(29 days)
Not Found
No
The description focuses on established navigation and robotic control technologies based on proximity and pre-defined geometry, with no mention of AI or ML terms or concepts.
No
The device is a surgical navigation and burring system and aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur, but it does not directly treat or restore health.
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, rather than diagnosing conditions. It assists in establishing bone models and controlling surgical cutting, which are functions related to treatment and intervention, not diagnosis.
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" that the system controls.
No, 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 provided 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 in planning and executing bone cuts based on intraoperative data and implant geometry.
- No 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, based on the provided information, CORI falls under the category of a surgical device, not an In Vitro Diagnostic.
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 (comma separated list FDA assigned to the subject device)
OLO
Device Description
The subject of this Special 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
Knee, 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)
Verification and validation testing demonstrated the safety and efficacy of CORI when the system is used to place porous UKR implants intended for use with or without bone cement. Summative usability testing (including labeling validation) demonstrated that participating surgeons were able use the subject device safely and effectively in a simulated use environment.
Blue Belt Technologies has concluded that all design inputs have been met and that the 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and 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" and "ADMINISTRATION" in blue text.
August 1, 2023
Blue Belt Technologies, Inc. Corrine Herlinger Senior Principal Regulatory Affairs Specialist 2875 Railroad Street Pittsburgh, Pennsylvania 15222
Re: K231963
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, 2023 Received: July 3, 2023
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image contains the letters FDA in a light blue color on the left side of the image. To the right of the letters, there is text that says "Tejen D. Soni -S". The text is in black and is in a simple font.
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
REAL INTELLIGENCE™ 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)
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
510(k) Summary
| 510(k) Owner | Blue Belt Technologies, Inc.
2875 Railroad Street
Pittsburgh, PA 15222 USA
Tel: (412) 683-3844
Fax: (412) 683-6447 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Corrine Herlinger
Senior Principal Regulatory Affairs Specialist
Tel: 412.552.6428
Email: corrine.herlinger@smith-nephew.com |
| Date of Submission | 30-June-2023 |
| Classification Reference | 21 CFR 882.4560 |
| Classification Name | Stereotaxic instrument |
| 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™ (K221224) |
| Reason for Submission | This Special 510(k) submission supports an update
to CORI to allow the system to be used with porous
Unicondylar Knee Replacement (UKR) Implants |
4
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 Special 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
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 |
| ENGAGE Partial Knee System | K190439 | NJD, HSX |
| JOURNEY II UK™ and ENGAGE™ Cementless Partial
Knee System | K222653 | NJD, HSX |
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Discussion of Similarities and Differences
This Special 510(k) submission supports an update to allow for porous UKR implants on Real Intelligence CORI for the following implant combinations:
- ENGAGE™ Partial Knee System consisting of the ENGAGE Femur and Tibia, intended for cemented or cementless implantation cleared per K190439
- JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System consisting of the Journey II Unicompartmental Cemented Femur and Engage Cemented or Cementless Tibia cleared per K222653
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 | K221224 | August 19, 2022 |
Table 2: Summary of Technological Similarities with Predicate
| Devices | Subject Device
CORI | Primary Predicate
CORI - K221224 |
|------------------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Same as 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. |
| Indications for
Use | Same as predicate. | 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). |
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| Devices | Subject Device
CORI | Primary Predicate
CORI - K221224 |
|--------------------------------------------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Knee Implant
Product Codes
Supported | HSX, JWH, MBH, NJD | 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. |
| 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. |
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Non-Clinical Testing (Bench)
Verification and validation testing demonstrated the safety and efficacy of CORI when the system is used to place porous UKR implants intended for use with or without bone cement. Summative usability testing (including labeling validation) demonstrated that participating surgeons were able use the subject device safely and effectively in a simulated use environment.
Blue Belt Technologies has concluded that all design inputs have been met and that the 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, indications for use, and the same technological characteristics as the predicate device, CORI (K221224). The difference between the two systems is an update to the CORI User Manual and an update to the Implant Database to include the ENGAGE™ Partial Knee System and the JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System.
Comprehensive verification testing demonstrated that the system meets required design inputs. Summative usability testing results demonstrate 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 may be used for the placement of porous UKR implants, and that CORI is as safe and effective as the predicate CORI system (K221224). Blue Belt Technologies believes that FDA can find CORI to be substantially equivalent to the predicate device.