(90 days)
Not Found
No
The summary describes a robotic surgical system for partial knee replacement that uses optical navigation and pre/intraoperative imaging/landmarks for planning and guidance. 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.
No.
The device is a stereotaxic instrumentation system that assists surgeons in performing Partial Knee Arthroplasty (PKA) by providing guidance for accurate placement of knee implant components, rather than directly treating a disease or condition.
No
Explanation: The device is described as a "stereotaxic instrumentation system" and "robotic arm" to "assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of the knee implant components." Its primary function is to guide surgical procedures and assist with implant positioning, not to diagnose medical conditions or diseases. While it uses imaging data and assists in assessing the "state of the soft tissues to facilitate implant positioning intraoperatively," this assessment is for surgical planning and execution related to placement of the implant, not for diagnosing a medical condition.
No
The device description explicitly states that the system includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The ROSA® Partial Knee System is a stereotaxic instrumentation system used during surgery to assist the surgeon in the accurate placement of knee implant components. It uses imaging data and anatomical landmarks to guide the robotic arm and surgical instruments.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is entirely focused on surgical guidance and positioning based on anatomical structures and imaging.
Therefore, the ROSA® Partial Knee System falls under the category of a surgical guidance or robotic-assisted surgical system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ROSA® Partial Knee System, for use with the ROSA® RECON platform, is indicated as a stereotaxic instrumentation system for Partial Knee replacement (PKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of the knee implant components.
The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and optionally based on a three-dimensional representation of the bone structures determined preoperatively using compatible X-ray or MRI based imaging technologies.
It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.
The ROSA® Partial Knee System is designed for use on a skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA® Partial Knee System.
The ROSA® Partial Knee System is to be used with Persona Partial Knee (PPK) fixed bearing knee replacement system in accordance with its indications and contraindications.
Product codes
OLO
Device Description
The ROSA® Partial Knee System for use with the ROSA® RECON Platform is used to assist surgeons in performing Partial Knee Arthroplasty (PKA) on the medial compartment with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intraoperatively.
The ROSA® Partial Knee System uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Drive Portal which manages the creation and tracking of the surgical cases. The cases reside on the portal until it is uploaded to the ROSA® RECON Platform 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 3D model of the patient's femur/tibia and allows the preparation of a pre-operative ROSA Total Knee System (TKA) surgical plan. However, the pre-operative surgical plan is not provided in the ROSA® Partial Knee System and is only made available if a switch is performed intra-operatively from ROSA® Partial Knee System to the ROSA® Knee System. Landmarks taken intra-operatively on the patient's bony anatomy are used to create the intraoperative surgical plan.
An image-free option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan.
Accuracy of resections, knee state evaluation, and soft tissue assessment are the same between image-based and image-free options as they are always based on intraoperative landmarks.
The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional PKA 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 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or MRI based imaging technologies.
The proposed device utilizes Magnetic Resonance (MR) and X-ray image data.
Anatomical Site
Partial Knee
Indicated Patient Age Range
skeletally mature patient population
Intended User / Care Setting
Not Found
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® Partial was conducted in accordance with ISO 10993. The evaluation reveals that the ROSA® Partial device meets biocompatibility requirements.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical Safety and EMC testing was conducted on the ROSA® RECON Platform. 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® Partial was conducted with the following aspects:
- Physical/Performance Tests- to ensure the performance of the implemented features and verify related design inputs
- Engineering Analysis- to ensure the performance of the implemented features and verify related design inputs
- Usability Engineering- addressed user interactions with ROSA® Partial Knee System
- Validation Lab- performed to validate that using ROSA® Partial Knee System is safe and effective and that the performances of the system are acceptable under full simulated use on cadaveric specimens
Software Verification and Validation Testing
Software tests were conducted to satisfy requirements of the FDA Guidance for the Content 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® Partial Knee System 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): 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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April 19, 2021
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.
Orthosoft d/b/a Zimmer CAS Kavina Veeren Regulatory Affairs Manager 75 Queen Street, Suite 3300 Montreal, Quebec H3C 2N6 Canada
Re: K210121
Trade/Device Name: ROSA Partial Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 15, 2021 Received: January 19, 2021
Dear Kavina Veeren:
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/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 mediation-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
2
Indications for Use
510(k) Number (if known) K210121
Device Name ROSA® Partial Knee System
Indications for Use (Describe)
The ROSA® Partial Knee System, for use with the ROSA® RECON platform, is indicated as a stereotaxic instrumentation system for Partial Knee replacement (PKA) 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 the knee implant components.
The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and optionally based on a three-dimensional representation of the bone structures determined preoperatively using compatible X-ray or MRI based imaging technologies.
It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.
The ROSA® Partial Knee System is designed for use on a skeletally mature patient population has the same characteristics as the population that is suitable for the implants compatible with the ROSA® Partial Knee System.
The ROSA® Partial Knee System is to be used with Persona Partial Knee (PPK) fixed bearing knee replacement system in accordance with its indications and contraindications ..
| 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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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® Partial Knee (PKA) 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: | Orthosoft, ULC d/b/a Zimmer CAS
75 Queen St., Suite 3300
Montreal, QC, H3C 2N6, CANADA
Establishment Registration Number: 9617840 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kavina Veeren
Manager, Regulatory Affairs
Telephone: (514-245-8906) |
| Date: | 15th January 2021 |
| Subject Device: | Trade Name: ROSA® Partial Knee System
Common Name: ROSA® Partial Knee System, ROSA®
PKA System |
| | Classification Name:
• OLO-Stereotaxic Instrument (21 CFR 882.4560) |
Predicate Device(s):
| 510(k)
| Number | Device Name | Manufacturer |
|---|---|---|
| K182964 | ROSA® Knee System | Zimmer CAS |
| *Primary | ||
| K170584 | MAKO Partial Knee | |
| Application | MAKO Surgical | |
| Corp. |
Purpose and Device Description:
The ROSA® Partial Knee System for use with the ROSA® RECON Platform is used to assist surgeons in performing Partial Knee Arthroplasty (PKA) on the medial compartment with features to assist with the bone
4
resections as well as assessing the state of the soft tissues to facilitate implant positioning intraoperatively.
The ROSA® Partial Knee System uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Drive Portal which manages the creation and tracking of the surgical cases. The cases reside on the portal until it is uploaded to the ROSA® RECON Platform 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 3D model of the patient's femur/tibia and allows the preparation of a pre-operative ROSA Total Knee System (TKA) surgical plan. However, the pre-operative surgical plan is not provided in the ROSA® Partial Knee System and is only made available if a switch is performed intra-operatively from ROSA® Partial Knee System to the ROSA® Knee System. Landmarks taken intra-operatively on the patient's bony anatomy are used to create the intraoperative surgical plan.
An image-free option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan.
Accuracy of resections, knee state evaluation, and soft tissue assessment are the same between image-based and image-free options as they are always based on intraoperative landmarks.
The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional PKA 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 using pre-operative imaging), and (3) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.
5
| Indications for Use: | The ROSA® Partial Knee System, for use with the ROSA® RECON platform, is indicated as a stereotaxic instrumentation system for Partial Knee replacement (PKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of the knee implant components. |
|---|---|
| The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and optionally based on a three-dimensional representation of the bone structures determined preoperatively using compatible X-ray or MRI based imaging technologies. | |
| It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories. | |
| The ROSA® Partial Knee System is designed for use on a skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA® Partial Knee System. | |
| The ROSA® Partial Knee System is to be used with Persona Partial Knee (PPK) fixed bearing knee replacement system in accordance with its indications and contraindications. | |
| Contraindications: | The ROSA® Partial Knee System may not be suitable for use in case of: |
| o hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or acetabulum); | |
| o hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation); | |
| o active infections of the knee joint area; | |
| o knee replacement revision surgery; |
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o presence of strong infrared sources or infrared reflectors in the vicinity of the trackers;
o contraindications for the implant as given by the implant manufacturer: and
o 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:
- O The proposed and predicate device(s) are intended to assist the surgeon in providing software defined spatial boundaries for orientation
- 0 The proposed and predicate device(s) assists in intraoperative navigation of the patient's anatomy and are utilized to facilitate implant positioning
- o The proposed and predicate device(s) assists in joint balancing techniques
- 0 The proposed and predicate device(s) utilizes image data that has been segmented to create a 3D model of the patient's bony anatomy
- 0 The proposed and primary predicate device utilize the ROSA® RECON Platform, and the proposed and predicate device(s) consists of major components including a 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® Partial was conducted in accordance with ISO 10993. The evaluation reveals that the ROSA® Partial device meets biocompatibility requirements.
7
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical Safety and EMC testing was conducted on the ROSA® RECON Platform. 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® Partial was conducted with the following aspects:
- Physical/Performance Tests- to ensure the performance of the implemented features and verify related design inputs
- Engineering Analysis- to ensure the performance of the 0 implemented features and verify related design inputs
- . Usability Engineering- addressed user interactions with ROSA® Partial Knee System
- Validation Lab- performed to validate that using ROSA® 0 Partial Knee System is safe and effective and that the performances of the system are acceptable under full simulated use on cadaveric specimens
Software Verification and Validation Testing
Software tests were conducted to satisfy requirements of the FDA Guidance for the Content 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® Partial Knee System 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 including that the proposed device utilizes Magnetic Resonance (MR) and X-ray image data, which is the same as the primary predicate device. The MAKO predicate device uses Computed Tomography (CT).
8
In addition, the proposed device uses cutting blocks to assist with bone preparation similar to traditional manual partial knee arthroplasty which is similar to the primary predicate device. The MAKO predicate device is equipped with an automated cutting system that does not require cutting blocks.
The proposed device does not perform any pre-operative surgical planning as compared to the predicate devices. The primary predicate and proposed device share the same previously cleared ROSA® RECON platform hardware and software core components and some of the same instrumentation between the two systems.
In summary, 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).