Who is the manufacturer of STRYKER NAV3I PLATFORM?

Stryker Corporate filed the 510(k) submission for STRYKER NAV3I PLATFORM (K130874).

What is the FDA product code for STRYKER NAV3I PLATFORM?

HAW. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for STRYKER NAV3I PLATFORM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for STRYKER NAV3I PLATFORM?

Stryker Navigation Cart (K002732).

Who can help prepare an FDA 510(k) submission like STRYKER NAV3I PLATFORM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

STRYKER NAV3I PLATFORM

K130874 · Stryker Corporate · HAW · Sep 27, 2013 · Neurology

Device Facts

Record ID	K130874
Device Name	STRYKER NAV3I PLATFORM
Applicant	Stryker Corporate
Product Code	HAW · Neurology
Decision Date	Sep 27, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Indications for Use

The NAV3i Platform is a computer workstation that, when used with specific Stryker Navigation surgical software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NAV3i Platform is that of a patient undergoing a surgical procedure using stereotactic techniques.

Device Story

NAV3i Platform is a mobile computer workstation for intraoperative surgical navigation. It functions as a host for Stryker Navigation software modules. Input: infrared signals from LEDs on surgical instruments; patient-specific medical images (CT, microscope). Operation: active optical tracking via three linear sensors in a Navigation Camera; system calculates instrument position relative to anatomy. Output: real-time visualization of instrument position on a 32-inch monitor. Used in OR by surgeons/staff. Benefits: assists in high-precision surgical interventions. Features include integrated IO-Tablet with touch screen, RFID card reader for licensing, and LiveCam for camera positioning. Connectivity: Ethernet/WLAN for remote service access. System is non-sterile, placed outside the sterile field.

Clinical Evidence

No clinical data. Bench testing only, including accuracy testing per ASTM F2554-10, electrical safety per IEC 60601-1, usability/human factors engineering, and integration testing with various navigation software modules.

Technological Characteristics

Mobile cart with Windows PC, 32-inch flat screen monitor, and active optical navigation camera. Sensing: three linear sensors detecting infrared LEDs. Connectivity: Ethernet, WLAN, VNC remote access. Power: 100/240V AC with UPS. Standards: IEC 60601-1 (electrical safety), ASTM F2554-10 (positional accuracy), ASTM D 4169-09 (shipment).

Indications for Use

Indicated for patients undergoing surgical procedures requiring stereotactic techniques for instrument localization and anatomical visualization.

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 Cart (K002732)

Submission Summary (Full Text)

{0}------------------------------------------------ K130874 stryker® Navigation ## SEP 2 7 2013 #### 510(k) Summary A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92. #### 1. Contact Details | Applicant Name: | Stryker Leibinger GmbH & Co. KG - Navigation | |-------------------------|----------------------------------------------| | | Boetzinger Strasse 41 | | | D-79111 Freiburg, Germany | | | Phone number: +49-761-4512117 | | | Fax number: +49-761-451249117 | | Registration No.: | 3007582679 | | Name of Contact Person: | Lilian Eckert | | | lilian.eckert@stryker.com | | Date prepared: | 24 September 2013 | ### 2. Device Name | Trade Name: | Stryker NAV3i Platform | | | | | |-------------------------|----------------------------|-----------------------------------------|----------------------|-------|--------------| | Common Name: | Navigation System Platform | | | | | | Classification Name: | Product Code | Device | Regulation Number | Class | Review Panel | | | Primary Code: HAW | Neurologic stereotaxic instrument | 21 CFR §882.4560 | II | Neurology | | | Secondary Code: OLO | Orthopedic stereotaxic instrument | 21 CFR §882.4560 | II | Orthopedic | {1}------------------------------------------------ #### 3. Legally Marketed Predicate Device The legally marketed predicate device is the Cart I Platform (trade name: Stryker Navigation Cart) as cleared in K002732 Stryker Navigation System - ENT Module. | 510(k) Number | Product Code Trade Name | | Manufacturer | |---------------|---------------------------|-------------------------|---------------------------------------------------------------------------------------------| | K002732 | HAW | Stryker Navigation Cart | Stryker Leibinger GmbH & Co. KG Boetzinger Strasse 41 D-79111 Freiburg, Germany | #### 4. Device Description The Stryker NAV3i Platform is a modular component of the Stryker Navigation System and is intended to run Stryker Navigation surgical software for surgical procedures using stereotactic techniques. The surgical navigation software used on this device is cleared as a separate 510(k). The Stryker Navigation System is a planning and intraoperative guidance system which assists in various surgical procedures. It allows for the localization of surgical instruments and visualization of their position relative to patient specific images and/or patient specific anatomical landmark information assisting the surgeon in performing the intervention at a high level of precision. For localization, active optical tracking based on infrared light is used. Using three linear sensors, the Navigation Camera detects signals from infrared light emitting diodes which are attached to the instruments to be localized. The NAV3i Platform consists of a mobile cart, a computer system, a monitor and a Navigation Camera. During surgery, the placed close to the operating room table but not within the sterile field. Articulated arms allow for the alignment of the Navigation Camera and the monitor to the operative field. The NAV3i Platform features for entering medical images such as CT images or microscope images which are required for navigation. The computer is used to install and run Stryker Navigation Software. while the monitor conveys navigation information to the user. There are two reasons for the traditional 510(k) submission. Firstly, it is intended to "unbundle" the clearance of the platform from the Stryker Navigation System as a whole. The predicate device submission included the platform as a component of the Stryker Navigation System -ENT Module. Secondly, some design modifications have been introduced to increase the user's comfort, to provide a more modern industrial design and to offer state-of-the-art technology for computer interfaces and components. {2}------------------------------------------------ #### 5. Indications for Use The NAV3i Platform is a computer workstation that, when used with specific Stryker Navigation surgical software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NAV3i Platform is that of a patient undergoing a surgical procedure using stereotactic techniques. #### 6. Substantial Equivalence Comparison The indications for use of the subject device Stryker NAV3i Platform are equivalent to the predicate device Cart I Platform for the Stryker Navigation System. Furthermore, the technological characteristics of the modified NAV3i Platform are substantially equivalent to the original Cart I Platform. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Consequently, the NAV3i Platform is substantially equivalent to the predicate device. The following table gives an overview of the substantial equivalence reflecting all modifications being made between the predicate device and the subject device. | Topic | Predicate Device | Subject Device | Equivalence assessment | |--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | LiveCam (USB Video Camera) | LiveCam was not offered. | Built-in LiveCam allows for easy positioning of the Navigation Camera. | Equivalent: This feature did not exist in the predicate device but does not alter the operating principle nor is it affecting the essential performance. | | Monitor | The main monitor used by the surgeon: 18 inch flat screen monitor mounted on an articulated arm. | The main monitor used by the surgeon: 32 inch flat screen monitor mounted on an articulated arm. | Equivalent: Changes do not affect the technology or the operating principle of the platform. | | IO-Tablet | Contained mouse and keyboard. | Mouse and touch screen monitor with implemented keyboard functionality are integrated in the IO-Tablet, IO-Tablet doubles as operator's monitor for the OR staff. | Equivalent: Ergonomic improvements by intuitive touch functionality and state-of- the-art technology for a data input device do not change the performance specification. | | Topic | Predicate Device | Subject Device | Equivalence assessment | | Computer | Windows PC based on Intel architecture. Configured Windows NT operating system. | Windows PC based on Intel state of the art architecture. Configured Windows XP operating system. | Equivalent: Performance specification changes due to additional state of the art PC interfaces and a new version of the operating system. | | RFID Card Reader for licensing and logistic reasons | Not existing. | RFID Card Reader for single case licensing integrated in the IO-Tablet. | Equivalent: The addition of the RFID Card Reader does not add any performance features and has no effect on the essential performance of the NAV3i Platform. | | Network connectivity | Connection type: Standard Ethernet connection and modem connection. | Connection type: Standard Ethernet connection and WLAN connection. | Equivalent: The extended network connectivity does not add any performance features in regards to the indications for use of the NAV3i Platform. | | Remote Service Connectivity | Remote service access by Virtual Network Computing (VNC) remote desktop service over network or modem connection. | Remote service access is offered by a remote access client over Ethernet or WLAN. | Equivalent: This represents the same technology for the remote service access. | | Navigation Camera | Active optical measurement system localizing infrared light emitting diodes (LED) using three linear sensors and a working space of 1.00 meter in diameter. The system is encapsulated in two separate housings: the camera and the localizer computer. | Active optical measurement system localizing infrared light emitting diodes (LED) using three linear sensors and a working space of 1.25 meter in diameter. The system is encapsulated in one housing and is called Navigation Camera. | Equivalent: The modified design of the Navigation Camera does not impact the operating principle, control mechanism, technology or energy source. Therefore, the change does not affect the essential performance of the NAV3i Platform. | | Topic | Predicate Device | Subject Device | Equivalence assessment | | Power Supply | External power source: AC Power supply, 120V, 50/60Hz including off-the- shelf uninterruptible power supply (UPS) for power interruptions less than or equal to 10 minutes. | External power source: AC Power supply, 100/240V, 50/60Hz. including off-the-shelf uninterruptible power supply (UPS) for power interruptions less than or equal to 6 minutes. | Equivalent: The time difference does not alter the operating principle and does not raise new safety or effectiveness issues. | | Articulated arms | Weight balanced articulated arms have the monitor and localization camera mounted. Approximately 1000 mm arms with three joints for camera and monitor movement are offered. | Same mechanical principal of spring arms with the same degrees of freedom. Change in arm lengths: monitor arm length is about 900 mm, Navigation Camera arm length is about 1300 mm. | Equivalent: Improved ergonomics for alignment and handling of the Navigation Camera and monitor in the OR space. The operating principle of the Platform is not affected. | | Cart Housing | The Cart I Platform is equipped with 4 castors with brakes. The cart housing contains the computer, the computer interfaces as well as the two articulated arms carrying the camera and the monitor. | The NAV3i Platform is equipped with 4 castors with brakes and additional cable guards. The cart housing contains the computer, the computer interfaces as well as the two articulated arms carrying the Navigation Camera and the monitor. | Equivalent: The industrial design is changed but the mechanical structure and functioning is similar. The performance of the platform is not changed and no new safety and effectiveness issues are raised. | | Dimensional Specifications | Outer dimensions: Length x Width x Height: 762 x 762 x 1880 mm Weight: 249.5 kg | Outer dimensions: Length x Width x Height: 960 x 720 x 1920 mm Weight: 250 kg | Equivalent: Only slight modifications which do not impact the performance of the Stryker Navigation Platform and do not raise new safety and effectiveness issues. | Table 1 {3}------------------------------------------------ : . . . 1 . {4}------------------------------------------------ . . . . . . {5}------------------------------------------------ The following table gives an overview of all design features which remain the same between the predicate device and the subject device. Table 2 | Design features which remain the same | | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Control mechanism | The Platform is controlled by a standard PC interface including mouse and keyboard input functions and a display. In addition, the Stryker Navigation Application Software can be remotely controlled by Stryker Smart Instruments over an infrared communication interface. During surgery, the software is controlled via Stryker Smart Instruments. | | Operating principle | The Platform runs Stryker Navigation Application Software on a Windows PC based system. For patient data import and export, the Platform provides standard state-of- the-art storage media and network interfaces. For video import the system provides a standard state-of-the-art video interface to capture live video. The Platform offers an active optical localization device, i.e. the Navigation Camera. The Navigation Camera allows three-dimensional localization of the Stryker Smart Instruments which are equipped with LEDs by detecting the position of the light center of each infrared LED. | | Movability | The Platform is equipped with four castors and is movable within a hospital. | | General design | Both devices have articulated arms to carry the monitor and the camera and have a housing body to carry a Windows-based computer. | | Microscope data interface | Both platform models encompass a microscope data interface. | The modifications do not alter the basic technology, do not raise any new issues regarding safety and effectiveness and support substantial equivalence of the subject device. {6}------------------------------------------------ #### 7. Non-clinical Testing Validation activities, including usability testing, have been conducted to provide assurance that the device meets the performance requirements under the indications for use conditions. In addition, verification tests, such as electrical safety acc. to IEC 60601-1, have been performed to show that the device is safe and effective. The following table contains a complete list of all tests performed to support substantial equivalence, gives a basic description of the test procedure in the column "Basic description" and the conclusion or results obtained from the test in the column "Conclusion/Result". | Test | Basic description | Conclusion/Result | |---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | User Need Validation | Scope of the test is to validate the Indications For Use and the user needs of the NAV3i Platform under simulated use case situations. | Validation successful, all user needs met | | Human Factors Engineering (HFE) | This test is conducted to validate the NAV3i Platform with respect to use errors following the FDA guidance paper Draft Guidance for Industry and Food and Drug Administration Staff. Applying Human Factors and Usability Engineering to Optimize Medical Device Design. | Validation successful, device safe and effective with respect to use errors | | Safety Test regarding risk analysis | Implementation and effectiveness of all risk control measures specified in the NAV3i Platform risk analysis are tested and verified. | Risk Control measures are effective and mitigate the associated risks | | Product Safety Test regarding medical electrical equipment | Compliance with AAMI/ANSI ES60601-1:2005/A1:2012 for medical electrical equipment is tested. Part 1: General requirements for basic safety and essential performance Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | Compliance with standards' requirements demonstrated, no deviations | | Accuracy Test | The Stryker Navigation System's accuracy is tested using the NAV3i Platform, a Stryker Navigation Software Application, Smart Instruments and Accessories following the ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. | All accuracy specifications met with statistical significance | {7}------------------------------------------------ | Test | Basic Description | Conclusion/ Result | |--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | Integration Tests with Stryker Navigation Software Applications | The NAV3i Platform is restricted to operation with Stryker Navigation Software Application Modules only. To demonstrate compatibility of the NAV3i Platform with existing Application Modules, integration tests have been performed. The integration of SpineMap 3D Navigation, OrthoMap 3D Navigation, Versatile Hip Navigation, Express Knee Navigation, Precision Knee Navigation, Fluoro Navigation, FluoroMap Navigation and CranialMap Navigation Software Application Modules has been tested with the NAV3i Platform according to Design Input requirements under simulated clinical use conditions. | All Application Modules meet specifications on NAV3i Platform as on previous platforms | | Startup Reliability | Tested NAV3i Platform start up reliability over lifetime including Stryker Navigation Software Application Modules across multiple usages. The number of test samples and test runs required to simulate reliability over lifetime was defined using statistical methods. | Device electronically reliable over the specified lifetime | | Robustness for every day use | Tested NAV3i Platform robustness by simulating transport inside hospital and intraoperative use over lifetime. The number of test samples and test runs required to simulate reliability over lifetime was defined using statistical methods. | Device mechanically robust over the specified lifetime | | Shipment Test | Test of shipment conditions of the NAV3i Platform in transport cases was performed according to ASTM D 4169-09. | Device fully functional after shipment | All non-clinical tests successfully passed demonstrating that the subject device performs as safely and effectively as the predicate device and supporting substantial equivalence. #### 8. Clinical Testing No clinical testing has been conducted. #### 9. Conclusions The conclusions drawn from the nonclinical tests demonstrate that the NAV3i Platform performs as safely and effectively as the legally marketed device identified in section 3. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the NAV3i Platform is substantially equivalent to the predicate device with respect to its indications for use, technological characteristics and performance characteristics. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 27, 2013 Stryker Navigation Ms. Lilian Eckert Senior Regulatory Affairs Specialist Boetzinger Strasse 41 Freiburg. Baden-Wuerttemberg 79111 Germany Rc: K130874 Trade/Device Name: NAV3i Platform Regulation Number: 21 CFR 882.4560 Regulation Name: Neurologic Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, OLO Dated: August 26, 2013 Received: August 28. 2013 Dear Ms. Eckert: 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. Issing of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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 (sec above) into cither 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 {9}------------------------------------------------ Page 2 - Ms. Eckert 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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/Industrv/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/Safetv/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance 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. # Joyce M. Whang -S for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ ## Indications for Use 510(k) Number (if known): Device Name: Styker NAV3i Platform Indications For Use: The NAV3i Platform is a computer workstation that, when used with specific Stryker Navigation surgical software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NAV3i Platform is that of a patient undergoing a surgical procedure using stereotactic techniques. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Joyce M. Whang -S | |-------------------| |-------------------| Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD) K130874 510(k) Number __ Page 1 of 1

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