The Scopis Hybrid Navigation System EM 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 the following ENT procedures:

· Transsphenoidal 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 Scopis Hybrid Navigation System EM displays the position of navigated instruments on a model of the patient's anatomy based on preoperative images (CT or MRI) using electromagnetic tracking technology. The position of the instruments and the patient are localized within an electromagnetic field produced by a field generator. The navigation of instruments relative to the patient's anatomy is established via registration of the patient's anatomy to the image set via fiducial markers, anatomical landmarks, or surface matching. The position of navigated instruments is then displayed on the model from the image set.

The Scopis Hybrid Navigation System EM consists of:

1. Navigation Unit
1. Electromagnetic field generator
1. Patient tracker with integrated localizers
1. Navigation instruments with integrated localizers
1. Navigation software (Nova Basic)

AI/ML Overview

This document describes the Scopis Hybrid Navigation System EM, an image-guided surgery system for ENT procedures. The information provided focuses on its substantial equivalence to a predicate device, as demonstrated through performance data.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (Scopis Hybrid Navigation System EM)
Navigation Accuracy: 0.9 ± 0.34 mm	Navigation Accuracy: 0.49 ± 0.27 mm

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated. The document mentions "bench testing of the navigation accuracy was performed," suggesting a controlled laboratory environment without specifying the number of measurements or tests conducted.
Data Provenance: The data is a result of "bench testing," meaning it was generated in a controlled laboratory setting (likely in Germany, given the submitter's address). It is prospective data collection for the purpose of demonstrating device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. Bench testing typically relies on metrology equipment and standardized procedures for ground truth, rather than expert human interpretation.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. The assessment of navigation accuracy in bench testing relies on direct measurement against a known physical standard, not on human adjudication of classifications.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted and is not relevant for this type of device. The Scopis Hybrid Navigation System EM is an image-guided surgery system, not a diagnostic AI system that "reads" cases or assists human readers in interpretation. Its performance is measured by its navigational accuracy.

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

Yes, the performance testing described is essentially a standalone (algorithm only) assessment of the device's navigation accuracy during bench testing. No human interaction or in-vivo performance is described in the provided "Performance Data" section for establishing substantial equivalence.

7. The type of ground truth used:

The ground truth used for the bench testing would be a precisely measured physical standard or reference, against which the device's navigational output is compared. For example, a known physical position measured by a highly accurate metrology system would serve as the ground truth for the "0.49 ± 0.27 mm" accuracy measurement.

8. The sample size for the training set:

This information is not provided and is not directly applicable in the context of this submission. The Scopis Hybrid Navigation System EM is an image-guided navigation system that uses patient-specific CT or MR images as reference. While the software itself would have been developed and tested, the document focuses on the performance of the product rather than the development of deep learning models requiring a "training set" in the typical sense.

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

This information is not provided and is not directly applicable for the reasons stated in point 8.

Summary

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

February 8, 2017

Scopis Gmbh % Mr. Roger N. White President Phiama, Inc. 236 McKinley Park Lane Louisville, CO 80027

Re: K161491

Trade/Device Name: Scopis Hybrid Navigation System EM Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: December 28, 2016 Received: December 30, 2016

Dear Mr. White:

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)

K161491

Device Name Scopis Hybrid Navigation System EM

Indications for Use (Describe)

Example procedures include, but are not limited to the following ENT procedures:

· Transsphenoidal access procedures;
Intranasal procedures;

· Sinus procedures, such as Maxillary antrostomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies;

· ENT related anterior skull base procedures.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X 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 Scopis Hybrid Navigation System EM

1. Submitter Information

Submitter:	Scopis GmbH
Address:	Heinrich Heine Platz 10, D-10179 Berlin, GERMANY

Telephone: +49 (30) 201 69 38 0

Telefax: +49 (30) 201 69 38 20

Contact:	Dr. Christopher Özbek
	Chief Technical Officer

Date Prepared: May 27, 2016

2. Device Information

Trade Name:	Scopis Hybrid Navigation System EM
Common Name:	Image Guided Surgery System
Classification:	Class II per 21 CFR 882.4560
Classification Name:	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 Image Guided Surgery System.

4. Predicate Device Information

The Scopis Hybrid Navigation System EM described in this submission is substantially equivalent to the following predicate:

Predicate Device	Manufacturer	510(k) No.:
Fiagon Navigation System	Fiagon GmbH	K133573

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Image /page/4/Picture/2 description: The image shows the logo for Scopus medical. The word "SCOPUS" is written in large, bold, red letters. Below the word "SCOPUS" is the word "medical" written in smaller, gray letters. The logo is simple and clean, and the colors are eye-catching.

5. Device Description

The Scopis Hybrid Navigation System EM consists of:

1. Navigation Unit
1. Electromagnetic field generator
1. Patient tracker with integrated localizers
1. Navigation instruments with integrated localizers
1. Navigation software (Nova Basic)

6. Intended Use

Example procedures include, but are not limited to the following ENT procedures:

. Transsphenoidal 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 substantial equivalence of the Scopis Hybrid Navigation System EM to the predicate is shown by similarity in intended use, indications for use, materials, and performance. Both the Scopis Hybrid Navigation System EM and the predicate utilize:

Electromagnetic tracking technology for navigation.
Fiducial or anatomical reference points for procedure registration to the imagebased model of the patient's anatomy.
Tracking of the navigation instruments via localizers mounted in the tip of the instruments.

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Use of CT or MR image sets as reference images for the image-based model of the patient's anatomy.

8. Performance Data

Bench testing of the navigation accuracy was performed to establish the substantial equivalence to the predicate device. The measured bench navigation accuracy of the Scopis Hybrid Navigation System was 0.49±0.27 mm, compared to the reported predicate device navigation accuracy of 0.9±0.34 mm.

9. Conclusion

Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, the Scopis Hybrid Navigation System EM 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).