(117 days)
Not Found
No
The description focuses on navigation, robotic assistance, and control based on proximity to a planned surface, using established technologies like passive infrared tracking. There is no mention of AI, ML, or related concepts like training data or complex algorithms that learn from data.
Yes.
The device is a robotic-assisted orthopedic surgical navigation and burring system used in surgical procedures such as knee and hip replacements. It directly aids the surgeon in executing the surgical plan by controlling the cutting engagement of a surgical bur, which is a therapeutic action.
No
The CORI device is described as a "robotic-assisted orthopedic surgical navigation and burring system." Its purpose is to aid surgeons in planning and executing surgical procedures like knee and hip replacements by controlling the cutting engagement of a surgical bur. It assists in surgery, rather than diagnosing a condition.
No
The device description explicitly states that CORI is a "robotic-assisted orthopedic surgical navigation and burring system" and describes hardware components like a "passive infrared tracking camera" and a "surgical bur" controlled by the system. It is not solely 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 such as blood, urine, or tissue taken from the human body to detect diseases or other conditions.
- 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 intraoperative data 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 and controlling surgical tools based on anatomical landmarks and surgical plans.
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),
- revision knee arthroplasty, and
- total hip arthroplasty (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 (related to unicondylar knee, total knee, revision knee, and total hip arthroplasty)
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)
Verification and validation activities were performed on CORI to demonstrate that changes presented in this submission meet all design input requirements and that CORI is as safe and effective as its predicate device.
Additionally, the following testing was conducted:
Usability Engineering Validation Testing: Summative usability testing demonstrated that participating surgeons were able use the subject device safely and effectively to complete a revision knee arthroplasty procedure in a simulated use environment. The summative usability testing also validated the instructions for the user to complete a revision knee arthroplasty procedure using CORI.
Implant and Cut Guide Position Accuracy Analysis: Analysis confirmed implant position and cut guide position accuracy is not impacted by the addition of revision knee arthroplasty to the CORI indications for use statement since no modifications have been made to CORI system, reusable or disposable components, software, implant/cut guide database, functional or performance requirements, or bone preparation methods.
No human clinical testing was required to determine the safety and effectiveness of CORI.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
REAL INTELLIGENCE® CORI® (K220255)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
July 27, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" surrounding a graphic. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is written in blue.
Blue Belt Technologies, Inc. Unnati Bhuptani Regulatory Affairs Specialist II 2905 Northwest Blvd., Ste. 40 Plymouth, Minnesota 55441
Re: K220958/S001
Trade/Device Name: Real Intelligence Cori Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 30, 2022 Received: July 1, 2022
Dear Unnati Bhuptani:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 mediation-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, 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
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Indications for Use
510(k) Number (if known) K220958
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),
- · revision knee arthroplasty, and
- · total hip arthroplasty (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 | Unnati Bhuptani
Regulatory Affairs Specialist II
Tel: (412) 853-6682
Email: unnati.bhuptani@smith-nephew.com |
| Date of Submission | March 31, 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® (K220255) |
| Reason for Submission | Updated Indications for Use |
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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.
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),
- . 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. 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.
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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 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 |
| 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 |
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 revision knee arthroplasty procedures. The modifications made to CORI to support the updated indications for use include:
- updates to the CORI labeling
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 (K220255).
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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 that, the word "TECHNOLOGIES" is written in a smaller, gray, sans-serif font. The overall design is clean and modern.
Table 2: Predicate Device
| Manufacturer | Description | Submission
Number | Clearance Date |
|------------------------------|------------------------|----------------------|----------------|
| Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI | K220255 | 03/29/2022 |
Table 3: Summary of Technological Similarities with Predicate
| Devices | Subject Device
CORI | Primary Predicate
CORI
K220255 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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), revision knee arthroplasty, and total hip arthroplasty (THA). | 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), total hip arthroplasty (THA). |
| Knee Implant
Product Codes
Supported | HSX, JWH, MBH | HSX, JWH, MBH |
| Environment
of Use | Same as predicate. | CORI is intended to be used by trained
medical professionals in a hospital or clinical
setting equivalent to an orthopedic surgery
suite. |
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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 logo is clean and modern, with a focus on the company name.
2905 Northwest Boulevard, Suite 40, Plymouth, Minnesota 55441 USA Tel 763.452.4950 Fax 763.452.4675 www.bluebelttech.com
| Devices | Subject Device
CORI | Primary Predicate
CORI
K220255 |
|----------------------------------|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | Same as 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.
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. |
Non-Clinical Testing (Bench)
Verification and validation activities were performed on CORI to demonstrate that changes presented in this submission meet all design input requirements and that CORI is as safe and effective as its predicate device.
Additionally, the following testing was conducted:
Usability Engineering Validation Testing: Summative usability testing demonstrated that participating surgeons were able use the subject device safely and effectively to complete a revision knee arthroplasty procedure in a simulated use environment. The summative usability testing also validated the instructions for the user to complete a revision knee arthroplasty procedure using CORI.
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.
Implant and Cut Guide Position Accuracy Analysis: Analysis confirmed implant position and cut guide position accuracy is not impacted by the addition of revision knee arthroplasty to the CORI indications for use statement since no modifications have been made to CORI system, reusable or disposable components, software, implant/cut guide database, functional or performance requirements, or bone preparation methods.
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 device, CORI (K220255). The primary difference between the two systems is the Indications for Use, which has been updated to allow the system to be used for revision knee arthroplasty procedures.
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 revision knee arthroplasty procedures, and that CORI is as safe and effective as the predicate CORI system (K220255). Blue Belt Technologies believes that FDA can find CORI to be substantially equivalent to the predicate device.