NAVIO™ Surgical System (NAVIO system)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is blue and white and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION". April 6, 2018 Blue Belt Technologies, Inc. Corrine Herlinger Senior Regulatory Affairs Associate 2905 Northwest Blvd., Ste. 40 Plymouth, Minnesota 55441 Re: K180271 Trade/Device Name: NAVIO™ Surgical System (NAVIO system) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 12, 2018 Received: March 13, 2018 Dear Corrine Herlinger: 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). 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) K180271 Device Name NAVIO™ Surgical System (NAVIO system) 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) | | |--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | ### 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. 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The logo is clean and modern, with a focus on the company name. # 510(k) Summary | 510(k) Owner | Blue Belt Technologies, Inc.<br>2905 Northwest Blvd Ste. 40<br>Plymouth, MN 55441 USA<br>Tel: (763) 452-4950<br>Fax: (763) 452-4675 | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Corrine Herlinger<br>Senior Regulatory Affairs Associate<br>Tel: (412) 683-3844 x 4128<br>Email: corrine.herlinger@smith-nephew.com | | Date of Submission | January 29, 2018 | | Classification Reference | 21 CFR 882.4560 | | Product Code | OLO | | Supported Codes | HSX, HRY, KRR, NPJ, JWH | | Common/Usual Name | Orthopedic Stereotaxic Instrument | | Trade/Proprietary Name | NAVIO™ Surgical System (NAVIO system) | | Predicate Device(s) | NAVIO system (K170360) | | Reason for Submission | The NAVIO system has been updated to<br>incorporate a newer model of the optical tracking<br>camera and upgrade the NAVIO system's Operating<br>System. | {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, bold, blue letters. Below "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters. The logo is clean and professional, suggesting a technology-oriented company. ## 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, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, light gray, sans-serif font. The overall design is clean and modern. ### Currently Supported Total Knee Implants The following total knee implants are supported on the Navio system: ### Table 1: Currently Supported Total Knee Implants | Implant Model Name | Manufacturer | 510(k) Number | |-----------------------|---------------------|---------------------------| | JOURNEY II CR | Smith and Nephew | K121443 | | JOURNEY II BCS | Smith and Nephew | K111711 | | JOURNEY II XR | Smith and Nephew | K141471, K152726 | | 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 | ## Discussion of Similarities and Differences The NAVIO system presented in this 510(k) submission is substantially equivalent to the predicate NAVIO, K170360. 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 NAVIO system tracking camera change, and - . the NAVIO system Operating System upgrade. The implant product codes supported by the subject device are consistent with the predicate device. 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. The UKR, PFA, and TKA workflows have not changed from the predicate device, cleared via K170360. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Blue Belt Technologies. The logo consists of a stylized blue swirl 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. The logo is clean and modern, and the blue color suggests trust and reliability. ### Table 2: Summary of Technological Similarities with Predicate | | Subject Device | Predicate Device | |----------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | NAVIO [Subject] | NAVIO [K170360] | | Intended use | Same as Predicate. | The NAVIO system is intended to assist<br>the surgeon in providing software-defined<br>spatial boundaries for orientation and<br>reference information to anatomical<br>structures during orthopedic procedures. | | Indications for Use | Same as Predicate. | The NAVIO system is indicated for use in<br>surgical knee procedures in which the use<br>of stereotactic surgery may be<br>appropriate, and where reference to rigid<br>anatomical bony structures can be<br>determined. These procedures include<br>unicondylar knee replacement (UKR),<br>patellofemoral arthroplasty (PFA), and<br>total knee arthroplasty (TKA).<br><br>The NAVIO system is indicated for use<br>with cemented implants only. | | Supported Product<br>Code(s) | Same as Predicate. | HSX, HRY, KRR, NPJ, JWH | | Environment of Use | Same as Predicate. | Intended for use by trained orthopedic<br>surgeons in an orthopedic surgical suite. | | Technological<br>Characteristics | Same as Predicate. | The NAVIO system uses established<br>technologies to prepare bone for<br>attachment of UKR, PFA, or TKA implant<br>components. In the case of a total knee<br>arthroplasty, the bone surface may also be<br>prepared to receive the femoral and tibial<br>cutting guides.<br><br>NAVIO uses intraoperative data collection<br>(image-free or non-CT data generation) to<br>create a model of the patient's femur<br>and/or tibia, dependent on the procedure<br>being performed, and allows the surgeon<br>to prepare a surgical plan.<br><br>The NAVIO system uses predefined<br>boundaries generated during the planning<br>process to control the motion of the<br>surgical bur and limit the amount of bone | | | | removed in order to shape the condyles,<br>tibial plateau, or patellofemoral joint in<br>preparation for placement of the surgical<br>implant. | | | | During a TKA procedure, the surgeon may<br>choose to prepare the bone surface for<br>receiving the implant by utilizing the Bur<br>All method or the bone surface may be<br>prepared to receive the femoral and tibial<br>cutting guides (if cut guides are utilized,<br>the bone surface is prepared using a<br>standard surgical saw). | | | | 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™ {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. The logo is clean and modern, with a focus on the company name. ## 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 verification, and drawing inspections. Trained technical support personnel performed verification accuracy testing using simulated knees (sawbones) to ensure that the changes made to the tracking camera and Operating System performed as intended and did not impact the accuracy of the NAVIO system. The testing verified that the NAVIO system with the updated optical tracking camera and upgraded Operating System is as safe and effective as the predicate device. ## 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 K170360. The differences in the updated tracking camera and Operating System do not raise any new questions of safety or effectiveness. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Blue Belt Technologies. The logo consists of a stylized blue swirl 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. The logo is clean and modern, with a focus on the company name. The key determining factor is whether NAVIO control can be applied accurately to accomplish the desired cutting in accordance with the plan. The accuracy testing performed demonstrates that the updated NAVIO system meets the same accuracy specifications required for the predicate device. The NAVIO system presented in this 510(k) premarket notification demonstrates that the updated NAVIO system, with the updated optical tracking camera and upgraded Operating System continues to be as safe and effective as the predicate NAVIO system (K170360).