Fusion Compact Navigation System

K153247 · Medtronic Navigation, Inc. · PGW · Feb 18, 2016 · Neurology

Device Facts

• Record ID: K153247
• Device Name: Fusion Compact Navigation System
• Applicant: Medtronic Navigation, Inc.
• Product Code: PGW · Neurology
• Decision Date: Feb 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Medtronic Fusion Compact computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT procedures. Their use 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 skull, can be identified relative to images of the anatomy.

Device Story

FUSION Compact is an electromagnetic (EM) image-guided surgical navigation platform for ENT procedures (e.g., skull base, FESS). It inputs pre-operative CT or MR images and tracks specialized surgical probes in real-time using an EM localization system (AxiEM II). The system consists of an all-in-one PC/monitor, EM field transmitter, and navigation software. During surgery, the system continuously updates the probe position on the displayed anatomical images. Surgeons use this real-time positional feedback to validate their judgment and guide instruments relative to patient anatomy. Used in medical offices or operating rooms by surgeons to improve precision in locating anatomical structures.

Clinical Evidence

Bench testing only. No clinical data. Testing included AAMI/ANSI ES 60601-1 and IEC 60601-1-2 compliance, software/hardware verification, and 3D positional accuracy testing. Accuracy was validated in simulated surgical office and OR environments, demonstrating a maximum error ≤ 3.0 mm.

Technological Characteristics

Electromagnetic navigation system; Intel-based PC/monitor all-in-one; AxiEM II localization; Class D amplifier; USB 1.1/2.0 connectivity. Software runs on Ubuntu Linux (C++). Emitter stand/clamp mounting. Supports 4-coil ports (up to 4 coils per port). Standards: AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 62366.

Indications for Use

Indicated for patients undergoing open or percutaneous ENT procedures where stereotactic surgery is appropriate and rigid anatomical structures (e.g., skull) can be referenced to imaging.

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 GoldenEye Micro-Magnetic Tracking System Option (K001284)

Submission Summary (Full Text)

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

February 18, 2016

Medtronic Navigation, Inc. Rishi Sinha Principal Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K153247

Trade/Device Name: Fusion Compact Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: January 15, 2016 Received: January 19, 2016

Dear Mr. Sinha:

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 devicerelated 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.

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go

to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet

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

Sincerely yours,

# Eric A. Mann -S

for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) N/A

Device Name Fusion Compact Navigation System

#### Indications for Use (Describe)

The Medtronic Fusion Compact computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT procedures. Their use 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 skull, can be identified relative to images of the anatomy.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|

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### 510(k) Summary

| Submitter: | Medtronic Navigation, Inc.<br>826 Coal Creek Circle<br>Louisville, CO 80027 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Rishi Sinha (Primary)<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| | Michael Blasco (Alternate)<br>Senior Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Summary Prepared: | January 15, 2016 |
| Device Trade Name: | Medtronic FUSION Compact™ Navigation System |
| Common Name: | Ear Nose and Throat Stereotaxic Instrument |
| Device Classification: | Class II |
| Product Code: | PGW |
| Classification Name: | 882.4560 - Stereotaxic Instrument |
| Predicate Device: | K001284 - StealthStation System GoldenEye Micro-Magnetic<br>Tracking System Option |
| Device Description: | The FUSION Compact™ system is a surgical guidance platform<br>that supports use of special application software and associated<br>instruments. The system reformats patient-specific CT or MR<br>images acquired before surgery and displays them on-screen from<br>a variety of perspectives (axial, sagittal, coronal). During surgery,<br>the system tracks the position of specialized surgical probes in or<br>on the patient anatomy and continuously updates the probe<br>position on these images. |
| | While the surgeon's judgment remains the ultimate authority,<br>real-time positional information obtained through the FUSION<br>Compact™ system can serve to validate this judgment as well as<br>guide. |
| | The FUSION Compact™ is an Electromagnetic-based navigation<br>system, also known as an Image Guided System (IGS), which<br>consists of clinical navigation software, a referencing system and |
| | platform/computer hardware. Navigation tracks the position of<br>navigated instruments in relation to the surgical anatomy and<br>identifies this position on diagnostic or intraoperative images of<br>the patient. The FUSION Compact™ system is modular and<br>designed for use in medical office or operating room environments<br>to conduct ENT procedures including Endoscopic Skull Base,<br>Lateral Skull Base, and Functional Endoscopic Sinus Surgery<br>(FESS) procedures. The FUSION Compact™ will utilize a monitor<br>and PC all-in-one computer and a free-standing emitter holder<br>option. The system supports the FUSION Compact™ 1.0<br>software application. The FUSION Compact™ will interface with<br>the existing Electromagnetic (EM) localization system and existing<br>ENT instruments. |
| Indications for Use: | The Medtronic FUSION Compact™ computer-assisted surgery<br>system and its associated applications are intended as an aid for<br>precisely locating anatomical structures in either open or<br>percutaneous ENT procedures. Their use is indicated for any<br>medical condition in which the use of stereotactic surgery may be<br>appropriate, and where reference to a rigid anatomical structure,<br>such as the skull, can be identified relative to images of the<br>anatomy. |

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| <b>Substantial Equivalence:</b> | The FUSION Compact™ Navigation System is substantially equivalent to the following device: |
|---------------------------------|--------------------------------------------------------------------------------------------|
|---------------------------------|--------------------------------------------------------------------------------------------|

- K001284 StealthStation System GoldenEye Micro-. Magnetic Tracking System Option

| | Subject Device | Predicate |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | FUSION Compact™<br>Navigation System | StealthStation GoldenEye<br>(K001284) |
| Classification | Class II | Class II |
| Product Code | PGW; 882.4560 - Stereotaxic<br>Instrument | HAW; 882.4560 - Stereotaxic<br>Instrument |
| Indications for<br>Use | The Medtronic FUSION<br>Compact™ computer-assisted<br>surgery system and its<br>associated applications are<br>intended as an aid for precisely<br>locating anatomical structures in<br>either open or percutaneous<br>ENT procedures. Their use is<br>indicated for any medical<br>condition in which the use of<br>stereotactic surgery may be<br>appropriate, and where | The StealthStation®<br>GoldenEye System is intended<br>as an aid for precisely locating<br>anatomical structures in either<br>open or percutaneous<br>procedures. The<br>StealthStation® System is<br>indicated for any medical<br>condition in which the use of<br>stereotactic surgery may be<br>appropriate, and where<br>reference to a rigid anatomical |
| | Subject Device | Predicate |
| | FUSION Compact™<br>Navigation System | StealthStation GoldenEye<br>(K001284) |
| | reference to a rigid anatomical<br>structure, such as the skull, can<br>be identified relative to a CT- or<br>MR-based model or digitized<br>landmarks of the anatomy. | structure, such as the skull, a<br>long bone, or vertebra, can be<br>identified relative to a CT-<br>based or MR-based model,<br>fluoroscopy images, or<br>digitized landmarks of the<br>anatomy. |
| | | Example procedures include<br>but are not limited to: |
| | | Cranial procedures:<br>■ Cranial biopsies<br>■ Tumor resections<br>■ Craniotomies/craniectomies<br>■ Skull base procedures<br>Thalamotomies/pallidotomies |
| | | Spinal implant procedures,<br>such as pedicle screw<br>placement |
| | | ENT procedures:<br>■ Transphenoidal procedures<br>■ Intranasal procedures<br>■ Orbital nerve decompression<br>procedures<br>Sinus procedures, such as<br>maxillary antrostomies,<br>ethmoidectomies,<br>sphenoidotomies/sphenoid<br>explorations, turbinate<br>resections, and frontal<br>sinusotomies |
| Operating<br>Principle | The electromagnetic system<br>collects measurements,<br>determines position and<br>orientation from each coil<br>independently. The system<br>transmits multiple magnetic<br>fields within which the receive<br>coils can be measured. A<br>measurement for each coil within<br>each transmitted field is used to | The electromagnetic system<br>collects measurements,<br>determines position and<br>orientation from each coil<br>independently. The system<br>transmits multiple magnetic<br>fields within which the receive<br>coils can be measured. A<br>measurement for each coil<br>within each transmitted field is |
| | Subject Device | Predicate |
| | FUSION Compact™<br>Navigation System | StealthStation GoldenEye<br>(K001284) |
| | determine the position and<br>orientation of the coil.<br>Measurement position andcombined to determine the<br>instrument position and<br>orientation. Two measured<br>positions, one from each coil,<br>are utilized to determine position<br>and orientation of a two coiled<br>instrument. Three measured<br>positions, one from each coil,<br>are utilized to determine position<br>and orientation of a three coiled<br>instrument. | used to determine the position<br>and orientation of the coil.<br>Measurement position and<br>orientation for the coils are<br>combined to determine the<br>instrument position and<br>orientation. Two measured<br>positions, one from each coil,<br>are utilized to determine position<br>and orientation of a two coiled<br>instrument. |
| System Accuracy | Maximum error less than 3.0 mm<br>at 95% confidence and 99.5%<br>reliability. | Mean error is less than 2.0 mm<br>with 99% confidence level of<br>4.0 mm |
| Computer and Software Technology | | |
| Computer | Intel-Based PC<br>Computer/Monitor all-in-one | Intel-Based PC |
| Operating<br>System | Linux-Based: Ubuntu | Linux-based IRIX |
| Programming<br>Language | C++ | C++ |
| Clinical Software<br>Features | Imaging modalities, registration<br>features, views (axial, coronal,<br>sagittal) | Imaging modalities, registration<br>features, views (axial, coronal,<br>sagittal) |
| Electromagnetic Technology | | |
| Electromagnetic<br>Localization<br>System | Medtronic Navigation AxiEM II<br>Integrated | Medtronic Navigation AxiEM I<br>Integrated |
| EM Configuration | EM field transmitter creates an<br>EM field that is used to track<br>and triangulate on the receive<br>coils | EM field transmitter creates an<br>EM field that is used to track<br>and triangulate on the receive<br>coils |
| Communication | USB 1.1 and 2.0 | Serial Line (RS-232) Connection |
| Amplifier<br>Technology | Class D | Class AB |
| Digitizer Box | CAC and NPI integrated into a<br>single unit, portable and<br>mountable | CAC and NPI provided in<br>separate components as cart on<br>wheels |
| Instrument ports | 4-coils per port, 8 ports in total | 2-coils per port, 6 ports in total |
| | Subject Device | Predicate |
| | FUSION Compact™<br>Navigation System | StealthStation GoldenEye<br>(K001284) |
| Mobile Emitter | Emitter generates a low-<br>intensity magnetic field to locate<br>coils mounted within the tracker | Emitter generates a low-<br>intensity magnetic field to locate<br>coils mounted within the tracker |
| EM Mounting<br>apparatus | Emitter Stand or Emitter Clamp | No mounting capability as this<br>unit is incorporated into the cart<br>and mounting is not needed. |
| Interfacing | Navigation Probe Interface (NPI)<br>is configured for up to 4 coils per<br>connection port. The<br>instruments used are designed<br>with 2 or 3 receive coils per<br>instrument. Each of the receive<br>coils is connected via the<br>instrument cable to the<br>instrument. | Navigation Probe Interface (NPI)<br>is configured for up to 2 coils per<br>connection port. The<br>instruments used are designed<br>with 2 receive coils per<br>instrument. Each of the receive<br>coils is connected via the<br>instrument cable to the<br>instrument connector, which is<br>then connected to the NPI<br>through a connection port. |

## Table 1: FUSION Compact™ Predicate Device Comparison Table

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Performance Testing: Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted on the FUSION Compact™ Navigation System to establish substantial equivalence of the system and verify that the device will perform as intended meeting all of the design inputs:

- AAMI/ANSI ES 60601-1:2012 Medical Electrical ● Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- . IEC 60601-1-2:2014 - Medical Electrical Equipment -Part 1-2: General requirements for safety; Electromagnetic Compatibility - Requirements and Tests (2/2014)
- Software Verification and Validation testing verifying the . software requirements are met and software performs as intended
- . Hardware Verification testing ensuring the hardware requirements identified for the system are met and hardware performs as intended
- Accuracy Testing was conducted to ensure that the ● FUSION Compact met the prescribed requirement for accuracy. The FUSION Compact System demonstrates performance in 3D positional accuracy with a maximum error ≤ 3.0 mm. This performance was determined using a peqboard in a surqical office and OR simulated environment with all of the typical instruments and equipment seen in those environments. The upper bound

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of the tip error data for both the surgical office and OR simulated environments was determined by statistical data analysis.

- Usability Testing was conducted in accordance to IEC . 62366 demonstrating that the usability and human factors requirements were adequately met.
Conclusion: The FUSION Compact™ Navigation System is similar in technological characteristics, imaging performance and indications for use as the predicate devices listed. These aspects, along with the functional testing conducted to the FDA recognized standards, demonstrate that FUSION Compact™ Navigation System does not raise new risks of safety and effectiveness when compared to the predicates.