NAVIO

K170360 · Blue Belt Technologies, Inc. · OLO · May 2, 2017 · Neurology

Device Facts

• Record ID: K170360
• Device Name: NAVIO
• Applicant: Blue Belt Technologies, Inc.
• Product Code: OLO · Neurology
• Decision Date: May 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The NAVIO system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

Device Story

Computer-assisted orthopedic surgical navigation and burring system; uses passive infrared tracking camera to create intraoperative image-free bone surface models; surgeon defines surgical plan based on landmarks and implant geometry. System controls surgical bur (Anspach eMax2 Plus) via exposure control (retracting bur into guard) or speed control (limiting motor speed) based on proximity to planned target surface. Used in OR by orthopedic surgeons. Provides spatial boundaries for bone preparation; enables 'Bur All' method for total knee arthroplasty (TKA) or placement of cut guides for manual saw use. Footpedal activation required for cutting. Benefits include precise bone removal and implant placement accuracy.

Clinical Evidence

No human clinical testing conducted. Evidence consists of bench testing, including software database reviews, labeling/drawing inspections, and usability testing. Verification accuracy testing performed on simulated knees (sawbones) and cadaver laboratory testing to validate TKA procedure performance in a simulated OR environment.

Technological Characteristics

Computer-assisted navigation system using passive infrared tracking. Employs image-free/non-CT intraoperative data collection. Controls off-the-shelf surgical drill motor/bur (Anspach eMax2 Plus) via software-defined spatial boundaries. Features include exposure control (guard retraction) and speed control. Supports cemented implants only. System is used in orthopedic surgical suites.

Indications for Use

Indicated for surgical knee procedures (UKR, PFA, TKA) where stereotactic surgery is appropriate and reference to rigid anatomical bony structures can be determined. Indicated for use with cemented implants only.

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

• NAVIO system (K160537)

Reference Devices

• Anspach eMax2 Plus System (K080802)
• JOURNEY II CR (K121443)
• JOURNEY II BCS (K111711)
• GENESIS II CR/PS (K951987, K962557)
• LEGION CR/PS (K951987, K962557, K093746)
• NEO Total Knee System (K142388)
• NAVIO (K121936)
• NAVIO (K140596)
• NAVIO (K143668)
• NAVIO (K152574)

Submission Summary (Full Text)

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

### 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

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

May 2, 2017

Blue Belt Technologies, Inc. Richard Confer Director, Regulatory Affairs 2905 Northwest Blvd. Ste. 40 Plymouth, Minnesota 55441

Re: K170360

Trade/Device Name: Navio Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, HRY, KRR, NPJ, JWH, HSX Dated: February 2, 2017 Received: February 6, 2017

Dear Richard Confer:

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

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

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.

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.

# 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)

K170360

Device Name Navio

### Indications for Use (Describe)

The Navio system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Navio system is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement (UKR), patellofemoral arthroplasty (PFA), and total knee arthroplasty (TKA),

The Navio system is indicated for use with cemented implants only.

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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

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

## K170360 - Page 1 of 8

Image /page/3/Picture/1 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The overall design is clean and modern.

2905 Northwest Boulevard, Suite 40, Plymouth, Minnesota 55441 USA Tel [phone] Fax [phone] www.bluebelttech.com

enhancements to the NAVIO system TKA software.

# 510(k) Summary

| 510(k) Owner | Blue Belt Technologies, Inc.<br>2905 Northwest Blvd Ste. 40<br>Plymouth, MN 55441 USA<br>Tel: [phone]<br>Fax: [phone] |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Richard G. Confer<br>Director, Regulatory Affairs<br>Tel: [phone] x 4106<br>Email: [e-mail] |
| Date of Submission | February 2, 2017 |
| Classification Reference | 21 CFR 882.4560 |
| Product Code | OLO |
| Supported Codes | HSX, HRY, KRR, NPJ, JWH |
| Common/Usual Name | Orthopedic Sterotaxic Instrument |
| Trade/Proprietary Name | NAVIO° Surgical System (NAVIO system) |
| Predicate Device(s) | NAVIO system (K160537) |
| Reason for Submission | Addition of the Smith & Nephew LEGION® Total<br>Knee System CR/PS and GENESIS® II CR/PS Total<br>Knee System to the list of supported implants,<br>updates to the NAVIO Total Knee Arthroplasty<br>(TKA) instrument kit and components, and feature |

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

Image /page/4/Picture/1 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The overall design is clean and modern.

## Intended Use

The NAVIO system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

## Indications for Use

The NAVIO system is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement (UKR), patellofemoral arthroplasty (PFA), and total knee arthroplasty (TKA).

The NAVIO system is indicated for use with cemented implants only.

The Intended Use and Indications for Use statements are the same as the predicate device.

## Device Description

The NAVIO system is a computer-assisted orthopedic surgical navigation and surgical burring system. The system uses established technologies of navigation, via a passive infrared tracking camera, to aid the surgeon in establishing a bone surface model for the target surgery and in planning the surgical implant location, based on intraoperativelydefined bone landmarks and known geometry of the surgical implant. The NAVIO system then aids the surgeon in executing the surgical plan by using a standard off-theshelf surgical drill motor and bur (Anspach eMax2 Plus System, cleared via K080802), which has been adapted using a tracking system.

The surgical bur is inserted into a handpiece, which allows the bur to move within the handpiece. The NAVIO system software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved in two ways:

- Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the NAVIO system retracts the bur inside the guard, disabling cutting.
- . Speed control regulates the signal going to the drill motor controller itself and will limit the speed of the drill if the target surface is approached. This mode of operation is useful in shaping surfaces of the condyle as well as placing post holes and fixation features for femoral and tibial cut guides.

Additionally, the surgeon can disable both controls and operate the NAVIO system handpiece as a standard navigated surgical drill. The surgeon must press on a footpedal to activate the surgical bur and enable cutting in all modes.

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

Image /page/5/Picture/1 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, bold, blue letters. Below "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters.

### UKR and PFA Overview

In the UKR and PFA applications, the NAVIO system uses established technologies to prepare bone for attachment of implant components. The NAVIO system uses intraoperative data collection (image-free or non-CT data generation) to create a model of the patient's femur and/or tibia, depending on the procedure being performed, and allows the surgeon to prepare a surgical plan. The NAVIO system uses pre-defined boundaries generated during the planning process to control the motion of the surgical bur and limit the amount of bone removed in order to shape the condyles, tibial plateau, or patellofemoral joint in preparation for placement of the surgical implant.

### TKA Overview

Similar to the UKR and PFA applications, the TKA application uses intraoperative data collection to create a model of the patient's femur and tibia and allows the surgeon to prepare a surgical plan. In the TKA application, the NAVIO system is used to plan the location of the femur and tibia implants, as well as cut guides and position the features used to secure the cut guides in place. The NAVIO system controls the cutting action of the bur during placement of the femur and tibia cut guides. The surgeon finishes the preparation of the bone surface using standard surgical saws, guided by the slots in the cut guides. Cutting action of the saw is not controlled by the NAVIO system. The surgeon follows the implant manufacturer's recommended procedure to remove bone and place the implant, just as if the cut guide had been placed manually. The manual instrumentation technique established by each implant's manufacturer is used to prepare the remainder of the bone surface to receive the total knee implant components.

One of the enhancements to the TKA application software is the addition of a Bur All feature that enables the surgeon to prepare bone for the attachment of total knee implant components. Using the same method of bone removal as the UKR and PFA applications, the NAVIO system controls the bur either by retracting the bur in a guard (Exposure Control) or by controlling the speed of the bur (Speed Control) as the target surface is approached. The Bur All feature also provides a way for a surgeon that performed bulk bone removal using a standard surgical saw to refine the bone model and make additional fine cuts to clean up the bone surface to receive the implant.

The following diagram shows the primary workflow steps in each application: UKR, PFA, and TKA. The three procedures are mutually independent and cannot be planned or completed in parallel. Note: The workflows for UKR and PFA procedures have not changed from the predicate device, cleared via K160537.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The logo is clean and modern, with a focus on the company name.

### Figure 1: NAVIO System Workflows - UKR, PFA, and TKA

Image /page/6/Figure/4 description: This image shows three flowcharts for different applications: PFA, TKA, and UKR. Each flowchart outlines the steps involved in the respective application, starting with hardware and handpiece connections. The flowcharts progress through various stages, including bur and control selection, handpiece retraction and calibration, and homing validation. The TKA and UKR applications include additional steps specific to those procedures, such as surgical case options, bone tracker attachment, and component placement.

ReshapingMobility™

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, bold, blue letters. Below "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters.

| Implant Model Name | Manufacturer | 510(k) Number |
|-----------------------|---------------------|---------------------------|
| JOURNEY II CR | Smith and Nephew | K121443 |
| JOURNEY II BCS | Smith and Nephew | K111711 |
| GENESIS II CR/PS | Smith and Nephew | K951987, K962557 |
| LEGION CR/PS | Smith and Nephew | K951987, K962557, K093746 |
| NEO Total Knee System | New Era Orthopedics | K142388 |

### Currently Supported Total Knee Implants

## Discussion of Similarities and Differences

The NAVIO system presented in this 510(k) submission is substantially equivalent to the predicate NAVIO, K160537. The intended use, indications for use, and the general functionality of the NAVIO system are unchanged from the previously submitted device.

This submission supports the following updates to the NAVIO system:

- the addition of the Smith & Nephew LEGION Total Knee System CR/PS and GENESIS II Total Knee System CR/PS to the list of supported implants,
- . updates to the NAVIO TKA instrument kit and components, and
- feature enhancements to the NAVIO system Total Knee Application software. ●

The implant product codes supported by the subject device are consistent with the predicate device. The LEGION Total Knee System CR/PS and GENESIS II Total Knee System are cemented implants that share the product code JWH, a currently supported NAVIO product code. These implants have been successfully imported and appropriately validated for use with the NAVIO system.

The NAVIO TKA instrument kit was updated to include two new components: a new femur drill guide to support the LEGION-GENESIS II CR/PS implants and a new Twin Peg Tibia Cut Guide.

Feature enhancements were made to the NAVIO TKA application software. The NAVIO system TKA workflow, described in K160537, has been updated to improve usability of the application, simplify the user interface to remove features that were not being utilized, and to introduce new features. One of the primary features that is being introduced is the option to use the NAVIO handpiece to bur away all bone necessary to accurately place a total knee implant component; this functionality is similar to the UKR and PFA applications.

The established technologies that are used by the NAVIO system to prepare bone for attachment of implant components or for the attachment of the TKA femur and tibia cutting guides are unchanged.

Figure 2: Summary of Technological Similarities with Predicate

ReshapingMobility™

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, bold, blue letters. Below "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters.

| | Subject Device<br>NAVIO [Subject] | Predicate Device<br>NAVIO [K160537] |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Same as Predicate. | The NAVIO system is intended to<br>assist the surgeon in providing<br>software-defined spatial boundaries<br>for orientation and reference<br>information to anatomical structures<br>during orthopedic procedures. |
| Indications for<br>Use | Same as Predicate. | The NAVIO system is indicated for use<br>in surgical knee procedures in which<br>the use of stereotactic surgery may be<br>appropriate, and where reference to<br>rigid anatomical bony structures can<br>be determined. These procedures<br>include unicondylar knee<br>replacement, patellofemoral<br>arthroplasty, and total knee<br>arthroplasty.<br><br>The NAVIO system is indicated for use<br>with cemented implants only. |
| Supported<br>Product Code(s) | Same as Predicate. | HSX, HRY, KRR, NPJ, JWH |
| Environment of<br>Use | Same as Predicate. | Intended for use by trained<br>orthopedic surgeons in an orthopedic<br>surgical suite. |
| Technological<br>Characteristics | The NAVIO system uses established<br>technologies to prepare bone for<br>attachment of UKR, PFA, or TKA<br>implant components. In the case of a<br>total knee arthroplasty, the bone<br>surface may also be prepared to<br>receive the femoral and tibial cutting<br>guides.<br><br>NAVIO uses intraoperative data<br>collection (image-free or non-CT data<br>generation) to create a model of the<br>patient's femur and/or tibia,<br>dependent on the procedure being | The NAVIO system uses established<br>technologies to prepare bone for<br>attachment of UKR and PFA implant<br>components, or in the case of a total<br>knee arthroplasty, the bone surface is<br>prepared to receive the femoral and<br>tibial cutting guides.<br><br>NAVIO uses intraoperative data<br>collection (image-free or non-CT data<br>generation) to create a model of the<br>patient's femur and/or tibia,<br>dependent on the procedure being |
| | | |
| performed, and allows the surgeon to<br>prepare a surgical plan. | performed, and allows the surgeon to<br>prepare a surgical plan. | |
| The NAVIO system uses predefined<br>boundaries generated during the<br>planning process to control the<br>motion of the surgical bur and limit<br>the amount of bone removed in<br>order to shape the condyles, tibial<br>plateau, or patellofemoral joint in<br>preparation for placement of the<br>surgical implant. | The NAVIO system uses predefined<br>boundaries generated during the<br>planning process to control the<br>motion of the surgical bur and limit<br>the amount of bone removed in order<br>to shape the condyles, tibial plateau,<br>or patellofemoral joint in preparation<br>for placement of the surgical implant, | |
| During a TKA procedure, the surgeon<br>may choose to prepare the bone<br>surface for receiving the implant by<br>utilizing the Bur All method or the<br>bone surface may be prepared to<br>receive the femoral and tibial cutting<br>guides (if cut guides are utilized, the<br>bone surface is prepared using a<br>standard surgical saw). | or in the case of a total knee<br>replacement procedure, the bone<br>surface is prepared to receive the<br>femoral and tibial cutting guides. Bone<br>surface for receiving the implant is<br>prepared using a standard surgical<br>saw. | |
| Bur cutting is controlled either by<br>retracting the bur in a guard, or by<br>controlling the speed of the bur as<br>the target surface is approached. | Bur cutting is controlled either by<br>retracting the bur in a guard, or by<br>controlling the speed of the bur as the<br>target surface is approached. | |

ReshapingMobility™

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, bold, blue letters. Below "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters.

## Non-Clinical Testing (Bench)

Design verification and validation tests were performed on the NAVIO system to support the updates presented in this submission. Testing included software database reviews, bench testing, labeling inspection, drawing inspections, and usability testing.

Trained surgeons and technical support personnel performed verification accuracy testing using simulated knees (sawbones) and cadaver laboratory testing. Usability testing validated that surgeon users were able to perform a TKA procedure on cadaver in a simulated operating room environment safely and effectively using the NAVIO system with TKA application.

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The overall design is clean and modern.

## Clinical Testing

No human clinical testing was conducted to determine safety and effectiveness of the NAVIO system.

## Conclusions

The NAVIO system described in this submission has the same intended use and the same technological characteristics as the NAVIO system, most recently cleared per K160537. The differences in the methodology of bone removal between the previously cleared NAVIO system (K160537) and the additional supported total knee implant systems, as well as updated instrumentation, and software feature enhancements, do not raise any new questions of safety or effectiveness.

The key determining factor is whether NAVIO control can be applied accurately to accomplish the desired cutting in accordance with the plan without exceeding the predefined limits. The accuracy verification testing performed indicates that the total knee implant placement accuracy using Bur All method of bone removal is acceptable and similar to the implant placement accuracy required for unicondylar and patellofemoral implant placement. Additionally, placement of the LEGION CR/PS and GENESIS II CR/PS Total Knee Implant systems using the NAVIO TKA cut guides (including the new Tibia Twin Peg cut guides) is acceptable and similar to the placement accuracy presented in the previous 510(k). Usability validation testing demonstrated that surgeon users were able to perform a TKA procedure on cadaver in a simulated operating room environment safely and effectively using the NAVIO system with TKA application.

The NAVIO system presented in this 510(k) premarket notification demonstrates that the updated NAVIO system, with these additional supported total knee implants, instrument tray and component changes, and software feature enhancements, continues to be as safe and effective as the predicate NAVIO system (K121936, K140596, K143668, K152574, and K160537).

Image /page/10/Picture/9 description: The image shows the text "ReshapingMobility™" in a blue color. The text is the main focus of the image and appears to be a logo or a slogan. The background is a solid blue color, which complements the text.