Ziehm RFD 3D Tracker

K180816 · Medtronic Navigation · OLO · Jul 11, 2018 · Neurology

Device Facts

• Record ID: K180816
• Device Name: Ziehm RFD 3D Tracker
• Applicant: Medtronic Navigation
• Product Code: OLO · Neurology
• Decision Date: Jul 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

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.

Device Story

Accessory to StealthStation navigation system; enables automatic transfer/registration of 3D images from Ziehm Vision RFD 3D C-arm. Device consists of optical tracker housing with reflective markers; attaches to C-arm. StealthStation camera tracks optical markers to determine C-arm detector position/orientation in 3D space. Upon scan, images and calibration data transfer via Ethernet (DICOM) to StealthStation; software automatically registers images to patient reference frame. Used in clinical settings (OR) by surgeons/staff for spinal navigation. Benefits include automated image registration, reducing manual steps, and improving navigation accuracy for spinal procedures.

Clinical Evidence

Bench testing only. Validation included summative validation for usability, functional verification of the integration kit, and accuracy testing. Accuracy results: 0.79 mm mean error, 1.73 mm upper reliability (95% confidence).

Technological Characteristics

Optical tracking system; consists of tracker housing with reflective markers. Connectivity via Ethernet (DICOM). Software-based automatic image registration. Non-sterile; manual cleaning required. Class II device.

Indications for Use

Indicated for use in image-guided spinal surgery to automatically transfer and register 3D images from the Ziehm Vision RFD 3D C-arm to the StealthStation System.

Regulatory Classification

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.

Predicate Devices

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

Reference Devices

• StealthStation™ Spine software (K170011)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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)

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CER 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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 [e-mail]

"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: [phone]
- Contact: Nicole Zimmerman Associate Regulatory Affairs Specialist Telephone Number: [phone] Fax: [phone] Email: [e-mail]

K. Elizabeth Waite Principal Regulatory Affairs Specialist Telephone Number: [phone] Fax: [phone] Email: [e-mail]

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:

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.

{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).

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.

### Indications for Use: VIII.

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.

### 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-StealthStationTM<br>System Three Dimensional C-Arm Interface (w/ Ziehm Vision FD Vario 3D Tracker) |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | OLO | HAW |
| Classification | Class II | Class II |
| Intended/<br>Indications for<br>Use | 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) |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principal<br>Mode of<br>Operation | The integration interface enables<br>automatic transfer and registration<br>of images received from Ziehm<br>RFD 3D system within<br>StealthStationTM system,<br>specifically within StealthStationTM<br>Spine software. | The StealthStation System Three<br>Dimensional C-Arm Interface is<br>intended to interact with a<br>commercially available 3D C-Arm. The 3D dataset will be<br>transferred to the<br>StealthStationTM or iONTM<br>System via DICOM. The user<br>may then use the 3D dataset for<br>surgical planning and/or<br>navigation |
| Navigation<br>method<br>(optical /<br>EM) | Optical | optical |
| Cleaning and<br>sterilization<br>methods | Manually clean the Ziehm trackers<br>with appropriate cleaning solutions.<br>Do not sterilize the tracker. | Manually clean the Ziehm<br>trackers with appropriate<br>cleaning solutions. Do not<br>sterilize the tracker. |
| Accuracy<br>testing values | 0.79 mm mean<br>1.73 mm upper reliability<br>95% confidence | 1.3 mm mean<br>2.30 mm upper reliability<br>95% 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-arm<br>Stealth Integration<br>Summative Validation | Provides confidence that the product can be used safely and effectively by the intended users. |
| Ziehm RFD 3D<br>Integration Kit -<br>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-arm<br>Accuracy for<br>StealthStation™ 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.