(53 days)
Not Found
No
The description focuses on established navigation and robotic control technologies based on pre-defined geometry and proximity, with no mention of AI or ML terms, training data, or complex pattern recognition.
No.
The device is a computer-assisted orthopedic surgical navigation and surgical burring system that aids in surgical procedures by establishing a bone surface model and planning implant locations. It does not directly provide therapy or treatment for a disease or condition itself.
No
The device is a computer-assisted orthopedic surgical navigation and surgical burring system used for knee procedures. Its primary function is to aid surgeons in planning implant location and controlling surgical burring, rather than diagnosing a condition or disease.
No
The device description explicitly states that CORI is a "computer-assisted orthopedic surgical navigation and surgical burring system" and mentions hardware components like a "passive infrared tracking camera" and a "surgical bur." It also describes software control over a "robotic system" and a "drill motor controller." This indicates it is a system with both software and hardware components, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical knee procedures (UKR and TKA) using stereotactic surgery and reference to rigid anatomical bony structures. This is a surgical guidance and execution system, not a diagnostic test performed on biological samples.
- Device Description: The device is described as a computer-assisted orthopedic surgical navigation and surgical burring system. It uses navigation and robotic control for bone cutting during surgery. This is a surgical tool, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases or conditions, or providing diagnostic information based on in vitro testing.
Therefore, CORI is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 (UKR) and total knee arthroplasty (TKA).
CORI is indicated for use with cemented implants only.
Product codes (comma separated list FDA assigned to the subject device)
OLO, HSX, HRY, NPJ
Device Description
CORI is a computer-assisted orthopedic surgical navigation and surgical burring system. CORI uses established technologies of navigation, via a passive infrared tracking camera, to aid the surgeon in establishing a bone surface model for the target surgery and in planning the surgical implant location. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, CORI aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location.
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.
- . Speed control regulates the signal going to the drill motor controller 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
intraoperative data collection (image-free or non-CT data generation)
Anatomical Site
knee (femur and/or tibia)
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 was performed to demonstrate that CORI meets all design requirements and is as safe and effective as its predicate devices.
Comprehensive performance testing demonstrated that the system meets required design inputs. Performance data consisted of physical performance test for all system components and system accuracy testing. Additionally, the following testing was conducted:
- Biocompatibility testing demonstrating that the system satisfies the requirements of BS EN ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process.
- 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 in a simulated use environment.
No human clinical testing was required to determine the safety and effectiveness of CORI.
Key results: The key determining factor in establishing substantial equivalence is whether CORI can accurately accomplish the desired bone cutting in accordance with the surgical plan. The comparative results of the cut-to-plan accuracy data is acceptable and equivalent to the predicate devices. Usability engineering test results demonstrate that representative users are able to use the subject device safely and effectively in a simulated use environment.
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).
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Image /page/0/Picture/0 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
June 12, 2020
Blue Belt Technologies, Inc. Corrine Herlinger Principal Regulatory Affairs Specialist 2905 Northwest Blvd., Ste. 40 Plymouth, Minnesota 55441
Re: K201022
Trade/Device Name: Real Intelligence Cori Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, HSX, HRY, NPJ Dated: May 14, 2020 Received: May 15, 2020
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 (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 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.
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
Enclosure
2
Indications for Use
510(k) Number (if known) K201022
Device Name REAL INTELLIGENCE CORI (CORI)
Indications for Use (Describe)
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 (UKR) and total knee arthroplasty (TKA).
CORI is indicated for use with cemented implants only.
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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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, bold, blue font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray font. The logo is clean and modern, with a focus on the company name.
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 x4128
Email: corrine.herlinger@smith-nephew.com |
| Date Prepared | June 12, 2020 |
| Classification Reference | 21 CFR 882.4560 |
| Product Code | OLO |
| Supported Codes | HSX, HRY, NPJ |
| Common/Usual Name | Orthopedic Stereotaxic Instrument |
| Trade/Proprietary Name | REAL INTELLIGENCE® CORI® (CORI) |
| Predicate Device(s) | REAL INTELLIGENCE® CORI® (CORI) (K193120) (Primary Predicate)
NAVIO Surgical System (Navio system) (K191223) |
| Reason for Submission | New Indication |
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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. The logo is clean and modern, with a focus on the company name.
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 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 (UKR) and total knee arthroplasty (TKA).
CORI is indicated for use with cemented implants only.
Device Description
CORI is a computer-assisted orthopedic surgical navigation and surgical burring system. CORI uses established technologies of navigation, via a passive infrared tracking camera, to aid the surgeon in establishing a bone surface model for the target surgery and in planning the surgical implant location. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, CORI aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location.
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.
- . Speed control regulates the signal going to the drill motor controller itself and limits the speed of the drill if the target surface is approached.
Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.
5
Image /page/5/Picture/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 knee implants are supported on CORI:
Table 1: Currently Supported Knee Implants
| Implant Model Name | Manufacturer | 510(k) Number |
|---|---|---|
| JOURNEY II Unicompartmental Knee System | Smith and Nephew | K191211 |
| JOURNEY UNI | Smith and Nephew | K102069 |
| STRIDE Unicondylar Knee | Smith and Nephew | K123380 |
| ZUK Select Knee System | Smith and Nephew | K160738 |
| JOURNEY II CR | Smith and Nephew | K121443 |
| JOURNEY II BCS | Smith and Nephew | K111711 |
| JOURNEY II XR | Smith and Nephew | K141471, K152726 |
| GENESIS II CR/PS | Smith and Nephew | K951987, K962557 |
| LEGION CR/PS | Smith and Nephew | K951987, K962557, K093746 |
| ANTHEM | Smith and Nephew | K142807 |
Discussion of Similarities and Differences
The subject device, CORI, is substantially equivalent to the predicate devices: CORI (K193120) and the Navio system (K191223). The intended use and the established technologies used to prepare bone for the attachment of implant components, including implant accuracy, is the same as the predicate devices. The CORI UKR and TKA software applications feature a workflow that is nearly identical to the predicate devices, cleared via K191223 and K193120.
Table 2: Summary of Technological Similarities with Predicates
| Devices | Subject Device
CORI | Primary Predicate
CORI
[K193120] | Secondary Predicate
NAVIO Surgical System
[K191223] |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The NAVIO Surgical System is
intended to assist the surgeon
in providing software-defined
spatial boundaries for
orientation and reference
information to anatomical
structures during orthopedic
procedures. |
| Devices | Subject Device
CORI | Primary Predicate
CORI
[K193120] | Secondary Predicate
NAVIO Surgical System
[K191223] |
| Indications for
Use | 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 and total
knee arthroplasty.
CORI is indicated for use
with cemented implants
only. | CORI is indicated for use in
unicondylar knee
replacement (UKR) surgical
knee procedures, in which
the use of stereotactic
surgery may be
appropriate, and where
reference to rigid
anatomical bony structures
can be determined.
CORI is indicated for use
with cemented implants
only. | The NAVIO system 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, patellofemoral
arthroplasty, and total knee
arthroplasty.
The NAVIO system is indicated
for use with cemented
implants only. |
| Implant
Product Codes
Supported | HSX, HRY, NPJ | | HRY, HSX, JWH, KRR, NPJ |
| Environment
of Use | 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. | |
| Technological
Characteristics | 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 | | The NAVIO system uses
established technologies to
prepare bone for attachment
of UKR, PFA, or 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.
NAVIO uses intraoperative
data collection (image-free or
non-CT data generation) to
create a model of the |
| Devices | Subject Device
CORI | Primary Predicate
CORI
[K193120] | Secondary Predicate
NAVIO Surgical System
[K191223] |
| | patient's femur and/or
tibia, dependent on the
procedure being
performed, and allows the
surgeon to prepare a
surgical plan.
CORI 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.
During a TKA procedure,
the surgeon may choose to
prepare the bone surface
for receiving the implant
using the Bur All method
or the bone surface is
prepared to receive the
femoral and tibial cutting
guides with final bone
surface for receiving the
implant prepared using a
standard surgical saw.
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. | | patient's femur and/or tibia,
dependent on the procedure
being performed, and allows
the surgeon to prepare a
surgical plan.
The NAVIO 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, tibial plateau, or
patellofemoral joint in
preparation for placement of
the surgical implant.
During a TKA procedure, the
surgeon may choose to
prepare the bone surface for
receiving the implant using
the Bur All method or the
bone surface is prepared to
receive the femoral and tibial
cutting guides with final bone
surface for receiving the
implant prepared using a
standard surgical saw.
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. |
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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 "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
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ReshapingMobility™
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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 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
Page 5 of 6
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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.
Non-Clinical Testing (Bench)
Design verification and validation testing was performed to demonstrate that CORI meets all design requirements and is as safe and effective as its predicate devices.
Comprehensive performance testing demonstrated that the system meets required design inputs. Performance data consisted of physical performance test for all system components and system accuracy testing. Additionally, the following testing was conducted:
- Biocompatibility testing demonstrating that the system satisfies the requirements of BS EN ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process.
- 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 in a simulated use environment.
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 devices, CORI (K193120) and the NAVIO system (K191223). The primary difference between the subject device and CORI (K193120) is the update to the system's indications for use to add the TKA application onto the CORI system. The CORI TKA application is based on existing NAVIO TKA software version 7.0. The main functionality of the TKA software is the same as presented in K191223, with modifications to allow for communication with the CORI accessories (robotic drill, tablet, foot pedal, camera, and optional monitor).
The key determining factor in establishing substantial equivalence is whether CORI can accurately accomplish the desired bone cutting in accordance with the surgical plan. The comparative results of the cut-to-plan accuracy data is acceptable and equivalent to the predicate devices. Usability engineering test 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 Special 510(k) premarket notification demonstrates that the updated CORI is as safe and effective as the predicates, CORI (K193120) and the NAVIO system (K191223). Blue Belt Technologies believes that FDA can find CORI to be substantially equivalent to the predicate devices.
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