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 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.

AI/ML Overview

The provided text describes a 510(k) submission for a device modification to an existing surgical navigation system (Navio). The primary change is the incorporation of a new reflective tracking marker. Therefore, the majority of the testing presented is focused on demonstrating that this modification does not negatively impact the device's safety and effectiveness compared to the predicate device.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text, noting limitations where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for the device's performance (e.g., accuracy, precision). Instead, the studies aim to demonstrate that the modified device performs "as safe and effective as" the predicate device, K143668.

The nonclinical testing section indicates "bench verification testing," "clinical simulation (usability validation testing)," and "simulated-use testing in simulated knees (sawbones) and cadaver lab testing." The outcome of these tests is stated as "successfully use the Navio system," which implies an acceptable level of performance was achieved, but specific metrics are not provided.

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly stated in quantitative terms)	Reported Device Performance
New Tracking Marker Design	Ensure the new disk-shaped reflective tracking marker functions equivalently to the spherical markers, maintaining the established accuracy and reliability of the Navio system.	Bench verification testing and simulated-use testing in sawbones and cadaver labs demonstrated that the new tracking marker allowed for successful use of the Navio system, implying equivalent performance to the predicate. No new issues of safety or effectiveness were raised.
Biocompatibility	Ensure the new tracking marker material is biocompatible.	Biocompatibility testing was performed.
Shelf-Life	Ensure the new tracking marker maintains its properties over its shelf-life.	Shelf-life testing was performed.
Labeling Validation	Ensure labeling for the modified device is accurate and appropriate.	Labeling validation was performed.
Usability	Ensure surgeons and technical support personnel can successfully use the Navio system with the new marker.	Clinical simulation (usability validation testing) with surgeons and technical support personnel demonstrated successful use of the Navio system.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- For simulated-use testing, "simulated knees (sawbones)" and "cadaver lab testing" were used. The exact number of sawbones or cadavers is not specified.
- For usability validation, "surgeons and technical support personnel" were involved, but the number of participants is not specified.
Data Provenance: The studies are described as nonclinical bench and simulated-use testing. The origin of the sawbones or cadavers is not specified, but it is implied to be laboratory-controlled since no human clinical tests were conducted. These are retrospective in the sense that they are performed on non-living specimens or models, not on live patients in a prospective clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: The document states that "Users included surgeons and technical support personnel who were able to successfully use the Navio system" during clinical simulation. The exact number of surgeons or technical support personnel is not specified.
Qualifications of Experts: The qualifications are generally stated as "surgeons" (implying orthopedic surgeons given the device's application) and "technical support personnel." Specific details like years of experience or board certifications are not provided.

4. Adjudication Method

The document does not describe a formal adjudication method for establishing ground truth or evaluating performance in the context of multiple expert opinions. The clinical simulation involved "users" (surgeons and technical support personnel) successfully using the system, suggesting a form of consensus or observation-based verification, but an explicit adjudication method (e.g., 2+1, 3+1) is not mentioned. Given the nature of a device modification and non-clinical testing, such a formal adjudication might not have been deemed necessary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No human clinical tests were conducted to determine safety and effectiveness of the Navio system." Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed.

6. Standalone Performance Study

Yes. The nonclinical testing, including bench verification and simulated-use testing (sawbones, cadaver lab), represents standalone performance testing of the device with the new tracking markers. While human "users" were involved in the simulation, the focus was on the device's ability to function correctly and facilitate the surgical procedure with the modification, without a comparison to human performance without the device or without the AI. The goal was to confirm that the device performs as intended.

7. Type of Ground Truth Used

The ground truth for these nonclinical tests appears to be based on:

Engineered/Simulated Ground Truth: For bench verification testing, the ground truth would be based on engineering specifications and known physical properties, ensuring the new marker functions according to design.
Simulated Anatomical Ground Truth: For testing in "simulated knees (sawbones)" and "cadaver lab testing," the ground truth would be the known anatomical structures or the planned surgical resections as assessed by the participating surgeons or technical personnel. This is a form of expert-guided assessment of surgical accuracy and outcome in a simulated environment.

8. Sample Size for the Training Set

This 510(k) submission is for a device modification (a new tracking marker) to an existing system. The Navio system itself is a "computer-assisted orthopedic surgical navigation and surgical burring system" that uses "intraoperative data collection (image-free or non-CT data generation) to create a model of the patient's femur and tibia."

The document does not mention a training set in the context of an AI/machine learning algorithm for the new tracking marker. The new marker is a hardware component. The existing Navio system presumably relies on established algorithms and data collected previously for its navigation and planning functions, but details on that training set (if it exists for the core algorithms) are not part of this submission. This submission is focused on demonstrating that the new marker integrates seamlessly with the existing, validated system.

9. How the Ground Truth for the Training Set was Established

As noted above, no training set for a new AI/ML algorithm related to the tracking marker is described in this document. Therefore, information on how such a ground truth would be established for a training set is not applicable/provided in this context.

Summary

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

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

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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

{2}------------------------------------------------

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 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)

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}------------------------------------------------

Section 6: 510(k) Summary

510(k) Summary

510(k) Owner	Blue Belt Technologies, Inc.2905 Northwest Blvd., Ste. 40Plymouth, MN 55441 USATel: (763) 452-4905Fax: (763) 452-4675
Establishment Registration #	3010266064
Contact Person	Richard G. ConferVice President of Regulatory AffairsTel: (412) 683-3844 x 4106Email: rconfer@bluebelttech.com
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[K143668]
Reason for Submission	Special 510(k) for a device modification to incorporatea new reflective tracking marker for use with theNavio surgical system.

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

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 with cemented implants only.

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

Device Description

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.

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

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".

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

Devices	Blue BeltTechnologiesNavio	Predicate ABlue Belt TechnologiesNavio (K143668)
Indications for use	Same as Predicate	The Navio system is intended to assist thesurgeon in providing software-defined spatialboundaries for orientation and referenceinformation to anatomical structures duringorthopedic procedures.
		The Navio System is indicated for use insurgical knee procedures in which the use ofstereotactic surgery may be appropriate, andwhere reference to rigid anatomical bonystructures can be determined.
		These procedures include unicondylar kneereplacement and patellofemoral arthroplasty.The Navio system is indicated for use withcemented implants only.
Supported ProductCode	Same as Predicate	Supported Product Codes:HSX, HRY, KRR, NPJ
Environment of Use	Same as Predicate	Used by trained orthopedic surgeons in anOrthopedic surgical suite.
TechnologicalCharacteristics	Same as Predicate	The Navio system uses establishedtechnologies to prepare bone for attachmentof implant components. Navio usesintraoperative data collection (image- free ornon-CT data generation) to create a model ofthe patient's femur and/or tibia, dependenton the procedure being performed, and allowsthe surgeon to prepare a surgical plan.The Navio system uses predefined boundariesgenerated during the planning process tocontrol the motion of the surgical bur andlimit the amount of bone removed in order toshape the condyles, tibial plateau, orpatellofemoral joint in preparation forplacement of the surgical implant.
		Bur cutting is controlled either by retractingthe bur in a guard, or by controlling the speedof the bur as the target surface is approached.

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

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

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).

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
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.(b)
Classification. Class II (performance standards).