Navio

K152574 · Blue Belt Technologies, Inc. · OLO · Oct 20, 2015 · Neurology

Device Facts

• Record ID: K152574
• Device Name: Navio
• Applicant: Blue Belt Technologies, Inc.
• Product Code: OLO · Neurology
• Decision Date: Oct 20, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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. 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 and patellofemoral arthroplasty. The Navio system is indicated for use with cemented implants only.

Device Story

Computer-assisted orthopedic surgical navigation and burring system; uses passive infrared tracking camera to collect intraoperative data; creates bone surface model; surgeon plans implant location based on landmarks; system provides software-defined spatial boundaries; controls surgical bur (eMax 2 Plus) to limit bone removal; bur retracts into guard or speed is controlled as target surface is reached; used in orthopedic surgical suite by trained surgeons; assists in shaping condyles, tibial plateau, or patellofemoral joint; benefits include precise bone preparation for cemented implants.

Clinical Evidence

No human clinical tests were conducted. Evidence consists of bench verification testing, biocompatibility testing, shelf-life testing, labeling validation, and clinical simulation (usability validation) using simulated knees (sawbones) and cadaver labs.

Technological Characteristics

Computer-assisted navigation system; passive infrared tracking camera; surgical bur handpiece with guard; image-free/non-CT data generation; software-defined spatial boundaries; cemented implant compatibility; disk-shaped infrared reflective tracking markers.

Indications for Use

Indicated for patients undergoing surgical knee procedures, specifically unicondylar knee replacement and patellofemoral arthroplasty, where stereotactic surgery is appropriate and rigid anatomical bony structures can be referenced. 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

• Blue Belt Technologies Navio Surgical System (K143668)

Reference Devices

• eMax 2 Plus System (K080802)

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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three human profiles facing to the right, stacked on top of each other.

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

October 20, 2015

Blue Belt Technologies, Incorporated Richard Confer Vice President of Regulatory Affairs 2905 Northwest Blvd., Suite 40 Plymouth, Minnesota 55441

Re: K152574

Trade/Device Name: Navio Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, HSX, HRY, KRR, NPJ Dated: September 4, 2015 Received: September 9, 2015

Dear Mr. 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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,

Lori A. Wiggins -S

for 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)

K152574

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 and patellofemoral arthroplasty.

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

| 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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# Section 6: 510(k) Summary

# 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] |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration # | 3010266064 |
| Contact Person | Richard G. Confer<br>Vice President of Regulatory Affairs<br>Tel: [phone] x 4106<br>Email: [e-mail] |
| Date of Submission | 09/04/2015 |
| Classification Name | 21 CFR 882.4560 [Orthopedic Stereotaxic Instrument] |
| Product Code | OLO |
| Supported Codes | HSX, HRY, KRR, NPJ |
| Common/Usual Name | Computer-Assisted Surgical System |
| Trade/Proprietary Name | NavioTM |
| Predicate Device(s) | Blue Belt Technologies Navio Surgical System<br>[K143668] |
| Reason for Submission | Special 510(k) for a device modification to incorporate<br>a new reflective tracking marker for use with the<br>Navio surgical system. |

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## 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.

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 and patellofemoral arthroplasty.

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

This intended use statement is the same as the predicate, Navio System per K143668.

## 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 to plan the surgical implant location based on predefined bone landmarks and known configuration of the surgical implant. The Navio system then aids the surgeon in executing the surgical plan by using a standard off-the-shelf surgical drill motor and bur (eMax 2 Plus System -K080802), which has been adapted using a tracking system. The surgical bur is located in a handpiece, which allows the bur to move within the handpiece. In the Navio system the software controls the position of the tip of the surgical bur relative to the end of a guard attached to the handpiece and prohibits the bur from cutting bone as it approaches the planned target surface. As the planned surface is reached, the tip of the bur is fully retracted within the guard.

An alternate mode of operation is the speed control mode. In this mode the speed of the bur is controlled and the bur stops as the planned surface is reached. In this mode of operation the bur does not retract into the guard. This mode of operation is useful in shaping surfaces of the condyle as well as placing post holes.

The Navio computer system maintains a log of the patient data and procedure data. Each entry is date and time stamped. Data log entries include date and time stamp for data line entry, patient and procedure ID, implant ID, step in process, and error messages. This data can be archived to a CD upon demand at the end of the procedure.

The following diagram shows the primary workflow steps in each application, UKR and PFA. Though the two procedures are very similar, they are mutually independent and cannot be planned or completed in parallel.

Note: The workflow has not changed from the predicate, Navio per K143668.

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#### Figure 6-1

Image /page/5/Figure/2 description: This image shows two flowcharts that describe the operative procedure for two different types of knee replacement surgeries. The flowchart on the left describes the procedure for Navio - UKR for Unicondylar Knee Replacement, while the flowchart on the right describes the procedure for Navio - PFA for Patellofemoral Arthroplasty. Both flowcharts start with "Hardware Connection" and end with "Bone Removal", but they have different steps in between. The UKR procedure has more steps than the PFA procedure, including "Malleoli Point Collection", "Femur Neutral Postion", "Femur Kinematic Axis", "Stressed ROM Collection", "Tibia Landmarks Collection", "Tibia Free Collection", "Gap Planning", "Adjust Component ML Position", and "Evaluate Knee ROM".

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| Devices | Blue Belt<br>Technologies<br>Navio | Predicate A<br>Blue Belt Technologies<br>Navio (K143668) |
|----------------------------------|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Same as Predicate | The Navio system is intended to assist the<br>surgeon in providing software-defined spatial<br>boundaries for orientation and reference<br>information to anatomical structures during<br>orthopedic procedures. |
| | | The Navio System is indicated for use in<br>surgical knee procedures in which the use of<br>stereotactic surgery may be appropriate, and<br>where reference to rigid anatomical bony<br>structures can be determined. |
| | | These procedures include unicondylar knee<br>replacement and patellofemoral arthroplasty.<br>The Navio system is indicated for use with<br>cemented implants only. |
| Supported Product<br>Code | Same as Predicate | Supported Product Codes:<br>HSX, HRY, KRR, NPJ |
| Environment of Use | Same as Predicate | Used by trained orthopedic surgeons in an<br>Orthopedic surgical suite. |
| Technological<br>Characteristics | Same as Predicate | The Navio system uses established<br>technologies to prepare bone for attachment<br>of implant components. Navio uses<br>intraoperative data collection (image- free or<br>non-CT data generation) to create a model of<br>the patient's femur and/or tibia, dependent<br>on the procedure being performed, and allows<br>the surgeon to prepare a surgical plan.<br>The Navio system uses predefined boundaries<br>generated during the planning process to<br>control the motion of the surgical bur and<br>limit the amount of bone removed in order to<br>shape the condyles, tibial plateau, or<br>patellofemoral joint in preparation for<br>placement of the surgical implant. |
| | | Bur cutting is controlled either by retracting<br>the bur in a guard, or by controlling the speed<br>of the bur as the target surface is approached. |

| Table 6-1: Summary of Technological Similarities with Predicates | | | | | |
|------------------------------------------------------------------|--|--|--|--|--|
|------------------------------------------------------------------|--|--|--|--|--|

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### Nonclinical Testing

Design verification tests were performed on the Blue Belt Technologies Navio system to support substantial equivalence of the subject device.

Testing to support the Flat Marker design included bench verification testing, biocompatibility testing, shelf-life testing, labeling validation, and a clinical simulation (usability validation testing). Simulated-use testing included testing in simulated knees (sawbones) and cadaver lab testing. Users included surgeons and technical support personnel who were able to successfully use the Navio system.

### Clinical Testing

No human clinical tests were conducted to determine safety and effectiveness of the Navio system.

### Discussion of Similarities and Differences

The Navio system uses established technologies to prepare bone for attachment of implant components. Navio uses intraoperative data collection (image-free or non-CT data generation) to create a model of the patient's femur and tibia and allow the surgeon to prepare a surgical plan. The Navio uses predefined 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.

The Navio uses predefined 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, and/or the patellofemoral joint in preparation for placement of the surgical implant.

The primary difference between the subject device described in this submission and the Navio system (K143668) is the change from the spherical infrared, reflective tracking markers to a new disk-shaped, infrared, reflective tracking marker. The new diskshaped infrared, reflective tracking marker is substantially equivalent to the currently used spherical reflecting tracking markers.

## Summary and Conclusions

The Navio system described in this submittal has the same intended use and the same fundamental scientific technology as the Navio system (K143668). Non-clinical testing was completed to verify that the use of the Navio system with the new, disc-shaped infrared, reflective tracking markers does not raise any new issues of safety or effectiveness. The information presented in this 510(k) notification demonstrates that the Navio system, with updated tracking markers, is as safe and effective as Navio (K143668).