The FlexPointer 1.5 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, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures.

Device Description

The Fiagon Navigation - FlexPointer 1.5 is a reusable instrument intended to be used with the Fiagon Navigation system. The instrument is an electromagnetically navigated devices that is

a. Navigated pointing devices (maleable, sensor within the tip)
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

This document describes the Fiagon FlexPointer 1.5mm, an electromagnetically navigated pointing device intended for aiding in precisely locating anatomical structures during ENT surgeries. The primary purpose of the submission is to gain clearance for a geometrically modified instrument for the existing Fiagon Navigation system (K133573).

Here's a breakdown of the requested information based on the provided text:

Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
95% confidence level of bench accuracy < 2mm	All 95% confidence levels were < 2mm
Bench accuracy comparable to unmodified devices (Fiagon FlexPointer and FinePointer) with mean values of 0.9 mm and 1.2 mm	Mean bench accuracy of 1.1 mm (Standard deviation 0.27 mm)

Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated. The document mentions "testing was performed" and "A mean bench accuracy of 1.1 mm (Standard deviation 0.27 mm) was measured," implying a quantitative assessment, but the number of measurements or samples is not specified.
- Data provenance: The testing appears to be bench testing (laboratory-based simulations) performed by the manufacturer, Fiagon GmbH, presumably in Germany. The document does not indicate the use of patient data (retrospective or 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 for bench accuracy testing would typically be established by precise metrology equipment or highly accurate measurement systems, not human experts.
Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical data. For bench testing, the "ground truth" is determined by the measurement instruments themselves.
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 document does not mention any MRMC study or evaluation of human reader performance with or without AI assistance. The device is a "navigated pointing device" for image-guided surgery, not an AI for image interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The performance data presented is for the device's accuracy in a standalone capacity (bench testing), without considering its use by a human surgeon in a clinical setting. The "algorithm" here is the electromagnetic tracking technology. The "bench accuracy" assessment is a standalone evaluation of the device's measurement capability.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the bench accuracy testing would have been established by highly precise metrological measurements using calibrated instruments designed for determining spatial coordinates, rather than expert consensus, pathology, or outcomes data.
The sample size for the training set:
- Not applicable. This device is an image-guided surgical instrument that uses electromagnetic tracking, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its accuracy is based on the physics of electromagnetism and precision manufacturing.
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

April 16, 2015

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

Re: K150473

Trade/Device Name: Fiagon FlexPointer 1.5mm Regulation Number: 21 CFR 882.4560 Regulation Name: Ear. Nose, and Throat Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: March 11, 2015 Received: March 17, 2015

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.

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 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.

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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):

Device Name: Fiagon Navigation - FlexPointer 1.5

Indications for Use:

Example procedures include, but are not limited to:

Prescription Use X Over-The-Counter-Use And / Or (Part 21 CFR 801 Subpart D) (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

January 30, 2015

Submitter Information/ 510(k) Holder 1.

Submitter:Address:	Fiagon GmbHNeuendorfstrasse 23b16761 Hennigsdorf, Germany
Telephone:	+49 3302 201 21 10
Telefax:	+49 3302 201 21 15
Contact:	Mr. Dirk Mucha, Manager Regulatory Affairs

2. Device Information

Trade Name:	Fiagon Navigation – FlexPointer 1.5
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 geometrically modified instrument for the Image Guided Surgery System, Fiagon Navigation system (K133573).

Predicate Device Information 4.

The device described in this submission is substantially equivalent to the following comparable unmodified devices:

	Predicate Device / legally marketed device	Manufacturer	510(k) No.
1	Fiagon Navigation System ComponentFlexPointer and FinePointer	Fiagon GmbH	K133573

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5. Device Description

The Fiagon Navigation - FlexPointer 1.5 is a reusable instrument intended to be used with the Fiagon Navigation system. The instrument is an electromagnetically navigated devices that is

a. Navigated pointing devices (maleable, sensor within the tip)
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)

6. Intended Use

Example procedures include, but are not limited to:

7. Comparison of Technological Characteristics

The substantial equivalence of the FlexPointer 1.5 to the unmodified devices FlexPointer and finePointer is shown by similarity in intended use, indications for use, materials, and performance. All devices utilize:

· Electromagnetic tracking technology for navigation included in surgical instruments
· Malleable s instruments enabled for image guidance (FlexPointer and FlexPpointer 1.5)
· Instruments with tracking sensor at the instrument tip, precalibrated

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The primary difference between the unmodified devices and the new device is geometrical change of the outer construction of the device (diameter and length). This different does 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:

A mean bench accuracy of 1.1 mm (Standard deviation 0.27 mm) was measured for the new device. All 95% confidence levels were < 2mm which compares to the values 0.9 mm and 1.2 mm (mean) resp. < 2 mm (95% confidence) reported for the unmodified devices.

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

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

9. Conclusion

Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, the FlexPointer 1.5 has been shown to be substantially equivalent to the comparable devices FlexPointer and FinePointer, 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).