The GuideWire 0.6 Single Use 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.

It 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, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures.

Device Description

The Fiagon Navigation - GuideWire 0.6 Single Use is a disposable instrument intended to be used with the Fiagon Navigation system. The instrument is an electromagnetically navigated pointing device (malleable, sensor within the tip).

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

This document is a 510(k) summary for the Fiagon Navigation - GuideWire 0.6 Single Use. It's a special 510(k) to clear a modified version of an already cleared device, primarily changing from a reprocessed device to a sterile, single-use, disposable one. Therefore, the "study that proves the device meets the acceptance criteria" largely focuses on demonstrating that the modifications do not negatively impact the device's performance or raise new safety/effectiveness concerns compared to the predicate device.

Here's an attempt to extract the requested information based on the provided text, recognizing that a 510(k) summary is designed to summarize, not provide the full detail of, the underlying studies. As such, some specific details might be less granular than typically expected for AI/software device studies.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria with corresponding reported performance for the modified device in a table format. It generally states that "Testing was performed in order to determine device precision and accuracy of the modified device" and "Testing was also completed to ensure functionality and compatibility with the Fiagon Navigation system."

However, since this is a Special 510(k) for a modified version of a predicate device (Fiagon Navigation - Guidewire 0.6, K160369), the implied acceptance criterion is that the modified device's performance (precision, accuracy, functionality) must be comparable to or not worse than the predicate device. The conclusion states: "the GuideWire 0.6 Single Use has been shown to be substantially equivalent to the comparable device GuideWire 0.6 and the modified device does not present any new issues of safety or effectiveness." This implies the tests successfully demonstrated this equivalency.

Therefore, we can infer the following (with details inferred or generally stated due to lack of specificity in the summary):

Acceptance Criteria (Implied)	Reported Device Performance
Precision and Accuracy comparable to predicate device	Demonstrated to be comparable (implied by SE conclusion)
Functionality and compatibility with Fiagon Navigation system	Functionality and compatibility ensured (stated)
No alteration of performance characteristics due to sterilization	Performance characteristics not altered (stated)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the test set, the country of origin of the data, or whether it was retrospective or prospective. It generally refers to "Testing was performed."

3. 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)

This section is not applicable (N/A) as the device is a stereotactic navigation guidewire, not an AI/software device that requires expert ground truth for interpretation of medical images or data. The "ground truth" for a guidewire's precision and accuracy would typically be established through physical measurements against reference standards in a controlled test environment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the primary focus of performance testing for a physical medical device like a guidewire.

5. 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

N/A. This is a physical medical device (guidewire) and not an AI/software device that would involve human readers or AI assistance for image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is a physical medical device, not an algorithm. The performance of the guidewire itself (precision, accuracy) would be evaluated in a standalone manner (without a human interpreting its output, but rather observing its physical performance or software-displayed position). The document states "Testing was performed in order to determine device precision and accuracy of the modified device."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a device determining "precision and accuracy" of a physical instrument in navigation, the ground truth would typically be established by highly accurate physical measurement systems (e.g., optical tracking systems, mechanical fixtures with known dimensions, or other calibration tools) within a controlled laboratory setting. The document does not specify the exact methods but implies standard metrology for precision and accuracy.

8. The sample size for the training set

N/A. This is a physical guidewire, not an AI/software device requiring a training set.

9. How the ground truth for the training set was established

N/A. This is a physical guidewire, not an AI/software device requiring a training set.

Summary

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Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is an emblem that resembles a stylized bird or eagle, composed of three curved lines that suggest feathers or wings.

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

September 15, 2016

Fiagon GmbH % Ms. Yarmela Pavlovic Regulatory Consultant Hogan Lovells 3 Embarcadero Center, Suite 1500 San Francisco, CA 94111

Re: K161940

Trade/Device Name: Guidewire 0.6 Single Use Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: August 22, 2016 Received: August 22, 2016

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)

K161940

Device Name GuideWire 0.6 Single Use

Indications for Use (Describe)

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

July 14, 2016

Submitter Information/ 510(k) Holder 1.

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, CTO

2. Device Information

Trade Name:	Fiagon Navigation - GuideWire 0.6 Single Use
Common Name:	Image guided surgery system
Classification:	Class II per 21 CFR 882.4560
Device:	Ear, Nose, and Throat Stereotaxic Instrument
Product Code:	PGW

Purpose of Submission 3.

The purpose of this submission is to gain clearance for a modified version of the previously cleared instrument, Fiagon Navigation - Guidewire 0.6 (K160369).

Predicate Device Information 4.

Fiagon Navigation - Guidewire 0.6 (K160369)

5. Device Description

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6. Intended Use

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.

7. Comparison of Technological Characteristics

The GuideWire 0.6 Single Use is a modified version of the previously cleared GuideWire 0.6 (K160369). The reason for this Special 510(k) is to describe a change in material as well as a change from a reprocessed device to one that is provided sterile and is Single Use and disposable. Sterilization validation tests reports are provided to demonstrate that these differences do not raise new issues of safety and effectiveness.

8. Performance Data

Testing was performed in order to determine device precision and accuracy of the modified device.

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Testing was also completed to ensure functionality and compatibility with the Fiagon Navigation system. Also testing was performed to ensure sterilization of the modified disposable 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 GuideWire 0.6 Single Use has been shown to be substantially equivalent to the comparable device GuideWire 0.6 and the modified device 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).