REAL INTELLIGENCE CORI (CORI)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that. June 12, 2020 Blue Belt Technologies, Inc. Corrine Herlinger Principal Regulatory Affairs Specialist 2905 Northwest Blvd., Ste. 40 Plymouth, Minnesota 55441 Re: K201022 Trade/Device Name: Real Intelligence Cori Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, HSX, HRY, NPJ Dated: May 14, 2020 Received: May 15, 2020 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K201022 Device Name REAL INTELLIGENCE CORI (CORI) Indications for Use (Describe) CORI 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) and total knee arthroplasty (TKA). CORI is indicated for use with cemented implants only. Type of Use (Select one or both, as applicable) | <span style="font-size:10px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------| | <span style="font-size:10px">☐</span> 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. 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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>Principal Regulatory Affairs Specialist<br>Tel: 412-683-3844 x4128<br>Email: corrine.herlinger@smith-nephew.com | | Date Prepared | June 12, 2020 | | Classification Reference | 21 CFR 882.4560 | | Product Code | OLO | | Supported Codes | HSX, HRY, NPJ | | Common/Usual Name | Orthopedic Stereotaxic Instrument | | Trade/Proprietary Name | REAL INTELLIGENCE® CORI® (CORI) | | Predicate Device(s) | REAL INTELLIGENCE® CORI® (CORI) (K193120) (Primary Predicate)<br>NAVIO Surgical System (Navio system) (K191223) | | Reason for Submission | New Indication | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo features 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. # Intended Use REAL INTELLIGENCE CORI (CORI) 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 CORI 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) and total knee arthroplasty (TKA). CORI is indicated for use with cemented implants only. # Device Description CORI is a computer-assisted orthopedic surgical navigation and surgical burring system. CORI 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 intraoperatively-defined bone landmarks and known geometry of the surgical implant, CORI aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. CORI software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes: - 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 robotic system retracts the bur inside the guard, disabling cutting. - . Speed control regulates the signal going to the drill motor controller itself and limits the speed of the drill if the target surface is approached. Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill. {5}------------------------------------------------ Image /page/5/Picture/0 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. # Currently Supported Knee Implants The following knee implants are supported on CORI: ### Table 1: Currently Supported Knee Implants | Implant Model Name | Manufacturer | 510(k) Number | |-----------------------------------------|------------------|---------------------------| | JOURNEY II Unicompartmental Knee System | Smith and Nephew | K191211 | | JOURNEY UNI | Smith and Nephew | K102069 | | STRIDE Unicondylar Knee | Smith and Nephew | K123380 | | ZUK Select Knee System | Smith and Nephew | K160738 | | 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 | | ANTHEM | Smith and Nephew | K142807 | ## Discussion of Similarities and Differences The subject device, CORI, is substantially equivalent to the predicate devices: CORI (K193120) and the Navio system (K191223). The intended use and the established technologies used to prepare bone for the attachment of implant components, including implant accuracy, is the same as the predicate devices. The CORI UKR and TKA software applications feature a workflow that is nearly identical to the predicate devices, cleared via K191223 and K193120. Table 2: Summary of Technological Similarities with Predicates | Devices | Subject Device<br>CORI | Primary Predicate<br>CORI<br>[K193120] | Secondary Predicate<br>NAVIO Surgical System<br>[K191223] | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | REAL INTELLIGENCE CORI<br>(CORI) is intended to assist<br>the surgeon in providing<br>software-defined spatial<br>boundaries for orientation<br>and reference information<br>to anatomical structures<br>during orthopedic<br>procedures. | REAL INTELLIGENCE CORI<br>(CORI) is intended to assist<br>the surgeon in providing<br>software-defined spatial<br>boundaries for orientation<br>and reference information<br>to anatomical structures<br>during orthopedic<br>procedures. | The NAVIO Surgical System is<br>intended to assist the surgeon<br>in providing software-defined<br>spatial boundaries for<br>orientation and reference<br>information to anatomical<br>structures during orthopedic<br>procedures. | | Devices | Subject Device<br>CORI | Primary Predicate<br>CORI<br>[K193120] | Secondary Predicate<br>NAVIO Surgical System<br>[K191223] | | Indications for<br>Use | CORI is indicated for use in<br>surgical knee procedures<br>in which the use of<br>stereotactic surgery may<br>be appropriate, and where<br>reference to rigid<br>anatomical bony<br>structures can be<br>determined. These<br>procedures include<br>unicondylar knee<br>replacement and total<br>knee arthroplasty.<br><br>CORI is indicated for use<br>with cemented implants<br>only. | CORI is indicated for use in<br>unicondylar knee<br>replacement (UKR) surgical<br>knee procedures, in which<br>the use of stereotactic<br>surgery may be<br>appropriate, and where<br>reference to rigid<br>anatomical bony structures<br>can be determined.<br><br>CORI is indicated for use<br>with cemented implants<br>only. | The NAVIO system is indicated<br>for use in surgical knee<br>procedures in which the use<br>of stereotactic surgery may be<br>appropriate, and where<br>reference to rigid anatomical<br>bony structures can be<br>determined. These<br>procedures include<br>unicondylar knee<br>replacement, patellofemoral<br>arthroplasty, and total knee<br>arthroplasty.<br><br>The NAVIO system is indicated<br>for use with cemented<br>implants only. | | Implant<br>Product Codes<br>Supported | HSX, HRY, NPJ | | HRY, HSX, JWH, KRR, NPJ | | Environment<br>of Use | Same as primary<br>predicate. | CORI is intended to be used<br>by trained medical<br>professionals in a hospital<br>or clinical setting equivalent<br>to an orthopedic surgery<br>suite. | | | Technological<br>Characteristics | CORI uses established<br>technologies to prepare<br>bone for attachment of<br>UKR and TKA implant<br>components. In the case of<br>a total knee arthroplasty,<br>the bone surface may also<br>be prepared to receive the<br>femoral and tibial cutting<br>guides.<br><br>CORI uses intraoperative<br>data collection (image-free<br>or non-CT data generation)<br>to create a model of the | | The NAVIO system uses<br>established technologies to<br>prepare bone for attachment<br>of UKR, PFA, or TKA implant<br>components. In the case of a<br>total knee arthroplasty, the<br>bone surface may also be<br>prepared to receive the<br>femoral and tibial cutting<br>guides.<br><br>NAVIO uses intraoperative<br>data collection (image-free or<br>non-CT data generation) to<br>create a model of the | | Devices | Subject Device<br>CORI | Primary Predicate<br>CORI<br>[K193120] | Secondary Predicate<br>NAVIO Surgical System<br>[K191223] | | | patient's femur and/or<br>tibia, dependent on the<br>procedure being<br>performed, and allows the<br>surgeon to prepare a<br>surgical plan.<br><br>CORI uses predefined<br>boundaries generated<br>during the planning<br>process to control the<br>motion of the surgical bur<br>and limit the amount of<br>bone removed in order to<br>shape the condyles or<br>tibial plateau in<br>preparation for placement<br>of the surgical implant.<br><br>During a TKA procedure,<br>the surgeon may choose to<br>prepare the bone surface<br>for receiving the implant<br>using the Bur All method<br>or the bone surface is<br>prepared to receive the<br>femoral and tibial cutting<br>guides with final bone<br>surface for receiving the<br>implant prepared using a<br>standard surgical saw.<br><br>Bur cutting is controlled<br>either by retracting the bur<br>in a guard, or by<br>controlling the speed of<br>the bur as the target<br>surface is approached. | | patient's femur and/or tibia,<br>dependent on the procedure<br>being performed, and allows<br>the surgeon to prepare a<br>surgical plan.<br><br>The NAVIO system uses<br>predefined boundaries<br>generated during the planning<br>process to control the motion<br>of the surgical bur and limit<br>the amount of bone removed<br>in order to shape the<br>condyles, tibial plateau, or<br>patellofemoral joint in<br>preparation for placement of<br>the surgical implant.<br><br>During a TKA procedure, the<br>surgeon may choose to<br>prepare the bone surface for<br>receiving the implant using<br>the Bur All method or the<br>bone surface is prepared to<br>receive the femoral and tibial<br>cutting guides with final bone<br>surface for receiving the<br>implant prepared using a<br>standard surgical saw.<br><br>Bur cutting is controlled either<br>by retracting the bur in a<br>guard, or by controlling the<br>speed of the bur as the target<br>surface is approached. | Page 3 of 6 {6}------------------------------------------------ Image /page/6/Picture/0 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 763.452.4950 Fax 763.452.4675 www.bluebelttech.com Page 4 of 6 ReshapingMobility™ {7}------------------------------------------------ Image /page/7/Picture/0 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 763.452.4950 Fax 763.452.4675 www.bluebelttech.com Page 5 of 6 {8}------------------------------------------------ Image /page/8/Picture/0 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. # Non-Clinical Testing (Bench) Design verification and validation testing was performed to demonstrate that CORI meets all design requirements and is as safe and effective as its predicate devices. Comprehensive performance testing demonstrated that the system meets required design inputs. Performance data consisted of physical performance test for all system components and system accuracy testing. Additionally, the following testing was conducted: - Biocompatibility testing demonstrating that the system satisfies the requirements of BS EN ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process. - Software verification testing, including software integration and workflow testing, was completed. Software was developed in accordance with IEC 62304 Medical device software - Software life cycle processes, and this submission contains documentation per the requirements of FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. - . Usability Engineering Validation Testing demonstrating that representative users were able to safely and effectively use CORI in a simulated use environment. No human clinical testing was required to determine the safety and effectiveness of CORI. ## Conclusions The subject device, CORI, described in this submission has the same intended use and the same technological characteristics as the predicate devices, CORI (K193120) and the NAVIO system (K191223). The primary difference between the subject device and CORI (K193120) is the update to the system's indications for use to add the TKA application onto the CORI system. The CORI TKA application is based on existing NAVIO TKA software version 7.0. The main functionality of the TKA software is the same as presented in K191223, with modifications to allow for communication with the CORI accessories (robotic drill, tablet, foot pedal, camera, and optional monitor). The key determining factor in establishing substantial equivalence is whether CORI can accurately accomplish the desired bone cutting in accordance with the surgical plan. The comparative results of the cut-to-plan accuracy data is acceptable and equivalent to the predicate devices. Usability engineering test results demonstrate that representative users are able to use the subject device safely and effectively in a simulated use environment. The information presented in this Special 510(k) premarket notification demonstrates that the updated CORI is as safe and effective as the predicates, CORI (K193120) and the NAVIO system (K191223). Blue Belt Technologies believes that FDA can find CORI to be substantially equivalent to the predicate devices. Page 6 of 6