Real Intelligence™ CORI™

K240139 · Blue Belt Technologies, Inc. · OLO · Mar 18, 2024 · Neurology

Device Facts

• Record ID: K240139
• Device Name: Real Intelligence™ CORI™
• Applicant: Blue Belt Technologies, Inc.
• Product Code: OLO · Neurology
• Decision Date: Mar 18, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

REAL INTELLIGENCE 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

CORI is a robotic-assisted orthopedic surgical navigation and burring system used in hospital/clinical settings by surgeons. It utilizes a passive infrared tracking camera to track anatomical structures. The system creates a 3D model of the patient's femur and tibia using either pre-operative image-based data or intraoperative data collection. Surgeons use this model to plan implant placement. During surgery, the system provides spatial boundaries; it controls the surgical bur by retracting it into a guard or regulating its speed based on proximity to the planned target surface. Surgeons can also operate the drill as a standard navigated tool. The system assists in precise bone preparation for UKR, TKA, revision knee, and THA procedures, potentially improving implant alignment and surgical accuracy.

Clinical Evidence

Bench testing only. Software verification testing performed per IEC 62304. Summative usability validation testing conducted in a simulated use environment per IEC 62366 demonstrated that representative users could safely and effectively perform TKA and UKA procedures using the updated software workflows.

Technological Characteristics

Robotic-assisted surgical navigation and burring system. Uses passive infrared tracking camera. Features software-defined spatial boundaries for bur control (exposure and speed regulation). Supports image-based (pre-operative) and image-free (intraoperative) data collection. Connectivity includes virtual machine with hypervisor for Windows-based software. Software developed per IEC 62304; usability per IEC 62366.

Indications for Use

Indicated for surgical procedures where stereotactic surgery is appropriate and reference to rigid anatomical bony structures can be determined, including unicondylar knee replacement (UKR), total knee arthroplasty (TKA), revision knee arthroplasty, 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™ (K231963)

Submission Summary (Full Text)

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March 18, 2024

Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Herlinger Corrine Senior Principal Regulatory Affairs Specialist 2828 Railroad Street Pittsburgh, Pennsylvania 15222

### Re: K240139

Trade/Device Name: Real Intelligence™ CORI™ Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 17, 2024 Received: January 18, 2024

### Dear Herlinger Corrine:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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### K240139 - Herlinger Corrine

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-S

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

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### Indications for Use

510(k) Number (if known) K240139

Device Name REAL INTELLIGENCE CORI

#### Indications for Use (Describe)

REAL INTELLIGENCE 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),
- · revision knee arthroplasty, and
- total hip arthroplasty (THA).

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

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Image /page/3/Picture/2 description: The image shows the logo for Smith+Nephew. The logo is in orange and features the company name in a bold, sans-serif font. The plus sign is slightly raised and connects the two words.

# 510(k) Summary

| 510(k) Owner | Blue Belt Technologies, Inc.<br>2875 Railroad Street<br>Pittsburgh, PA 15222 USA<br>Tel: [phone] |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Corrine Herlinger<br>Senior Principal Regulatory Affairs Specialist<br>Tel: [phone]<br>Email: [e-mail] |
| Date Prepared | March 14, 2024 |
| Classification Reference | 21 CFR 882.4560 |
| Product Code | OLO |
| Supported Codes | HSX, JWH, MBH, NJD |
| Common/Usual Name | Orthopedic Stereotaxic Instrument |
| Trade/Proprietary Name | REAL INTELLIGENCE™ CORI™ (CORI) |
| Predicate Device(s) | REAL INTELLIGENCE™ CORI™ (K231963) |
| Reason for Submission | The purpose of this Traditional 510(k) submission is<br>to seek clearance for a modification to CORI to<br>integrate an image-based planning option into the<br>Total Knee Arthroplasty (TKA) and Unicondylar<br>Knee Replacement (UKR) applications. |

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Smith+Nephew

## Intended Use

REAL INTELLIGENCE 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

REAL INTELLIGENCE 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),
- revision knee arthroplasty, 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. For knee applications, CORI aids the surgeon in planning the surgical implant location and in executing the surgical plan by controlling the cutting engagement of the surgical bur.

For knee applications, 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.
- o 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.

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Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc.

## 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 |
| SMITH & NEPHEW, INC. REVISION KNEE SYSTEM | K043440 | JWH |
| REVISION KNEE SYSTEM | K041106 | JWH |
| LEGION RK TIBIAL WEDGES (Hemi-Step & Full-Step) | K953274 | JWH |
| LEGION COBALT CHROME REVISION KNEE SYSTEM | K060742 | JWH |
| LEGION Knee System | K180334 | JWH, MBH |
| ENGAGE Partial Knee System | K190439 | NJD, HSX |
| JOURNEY II UK™ and ENGAGE™ Cementless Partial<br>Knee System | K222653 | NJD, HSX |

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Smith+Nephew

## Discussion of Similarities and Differences

This Traditional 510(k) submission supports an update to integrate an image-based planning option into the TKA and UKR applications. The proposed modification to CORI will allow the CORI 3.0 software to import a pre-operative plan if desired by the surgeon.

The modifications made to support the change do not impact the system's intended use, indications for 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 (K221224).

#### Table 1: Predicate Device

| Manufacturer | Description | Submission Number | Clearance Date |
|------------------------------|------------------------|-------------------|----------------|
| Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI | K231963 | 08/01/2023 |

| Feature | Subject Device<br>CORI | Primary Predicate<br>CORI – K231963 |
|--------------------------------------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same as predicate. | REAL INTELLIGENCE CORI (CORI) is intended to<br>assist the surgeon in providing software-<br>defined spatial boundaries for orientation and<br>reference information to anatomical structures<br>during orthopedic procedures. |
| Indications for<br>Use | Same as predicate. | 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),<br>• total knee arthroplasty (TKA),<br>• revision knee arthroplasty, and<br>• total hip arthroplasty (THA). |
| Knee Implant<br>Product Codes<br>Supported | Same as predicate. | HSX, JWH, MBH, NJD |
| Environment of<br>Use | Same as predicate. | CORI is intended to be used by trained medical<br>professionals in a hospital or clinical setting<br>equivalent to an orthopedic surgery suite. |

#### Table 2: Summary of Technological Similarities with Predicate

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Image /page/7/Picture/2 description: The image shows the logo for Smith+Nephew. The logo is in orange font. The plus sign is slightly raised between the two names.

| Feature | Subject Device<br>CORI | Primary Predicate<br>CORI - K231963 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | 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. | 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. |
| | CORI uses either pre-operative data (for<br>image-based cases) or intraoperative data<br>collection (for image-free or non-CT data<br>generation cases) to create a model of the<br>patient's femur and tibia in CORI tracking<br>space and allows the surgeon to<br>prepare/modify the surgical plan. | CORI uses intraoperative data collection<br>(image-free or non-CT data generation) to<br>create a model of the patient's femur and tibia<br>in CORI tracking space and allows the surgeon<br>to prepare/modify a surgical plan. |
| | 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 to shape<br>the operative condyle or tibial plateau in<br>preparation for placement of the surgical<br>implant. | The system uses predefined boundaries<br>generated during the planning process to<br>control the motion of the surgical bur and limit<br>the amount of bone removed to shape the<br>condyles or tibial plateau in preparation for<br>placement of the surgical implant. |
| | Bur cutting is controlled either by retracting<br>the bur in a guard, or by controlling the speed<br>of the bur as the target surface is<br>approached. | Bur cutting is controlled either by retracting<br>the bur in a guard, or by controlling the speed<br>of the bur as the target surface is approached.<br>To support the hip application, CORI uses a<br>Virtual Machine with hypervisor to enable the |
| | To support the hip application, CORI uses a<br>Virtual Machine with hypervisor to enable the<br>Windows-based HIP7 software to run on<br>CORI. | Windows-based HIP7 software to run on CORI. |

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Smith+Nephew

# Non-Clinical Testing (Bench)

Design verification and validation testing demonstrated that CORI meets all design requirements and is as safe and effective as its predicate device (K231963). Comprehensive testing demonstrated that the system meets required design inputs. Additionally, the following evidence was provided:

- . 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 Device Software Functions.
- . Summative usability validation testing demonstrating that representative users were able to use the subject device safely and effectively in a simulated use environment. Human factors and usability engineering processes were followed per IEC 62366 - Application of Usability Engineering to Medical Devices.

Per Human Factors evaluation, updates made to the graphical user interface and software workflows for TKA and UKA in support of the RI.KNEE-v3.0.0 software were found to be safe and effective for the intended users, uses, and use environments. The study demonstrated that the surgeon users were able to safely and effectively perform tasks necessary to execute TKA and UKA procedures using the CORI system.

# Conclusion

The subject device, CORI, described in this submission has the same intended use, indications for use, and fundamental scientific technology as the predicate device, CORI (K231963). The difference between the two systems is an update to CORI to integrate an image-based planning option into the Total Knee Arthroplasty (TKA) and Unicondylar Knee Replacement (UKR) applications. The proposed modification to CORI will allow the CORI 3.0 software to import a pre-operative plan if desired by the surgeon.

The key determining factor in establishing substantial equivalence is whether CORI can register the pre-operative plans safely and effectively. Comprehensive verification testing demonstrated that the system meets required design inputs. Summative usability validation testing established that representative users can use the subject device safely and effectively in a simulated use environment.

The information presented in this 510(k) premarket notification demonstrates that CORI with image-based planning is as safe and effective as the predicate device (K231963). Blue Belt Technologies believes that FDA can find CORI to be substantially equivalent to the predicate device.