The Scopis Extended Instrument Set 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, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies:
. ENT related anterior skull base procedures.

Device Description

The Scopis Extended Instrument Set EM is a set of accessories for the Scopis Hybrid Navigation Unit EM and is intended to localize the patient, track the position of the patient, display 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 Extended Instrument Set EM consists of:

1. Navigation Software (NOVA AR)
1. Navigated instruments with integrated localizers
1. Patient tracker with integrated localizer
1. Non-tracked accessories for mechanical fixation

AI/ML Overview

The Scopis Extended Instrument Set EM is a set of accessories for the Scopis Hybrid Navigation Unit EM, intended to localize the patient, track the position of the patient, and display the position of navigated instruments on a model of the patient's anatomy based on preoperative CT or MRI images using electromagnetic tracking technology.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from predicate devices)	Reported Device Performance (Scopis Extended Instrument Set EM)
Fiagon predicate K133573: Navigation Accuracy of 0.9 mm ± 0.34 mm (for Precision Pointer equivalent)	Scopis Hybrid Navigation System EM (K161491) Navigation Accuracy (Precision Pointer EM): 0.49 mm ± 0.27 mm
Fiagon predicate K141456: Bench Accuracy of 0.7 mm to 1.2 mm ± 0.29 mm to 0.42 mm (for Registration pointer equivalent)	Scopis Extended Instrument Set EM Bench Accuracy (Registration pointer EM-D): 0.64 mm ± 0.27 mm

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

The document only states "bench testing of the navigation accuracy was performed". It does not specify the sample size (number of measurements or trials) for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

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

Not applicable. The ground truth for the test set appears to be based on physical measurements of navigation accuracy on a test bench, not on expert consensus of medical images.

4. Adjudication Method for the Test Set:

Not applicable. The "study" appears to be a bench test involving physical accuracy measurements, not a human-adjudicated test set.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes bench testing for navigation accuracy, not a study involving human readers or AI assistance.

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

Yes, the described performance testing is a standalone assessment of the device's accuracy. The "bench testing of the navigation accuracy" assesses the algorithm and hardware's ability to precisely track and display instrument positions, independent of a human operator's performance in a surgical setting.

7. Type of Ground Truth Used:

The ground truth used for the performance testing was physical measurements of navigation accuracy. This likely involves comparing the device's reported position of an instrument to its actual physical position, as measured by a highly accurate reference system on a test bench.

8. Sample Size for the Training Set:

The document does not provide any information regarding the sample size for a training set. This is a medical device clearance, and the focus is on the safety and effectiveness of the device as a whole, not specifically on the details of an AI model's training if one were present as a distinct component. The "Navigation Software (NOVA AR)" is listed, but its development methodology (e.g., if it uses machine learning and thus a training set) is not detailed.

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

The document does not provide any information on how ground truth for a training set was established. As mentioned in point 8, details about the software's development, especially if it involved machine learning requiring a training set, are not present in this document.

Summary

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

September 27, 2017

Scopis GmbH Christopher Özbek. CTO Heinrich-Heine-Platz 10 Berlin, Germany D-10719

Re: K171661

Trade/Device Name: Scopis Extended Instrument Set EM Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: August 24, 2017 Received: August 28, 2017

Dear Christopher Özbek:

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.

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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 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.

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 (DICE) 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 (DICE) 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.

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)

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.

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 Extended Instrument Set 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

Dr. Christopher Özbek Contact: Chief Technical Officer

Date Prepared: May 31, 2017

2. Device Information

Trade Name:	Scopis Extended Instrument Set 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 an extension to the previously cleared Image Guided Surgery System.

4. Predicate Device Information

The Scopis Extended Instrument Set EM described in this submission is substantially equivalent to the following predicates:

Predicate Device	Manufacturer	510(k) No.:
Fiagon Navigation – Extended Instrument Set ENT	Fiagon GmbH	K141456
Cranial Image Guided Surgery System.	BrainLAB AG	K092467

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Image /page/4/Picture/2 description: The image contains the logo for Scopis Medical. The word "SCOPIS" is written in large, red, sans-serif letters. Below the word "SCOPIS" is the word "medical" written in smaller, gray, sans-serif letters. The logo is simple and modern.

5. Device Description

The Scopis Extended Instrument Set EM consists of:

1. Navigation Software (NOVA AR)
1. Navigated instruments with integrated localizers
1. Patient tracker with integrated localizer
1. Non-tracked accessories for mechanical fixation

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 Extended Instrument Set EM to the predicates is shown by similarity in intended use, indications for use, materials, and performance. Both the Scopis Extended Instrument Set EM and the predicates utilize:

Electromagnetic tracking technology for navigation. ●
Fiducial or anatomical reference points for procedure registration to the image-. based model of the patient's anatomy.
. Tracking of the navigation instruments via localizers mounted in the tip of the instruments.
. Use of CT or MR image sets as reference images for the image-based model of the patient's anatomy.

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Image /page/5/Picture/2 description: The image shows the logo for SCOPIS medical. The word "SCOPIS" is written in large, red, sans-serif letters. Below the word "SCOPIS" is the word "medical" written in a smaller, gray, sans-serif font. The logo is simple and modern.

Software functionality for pre-operative planning for points, lines and shapes. ●
. Image injection into intra-operative imaging modalities

All devices are subject to the same cyber security threat model of a networked PC with software and patient image data in a protected hospital environment.

8. Performance Data

Bench testing of the navigation accuracy was performed to establish the substantial equivalence to the respective predicate devices:

The measured navigation accuracy of the corresponding Scopis Hybrid Navigation System EM (cf. 510(k) No. K161491) is 0.49 ± 0.27 mm for the Precision Pointer EM compared to the reported device navigation accuracy of 0.9 mm =0.34 mm of the Fiagon predicate K133573.

The accessory set in this 510(k) reaches a bench accuracy of 0.64 ± 0.27 mm with the use of the Registration pointer EM-D compared to the Fiagon predicate device K141456 with a bench accuracy 0.7 mm to 1.2 mm ± 0.29 mm to 0.42 mm.

9. Conclusion

Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, the Scopis Extended Instrument Set 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).