(113 days)
No
The description focuses on established navigation and robotic control technologies based on pre-defined bone landmarks and surgical plans, without mentioning AI or ML algorithms for tasks like image analysis, planning optimization, or adaptive control. The control modes described are rule-based (proximity to target surface).
Yes
The device is a robotic-assisted orthopedic surgical navigation and burring system indicated for use in surgical procedures such as unicondylar knee replacement (UKR), total knee arthroplasty (TKA), and total hip arthroplasty (THA). These procedures are therapeutic interventions aimed at treating conditions affecting joints.
No
The device is described as a "robotic-assisted orthopedic surgical navigation and burring system" that aids in "establishing a bone surface model for the target surgery and planning the surgical implant location" and "aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur." Its function is surgical assistance and execution, not diagnosis.
No
The device description explicitly states it is a "robotic-assisted orthopedic surgical navigation and burring system" and mentions controlling the "cutting engagement of the surgical bur," indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- CORI's Function: The description clearly states that CORI is a robotic-assisted orthopedic surgical navigation and burring system used during surgical procedures on rigid anatomical bony structures. It aids the surgeon in planning and executing bone cuts based on intraoperatively-defined landmarks and known implant geometry.
- Lack of Sample Analysis: There is no mention of CORI analyzing any biological samples from the patient. Its function is entirely focused on guiding surgical tools and controlling bone cutting based on anatomical references.
Therefore, CORI falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / 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 atthroplasty (THA).
Product codes
OLO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rigid anatomical bony structures, unicondylar knee, total knee, total hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
CORI is intended to be used by trained medical professionals in a hospital or clinical setting equivalent to an orthopedic surgery suite.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification and validation testing demonstrated that CORI meets all design requirements and is as safe and effective as its primary predicate device (K220255) and secondary predicate device OMNIBotics Knee System (K200888). Comprehensive performance testing demonstrated that the system meets required design inputs. Performance data consisted of physical performance testing for all system components. Additionally, the following evidence was provided:
-
. Biocompatibility evaluation demonstrating that the system satisfies the requirements of ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process.
-
. Safety and Electromagnetic Compatibility (EMC) testing demonstrating that the device complies with IEC 60601-1 Medical Electric Equipment – Part 1: General Requirements for Basic Safety and Essential Performance and IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
-
. 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 and TENSIONER in a simulated use environment. Human factors and usability engineering processes were followed per IEC 62366-1:2015+A1:2020 Application of Usability Engineering to Medical Devices.
All verification and validation testing concluded with acceptable results. Based on these test results, Blue Belt Technologies has concluded that all design inputs have been met and that the design verification and validation testing performed did not raise any new questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
REAL INTELLIGENCE® CORI® (K220255), OMNIBotics Knee System (K200888)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).
0
August 19, 2022
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Blue Belt Technologies, Inc. Corrine Herlinger Principal Regulatory Affairs Specialist 2905 Northwest Blvd., Ste. 40 Plymouth, Minnesota 55441
Re: K221224
Trade/Device Name: Real Intelligence Cori (Cori) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 21, 2022 Received: July 21, 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.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For: 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
Enclosure
2
Indications for Use
510(k) Number (if known) K221224
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 atthroplasty (THA).
| 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) |
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3
Image /page/3/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
510(k) Summary
| 510(k) Owner | Blue Belt Technologies, Inc.
2905 Northwest Blvd Ste. 40
Plymouth, MN 55441 USA
Tel: (763) 452-4950
Fax: (763) 452-4675 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Corrine Herlinger
Principal Regulatory Affairs Specialist
Tel: (412) 683-3844 x 4128
Email: corrine.herlinger@smith-nephew.com |
| Date of Submission | April 26, 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) |
| Primary Predicate Device | REAL INTELLIGENCE® CORI® (K220255) |
| Secondary Predicate Device | OMNIBotics Knee System (K200888) |
| Reason for Submission | This Traditional 510(k) submission supports an
update to CORI to allow the system to be used with
the CORI Knee TENSIONER (TENSIONER) and the
associated software upgrade, CORI 1.7. |
K221224 - Page 1 of 8
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Image /page/4/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.
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.
K221224 - Page 2 of 8
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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
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 System to allow the system to be used with the CORI Knee TENSIONER (TENSIONER) and the associated software upgrade, CORI 1.7. The TENSIONER is an electromechanical accessory designed to provide feedback to CORI with respect to the force that the user applies to the joint during gap assessment. It is used by the surgeon in the gap planning stages of a total knee replacement procedure to provide a quantitative assessment of soft tissue laxity.
The modifications made to CORI 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 system, K220255, and the OMNIBotics Knee System, K200888.
K221224 - Page 3 of 8
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Table 2: Predicate Device
| Manufacturer | Description | Submission
Number | Clearance Date |
|------------------------------|------------------------|----------------------|----------------|
| Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI | K220255 | 03/29/2022 |
| Corin Ltd. | OMNIBotics Knee System | K200888 | 06/27/2020 |
Table 3: Summary of Technological Similarities with Predicate
| Devices | Subject Device
CORI | Primary Predicate
CORI
K220255 | Secondary Predicate
OMNIBotics Knee System
K200888 |
|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use and
Indications for Use
[Same] | Same as primary
predicate. | 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. | The OMNIBotics Knee
System is indicated for
stereotaxic surgery to aid the
surgeon in locating
anatomical structures and
aligning endoprostheses with
these anatomical structures
during Total Knee
Arthroplasty. |
| | | 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, total knee
arthroplasty, and total hip
arthroplasty. | The BalanceBot™ is indicated
as a tool for adjustment of
soft tissue and the femoral
implant to reduce instability
from flexion gap asymmetry.
The OMNIBotics Knee
System supports OMNI Apex
Knee™ implants and CORIN
Unity Knee™ implants. |
| Devices | Subject Device
CORI | Primary Predicate
CORI
K220255 | Secondary Predicate
OMNIBotics Knee System
K200888 |
| Technological
Characteristics –
Operating Principle
[Same] | Same as primary
predicate. | For knee applications, CORI uses
established technologies to
prepare bone for attachment of
UKR and TKA implant
components. In the case of a
total knee arthroplasty, the
bone surface may also be
prepared to receive the femoral
and tibial cutting guides with
final bone surface for receiving
the implant prepared using a
standard surgical saw.
CORI 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.
The system 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 or 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.
To support the hip application,
CORI uses a Virtual Machine
with hypervisor to enable the
Windows-based HIP7 software
to run on CORI. | N/A |
| Devices | Subject Device
CORI | Primary Predicate
CORI
K220255 | Secondary Predicate
OMNIBotics Knee System
K200888 |
| Technological
Characteristics -
Tensioning
Instrument
[Substantially
Equivalent] | The TENSIONER is an
electromechanical
tensioning
instrument with
reverse-action pliers
to distract the joint. | Consists of a Gap Planning stage
to assist users with (manual)
ligament balancing. | The BalanceBot is an electro-
mechanical tensioning
instrument with integrated
force sensors and position
actuators. |
| Technological
Characteristics -
Gap Balancing
[Substantially
Equivalent] | The TENSIONER is
used during the Gap
Planning stage of the
CORI Total Knee
Arthroplasty
application and
provides feedback to
CORI with respect to
the force that the
user applies to the
joint to assist with
ligament balancing. | Consists of a Gap Planning stage
to assist users with (manual)
ligament balancing. | BalanceBot assists the
surgeon with ligament
balancing during total knee
arthroplasty. |
| Knee Implant
Product Codes
Supported
[Same] | Same as primary
predicate. | HSX, JWH, MBH | N/A |
| Environment of Use
[Same] | Same as primary
predicate. | CORI is intended to be used by
trained medical professionals in
a hospital or clinical setting
equivalent to an orthopedic
surgery suite. | N/A |
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Image /page/7/Picture/0 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.
2905 Northwest Boulevard, Suite 40, Plymouth, Minnesota 55441 USA Tel 763.452.4950 Fax 763.452.4675 www.bluebelttech.com
K221224 - Page 5 of 8
ReshapingMobility™
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2905 Northwest Boulevard, Suite 40, Plymouth, Minnesota 55441 USA Tel 763.452.4950 Fax 763.452.4675 www.bluebelttech.com
K221224 - Page 6 of 8
ReshapingMobility™
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Non-Clinical Testing (Bench)
Design verification and validation testing demonstrated that CORI meets all design requirements and is as safe and effective as its primary predicate device (K220255) and secondary predicate device OMNIBotics Knee System (K200888). Comprehensive performance testing demonstrated that the system meets required design inputs. Performance data consisted of physical performance testing for all system components. Additionally, the following evidence was provided:
- . Biocompatibility evaluation demonstrating that the system satisfies the requirements of ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process.
- . Safety and Electromagnetic Compatibility (EMC) testing demonstrating that the device complies with IEC 60601-1 Medical Electric Equipment – Part 1: General Requirements for Basic Safety and Essential Performance and IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
- . 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 and TENSIONER in a simulated use environment. Human factors and usability engineering processes were followed per IEC 62366-1:2015+A1:2020 Application of Usability Engineering to Medical Devices.
All verification and validation testing concluded with acceptable results. Based on these test results, Blue Belt Technologies has concluded that all design inputs have been met and that the design verification and validation testing performed did not raise any new questions of safety or effectiveness.
Conclusions
The subject device, CORI, described in this submission has the same intended use and the same fundamental scientific technology as the primary predicate device, K220255. The primary difference between the subject device and CORI (K220255) is the update to allow the system to be used with TENSIONER and the associated software upgrade, CORI 1.7. The main functionality of the Total Knee Arthroplasty (TKA) software is the same as presented in K201022, with modifications to allow for communication with TENSIONER. The addition of TENSIONER does not change the system's method for gap calculation, which remains the same as the previously cleared devices.
While the technological characteristics differ between manual and a tool-assisted gap-balancing measurement, the questions regarding accuracy and implementation of intraoperative gap-balancing
K221224 - Page 7 of 8
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apply to both the subject and primary predicate device. Additionally, usability testing demonstrated that users are able to successfully perform gap balancing using TENSIONER and the CORI system; therefore, the difference of the technological characteristics does not introduce new questions of safety or effectiveness.
Blue Belt Technologies believes that FDA can find CORI to be substantially equivalent to the predicate devices, REAL INTELLIGENCE CORI system, K220255, and the OMNIBotics Knee System, K200888. The information presented in this 510(k) premarket notification demonstrates that CORI is as safe and effective as the primary predicate CORI system (K220255).
K221224 - Page 8 of 8