The Ziehm RFD 3D Interface is an accessory to the StealthStation™ System. It is intended to be used with the Ziehm Vision RFD 3D C-arm to automatically transfer to and register three dimensional images on the StealthStation™ System for use in imageguided spinal surgery.

Device Description

The Ziehm RFD 3D Tracker works by making the Ziehm RFD 3D C-arm visible to the StealthStation™ Navigation Systems. The optical reflective markers in the tracker housings interact with the camera and software to identify the position and orientation of the C-arm detector in three-dimensional space.

When optical markers are inserted into the magnetic mounting sockets on the housing, the combination is then referred to as the tracker assembly. The optical markers interact with the camera and software to identify the position and orientation of the C-arm detector in three-dimensional space.

The integration interface (tracker and C-Arm) enables automatic transfer and registration of images received from Ziehm RFD 3D system within StealthStation system, specifically within StealthStation™ Spine software (K170011).

To enable automatic image registration, at the beginning of each scan the StealthStation™ camera captures the position of an optical tracker attached to the C-arm in relation to the patient reference frame. Upon image acquisition, the images from Ziehm RFD 3D system and associated calibration information are automatically transferred to the StealthStation™ system as a DICOM volume over an Ethernet cable. Upon completion of the DICOM volume transfer, the StealthStation™ software automatically registers the image relative to the patient reference frame.

AI/ML Overview

The provided text describes the Ziehm RFD 3D Tracker, an accessory to the StealthStation System, intended for automatically transferring and registering three-dimensional images from the Ziehm Vision RFD 3D C-arm for image-guided spinal surgery.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a defined "acceptance criteria" section but can be inferred from the "Accuracy testing values" for the device. The "reported device performance" is the measured accuracy.

Metric (Inferred Acceptance Criterion)	Reported Device Performance (Ziehm RFD 3D Tracker)	Predicate Device Performance (K022414)
Mean Accuracy	0.79 mm	1.3 mm
Upper Reliability (95% confidence)	1.73 mm	2.30 mm

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

The document does not explicitly state the sample size for the test set. It mentions "Testing conducted to demonstrate the performance," but details regarding the number of cases or scans are absent.

The data provenance (country of origin, retrospective/prospective) is not specified.

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

This information is not provided. The document does not describe how ground truth was established for the accuracy testing.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study is mentioned. The study focuses on the device's accuracy rather than human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is a standalone performance test. The "Ziehm RFD 3D C-arm Accuracy for StealthStation™ S8" test directly measures the accuracy of the device's integration and image registration, implying an assessment of the algorithm's performance without direct human intervention in the measurement process itself. The "human-in-the-loop" aspect during surgical use would be for navigation after image registration, not for the accuracy measurement of the registration step itself.

7. The Type of Ground Truth Used

The document does not explicitly state the type of "ground truth" used for accuracy testing. Given the nature of a stereotaxic instrument and accuracy testing in this context, it is highly likely that a precisely measured physical phantom or reference markers with known spatial relationships would be used as the ground truth. This would fall under a form of physical measurement/phantom-based ground truth, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not mention any training set or machine learning models. The device functionality described is related to image transfer and registration based on optical tracking and calibration, not a learned algorithm that requires a separate training set.

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

Not applicable, as no training set is mentioned or implied.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

July 11, 2018

Medtronic Navigation Nicole Zimmerman Associate Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K180816

Trade/Device Name: Ziehm RFD 3D Tracker Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 16, 2018 Received: April 17, 2018

Dear Nicole Zimmerman:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

ulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K180816

Device Name Ziehm RFD 3D Tracker

Indications for Use (Describe)

The Ziehm RFD 3D Interface is an accessory to the StealthStation System. It is intended to be used with the Ziehm Vision RFD 3D C-arm to automatically transfer to and register three dimensional images on the StealthStation System for use in image-guided spinal surgery.

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

☑ Prescription Use (Part 21 CER 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

I. Company: Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 Telephone Number: (720) 890-3200
- Contact: Nicole Zimmerman Associate Regulatory Affairs Specialist Telephone Number: (720) 890-2342 Fax: (720) 890-3500 Email: nicole.r.zimmerman@medtronic.com

K. Elizabeth Waite Principal Regulatory Affairs Specialist Telephone Number: (720) 890-2182 Fax: (720) 890-3500 Email: elizabeth.waite@medtronic.com

Date: 30 April 2018

II. Proprietary Trade Name: Ziehm RFD 3D Tracker
III. Common Name: Orthopedic Stereotaxic Instrument
Classification Name: Stereotaxic Instrument (21 CFR 882.4560) IV.
V. Classification: Class II

VI. Product Code: OLO

VII. Product Description:

{4}------------------------------------------------

The integration interface (tracker and C-Arm) enables automatic transfer and registration of images received from Ziehm RFD 3D system within StealthStation1114 system, specifically within StealthStation™ Spine software (K170011).

Indications for Use: VIII.

IX. Identification of Legally Marketed Devices (Predicate Devices):

StealthStation™ System Three Dimensional C-Arm Interface (K022414)

X. Comparison of the Technological Characteristics:

See Table 5.1 for comparison of the subject device versus predicate.

Feature	Ziehm RFD 3D Tracker (subject devices)	K022414-StealthStationTMSystem Three Dimensional C-Arm Interface (w/ Ziehm Vision FD Vario 3D Tracker)
Product Code	OLO	HAW
Classification	Class II	Class II
Intended/Indications forUse	The Ziehm RFD 3D Interface is an accessory to the StealthStationTM System. It is intended to be used with the Ziehm Vision RFD 3D C-arm to automatically transfer to and register three dimensional images on the StealthStationTM System for use in image-guided spinal surgery.	The StealthStationTM is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStationTM system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the scull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy

Table 5.1 Comparison Summary

{5}------------------------------------------------

Feature	Ziehm RFD 3D Tracker (subject devices)	K022414-StealthStationTM System Three Dimensional C-Arm Interface (w/ Ziehm Vision FD Vario 3D Tracker)
PrincipalMode ofOperation	The integration interface enablesautomatic transfer and registrationof images received from ZiehmRFD 3D system withinStealthStationTM system,specifically within StealthStationTMSpine software.	The StealthStation System ThreeDimensional C-Arm Interface isintended to interact with acommercially available 3D C-Arm. The 3D dataset will betransferred to theStealthStationTM or iONTMSystem via DICOM. The usermay then use the 3D dataset forsurgical planning and/ornavigation
Navigationmethod(optical /EM)	Optical	optical
Cleaning andsterilizationmethods	Manually clean the Ziehm trackerswith appropriate cleaning solutions.Do not sterilize the tracker.	Manually clean the Ziehmtrackers with appropriatecleaning solutions. Do notsterilize the tracker.
Accuracytesting values	0.79 mm mean1.73 mm upper reliability95% confidence	1.3 mm mean2.30 mm upper reliability95% confidence

XI. Discussion of the Performance Testing:

Testing conducted to demonstrate the performance of the Ziehm RFD 3D Trackers is summarized as follows:

Test	Description
Ziehm RFD 3D C-armStealth IntegrationSummative Validation	Provides confidence that the product can be used safely and effectively by the intended users.
Ziehm RFD 3DIntegration Kit -Functional Verification	Provides confirmation that the design and implementation of the Ziehm RFD 3D Integration Kit correctly fulfills all product functional requirements.
Ziehm RFD 3D C-armAccuracy forStealthStation™ S8	Provides confirmation that the design and implementation of the Ziehm RFD 3D Integration Kit correctly fulfills all product accuracy requirements.

XII. Conclusions

The Ziehm RFD 3D Tracker has shown through comparison to be substantially equivalent to the identified predicate device and do not raise 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).