(113 days)
CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined.
These procedures include unicondylar knee replacement (UKR), total knee arthroplasty (TKA), and total hip atthroplasty (THA).
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.
Here's a breakdown of the acceptance criteria and study information for the Real Intelligence Cori (Cori) device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than explicit numerical acceptance criteria for a new clinical study. The "acceptance criteria" are implied through various verification and validation activities.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Design Requirements Met | Design verification and validation testing demonstrated that CORI meets all design requirements. |
| Safety and Effectiveness Equivalence to Predicate | CORI is as safe and effective as its primary predicate device (K220255) and secondary predicate device OMNIBotics Knee System (K200888). |
| Physical Performance | Comprehensive performance testing demonstrated that the system meets required design inputs. Performance data consisted of physical performance testing for all system components. |
| Biocompatibility (for patient-contacting components) | Biocompatibility evaluation demonstrating that the system satisfies the requirements of ISO 10993-1. |
| Safety and Electromagnetic Compatibility (EMC) | Safety and Electromagnetic Compatibility (EMC) testing demonstrating that the device complies with IEC 60601-1 and IEC 60601-1-2. |
| Software Verification and Validation | Software verification testing, including software integration and workflow testing, was completed. Software was developed in accordance with IEC 62304. This submission contains documentation per the requirements of FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. |
| Usability (safe and effective use by representative users) | Usability Engineering Validation Testing demonstrating that representative users were able to safely and effectively use CORI and TENSIONER in a simulated use environment. Human factors and usability engineering processes were followed per IEC 62366-1:2015+A1:2020. Additionally, "usability testing demonstrated that users are able to successfully perform gap balancing using TENSIONER and the CORI system; therefore, the difference of the technological characteristics does not introduce new questions of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of a clinical study with real patient data for the TENSIONER update. The testing described is primarily bench testing, software verification, and usability engineering validation.
- Bench Testing: No specific sample sizes for physical components are detailed, but "comprehensive performance testing" and "physical performance testing for all system components" are mentioned.
- Usability Engineering Validation: It involved "representative users" in a "simulated use environment." The exact number of users is not provided nor is the data provenance (e.g., country) specified. Given it's a simulated environment, it's not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing described does not seem to involve the establishment of "ground truth" by experts in the context of a diagnostic or predictive device study, but rather verification against design requirements and usability assessments.
4. Adjudication Method for the Test Set
This information is not provided as the document does not describe a study involving expert review for establishing ground truth in a clinical data set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The submission focuses on demonstrating substantial equivalence through non-clinical testing and usability, particularly regarding the addition of the TENSIONER accessory and associated software update. There is no information on how human readers (or surgeons, in this context) improve with or without AI assistance, as the device itself is a surgical navigation and robotic-assisted system, not an AI diagnostic tool that assists human readers in interpreting images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable in the terms of a diagnostic AI algorithm. The CORI system is a robotic-assisted surgical navigation and burring system. Its "performance" is inherently tied to its interaction with a human surgeon during a procedure (e.g., controlling bur engagement, providing navigation). The document describes rigorous software verification and validation, which would assess the algorithm's functionality in a standalone manner prior to human interaction, but not as an "algorithm only without human-in-the-loop performance" in the typical sense of a diagnostic AI system's clinical performance.
7. The Type of Ground Truth Used
For the software and system performance, the "ground truth" would be the design specifications and requirements that the device and its algorithms are designed to meet. For usability, the ground truth is the ability of users to safely and effectively operate the device as intended, which is assessed through usability engineering validation. There is no mention of pathology, outcomes data, or expert consensus on clinical cases.
8. The Sample Size for the Training Set
This submission is for an update to an existing system (CORI K220255) to integrate the TENSIONER accessory and software upgrade. The document does not describe the development or training of a new AI algorithm for which a "training set" would typically be referenced. Therefore, no sample size for a training set is provided. The "training" for this submission would involve the development of the software to manage the TENSIONER, which is verified against design requirements.
9. How the Ground Truth for the Training Set was Established
As no training set for a new AI algorithm is described, this information is not applicable/not provided. The software associated with the TENSIONER is verified against engineering and design specifications.
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August 19, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Blue Belt Technologies, Inc. Corrine Herlinger Principal Regulatory Affairs Specialist 2905 Northwest Blvd., Ste. 40 Plymouth, Minnesota 55441
Re: K221224
Trade/Device Name: Real Intelligence Cori (Cori) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 21, 2022 Received: July 21, 2022
Dear Corrine Herlinger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221224
Device Name REAL INTELLIGENCE CORI (CORI)
Indications for Use (Describe)
CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined.
These procedures include unicondylar knee replacement (UKR), total knee arthroplasty (TKA), and total hip atthroplasty (THA).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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. 40Plymouth, MN 55441 USATel: (763) 452-4950Fax: (763) 452-4675 |
|---|---|
| Contact Person | Corrine HerlingerPrincipal Regulatory Affairs SpecialistTel: (412) 683-3844 x 4128Email: corrine.herlinger@smith-nephew.com |
| Date of Submission | April 26, 2022 |
| Classification Reference | 21 CFR 882.4560 |
| Product Code | OLO |
| Supported Codes | HSX, JWH, MBH |
| Common/Usual Name | Orthopedic Stereotaxic Instrument |
| Trade/Proprietary Name | REAL INTELLIGENCE® CORI® (CORI) |
| Primary Predicate Device | REAL INTELLIGENCE® CORI® (K220255) |
| Secondary Predicate Device | OMNIBotics Knee System (K200888) |
| Reason for Submission | This Traditional 510(k) submission supports anupdate to CORI to allow the system to be used withthe CORI Knee TENSIONER (TENSIONER) and theassociated software upgrade, CORI 1.7. |
K221224 - Page 1 of 8
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Image /page/4/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The overall design is clean and modern.
Intended Use
Real Intelligence CORI (CORI) is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Indications for Use
CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement (UKR), total knee arthroplasty (TKA), and total hip arthroplasty (THA).
Device Description
The subject of this Traditional 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, the system aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. For knee applications, CORI then aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur.
CORI knee application software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes:
- . Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting.
- Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached.
Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.
K221224 - Page 2 of 8
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Currently Supported Knee Implants
The following Smith+Nephew knee implants are supported on CORI:
Table 1: Currently Supported Smith+ Nephew Knee Implants
| Implant Model Name | 510(k) Number | ClassificationProduct Code |
|---|---|---|
| STRIDE Unicondylar Knee | K123380 | HSX |
| ZUK Select Knee System | K160738 | HSX |
| JOURNEY II Unicompartmental Knee System | K191211 | HSX |
| JOURNEY UNI | K102069 | HSX |
| JOURNEY II CR | K121443 | JWH |
| JOURNEY II BCS | K111711 | JWH |
| JOURNEY II XR | K141471, K152726 | JWH |
| LEGION CR/PS | K951987, K962557, K093746 | JWH |
| LEGION Porous CR Femoral Components | K073325, K091543 | MBH |
| LEGION Porous CR Narrow Femoral Components | K210566 | MBH |
| LEGION Porous Tibia | K100897 | MBH |
| Porous Tibia Baseplate | K211221 | MBH |
| GENESIS II CR/PS | K951987, K962557 | JWH |
| ANTHEM | K142807 | JWH |
Discussion of Similarities and Differences
This Traditional 510(k) submission supports an update to the CORI System to allow the system to be used with the CORI Knee TENSIONER (TENSIONER) and the associated software upgrade, CORI 1.7. The TENSIONER is an electromechanical accessory designed to provide feedback to CORI with respect to the force that the user applies to the joint during gap assessment. It is used by the surgeon in the gap planning stages of a total knee replacement procedure to provide a quantitative assessment of soft tissue laxity.
The modifications made to CORI do not impact the system's intended use, indications for use, or fundamental scientific technology.
Blue Belt Technologies believes that CORI is subject to premarket notification requirements under Section 510(k) of the Federal Food, Drug and Cosmetic Act ("FFDCA" or "the Act") and is substantially equivalent to the previously cleared REAL INTELLIGENCE CORI system, K220255, and the OMNIBotics Knee System, K200888.
K221224 - Page 3 of 8
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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, 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.
Table 2: Predicate Device
| Manufacturer | Description | SubmissionNumber | Clearance Date |
|---|---|---|---|
| Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI | K220255 | 03/29/2022 |
| Corin Ltd. | OMNIBotics Knee System | K200888 | 06/27/2020 |
Table 3: Summary of Technological Similarities with Predicate
| Devices | Subject DeviceCORI | Primary PredicateCORIK220255 | Secondary PredicateOMNIBotics Knee SystemK200888 |
|---|---|---|---|
| Intended use andIndications for Use[Same] | Same as primarypredicate. | REAL INTELLIGENCE CORI (CORI)is intended to assist the surgeonin providing software-definedspatial boundaries fororientation and referenceinformation to anatomicalstructures during orthopedicprocedures. | The OMNIBotics KneeSystem is indicated forstereotaxic surgery to aid thesurgeon in locatinganatomical structures andaligning endoprostheses withthese anatomical structuresduring Total KneeArthroplasty. |
| CORI is indicated for use insurgical knee procedures inwhich the use of stereotacticsurgery may be appropriate, andwhere reference to rigidanatomical bony structures canbe determined. Theseprocedures include unicondylarknee replacement, total kneearthroplasty, and total hiparthroplasty. | The BalanceBot™ is indicatedas a tool for adjustment ofsoft tissue and the femoralimplant to reduce instabilityfrom flexion gap asymmetry.The OMNIBotics KneeSystem supports OMNI ApexKnee™ implants and CORINUnity Knee™ implants. | ||
| Devices | Subject DeviceCORI | Primary PredicateCORIK220255 | Secondary PredicateOMNIBotics Knee SystemK200888 |
| TechnologicalCharacteristics –Operating Principle[Same] | Same as primarypredicate. | For knee applications, CORI usesestablished technologies toprepare bone for attachment ofUKR and TKA implantcomponents. In the case of atotal knee arthroplasty, thebone surface may also beprepared to receive the femoraland tibial cutting guides withfinal bone surface for receivingthe implant prepared using astandard surgical saw.CORI uses intraoperative datacollection (image-free or non-CTdata generation) to create amodel of the patient's femurand/or tibia, dependent on theprocedure being performed, andallows the surgeon to prepare asurgical plan.The system uses predefinedboundaries generated duringthe planning process to controlthe motion of the surgical burand limit the amount of boneremoved in order to shape thecondyles or tibial plateau inpreparation for placement ofthe surgical implant.Bur cutting is controlled eitherby retracting the bur in a guard,or by controlling the speed ofthe bur as the target surface isapproached.To support the hip application,CORI uses a Virtual Machinewith hypervisor to enable theWindows-based HIP7 softwareto run on CORI. | N/A |
| Devices | Subject DeviceCORI | Primary PredicateCORIK220255 | Secondary PredicateOMNIBotics Knee SystemK200888 |
| TechnologicalCharacteristics -TensioningInstrument[SubstantiallyEquivalent] | The TENSIONER is anelectromechanicaltensioninginstrument withreverse-action pliersto distract the joint. | Consists of a Gap Planning stageto assist users with (manual)ligament balancing. | The BalanceBot is an electro-mechanical tensioninginstrument with integratedforce sensors and positionactuators. |
| TechnologicalCharacteristics -Gap Balancing[SubstantiallyEquivalent] | The TENSIONER isused during the GapPlanning stage of theCORI Total KneeArthroplastyapplication andprovides feedback toCORI with respect tothe force that theuser applies to thejoint to assist withligament balancing. | Consists of a Gap Planning stageto assist users with (manual)ligament balancing. | BalanceBot assists thesurgeon with ligamentbalancing during total kneearthroplasty. |
| Knee ImplantProduct CodesSupported[Same] | Same as primarypredicate. | HSX, JWH, MBH | N/A |
| Environment of Use[Same] | Same as primarypredicate. | CORI is intended to be used bytrained medical professionals ina hospital or clinical settingequivalent to an orthopedicsurgery suite. | N/A |
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Image /page/7/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo features a blue swirl design on the left, followed by the words "BLUE BELT" in large, bold, blue letters. Below "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters.
2905 Northwest Boulevard, Suite 40, Plymouth, Minnesota 55441 USA Tel 763.452.4950 Fax 763.452.4675 www.bluebelttech.com
K221224 - Page 5 of 8
ReshapingMobility™
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Image /page/8/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of 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.
2905 Northwest Boulevard, Suite 40, Plymouth, Minnesota 55441 USA Tel 763.452.4950 Fax 763.452.4675 www.bluebelttech.com
K221224 - Page 6 of 8
ReshapingMobility™
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Image /page/9/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 letters. Below "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters.
Non-Clinical Testing (Bench)
Design verification and validation testing demonstrated that CORI meets all design requirements and is as safe and effective as its primary predicate device (K220255) and secondary predicate device OMNIBotics Knee System (K200888). Comprehensive performance testing demonstrated that the system meets required design inputs. Performance data consisted of physical performance testing for all system components. Additionally, the following evidence was provided:
- . Biocompatibility evaluation demonstrating that the system satisfies the requirements of ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process.
- . Safety and Electromagnetic Compatibility (EMC) testing demonstrating that the device complies with IEC 60601-1 Medical Electric Equipment – Part 1: General Requirements for Basic Safety and Essential Performance and IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
- . Software verification testing, including software integration and workflow testing, was completed. Software was developed in accordance with IEC 62304 Medical device software -Software life cycle processes, and this submission contains documentation per the requirements of FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- . Usability Engineering Validation Testing demonstrating that representative users were able to safely and effectively use CORI and TENSIONER in a simulated use environment. Human factors and usability engineering processes were followed per IEC 62366-1:2015+A1:2020 Application of Usability Engineering to Medical Devices.
All verification and validation testing concluded with acceptable results. Based on these test results, Blue Belt Technologies has concluded that all design inputs have been met and that the design verification and validation testing performed did not raise any new questions of safety or effectiveness.
Conclusions
The subject device, CORI, described in this submission has the same intended use and the same fundamental scientific technology as the primary predicate device, K220255. The primary difference between the subject device and CORI (K220255) is the update to allow the system to be used with TENSIONER and the associated software upgrade, CORI 1.7. The main functionality of the Total Knee Arthroplasty (TKA) software is the same as presented in K201022, with modifications to allow for communication with TENSIONER. The addition of TENSIONER does not change the system's method for gap calculation, which remains the same as the previously cleared devices.
While the technological characteristics differ between manual and a tool-assisted gap-balancing measurement, the questions regarding accuracy and implementation of intraoperative gap-balancing
K221224 - Page 7 of 8
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apply to both the subject and primary predicate device. Additionally, usability testing demonstrated that users are able to successfully perform gap balancing using TENSIONER and the CORI system; therefore, the difference of the technological characteristics does not introduce new questions of safety or effectiveness.
Blue Belt Technologies believes that FDA can find CORI to be substantially equivalent to the predicate devices, REAL INTELLIGENCE CORI system, K220255, and the OMNIBotics Knee System, K200888. The information presented in this 510(k) premarket notification demonstrates that CORI is as safe and effective as the primary predicate CORI system (K220255).
K221224 - Page 8 of 8
§ 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).