SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D

K141941 · Stryker Corporate · OLO · Oct 31, 2014 · Neurology

Device Facts

• Record ID: K141941
• Device Name: SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D
• Applicant: Stryker Corporate
• Product Code: OLO · Neurology
• Decision Date: Oct 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Stryker SpineMap® 3D Navigation System, when used with a Stryker computer workstation, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer-assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The Stryker SpineMap® 3D Navigation System assists in precise positioning of instruments for procedures on the spine, including: Pedicle screw placement. The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker SpineMap® 3D Navigation System. It is placed onto the patient's skin dorsal to the spine. In combination with intraoperative imaging devices, it enables automatic patient registration for open or percutaneous computer assisted surgery. When used for patient tracking, the Stryker SpineMask™ Tracker supports minimally invasive procedures on the lumbar and thoracic spine.

Device Story

Image-guided surgery system for open or percutaneous spinal procedures; utilizes CT, MRI, PET, or 3D C-arm images. System comprises computer workstation, navigation camera, software, and smart instruments (trackers, pointers). SpineMask™ Tracker (adhesive-backed) applied to patient's dorsal skin for automatic registration and tracking. Infrared optical active sensing technology: camera array tracks infrared diodes on instruments to compute spatial coordinates. Software displays instrument position relative to imported DICOM images on monitor. Used by surgeons in OR to guide precise instrument positioning (e.g., pedicle screws). Benefits include improved surgical accuracy and support for minimally invasive techniques.

Clinical Evidence

No clinical testing conducted. Evidence based on non-clinical bench testing, including phantom accuracy tests (ASTM F2554:2010), cadaver lab validation, biocompatibility (ISO 10993-1), electrical safety (ANSI/AAMI ES 60601-1), and electromagnetic compatibility (IEC 60601-1-2).

Technological Characteristics

Infrared optical active sensing; infrared diodes on instruments tracked by camera array. Accuracy: ±2mm point displacement, ±2° angular displacement. Connectivity: DICOM image import. Software: SpineMap 3D 3.0. Biocompatibility: ISO 10993-1. Sterilization: EO (ISO 11135-1, SAL 10^-6). Electrical: ANSI/AAMI ES 60601-1. EMC: IEC 60601-1-2.

Indications for Use

Indicated for patients requiring computer-assisted planning and surgery for spinal procedures, including pedicle screw placement, where rigid anatomical structures can be identified. Contraindicated for use in MR environments (MR unsafe).

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

• Stryker Navigation System - Spine & Fluoroscopy Module (K012380)
• Stryker Navigation System - CranialMap Neuro Module (K131214)
• Stryker Navigation System – Knee Module (K022579)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and well-being. The logo is simple, clean, and easily recognizable.

October 31, 2014

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

Stryker Leibinger GmbH & Company. KG Ms. Becky Ditty Senior Staff Regulatory Affairs Specialist 4100 E. Milham Avenue Kalamazoo, Michigan 49001

Re: K141941

Trade/Device Name: Stryker SpineMap® 3D Navigation System, Stryker SpineMask™ Tracker Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: October 16, 2014 Received: October 17, 2014

Dear Ms. Ditty:

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 (reporting of medical

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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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Mark N. Melkerson -S

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

Enclosure

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## Indications for Use

510(k) Number (if known) K141941

Device Name Stryker SpineMap® 3D Navigation System

Indications for Use (Describe)

The Stryker SpineMap® 3D Navigation System, when used with a Stryker computer workstation, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery.

The system is indicated for any medical condition in which the use of computer-assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a rigid anatomical structure can be identified.

The Stryker SpineMap® 3D Navigation System assists in precise positioning of instruments for procedures on the spine, including:

· Pedicle screw placement

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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## Indications for Use

510(k) Number (if known) K141941

Device Name Stryker SpineMask™ Tracker

#### Indications for Use (Describe)

Indications for Use

The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker SpineMap® 3D Navigation System. It is placed onto the patient's skin dorsal to the spine.

- · In combination with intraoperative imaging devices, it enables automatic patient registration for open or percutaneous computer assisted surgery.
- · When used for patient tracking, the Stryker SpineMask™ Tracker supports minimally invasive procedures on the lumbar and thoracic spine.

Contraindication

The SpineMask™ Tracker is not intended for use in a MR Environment. The SpineMask™ Tracker is MR unsafe.

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

| <div style="display:inline-block"><span style="text-decoration:overline"></span>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:inline-block"><span style="text-decoration:overline"></span>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | | |
|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--|
| <div style="display:inline-block"> <table border="1"><tr><td><div style="text-align:center"><b>X</b></div></td></tr></table> </div> | <div style="text-align:center"><b>X</b></div> | <div style="display:inline-block"> <table border="1"><tr><td></td></tr></table> </div> | |
| <div style="text-align:center"><b>X</b></div> | | | |
| | | | |

| > Prescription Use (Part 21 CFR 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."

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Image /page/4/Picture/0 description: The image shows the Stryker logo. The word "stryker" is in bold, black letters. Below the word "stryker" is the word "navigation" in a smaller, non-bolded font.

#### 510(k) Summary റ

This chapter provides a summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

## 5.1 Contact Details

| Applicant Name: | Stryker Leibinger GmbH & Co. KG<br>Boetzinger Strasse 41<br>D-79111 Freiburg, Germany<br>Phone number: [phone]<br>Fax number: [phone] |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration No.: | 8010177 |
| Name of Contact Person: | Becky Ditty<br>Sr. Staff Regulatory Affairs Specialist<br>4100 E. Milham Ave<br>Kalamazoo, MI 49001<br>[e-mail]<br>[phone] |
| Date Prepared: | October 16, 2014 |

#### Table 5-1: Contact Details

## 5.2 Device Name

| Trade Name: | Stryker SpineMap® 3D Navigation System | | | | |
|-------------------------|----------------------------------------|-----------------------------------------|----------------------|-------|-----------------|
| Common Name: | Spine Navigation System | | | | |
| Classification<br>Name: | Product<br>Code | Device | Regulation<br>Number | Class | Review<br>Panel |
| | Primary<br>Code<br>OLO | Orthopedic<br>Stereotaxic<br>Instrument | 21 CFR<br>§882.4560 | II | Orthopedic |

Table 5-2: Device Name

## 5.3 Device Description

The Stryker SpineMap® 3D Navigation System is an image guided surgery system to enable open or percutaneous computer-assisted spinal surgery.

The system uses wireless optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a CT image.

The system consists of a software application, smart instruments (e.g. patient/instrument trackers, pointers, navigated surgical instruments), and several accessories to enable the tracking of surgical instruments. The system also includes the SpineMask™ Tracker, a new patient tracking device.

The software application runs on a Stryker computer platform, consisting of a Stryker computer, a navigation camera and an IO-Tablet.

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Image /page/5/Picture/0 description: The image shows the Stryker logo. The word "stryker" is in bold, black letters. Below the word "stryker" is the word "navigation" in smaller, black letters.

## 5.4 Intended Use / Indications for Use

#### Stryker SpineMap® 3D Navigation System Indications for Use

The Stryker SpineMap® 3D Navigation System, when used with a Stryker computer workstation, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery.

The system is indicated for any medical condition in which the use of computer-assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

The Stryker SpineMap® 3D Navigation System assists in precise positioning of instruments for procedures on the spine, including:

- . Pedicle screw placement
#### Stryker SpineMask™ Tracker Indications for Use

The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker SpineMap® 3D Navigation System. It is placed onto the patient's skin dorsal to the spine.

- . In combination with intraoperative imaging devices, it enables automatic patient registration for open or percutaneous computer assisted surgery.
- . When used for patient tracking, the Stryker SpineMask™ Tracker supports minimally invasive procedures on the lumbar and thoracic spine.

#### Contraindication

The SpineMask™ Tracker is not intended for use in a MR Environment. The SpineMask™ Tracker is MR unsafe.

### 5.5 Predicate Devices

The Stryker SpineMap 3D Navigation System, including the SpineMask™ Tracker, has the same intended use and substantially equivalent technological characteristics as the predicate devices shown in the following table:

| 510(k) Number | K012380 | K131214 | K022579 |
|----------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------|
| Product Code | HAW | HAW | HAW |
| Trade Name | Stryker Navigation<br>System - Spine &<br>Fluoroscopy Module | Stryker Navigation<br>System - CranialMap<br>Neuro Module | Stryker Navigation<br>System – Knee<br>Module |
| Manufacturer | Stryker Leibinger<br>GmbH & Co. KG | Stryker Leibinger<br>GmbH & Co. KG | Stryker Leibinger<br>GmbH & Co. KG |
| Substantial<br>Equivalence<br>Characteristic | Intended Use<br>Technological<br>Features | Intended Use<br>Technological<br>Features | Intended Use |

#### Table 5-3: Legally Marketed Predicate Devices

### 5.6 Substantial Equivalence Comparison

Table 5-4 provides an overview of the substantial equivalence between the predicate devices and the subject devices.

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Image /page/6/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase. The letter "y" has a long tail that extends below the baseline of the other letters. There is a registered trademark symbol after the word.

| Topic | Subject Device | Predicate Devices | Equivalence<br>Assessment |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Intended Use | | | |
| Indications for use | Stryker SpineMap® 3D Navigation System Indications for Use The Stryker SpineMap® 3D Navigation System, when used with a Stryker computer workstation, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer-assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The Stryker SpineMap® 3D Navigation System assists in precise positioning of instruments for procedures on the spine, including: Pedicle screw placement Stryker SpineMask™ Tracker Indications for Use The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker SpineMap® 3D Navigation System. It is placed onto the patient's skin dorsal to the spine. In combination with intraoperative imaging devices, it enables automatic patient registration for open or percutaneous computer assisted surgery. When used for patient tracking, the Stryker SpineMask™ Tracker supports minimally invasive procedures on the lumbar and thoracic spine. Stryker SpineMask™ Tracker Contraindication The SpineMask™ Tracker is not intended for use in a MR | K012380, Stryker Navigation System - Spine & Fluoroscopy Module The Stryker Navigation System is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure such as the skull, or vertebra, can be identified relative to medical images. The Stryker Navigation System – Spine & Fluoroscopy Module supports, but is not limited to, the following surgical procedures: Pedicle screw placement Navigation Precisely positioning instruments such as internal and external fixation devices during orthopedic surgery, to include operations performed with spinal structure, hip and bones. The system is not intended for total joint replacement procedures. | Equivalent |
| Topic | Subject Device | Predicate Devices | Equivalence<br>Assessment |
| Indications for use<br>(continued) | See above | K131214, Stryker Navigation System - CranialMap Neuro<br>Module | Equivalent |
| | | The Stryker Navigation System - Cranial Module is intended<br>as a planning and intraoperative guidance system to enable<br>open or percutaneous computer assisted surgery. | |
| | | The system is indicated for any medical condition in which the<br>use of computer assisted planning and surgery may be<br>appropriate. The system can be used for intra-operative<br>guidance where a reference to a rigid anatomical structure can<br>be identified. | |
| | | The system should be operated only by trained personnel such<br>as surgeons and clinic staff. | |
| | | The Cranial Navigation system supports, but is not limited to,<br>the following surgical procedures: | |
| | | <i>ENT Procedures</i> Endoscopic Sinus Surgery (ESS) Intranasal procedures Ear implant procedures | |
| | | <i>Neuro Procedures</i> Cranial biopsies Puncture of abscesses Craniotomies Craniectomies Resection of tumors and other lesions Removal of foreign objects Skull base procedures Transnasal neurosurgical procedures Transphenoidal pituitary surgery Shunt placement, including pediatric shunt placement Placement of electrodes for recording, stimulation and lesion generation Craniofacial procedures Skull reconstruction procedures Orbital cavity reconstruction procedures | |
| | | Contraindications Surgical situation where increasing surgical time may be<br>detrimental to the patient | |
| Topic | Subject Device | Predicate Devices | Equivalence<br>Assessment |
| Indications for use<br>(continued) | See above | K022579, Stryker Navigation System - Knee Module<br>The Stryker Navigation System - Knee Module is intended as<br>a planning and intraoperative guidance system to enable open<br>or percutaneous computer assisted surgery.<br>The system is indicated for conditions of the knee joint in which<br>the use of computer assisted surgery may be appropriate.<br>The surgeon has to determine whether the patient's conditions<br>are appropriate for this kind of procedure or not. A pathological<br>condition against the use of this system could be in some<br>cases advanced osteoporosis or a displastic hip. | Equivalent |
| Main system<br>components | Computer Platform SpineMap 3D Software Application Smart Instruments Patient Tracker Fixation Navigated Manual Instruments Instrument Battery, Trays | K012380, Stryker Navigation System – Spine &<br>Fluoroscopy Module Computer Platform Spine Software Application Smart Instruments Patient Tracker Fixation Navigated Manual Instruments Instrument Battery, Trays K131214, Stryker Navigation System - CranialMap Neuro<br>Module Computer Platform CranialMap Neuro Software Application Smart Instruments Patient Tracker Fixation Navigated Manual Instruments | Equivalent |

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# stryker

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# stryker

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Image /page/9/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are closely spaced together, creating a compact and solid appearance. A small trademark symbol is located to the right of the word.

| Topic | Subject Device | Predicate Devices | Equivalence<br>Assessment |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Main system<br>components (continued) | See above | K022579, Stryker Navigation System - Knee Module Computer Platform Knee Software Application Smart Instruments Patient Tracker Fixation Navigated Manual Instruments Instrument Battery, Trays | Equivalent |
| Modes of operation | Patient Preparation System Setup Image Import Planning Patient Registration Navigation | K012380, Stryker Navigation System - Spine &<br>Fluoroscopy Module<br>K131214, Stryker Navigation System - CranialMap Neuro<br>Module Patient Preparation System Setup Image Import Planning Patient Registration Navigation K022579, Stryker Navigation System - Knee Module Patient Preparation System Setup Patient Registration | Equivalent |
| Topic | Subject Device | Predicate Devices | Equivalence<br>Assessment |
| Localization and tracking<br>technology | Infrared optical active sensing technology: Infrared light emitted by diodes placed in a known fashion on navigated surgical instruments is sensed by a camera array (navigation camera) on the computer platform, thus allowing for computation of the spatial information | K012380, Stryker Navigation System – Spine &<br>Fluoroscopy Module<br>K131214, Stryker Navigation System – CranialMap Neuro<br>Module<br>K022579, Stryker Navigation System – Knee Module Infrared optical active sensing technology: Infrared light emitted by diodes placed in a known fashion on navigated surgical instruments is sensed by a camera array (navigation camera) on the computer platform, thus allowing for computation of the spatial information | Equivalent |
| Operating principle | The software is installed on the computer that is part of the computer platform Images are imported in DICOM format The software displays the images and planned items with navigational information on a monitor | K012380, Stryker Navigation System – Spine &<br>Fluoroscopy Module<br>K131214, Stryker Navigation System – CranialMap Neuro<br>Module The software is installed on the computer that is part of the computer platform Images are imported in DICOM format The software displays the images and planned items with navigational information on a monitor K022579, Stryker Navigation System – Knee Module The software is installed on the computer that is part of the computer platform The software displays the images and planned items with navigational information on a monitor | Equivalent |
| Topic | Subject Device | Predicate Devices | Equivalence<br>Assessment |
| Technological Characteristics - SpineMap 3D 3.0 Software | | | |
| System accuracy<br>statement | Mean navigation accuracy of $\pm$ 2mm point (tip) displacement and $\pm$ 2° angular axis displacement | K012380, Stryker Navigation System - Spine &<br>Fluoroscopy Module<br>K131214, Stryker Navigation System - CranialMap Neuro<br>Module Mean navigation accuracy of $\pm$ 2mm point (tip) displacement and $\pm$ 2° angular axis displacement | Equivalent |
| Supported image<br>modalities | CT MRI PET 3D C-Arm | K012380, Stryker Navigation System - Spine &<br>Fluoroscopy Module CT MRI PET 3D C-Arm K131214, Stryker Navigation System - CranialMap Neuro<br>Module CT MRI PET | Equivalent |
| Topic | Subject Device | Predicate Devices | Equivalence<br>Assessment |
| Planning features | Screws Measurements Planes Annotation Points Trajectories Segmentations Anatomical Systems Correlation 3D Models Compositions | K012380, Stryker Navigation System - Spine &<br>Fluoroscopy Module Screws Measurements K131214, Stryker Navigation System - CranialMap Neuro<br>Module Measurements Annotation Points Trajectories Segmentations Anatomical Systems Correlation 3D Models Compositions | Equivalent |
| Registration features | Anatomical Registration 3D C-arm Registration Automatic Intraoperative Mask (AIM) Registration | K012380, Stryker Navigation System – Spine &<br>Fluoroscopy Module Anatomical Registration 3D C-arm Registration K131214, Stryker Navigation System - CranialMap Neuro<br>Module Anatomical Registration Automatic Intraoperative Mask (AIM) Registration | Equivalent |
| Topic | Subject Device | Predicate Devices | Equivalence<br>Assessment |
| Technological Characteristics - SpineMask Tracker | | | |
| Patient attachment | • Adhesive tape applied to patient's skin | K012380, Stryker Navigation System - Spine &<br>Fluoroscopy Module Spine Clamp is attached to patient's spinous process K131214, Stryker Navigation System - CranialMap Neuro<br>Module Adhesive tape applied to patient's skin | Equivalent |
| Patient tracking | • SpineMask Tracker applied to the dorsal surface of the patient. | K012380, Stryker Navigation System - Spine &<br>Fluoroscopy Module Spine Tracker together with Spine Clamp, with the clamp attached to the spinous process K131214, Stryker Navigation System - CranialMap Neuro<br>Module Patient Tracker together with Mayfield Clamp, with the clamp attached to the patient's skull Patient Registration Mask Tracker that is applied to the patient's face | Equivalent |

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## stryker

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Image /page/11/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is uppercase. The word is black and the background is white. The image is a logo for the Stryker Corporation, a medical technology company.

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Image /page/12/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black, and the background is white. The word is slightly italicized, giving it a sense of movement.

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Image /page/13/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and there is a registered trademark symbol to the right of the "r". The logo is simple and modern, with a focus on readability.

Table 5-4: Substantial Equivalence Comparison

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The conclusions drawn from the nonclinical tests demonstrate that the Stryker SpineMap® 3D Navigation System performs substantially equivalent to the predicate devices. The differences in the indications for use, technological characteristics and performance characteristics do not raise new questions of safety and effectiveness. Consequently, the Stryker SpineMap® 3D Navigation System is substantially equivalent to the predicate device. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the Stryker SpineMap® 3D Navigation System is substantially equivalent to the predicate device with respect to its indications for use, technological characteristics and performance characteristics.

## 5.7 Non-Clinical Testing

Validation activities have been conducted to provide assurance that the device meets the performance requirements under its indications for use conditions.

| Test | Description…