(91 days)
No
The summary describes a robotic surgical system for total knee replacement that uses navigation and pre/intra-operative planning based on anatomical landmarks and imaging. There is no mention of AI or ML being used for tasks like image analysis, decision support, or robotic control beyond pre-programmed movements based on the surgical plan. The software is described as a "Medical Device Data System" and its testing focuses on standard software validation and safety, not AI/ML specific performance metrics.
No.
The device is a stereotaxic instrumentation system that assists surgeons in total knee replacement surgery by providing software-defined spatial boundaries for orientation, planning, and precise positioning of implant components. It is a surgical aid, not a device that directly treats a medical condition.
No
Explanation: The device is described as a "stereotaxic instrumentation system for total knee replacement (TKA) surgery" that "assists the surgeon in providing software-defined spatial boundaries for orientation to identifiable anatomical structures for the accurate placement of knee implant components." It helps with "bone resections" and "assessing the state of the soft tissues to facilitate implant positioning intra-operatively." This clearly indicates its role as a surgical assistance and guidance system, rather than one that diagnoses a medical condition or disease.
No
The device description explicitly states that the system includes a robotic arm, an optical sensor navigation system and accessories, a software system, and surgical instruments and accessories. This indicates it is a system with significant hardware components, not solely software.
Based on the provided information, the ROSA® Knee System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is a "stereotaxic instrumentation system for total knee replacement (TKA) surgery." It assists the surgeon in "providing software-defined spatial boundaries for orientation to identifiable anatomical structures for the accurate placement of knee implant components." This describes a surgical guidance and assistance system used during a surgical procedure on a patient's body.
- Device Description: The description reinforces this by explaining how the system assists surgeons in performing TKA, including bone resections and soft tissue assessment intra-operatively.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. The ROSA® Knee System does not perform any such analysis of biological samples. It interacts directly with the patient's anatomy during surgery.
The system uses imaging (X-ray or MRI) for pre-operative planning, but this is for creating a surgical plan and guiding the robotic arm during the surgery, not for diagnosing a condition based on analysis of a biological sample.
Therefore, the ROSA® Knee System falls under the category of surgical guidance or robotic-assisted surgical systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ROSA® Knee System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation to identifiable anatomical structures for the accurate placement of knee implant components.
The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan, optionally determined pre-operatively using compatible X-ray or MRI based surgical planning tools.
It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.
The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA® Knee System. The ROSA® Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications:
NexGen® CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Vanguard® CR, and Vanguard PS.
Product codes
OLO
Device Description
The ROSA® Knee System is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intra-operatively. The ROSA® Knee System uses a Medical Device Data System (MDDS) called the Zimmer Biomet Drive Portal which manages the creation and tracking of surgical cases. The cases reside on the portal until it is uploaded to the ROSA® Knee System before surgeries.
If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI systems (X-PSI Knee System or CAS PSI Knee System) to create a model of the patient's femur/tibia and allows for the preparation of a pre-operative surgical plan as well as visualization of planned cuts. The pre-operative plan is then matched to the landmarks taken intra-operatively on the patient's bony anatomy. An imageless option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan directly in the surgery. Accuracy of resections, knee state evaluation, and soft tissue assessment are the same between image-based and imageless options as they are always based on intra-operative landmarks.
The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional TKA workflow. As such, at the time of the surgery , the system mainly assists the surgeon in (1) determining reference alignment axes in relation to anatomical landmarks, (2) planning the orthopedic implants location based on these reference alignment axes and orthopedic implant geometry (planning optionally based on a pre-operative plan using pre-operative imaging),, and (3) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.
Mentions image processing
If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI systems (X-PSI Knee System or CAS PSI Knee System) to create a model of the patient's femur/tibia and allows for the preparation of a pre-operative surgical plan as well as visualization of planned cuts. The pre-operative plan is then matched to the landmarks taken intra-operatively on the patient's bony anatomy. An imageless option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan directly in the surgery. Accuracy of resections, knee state evaluation, and soft tissue assessment are the same between image-based and imageless options as they are always based on intra-operative landmarks.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or MRI; Magnetic Resonance (MR) and X-Ray image data
Anatomical Site
Knee, femur, tibia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Hospital (Inferenced from surgical context)
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)
The following performance data was provided in support of the substantial equivalence determination:
Biocompatibility Testing
The biocompatibility evaluation for ROSA Knee was conducted in accordance with ISO 10993. The evaluation reveals that the ROSA Knee device meets biocompatibility requirements.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing was conducted on ROSA Knee. The device complies with recognized electrical safety standards: IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility.
Device Performance Testing
Verification and Validation Testing for ROSA Knee was conducted with the following aspects:
- Physical/Performance Tests- to ensure the performance of O the implemented features and verify related design inputs
- Engineering Analysis- to ensure the performance of the O implemented features and verify related design inputs
- Usability Engineering- addressed user interactions with the O ROSA Knee
- Validation Lab- performed to validate that using the ROSA O Knee is safe and effective and that the performances of the ROSA Knee are acceptable under full simulated use on cadaveric specimens
Software Verification and Validation Testing
Software tests were conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process). The software was considered a "major" level of concern, since a failure of the software could result in serious injury or death to the patient. The testing demonstrates that the ROSA Knee does not raise any new issues of safety and effectiveness as compared to the predicate device(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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Orthosoft Inc. (d/b/a Zimmer CAS) Paul Hardy Sr. Specialist, Regulatory Affairs 75 Queen Street Ste. 3300 Montreal QC, H3C 2N6 CA
January 24, 2019
Re: K182964
Trade/Device Name: ROSA Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 24, 2018 Received: October 25, 2018
Dear Paul Hardy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed Jesse by Jesse Muir -S Date: 2019.01.24 Muir -S Date: 2019.01.2
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182964
Device Name ROSA® Knee System
Indications for Use (Describe)
The ROSA® Knee System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation to identifiable anatomical structures for the accurate placement of knee implant components.
The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan, optionally determined pre-operatively using compatible X-ray or MRI based surgical planning tools.
It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.
The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA® Knee System. The ROSA® Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications:
NexGen® CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Vanguard® CR, and Vanguard PS.
| 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
K182964
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the ROSA® Knee System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Zimmer CAS d/b/a Orthosoft, Inc.
75 Queen St., Suite 3300
Montreal, QC, CANADA H3C 2N6
Establishment Registration Number: 9617840 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paul Hardy
Regulatory Affairs Sr. Specialist
Telephone: 574-372-6799 |
| Date: | January 23, 2019 |
| Subject Device: | Trade Name: ROSA® Knee System
Common Name: ROSA® Knee System |
| | Classification Name:
• OLO- Orthopedic Stereotaxic Instrument (21 CFR
882.4560) |
Predicate Device(s):
| Manufacturer | Device Name | 510(k) Number |
|---|---|---|
| Medtech S.A. | ROSA Spine | K151511 |
| MAKO Surgical | ||
| Corp. | Mako Total Knee | |
| Application | K172219 |
Purpose and Device Description:
The ROSA® Knee System is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intra-operatively. The ROSA® Knee System uses a Medical Device Data System (MDDS) called the Zimmer
4
Biomet Drive Portal which manages the creation and tracking of surgical cases. The cases reside on the portal until it is uploaded to the ROSA® Knee System before surgeries.
If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI systems (X-PSI Knee System or CAS PSI Knee System) to create a model of the patient's femur/tibia and allows for the preparation of a pre-operative surgical plan as well as visualization of planned cuts. The pre-operative plan is then matched to the landmarks taken intra-operatively on the patient's bony anatomy. An imageless option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan directly in the surgery. Accuracy of resections, knee state evaluation, and soft tissue assessment are the same between image-based and imageless options as they are always based on intra-operative landmarks.
The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional TKA workflow. As such, at the time of the surgery , the system mainly assists the surgeon in (1) determining reference alignment axes in relation to anatomical landmarks, (2) planning the orthopedic implants location based on these reference alignment axes and orthopedic implant geometry (planning optionally based on a pre-operative plan using pre-operative imaging),, and (3) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.
Indications for Use: The ROSA® Knee System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing softwaredefined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.
The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan, optionally determined pre-operatively using compatible X-ray or MRI based surgical planning tools.
5
| | It includes a robotic arm, an optical sensor navigation
system and accessories, software system, surgical
instruments and accessories. |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The targeted population has the same characteristics as the
population that is suitable for the implants compatible with
the ROSA® Knee System. The ROSA® Knee System is to
be used with the following fixed bearing knee replacement
systems in accordance with their indications and
contraindications: NexGen® CR, NexGen CR-Flex,
NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-
Flex, NexGen LPS-Flex Gender, Persona® CR, Persona
PS, Vanguard® CR, and Vanguard PS. |
| Contraindications: | The ROSA® Knee System may not be suitable for use in case
of: |
| | hip pathology with significant bone loss (e.g. avascular
necrosis of the femoral head with collapse, severe dysplasia
of the femoral head or the acetabulum); hip pathology severely limiting range of motion (e.g.
arthrodesis, severe contractures, chronic severe dislocation); active infections of the knee joint area; knee replacement revision surgery; presence of strong infrared sources or infrared reflectors in
the vicinity of the trackers; contraindications for the implant as given by the implant
manufacturer; and implants that are not compatible with the system |
| Summary of Technological
Characteristics: | The rationale for substantial equivalence is based on
consideration of the following characteristics: |
| | The proposed and predicate device(s) are intended to assist
the surgeon in providing software defined spatial boundaries
for orientation |
- The proposed and predicate device(s) assists in intraoperative ● navigation of the patient's anatomy and are utilized to facilitate implant positioning
- . The propose and predicate device(s) assist in joint balancing techniques
6
- The proposed and predicate device(s) utilizes image data that ● has been segmented to create a 3D model of the patient's bony anatomy
- . The proposed and predicate device(s) consists of major components including a robotic arm, software system, navigation system, various instrumentation including reusable and disposable
Summary of Performance Data (Nonclinical and/or Clinical)
The following performance data was provided in support of the substantial equivalence determination:
Biocompatibility Testing
The biocompatibility evaluation for ROSA Knee was conducted in accordance with ISO 10993. The evaluation reveals that the ROSA Knee device meets biocompatibility requirements.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing was conducted on ROSA Knee. The device complies with recognized electrical safety standards: IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility.
Device Performance Testing
Verification and Validation Testing for ROSA Knee was conducted with the following aspects:
- Physical/Performance Tests- to ensure the performance of O the implemented features and verify related design inputs
- Engineering Analysis- to ensure the performance of the O implemented features and verify related design inputs
- Usability Engineering- addressed user interactions with the O ROSA Knee
- Validation Lab- performed to validate that using the ROSA O Knee is safe and effective and that the performances of the ROSA Knee are acceptable under full simulated use on cadaveric specimens
7
Software Verification and Validation Testing
Software tests were conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process). The software was considered a "major" level of concern, since a failure of the software could result in serious injury or death to the patient. The testing demonstrates that the ROSA Knee does not raise any new issues of safety and effectiveness as compared to the predicate device(s).
Substantial Equivalence Conclusion
The proposed and predicate device(s) have the same intended use and similar technological characteristics with the exception that the proposed device utilizes Magnetic Resonance (MR) and X-Ray image data and the predicate device(s) uses Computed Tomography (CT). These imaging modalities have been used in various Zimmer Biomet platforms. In addition, the proposed device uses cutting blocks to assist with bone preparation similar to traditional manual total knee arthroplasty while the predicate device(s) are equipped with an automated cutting system that does not require cutting blocks or pedicle screws that are placed by the surgeon and surgical tools are inserted in tool guides on the robotic arm. In sum, any differences between the devices do not raise new questions of safety and effectiveness and the proposed device is at least as safe and effective as the legally marketed predicate device(s).