction instruments of the Extended Instrument Set ENT do not raise new issues of safety and effectiveness.

Instrument adapters have been demonstrated by predicate 3. Therefore, the instrument adapters of the Extended Instrument Set ENT do not raise new issues of safety and effectiveness

8. Performance Data

Testing was performed in order to determine device precision and accuracy. 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 0.7 mm - 1.2 mm (Standard deviation 0.29 mm - 0.42 mm) was measured for the different instrunents. All 95% confidence levels were < 2mm which compares to the values 0.9 mm (mean) resp. < 3 mm (95% confidence) reported for the predicate devices.

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

Testing was completed to ensure functionality and compatibility with the Fiagon Navigation system.

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9. Conclusion

Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, the Fiagon Navigation – Extended Instrument Set ENT 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).