The PointerShell Universal and PointerShell LS are 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.

Both 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. ENT related anterior skull base procedures.

Device Description

The Fiagon Navigation - PointerShell Universal and PointerShell LS are reusable instruments intended to be used with the Fiagon Navigation system. The instruments are electromagnetically navigated devices that are

Instrument adapters (designed for mechanical connection to shavers or surgical instruments a. with different diameters without motor).
Each device incorporates a sensor device, which is tracked by the navigation system with in 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

This document describes Fiagon GmbH's K160479 510(k) submission for the PointerShell Universal and PointerShell LS, which are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures using electromagnetic navigation.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format. However, it indicates a comparison against the predicate devices. The implicit acceptance criterion for precision/accuracy is that the new devices perform comparably to or better than the predicate devices, which had a mean target registration error of less than 1.5 mm.

Performance Metric	Acceptance Criteria (Implied from Predicate)	Reported Device Performance (PointerShell Universal)	Reported Device Performance (PointerShell LS)
Bench Accuracy (Mean Target Registration Error)	< 1.5 mm	1.1 mm	1.1 mm

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

The document states, "A mean bench accuracy as target registration error of 1.1 mm for Pointershell Universal and 1.1 mm for PointerShell LS was measured for the new devices, which compares to the values mean < 1.5 mm for the predicate devices in an identical test setup."

Sample Size: The document does not specify the exact number of measurements or the sample size used for the test set (the new devices). It only provides the mean accuracy.
Data Provenance: The study was a "bench accuracy" test, implying it was conducted in a laboratory setting. The country of origin of the data is not explicitly stated, but since Fiagon GmbH is in Germany, it is likely the testing was conducted there. It is a prospective test specifically for this submission.

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

The type of test conducted was "bench accuracy" measuring target registration error. This is a technical performance measurement against a known physical target, not a clinical assessment requiring expert interpretation of images or patient outcomes. Therefore, no human experts were used to establish the ground truth for this specific performance test. The ground truth would be the precisely known physical locations in the bench setup.

4. Adjudication Method for the Test Set:

As no human experts were involved in establishing the ground truth for the bench accuracy test, no adjudication method was applicable or used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done for this submission. The testing described is solely focused on the technical precision and accuracy of the device in a bench setting, not on its impact on human reader performance or diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone performance evaluation was done. The "bench accuracy" test described measures the performance of the navigation system (including the PointerShell instruments) in precisely locating anatomical structures. This is a direct measurement of the device's technical capability without human interpretation or intervention in the measurement of accuracy itself.

7. Type of Ground Truth Used:

The ground truth used for the bench accuracy test was known physical locations/targets. In a bench test for navigation systems, targets with precisely known coordinates are typically used to assess the system's ability to accurately register and track instruments relative to those targets.

8. Sample Size for the Training Set:

The document describes a 510(k) submission for a geometrically modified instrument. It does not mention any "training set" in the context of machine learning or AI algorithms. The PointerShell devices are hardware instruments that integrate with the existing Fiagon Navigation system, which uses electromagnetic tracking technology. The core navigation technology itself would have been developed and validated previously (e.g., in K141456), but this submission is for new physical instruments, not a new or re-trained algorithm.

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

As there is no mention of a training set in the context of an AI/ML algorithm for this specific submission, this point is not applicable. The device is a hardware instrument, not a software-only AI/ML medical device where a training set would be common.

Summary

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

March 23, 2016

Fiagon Gmbh Dr. Dirk Mucha CTO Neuendorfstrasse 23b 16761 Hennigsdorf Germany

Re: K160479

Trade/Device Name: Pointershell Universal, Pointershell LS Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: February 16, 2016 Received: February 22, 2016

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 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): K160479

Device Name: Fiagon Navigation - PointerShell Universal , PointerShell LS

Indications for Use:

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)

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510(k) Summary

February 16, 2016

1. Submitter Information/ 510(k) Holder

Submitter:	Fiagon GmbH
Address:	Neuendorfstrasse 23b16761 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 - PointerShell Universal, PointerShell LS 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. The instruments involved in this submission are a modified version of instruments that have been approved within Fiagon Navigation extended instrument Set ENT (K141456).

4. Predicate Device Information

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

Predicate Device / legally marketeddevice	Manufacturer	510(k) No.
1	Fiagon Navigation Extended InstrumentSet ENTComponentPointerShell 3mm, 4mm and 5mm	Fiagon GmbH	K141456

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5. Device Description

Instrument adapters (designed for mechanical connection to shavers or surgical instruments a. with different diameters without motor).
Each device incorporates a sensor device, which is tracked by the navigation system with in 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)

6. List of components

Components	Grouping	Sterility State
PointerShell Universal	Instrument Adapter	user sterilized, reusable, delivered in non-sterile state
PointerShell LS	Instrument Adapter	user sterilized, reusable, delivered in non-sterile state

7. Intended Use

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.

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8. Comparison of Technological Characteristics

The substantial equivalence of the PointerShell Universal and PointerShell LS to the PointerShell 3mm, 4mm and 5mm are shown by similarities in their intended use, indications for use, materials, and performance.

All devices utilize:

· Electromagnetic tracking technology for navigation included in surgical instruments
· Are adapters for instruments for enabling image guidance

The primary difference between the unmodified devices and the new devices is change in the shaft diameter of the devices. While the PointerShell 3mm, 4mm and 5mm incorporate devices of their respective diameters, the PointerShell Universal is a combination of all these 3 devices in one. It incorporates instruments of shaft diameters ranging from 2.5mm.The PointerShell LS is used for navigation of octagonal shavers or octagonal surgical instruments with a maximum shaft diameter of 6mm. These changes do not raise new issues of safety and effectiveness.

9. 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 as target registration error of 1.1 mm for Pointershell Universal and 1.1 mm for PointerShell LS was measured for the new devices, which compares to the values mean < 1.5 mm for the predicate devices in an identical test setup.

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

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

10. Conclusion

Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the PointerShell Universal and the PointerShell LS have been shown to be substantially equivalent to the comparable devices PointerShell 3mm, 4mm and 5mm 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).