The Fiagon Navigation - PointerTube Straight and the PointerTube Keat are intended as aids for precisely locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation.

The instruments are 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 - PointerTube Straight and the PointerTube Keat are 10 time use instruments intended to be used with the Fiagon Navigation system.

Each device incorporates a sensor, which is tracked by the navigation system within the lowenergy 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

The provided document is a 510(k) premarket notification letter and summary for the Fiagon Navigation - PointerTube Straight and PointerTube Keat. It addresses the substantial equivalence of these devices to previously cleared predicate devices.

Acceptance Criteria and Device Performance:

The document explicitly states that the purpose of the submission is for clearance of modified versions of existing instruments and that "Testing was performed in order to confirm continued precision and accuracy of the modified devices. Testing was also completed to ensure functionality and compatibility with the Fiagon Navigation system, as well as to confirm that the change in design of the modified instrument does not alter the performance characteristics of the device."

However, no specific acceptance criteria or quantitative performance data are provided in the document. The submission relies on the concept of "substantial equivalence" to predicate devices (Fiagon Navigation - PointerTube Straight (K141456) and PointerTube Sinus Frontalis (K141456)).

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text as this detailed information is not included.

Study Information Pertaining to Device Acceptance:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not specified. This document describes a medical device (surgical tools) and its navigation system, not an AI or diagnostic imaging device that requires expert ground truth for interpretation. The testing likely involved engineering and performance validation rather than medical expert assessment of diagnostic accuracy.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. (See point 2).
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:
- No. This is not an AI or diagnostic imaging device. It is a surgical navigation instrument. Therefore, an MRMC study is not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical surgical instrument used with a navigation system, not a standalone algorithm. The device itself (PointerTube) is a tool for human use, and its performance is inherently tied to being "in-the-loop" with the human surgeon and the navigation system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated. Given the nature of the device (surgical navigation tools), the "ground truth" for performance testing would typically involve engineering metrics related to precision, accuracy, and functionality (e.g., tracking accuracy, mechanical integrity, compatibility with the navigation system). This is not a diagnostic device where pathology or expert consensus on images would be the ground truth.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. (See point 7).

Summary

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

February 16, 2017

Fiagon Gmbh % Ms. Yarmela Pavlovic Regulatory Counsel Hogan Lovells US LLP 3 Embarcadero Center, Ste. 1500 San Francisco, CA 94111

Re: K163416

Trade/Device Name: Fiagon Navigation - Pointertube Straight And Pointertube Keat Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: January 18, 2017 Received: January 18, 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.

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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 devicerelated 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" (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 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)

K163416

Device Name

Fiagon Navigation - PointerTube Straight and PointerTube Keat

Indications for Use (Describe) Indications for Use (Describe)

The Fiagon Navigation - PointerTube Straight and the PointerTube Keat are intended as aids for precisely locating anatomical structures in either open or percutaneous procedures. They are with the Fiagon Navigation system using electromagnetic navigation.

Example procedures include, but are not limited to:

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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SECTION 5 - 510(K) SUMMARY

510(k) Summary

December 5, 2016

1. Submitter Information/ 510(k) Holder

Submitter:	Fiagon GmbH
Address:	Neuendorfstrasse 23b
	16761 Hennigsdorf, Germany

Telephone:	+49 3302 201 21 10
Telefax:	+49 3302 201 21 15

Mr. Dirk Mucha, CTO Contact:

2. Device Information

Trade Name:	Fiagon Navigation – PointerTube Straight and PointerTube Kea
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 modified versions of two previously cleared instruments, Fiagon Navigation - PointerTube Straight (K141456) and PointerTube Sinus Frontalis (K141456). The modified version of the PointerTube Straight has modified olive leaf-shaped tip with a different inner and outer diameter. The tube length remains identical in this case. The Sinus Frontalis has been modified in instrument length as well as diameter to a new instrument - the PointerTube Keat.

4. Predicate Device Information

Fiagon Navigation - PointerTube Straight (K141456) and PointerTube Sinus Frontalis (K141456)

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ક. Device Description

The Fiagon Navigation - PointerTube Straight and the PointerTube Keat are 10 time use instruments intended to be used with the Fiagon Navigation system.

6. Intended Use

The instruments are indicated for any medical condition in which the use of stereotactic surgerv 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:

Comparison of Technological Characteristics 7.

The PointerTube Straight and the PointerTube Keat are modified versions of previously cleared PointerTube Straight (K141456) and PointerTube Sinus Frontalis (K141456) respectively. The reason for this Special 510(k) is to describe changes in the diameter and shape of the tip for the PointerTube Straight and change of diameter, length and tip for the PointerTube Keat. These changes do not raise new issues of safety and effectiveness of the instruments.

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8. Performance Data

Testing was performed in order to confirm continued precision and accuracy of the modified devices. Testing was also completed to ensure functionality and compatibility with the Fiagon Navigation system, as well as to confirm that the change in design of the modified instrument does not alter the performance characteristics of the device.

9. Conclusion

Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, the PointerTube Straight and the PointerTube Keat have been shown to be substantially equivalent to the predicate PointerTube Straight and the PointerTube Sinus Frontalis, respectively, and do 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).