Who is the manufacturer of NAVIO?

Blue Belt Technologies, Inc. filed the 510(k) submission for NAVIO (K140596).

What is the FDA product code for NAVIO?

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

What is the regulatory pathway for NAVIO?

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

What are the predicate devices for NAVIO?

Blue Belt Technologies, Inc. NavioPFS™ (K121936); MAKO Surgical Corp. Tactile Guidance System v2.0 (K081867).

Who can help prepare an FDA 510(k) submission like NAVIO?

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.

NAVIO

K140596 · Blue Belt Technologies, Inc. · OLO · Jul 2, 2014 · Neurology

Device Facts

Record ID	K140596
Device Name	NAVIO
Applicant	Blue Belt Technologies, Inc.
Product Code	OLO · Neurology
Decision Date	Jul 2, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Navio is a computer-assisted orthopedic surgical navigation and burring system. It uses a passive infrared tracking camera (Northern Digital Polaris) to track anatomical structures and surgical instruments. The system creates an intraoperative, image-free bone surface model to plan implant placement. During surgery, the system provides software-defined spatial boundaries to guide the surgeon. The device utilizes a standard surgical drill motor and bur (eMax 2 Plus System) adapted with a tracking system. The software controls the bur tip position relative to a guard; it either retracts the bur into the guard or modulates bur speed as the surgeon approaches the planned target surface to prevent bone removal beyond the plan. Used in clinical settings by surgeons to assist in unicondylar knee replacement and patellofemoral arthroplasty. The system logs procedure data, including patient ID, implant ID, and process steps, which can be archived. It aids in precise bone shaping, potentially improving implant alignment and patient outcomes.

Clinical Evidence

No human clinical tests were conducted. Evidence consists of bench testing, including software code reviews, unit/integration testing, and clinical simulation (usability testing) using sawbones and cadaver labs. Testing demonstrated that surgeons, physician assistants, and technical support could successfully use the system to place implants per specifications.

Technological Characteristics

System includes IR tracking camera (Northern Digital Polaris), reflective trackers, computer, display, probes, surgical bur, and reusable bur guards. Operates via intraoperative, image-free data collection to generate bone models. Controls bur motion/speed via software-defined boundaries. Connectivity includes CD archiving for data logs. Software-controlled mechanical retraction or speed modulation of the bur.

Indications for Use

Indicated for surgical knee procedures, specifically unicondylar knee replacement and patellofemoral arthroplasty, where stereotactic surgery is appropriate and rigid bony landmarks are identifiable. 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, Inc. NavioPFS™ (K121936)
MAKO Surgical Corp. Tactile Guidance System v2.0 (K081867)

Reference Devices

eMax 2 Plus System (K080802)

Related Devices

K121936 — NAVIOPFS · Blue Belt Technologies, Inc. · Nov 30, 2012
K143668 — Navio · Blue Belt Technologies, Inc. · Mar 20, 2015
K152574 — Navio · Blue Belt Technologies, Inc. · Oct 20, 2015
K180271 — NAVIO Surgical System (NAVIO system) · Blue Belt Technologies, Inc. · Apr 6, 2018
K160537 — Navio · Blue Belt Technologies, Inc. · May 19, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ # JUL 0 2 2014 #### Traditional 510(k) 005_510(k) Summary K140596 Navio™ | | - | | : . | : 2 | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------| | V | | | | 0.97 | | : | - ﻳﺔ ﺍﻟﺘﻲ ﺗﻌﻠﻴﻤﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ 动 … -44-4 | : | - | : 2014 16 - | | | 41 6 | | -20-6 | . | | Salens of the a Parte 4.200 2 300 - 1 | en u Vs. . A 1 .V | ﺘ : | | ﺒ 16-08-28 11: | | IM B | | | 20 1 ﺮ | | | ﻨﺔ : | 1000 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | : . | . | | | - And Controller of the Comments of Children ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | . | 1976 - 1975 - 1991 - 1991 - 1991 - 1991 - 1991 - 19 | Company Control Concession Company Concession | . and the contraction of the contraction of the comments of the comments of the comments of the comments of | | 510(k) Owner | Blue Belt Technologies, Inc. 2828 Liberty Ave., Suite 100 Pittsburgh, PA 15222 Tel: (412) 683-3844 Fax: (412) 683-6447 | |--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Richard G. Confer Vice President of Quality Assurance and Regulatory Affairs Tel: (412) 683-3844 x 4106 Email: rconfer@bluebelttech.com | | Date of Submission | June 27, 2014 | | Classification Reference | 21 CFR 882.4560 | | Product Code | OLO | | Product Codes of Implants Supported by the Navio | HSX, HRY, KRR | | Common/Usual Name | Orthopedic Sterotaxic Instrument | | Trade/Proprietary Name | Navio™ | | Predicate Device(s) | Blue Belt Technologies, Inc. NavioPFS™ (K121936) MAKO Surgical Corp. Tactile Guidance System v2.0 (K081867) | | Reason for Submission | Expanded Indications | {1}------------------------------------------------ #### 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, MAKO TGS (K081867) and expands the intended use statement of the NavioPFS (K121936) to include the patellofemoral knee replacement application. #### 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. {2}------------------------------------------------ During Patient Registration, the user selects the operative procedure to be completed: Navio - UKR for Unicondylar Knee Replacement > Hardware Connection Handpiece Connection Bur/Control Selection Handpiece Retraction Handpiece Calibration Handpiece Home Position Homing Validation Bone Tracker Attachment Camera Orientation Adjustment Point Probe Verification Checkpoint Definition Malleoli Point Collection Hip Center Calculation Femur Neutral Postion Femur Kinematic Axis Stressed ROM Collection Femur Landmark Point Selection Femur Free Collection Tibia Landmarks Collection Tibia Free Collection Prosthesis Placement Gap Planning Adjust Component ML Position Checkpoint Verification Bone Model Refinement Bone Removal Evaluate Knee ROM During Patient Registration, the user selects the operative procedure to be completed: Navio - PFA for Patellofemoral Arthroplasty > Hardware Connection Handpiece Connection Bur/Control Selection Handpiece Retraction Handpiece Calibration Handpiece Home Position Homing Validation Bone Tracker Attachment Camera Orientation Adjustment Point Probe Verification Checkpoint Definition Hip Center Calculation Femur Landmark Point Selection Femur Free Collection Prosthesis Placement Checkpoint Verification Bone Model Refinement Bone Removal Blue Belt Technologies, Inc. Navio™ {3}------------------------------------------------ Navio™ | Summary of Similarities and Differences Navio, NavioPFS™, and Tactile Guidance System v2.0 | | | | |-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Devices | Premarket Notification Subject Device | Predicate A | Predicate B | | | Blue Belt Technologies Navio™ | Blue Belt Technologies NavioPFS™ (K121936) | MAKO Surgical Corp. Tactile Guidance System v2.0 (K081867) | | | Technological Characteristics | The Navio system uses established technologies, as described for the NavioPFS, 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/or tibia, dependent on the procedure being performed, and allows the surgeon to prepare a surgical plan. This is equivalent to the methodology used by the NavioPFS. 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. Bur cutting is controlled either by retracting the bur in a guard, or by controlling the speed of the bur as the target surface is approached. | The NavioPFS™ uses intraoperative data collection (image free or non-CT data generation) to create a model of the patient's femur and tibia and allows the surgeon to prepare a surgical plan. The NavioPFS™ 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 and tibial plateau in preparation for placement of the surgical implant. Bur cutting is controlled either by retracting the bur in a guard, or by controlling the speed of the bur as the target surface is approached. | | Construction | Consists of an IR image system (Northern Digital Polaris), reflective trackers, computer, user interface display, various probes, a surgical bur, reusable bur guards, bone screws and clamps | Consists of an IR image system (Northern Digital Polaris), reflective trackers, computer, user interface display, various probes, a surgical bur, sterile bur guards, bone screws and clamps | Consists of an IR image system (Northern Digital Polaris), reflective trackers, computer, user interface display, various probes, a surgical bur, bone screws and clamps. | | | clamps. | | | | Summary of Similarities and Differences | | | | | Navio, NavioPFSTM, and Tactile Guidance System v2.0 | | | | | Devices | Premarket Notification Subject Device | Predicate A | Predicate B | | | Blue Belt Technologies NavioTM | Blue Belt Technologies NavioPFSTM (K121936) | MAKO Surgical Corp. Tactile Guidance System v2.0 (K081867) | | Pre-Surgical Planning Method | Uses data collected intra- operatively by surgeon during the initial surgical procedure to generate a real time plan of cut surfaces. | Uses data collected intra- operatively by surgeon during the initial surgical procedure to generate a real time plan of cut surfaces. | Uses DICOM data imported from pre-operative CT scans. | | Imaging Requirements | None preoperative. Possible post-operative to verify implant placement after surgeon finalizes placement | None preoperative. Possible post-operative to verify implant placement after surgeon finalizes placement | CT Scans required preoperatively. Possible post-operative scans to confirm implant placement after surgeon finalizes placement. | ## Summary of Technological Similarities with Predicates: Blue Belt Technologies, Inc. {4}------------------------------------------------ Navio™ ### Nonclinical testing: Design verification tests were performed on the Blue Belt Technologies Navio system as a result of the risk analysis and product requirements. Testing included software code reviews, software unit testing, software integration testing, bench verification testing, user manual/labeling inspection, drawing inspections, and a clinical simulation (usability testing). Simulated-use testing included testing in simulated knees (sawbones) and cadaver lab testing. Users included surgeons, physician's assistants, and technical support personnel who were able to successfully use the Navio system and place implants per Blue Belt Technologies' specifications after being adequately trained. ## 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 allows the surgeon to prepare a surgical plan. The Navio uses predefined boundaries generated during the planning process to control 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. This is equivalent to the methodology used by the NavioPFS™ system except for the Navio's additional capability to prepare the patellofemoral joint for 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. This is similar to the methods used by the MAKO TGS system to prepare the condyles, tibial plateau, and patellofemoral joint, although the MAKO TGS system uses a preoperative CT scan in addition to intra-operatively acquired data to plan the position of implant components. Though the UKR and PFA procedures are very similar, they are mutually independent and cannot be planned or completed in parallel. If the user is completing a bi-compartmental knee joint replacement in which a patellofemoral arthroplasty and a unicondylar knee replacement are both being performed, preparation of the patellofemoral joint must be completed independently of the preparations of the femoral condyle and tibial plateau surfaces. Blue Belt Technologies, Inc. {5}------------------------------------------------ ## Clinical testing No human clinical tests were conducted to determine safety and effectiveness of the Navio system. ## Summary and Conclusions The Navio system has the same intended use as the MAKO TGS system (K081867) and has the same technological characteristics as the NavioPFS system (K121936). Non clinical testing was completed to verify that the differences in technological characteristics and workflow do not raise any new issues of safety or effectiveness. The information presented in this 510(k) notification demonstrates that the Navio is as safe and effective and performs as well as the Blue Belt Technologies NavioPFS™ (K121936) or the MAKO Surgical Corp. Tactile Guidance System v2.0 (K081867). {End of tab} {6}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three lines representing its wings and body. The eagle is facing left, and the overall design is simple and iconic. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Blue Belt Technologies, Incorporated Mr. Richard G. Confer Vice President of Quality Assurance and Regulatory Affairs 2828 Liberty Avenue, Suite 100 Pittsburgh, Pennsylvania 15222 July 2, 2014 Re: K140596 Trade/Device Name: Navio Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HSX, HRY, KRR Dated: June 5, 2014 Received: June 6. 2014 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. Iisting 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 he advised that FDA`s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 {7}------------------------------------------------ #### Page 2 - Mr. Richard G. Confer 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/ResourcesforYou/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, ## Mark N. Melkerson -S - Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. 510(k) Number (if known) unknown K140596 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) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ... のお店での中国の一部に、採用・保育・保育・FOR FOR FOR FOR FOR FOR FOR FOR MAN Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) **Casey L. Hanley, Ph.D.** Division of Orthopedic Devices