REAL INTELLIGENCE CORI

K220255 · Blue Belt Technologies, Inc. · OLO · Mar 29, 2022 · Neurology

Device Facts

• Record ID: K220255
• Device Name: REAL INTELLIGENCE CORI
• Applicant: Blue Belt Technologies, Inc.
• Product Code: OLO · Neurology
• Decision Date: Mar 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Robotic-assisted orthopedic surgical navigation and burring system; uses passive infrared tracking camera to navigate; creates intraoperative bone surface models from landmarks; assists surgeon in planning implant location. For knee applications, system controls cutting engagement of surgical bur via exposure control (retracting bur into guard) or speed control (limiting drill speed) based on proximity to planned target surface. Surgeon can disable controls for manual navigation. Used in hospital/clinical orthopedic surgery suites by trained medical professionals. Output provides spatial boundaries and reference information; assists surgeon in shaping bone for implant placement; improves precision of bone removal and implant alignment.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed system performance for placing porous total knee implants. Summative usability testing in a simulated environment demonstrated that surgeons could use the device safely and effectively.

Technological Characteristics

Passive infrared tracking navigation; robotic-assisted burring system; software-defined spatial boundaries; exposure/speed control for bur engagement. Includes Virtual Machine with hypervisor for hip application software. Connectivity: Standalone/networked. Sterilization: Not specified. Software: Rule-based control logic for bur engagement.

Indications for Use

Indicated for surgical procedures where stereotactic surgery is appropriate and reference to rigid anatomical bony structures can be determined. Procedures include unicondylar knee replacement (UKR), total knee arthroplasty (TKA), and total hip arthroplasty (THA).

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

• REAL INTELLIGENCE CORI (K212537)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the date March 29, 2022. The text is in a simple, sans-serif font. The date is written out in full, with the month, day, and year clearly visible. The text is centered and takes up most of the image.

Image /page/0/Picture/9 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Blue Belt Technologies, Inc. Corrine Herlinger Principal Regulatory Affairs Specialist 2905 Northwest Blvd., Ste. 40 Plymouth, Minnesota 55441

Re: K220255

Trade/Device Name: REAL INTELLEGENCE CORI Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, HSX, JWH, MBH Dated: January 28, 2022 Received: January 31, 2022

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 (QS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Shumaya Ali, M.P.H. 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

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

## Indications for Use

510(k) Number (if known) K220255

Device Name REAL INTELLIGENCE CORI (CORI)

Indications for Use (Describe)

CORI is indicated for use in surgical 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), total knee arthroplasty (TKA), and total hip arthroplasty (THA).

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### 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}------------------------------------------------

Image /page/3/Picture/1 description: The image is the logo for Blue Belt Technologies. The logo has a blue swirl design on the left, followed by the words "BLUE BELT" in large blue font. Below that, the word "TECHNOLOGIES" is written in a smaller gray font.

# 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] |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Corrine Herlinger<br>Principal Regulatory Affairs Specialist<br>Tel: [phone] x 4128<br>Email: [e-mail] |
| Date of Submission | January 28, 2022 |
| Classification Reference | 21 CFR 882.4560 |
| Product Code | OLO |
| Supported Codes | HSX, JWH, MBH |
| Common/Usual Name | Orthopedic Stereotaxic Instrument |
| Trade/Proprietary Name | REAL INTELLIGENCE® CORI® (CORI) |
| Predicate Device(s) | REAL INTELLIGENCE® CORI® (K212537) |
| Reason for Submission | Updated Indications for Use |

{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, 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.

## 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 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), total knee arthroplasty (TKA), and total hip arthroplasty (THA).

## Device Description

The subject of this Traditional 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, the system aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. For knee applications, CORI then aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur.

CORI knee application 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 tool control unit 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/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, gray, sans-serif font. The logo is clean and modern, with a focus on the company name.

## Currently Supported Knee Implants

The following Smith+Nephew knee implants are supported on CORI:

### Table 1: Currently Supported Smith+ Nephew Knee Implants

| Implant Model Name | 510(k) Number | Classification<br>Product Code |
|--------------------------------------------|---------------------------|--------------------------------|
| STRIDE Unicondylar Knee | K123380 | HSX |
| ZUK Select Knee System | K160738 | HSX |
| JOURNEY II Unicompartmental Knee System | K191211 | HSX |
| JOURNEY UNI | K102069 | HSX |
| JOURNEY II CR | K121443 | JWH |
| JOURNEY II BCS | K111711 | JWH |
| JOURNEY II XR | K141471, K152726 | JWH |
| LEGION CR/PS | K951987, K962557, K093746 | JWH |
| LEGION Porous CR Femoral Components | K073325, K091543 | MBH |
| LEGION Porous CR Narrow Femoral Components | K210566 | MBH |
| LEGION Porous Tibia | K100897 | MBH |
| Porous Tibia Baseplate | K211221 | MBH |
| GENESIS II CR/PS | K951987, K962557 | JWH |
| ANTHEM | K142807 | JWH |

## Discussion of Similarities and Differences

This Traditional 510(k) submission supports an update to the CORI Indications for Use to allow the system to be used for the placement of porous total knee implants intended for use without bone cement. The modifications made to CORI to support the updated indications for use include:

- updates to the CORI labeling, and
- updates to the Implant Database (IDB) to include Smith+Nephew LEGION Porous TKS.

The modifications made to support the updated indications for use do not impact the system's intended use or fundamental scientific technology.

Blue Belt Technologies believes that CORI is subject to premarket notification requirements under Section 510(k) of the Federal Food, Drug and Cosmetic Act ("FFDCA" or "the Act") and is substantially equivalent to the previously cleared REAL INTELLIGENCE CORI (K212537).

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

Image /page/6/Picture/1 description: The image shows the logo for Blue Belt Technologies. The logo features 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.

### Table 2: Predicate Device

| Manufacturer | Description | Submission<br>Number | Clearance Date |
|------------------------------|------------------------|----------------------|----------------|
| Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI | K212537 | 11/03/2021 |

### Table 3: Summary of Technological Similarities with Predicate

| Devices | Subject Device<br>CORI | Primary Predicate<br>CORI |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K212537 |
| Intended use | REAL INTELLIGENCE CORI (CORI) is intended<br>to assist the surgeon in providing software-<br>defined spatial boundaries for orientation<br>and reference information to anatomical<br>structures during orthopedic procedures. | REAL INTELLIGENCE CORI (CORI) is intended<br>to assist the surgeon in providing software-<br>defined spatial boundaries for orientation<br>and reference information to anatomical<br>structures during orthopedic procedures. |
| Indications for<br>Use | CORI is indicated for use in surgical<br>procedures in which the use of stereotactic<br>surgery may be appropriate, and where<br>reference to rigid anatomical bony structures<br>can be determined. These procedures include<br>unicondylar knee replacement (UKR), total<br>knee arthroplasty (TKA), and total hip<br>arthroplasty (THA). | CORI is indicated for use in surgical<br>procedures in which the use of stereotactic<br>surgery may be appropriate, and where<br>reference to rigid anatomical bony structures<br>can be determined. These procedures include<br>unicondylar knee replacement (UKR), total<br>knee arthroplasty (TKA), and total hip<br>arthroplasty (THA).<br>For Knee applications, CORI is indicated for<br>use with cemented implants only. |
| Knee Implant<br>Product Codes<br>Supported | HSX, JWH, MBH | HSX, JWH |
| Environment<br>of Use | Same as predicate. | CORI is intended to be used by trained<br>medical professionals in a hospital or clinical<br>setting equivalent to an orthopedic surgery<br>suite. |

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

Image /page/7/Picture/1 description: The image is a 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.

| Devices | Subject Device<br>CORI | Primary Predicate<br>CORI<br>K212537 |
|----------------------------------|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | Same as predicate. | For knee applications, CORI uses established<br>technologies to prepare bone for attachment<br>of UKR and TKA implant components. In the<br>case of a total knee arthroplasty, the bone<br>surface may also be prepared to receive the<br>femoral and tibial cutting guides.<br><br>CORI uses intraoperative data collection<br>(image-free or non-CT data generation) to<br>create a model of the patient's femur and/or<br>tibia, dependent on the procedure being<br>performed, and allows the surgeon to<br>prepare a surgical plan.<br><br>The 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 or tibial plateau in<br>preparation for placement of the surgical<br>implant. Bur cutting is controlled either by<br>retracting the bur in a guard, or by controlling<br>the speed of the bur as the target surface is<br>approached.<br><br>To support the hip application, CORI uses a<br>Virtual Machine with hypervisor to enable<br>the Windows-based HIP7 software to run on<br>CORI. |

## Non-Clinical Testing (Bench)

Verification and validation testing demonstrated the safety and efficacy of CORI when the system is used to place porous total knee implants intended for use without bone cement. Summative usability testing demonstrated that participating surgeons were able use the subject device safely and effectively in a simulated use environment.

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image is a 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, and the blue color gives it a sense of trustworthiness and reliability.

## Conclusions

The subject device, CORI, described in this submission, has the same intended use and the same technological characteristics as the predicate device, CORI (K212537). The primary difference between the two systems is the Indications for Use, which has been updated to allow the system to be used for the placement of porous total knee implants intended for use without bone cement.

Comprehensive verification testing demonstrated that the system meets required design inputs. Summative usability testing 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 510(k) premarket notification demonstrates that CORI may be used for the placement of porous total knee implants, and that CORI is as safe and effective as the predicate CORI system (K212537). Blue Belt Technologies believes that FDA can find CORI to be substantially equivalent to the predicate device.