(94 days)
Not Found
No
The description focuses on established navigation and robotic control technologies based on pre-defined plans and proximity sensors, without mentioning learning or adaptive algorithms.
No.
The device is a surgical navigation and burring system designed to aid surgeons in knee replacement procedures and is not directly used for therapy, but rather for surgical intervention.
No.
The CORI system is described as a computer-assisted orthopedic surgical navigation and surgical burring system. Its purpose is to aid the surgeon in planning and executing surgical implant placement and controlling a surgical drill/bur, not to diagnose a condition.
No
The device description explicitly states that CORI is a "computer-assisted orthopedic surgical navigation and surgical burring system" and describes hardware components like a "passive infrared tracking camera" and a "surgical bur." It also mentions controlling the "cutting engagement of the surgical bur" and regulating the "signal going to the drill motor controller." This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the CORI 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 "computer-assisted orthopedic surgical navigation and surgical burring system." It is used during surgery to aid the surgeon in planning and executing bone cuts for knee replacement.
- No Sample Analysis: There is no mention of CORI analyzing any biological samples from the patient. Its function is entirely focused on surgical guidance and execution based on anatomical structures and pre-operative planning.
Therefore, CORI falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indications for use:
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.
Product codes
OLO, HSX
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
Not Found
Anatomical Site
unicondylar knee
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 device.
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 test data was provided:
. 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.
. 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 in a simulated use environment.
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)
NAVIO Surgical System (NAVIO System) (K191223)
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
February 14, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Blue Belt Technologies, Inc. Corrine Herlinger Principal Regulatory Affairs Specialist 2905 Northwest Blvd. Ste. 40 Plymouth, Minnesota 55441
Re: K193120
Trade/Device Name: Real Intelligence Cori Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 8, 2019 Received: November 12, 2019
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,
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) K193120
Device Name REAL INTELLIGENCE CORI (CORI)
Indications for Use (Describe)
Indications for use:
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.
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/1 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 | November 8, 2019 |
| Classification Reference | 21 CFR 882.4560 |
| Product Code | OLO |
| Supported Codes | HSX |
| Common/Usual Name | Orthopedic Stereotaxic Instrument |
| Trade/Proprietary Name | REAL INTELLIGENCE® CORI® (CORI) |
| Predicate Device(s) | NAVIO Surgical System (NAVIO System) (K191223) |
| Reason for Submission | New Device |
Section 6 – Page 1
4
Image /page/4/Picture/1 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 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 softwaredefined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Indications for Use
CORI is indicated for use in unicondylar knee replacement (UKR) surqical 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.
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/1 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, bold letters. Below the words "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters.
Currently Supported Unicondylar Knee Implants
The following unicondylar knee implants are supported on CORI:
Table 1: Currently Supported UKR 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 |
Discussion of Similarities and Differences
CORI is substantially equivalent to the predicate device, 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 device. The CORI UKR software application features a workflow that is nearly identical to the predicate device, cleared via K191223.
| | Subject Device
CORI [Subject] | Predicate Device
NAVIO [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. | 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. |
| Indications for Use | 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. |
| Supported Product
Code(s) | HSX | HRY, HSX, JWH, KRR, NPJ |
| Environment of Use | CORI is intended to be used by
trained medical professionals in a
hospital or clinical setting equivalent
to an orthopedic surgery suite. | The NAVIO system is intended for use by
trained orthopedic surgeons in an
orthopedic surgical suite. |
| Technological
Characteristics | CORI uses established technologies
to prepare bone for attachment of
UKR implant components.
CORI uses intraoperative data
collection (image-free or non-CT data
generation) to create a model of the
patient's femur and tibia 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.
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. | 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 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. |
Table 2: Summary of Technological Similarities with Predicate
Section 6 - Page 3
6
Image /page/6/Picture/1 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
Section 6 – Page 4
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Image /page/7/Picture/1 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
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 device.
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 test data was provided:
- . 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.
- . 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 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 device, the NAVIO system (K191223). The primary difference between the two systems is that CORI is a nextgeneration system designed to improve overall system usability and ergonomics, offer increased system performance, and reduce the dependency on outside vendor components. The differences in the system hardware and accessories do not raise any new questions of safety or effectiveness.
Section 6 - Page 5
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Image /page/8/Picture/1 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
The key determining factor in establishing substantial equivalence is whether CORI hardware and accessories can accurately accomplish the desired bone cutting in accordance with the surgical plan. The comparative results of the cut-to-plan accuracy indicate that CORI implant placement accuracy data is acceptable and equivalent to the UKR implant placement accuracy data for the NAVIO system. 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 510(k) premarket notification demonstrates that the redesigned system is substantially equivalent to the NAVIO system (K191223) and that CORI is as safe and effective as the predicate.
Section 6 - Page 6
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