Perseus

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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. September 9, 2020 Orthokey Italia S.r.l. % Guido Bonapace Regulatory Affair Isemed srl Via P. Togliatti, 19/X Imola, 40026 Italy Re: K192653 Trade/Device Name: Perseus Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 6, 2020 Received: August 10, 2020 Dear Guido Bonapace: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K192653 Device Name PERSEUS Indications for Use (Describe) PERSEUS is a computer-controlled system, intended to assist in distal femoral resection and tibial resection during Total Knee Arthroplasty, determining reference alignment axes in relation to anatomical and instrumentation structures during stereotaxic orthopaedic surgical procedures. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary This 510(k) Summary is being submitted as required by 21 CFR 807.92. #### 5.1 General Information | Submitter : | ORTHOKEY Italia S.r.l | |-------------|--------------------------| | | Piazza Nazioni Unite, 15 | | | 54033 Carrara (MS)-Italy | | | Tel. +39 055 354829 | | | Fax +39 055 3246012 | Consultant/ Contact: Guido Bonapace ISEMED srl Via Palmiro Togliatti 19/X Imola, BO 40026 ITALY Tel. +39 0542 683803 Fax +39 0542 698456 Email: regulatory@isemed.eu Summary Prepared Date: September the 7th, 2020 #### 5.2 Names | Device Name: | PERSEUS | |------------------|-----------------------------------| | Common Name: | Orthopedic Stereotaxic Instrument | | Regulation Name: | Stereotaxic Instrument | | Product Code: | OLO | | Classification: | 21 CFR 882.4560, Class II | #### 5.3 Predicate Devices The medical device PERSEUS is substantially equivalent to the following device legally marketed in the US: | Applicant | PREDICATE Device name | 510(k) Number | |----------------|-----------------------|---------------| | OrthAlign Inc. | KneeAlign 2 System | K163379 | Moreover, the following reference device has been considered: | Applicant | REFERENCE Device name | 510(k) Number | |------------|-----------------------|---------------| | Zimmer CAS | iASSIST™ Knee System | K141601 | {4}------------------------------------------------ ### 5.4 Device Description PERSEUS is a computer assisted system, that helps surgeon in the positioning of implant components, during total knee implant surgical procedure, according to the conventional reference axes in relation to anatomical landmarks. Perseus System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The device assists the surgeon in: - Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur. - Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia. Perseus system utilizes triaxial accelerometer and triaxial gyroscope to determine, through limb movement, reference axes of femur and tibia and relative orientation of distal femoral and tibial cutting guide with respect to frontal and sagittal planes of the limb. #### 5.5 Indications for Use PERSEUS is a computer-controlled system, intended to assist in distal femoral resection and tibial resection during Total Knee Arthroplasty, by determining reference alignment axes in relation to anatomical and instrumentation structures during stereotaxic orthopedic surgical procedures. | | Proposed Device | Predicate Device | Reference Devices | |------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Name | PERSEUS | KneeAlign 2 System | iASSIST Knee System | | Manufacturer | Orthokey Italia S.r.l. | OrthAlign Inc. | Zimmer CAS | | 510(K) No. | | K163379 | K141601 | | Classification<br>Name | Orthopedic Stereotaxic<br>Instrument | Orthopedic Stereotaxic<br>Instrument | Orthopedic Stereotaxic<br>Instrument | | Figure | Image: PERSEUS | Image: KneeAlign 2 System | Image: iASSIST Knee System | | Regulation<br>Number | 882.4560 | 882.4560 | 882.4560 | | Regulatory Class | II | II | II | | Classification<br>Product Code | OLO | OLO | OLO | | Intended use | | | | | Indications for<br>use | PERSEUS is a computer-<br>controlled system, intended<br>to assist in distal femoral<br>resection and tibial | The OrthAlign Plus®System is a<br>computer-controlled system<br>intended to assist the surgeon<br>in determining reference | The iASSIST Knee System is a<br>computer assisted stereotaxic<br>surgical instrument system to<br>assist the surgeon in the | | | Proposed Device | Predicate Device | Reference Devices | | Product Name | PERSEUS | KneeAlign 2 System | iASSIST Knee System | | | resection during Total Knee<br>Arthroplasty, by<br>determining reference<br>alignment axes in relation to<br>anatomical and<br>instrumentation structures<br>during sterotactic<br>orthopaedic surgical<br>procedures. | alignment axes in relation to<br>anatomical structures during<br>stereotactic orthopedic surgical<br>procedures. The KneeAlign<br>system facilitates the accurate<br>positioning of implants and<br>instrumentation, relative to<br>these alignment axes.<br>Orthopedic surgical procedures<br>include but are not limited to:<br>Total Knee Arthroplasty<br>Unicompartmental Knee<br>Arthroplasty – Tibial Transverse<br>Resection | positioning of orthopedic<br>implant system components<br>intra-operatively. It involves<br>surgical instruments and<br>position sensors to determine<br>alignment axes in relation to<br>anatomical landmarks and to<br>precisely position alignment<br>instruments and implant<br>components relative to these<br>axes. Example orthopedic<br>surgical procedures include<br>but are not limited to: Total<br>Knee Arthroplasty. | | Target<br>population | Orthopedic surgical<br>procedures include:<br>Total knee arthroplasty | Orthopedic surgical procedures<br>include but are not limited to:<br>Total Knee Arthroplasty<br>Uni-compartmental Knee<br>Arthroplasty - Tibial Transverse<br>Resection | Orthopedic surgical<br>procedures include but are<br>not limited to:<br>Total knee arthroplasty | | Anatomical site | knee | knee | Knee | | Where used<br>(hospital, home,<br>ambulance, etc) | For professional use in<br>operating room | For professional use in<br>operating room | For professional use in<br>operating room | | Technology | | | | | Energy used<br>and/or<br>delivered | • Navigation unit, reference<br>sensor: DC battery power.<br>• Instruments: manual<br>position and orientation | • Navigation unit, reference<br>sensor and laser module: DC<br>battery power<br>• Instruments: manual position<br>and orientation | • Reference sensor: DC<br>battery power.<br>• Instruments: manual<br>position and orientation | | User Interface | Graphical user interface, on<br>computer unit, outside<br>sterile field. | Integrated graphical user<br>interface, on an electronic unit<br>that attaches to<br>instrumentation. | Integrated graphical user<br>interface, on an electronic<br>unit that attaches to<br>instrumentation. | | Control<br>Mechanism | Computer generation of<br>positional information, using<br>inertial sensors,<br>microcontroller, digital<br>signal processor and<br>physical positions of<br>registration instruments. | Computer generation of<br>positional information, using<br>inertial sensors,<br>microcontroller, digital signal<br>processor and physical<br>positions of registration<br>instruments. | Computer generation of<br>positional information, using<br>inertial sensors,<br>microcontroller, digital signal<br>processor and physical<br>positions of registration<br>instruments. | | Operating<br>Principles<br>Registration of<br>anatomy | Electronics attached to<br>movable instruments,<br>placed in specified<br>procedural positions, for<br>recording sensor data. | Electronics attached to movable<br>instruments, placed in specified<br>procedural positions, on or in<br>contact with bony anatomy, for<br>recording sensor data. | Electronics attached to<br>movable instruments, placed<br>in specified procedural<br>positions, on or in contact<br>with bony anatomy, for<br>recording sensor data. | | Measurement<br>of change in<br>angular<br>orientations | • Computer displayed<br>values based on internal<br>calculations.<br>• Accelerometer | • Computer displayed values<br>based on internal calculation.<br>• Accelerometer measurement<br>of angular change in | • Computer displayed values<br>based on internal<br>calculation.<br>• Accelerometer | | | Proposed Device | Predicate Device | Reference Devices | | Product Name | PERSEUS | KneeAlign 2 System | iASSIST Knee System | | | change in instrument<br>positions. | | change in instrument<br>positions. | | Patient interface | Instrument fixation to bone<br>with pins or screws.<br>Instrument indications and<br>engagement of bony<br>anatomy via physical surface<br>contact | Instrument fixation to bone<br>with pins or screws. Instrument<br>indications and engagement of<br>bony anatomy via physical<br>surface contact | Instrument fixation to bone<br>with pins or screws.<br>Instrument indications and<br>engagement of bony anatomy<br>via physical surface contact | | Main System<br>Components | • Non sterile reusable<br>computer unit<br>• Navigation and<br>measurement software<br>• Reusable instrument sets<br>• Single-use sensor | • Single-use computer unit<br>• Navigation and measurement<br>software<br>• Reusable instrument sets | • Non sterile reusable<br>computer unit<br>• Navigation and<br>measurement software<br>• Reusable instrument sets<br>• Single-use sensor | | Performance | HKA angle within 3° | HKA angle within 3° | HKA angle within 3° | | Electrical Safety<br>and EMC | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2 | | Materials | Stainless Steel grades<br>common to orthopedic<br>surgical instruments<br>Polymer grades common to<br>orthopedic surgical<br>instruments<br>Internal electronics | Stainless Steel grades common<br>to orthopedic surgical<br>instruments<br>Polymer grades common to<br>orthopedic surgical instruments<br>Internal electronics | Stainless Steel grades<br>common to orthopedic<br>surgical instruments<br>Polymer grades common to<br>orthopedic surgical<br>instruments<br>Internal electronics | | Biocompatibility | Per ISO 10993-1, External<br>Communicating Device,<br>Tissue/Bone/Dentin<br>Communicating, with<br>subsystems that have<br>potential indirect contact<br>for a limited contact<br>duration (< 24 hours) | Per ISO 10993-1, External<br>Communicating Device,<br>Tissue/Bone/Dentin<br>Communicating, with<br>subsystems that have direct<br>and potential indirect contact<br>for a limited contact duration (< 24 hours) | Per ISO 10993-1, External<br>Communicating Device,<br>Tissue/Bone/Dentin<br>Communicating, with<br>subsystems that have direct<br>and potential indirect contact<br>for a limited contact duration<br>(< 24 hours) | | Compatibility<br>with the<br>environment<br>and other<br>devices | Specified storage and<br>operating environments for<br>typical transport and<br>surgical environments. | Specified storage and operating<br>environments for typical<br>transport and surgical<br>environments. | Specified storage and<br>operating environments for<br>typical transport and surgical<br>environments. | | Sterilization | • Navigation unit: EO<br>sterilization.<br>• Instruments: autoclave<br>sterilization | • Navigation unit: EO<br>sterilization.<br>• Instruments: autoclave<br>sterilization | • Navigation unit: EO<br>sterilization.<br>• Instruments: autoclave<br>sterilization | ### 5.6 Comparison with the predicate and the reference device {5}------------------------------------------------ {6}------------------------------------------------ ## ORTHOKEY ITALIA SRL 510(K) PREMARKET NOTIFICATION The subject device PERSEUS fall under the same Regulation number, Regulatory Class and Product Code as the predicate device K163379 and the reference device K141601. The indication for use of the subject device PERSEUS is similar to the one declared by the predicate device K163379 and the reference device K141601. As per information provided in the table above, the technical and performance features of the proposed and predicate devices are similar or identical. In order to demonstrate the effective comparison related to clinical performance, biocompatibility, sterilization, packaging, shelf life, electrical and EMC safety, specific clinical evaluation and tests based on international standards have been performed. {7}------------------------------------------------ In light of evidence listed in the table above, the proposed device PERSEUS can be considered substantially equivalent to the predicate device K163379 and the reference device K141601. #### 5.7 Performance Data In order to demonstrate the accuracy and repeatability of the proposed device PERSEUS in terms of alignment of the resection level, with respect to mechanical axis, performance tests have been conducted. Bench tests performance evaluation of Perseus has been done, verifying the orientation of femoral or tibial resections. Clinical evaluation has been done with the same performance requirement when possible or, in alternative, looking at final leg alignment with post-operative x-rays. The clinical evaluation has been prepared considering: - Bench testing - Pre-clinical evaluation testing - Aftermarket Clinical evaluation (Europe) - Data generated from literature Bench testing have been conducted introducing controlled variables within an appropriate test setup throughout the subject device's operational range, to quantify the accuracy of the device. A set of bench tests have been designed in order to: - Verify the measurement repeatability on a controlled setup, with different cursor positions of the jig - Verify the error introduced by mispositioning of the ankle instrumentation - Verify the repeatability of the measurement with different sensors - Verify the repeatability of the measurement with different instrument positioning Pre-clinical activities have been conducted to verify accuracy, repeatability and reproducibility in a simulated OR setup and to verify the consistency of the procedure when performed by different users with different level of experience. Aftermarket clinical evaluation. Since Perseus is CE marked, aftermarket clinical evaluation has been done in Europe. Studies were conducted involving research centers in order to verify clinical results and performances of Perseus. A study involved 3 cohorts of 10 patients each randomly selected, operated by the same surgical equipe, where perseus was used only for distal femoral resection. The cohorts were dividend in: - EM Perseus; patients operated with Perseus ● - EM Nav; patients operated with surgical navigation system, - IM Conv; patients operated with conventional mechanical instrumentations. Final limb alignment on frontal and lateral planes and blood loss have been measured postoperatively. Perseus has demonstrated to fulfil surgical goal of final HKA alignment within 3° of deviation and femoral distal resection within 2° of deviation, and a reduced blood loss, compared to conventional technique. A second study only on femoral resection has been performed on a multicentric study involving two centers. The goal of the study was to verify blood loss and angular deviation of femoral distal resection on frontal and lateral planes, for two cohorts of 18 patients: 1 operated with the use of Perseus; 2 operated with conventional instrumentation. Perseus for the femoral resection has confirmed to satisfy the requirements of have a deviation < 2° in both frontal and lateral planes. A third study was a single cohort evaluation, on 20 patients, of final limb alignment, blood loss and surgical time. Results show an average femoral resection alignment of 91±0.5° varus in frontal plane and 1.5±1.0° on sagittal plane. {8}------------------------------------------------ Data on post-operative x-rays obtained from first 20 cases performed by the same user have been obtained. Results show an average post-operative deviation of HKA angle of 0.3±1.5°, femoral implant flexion of 0.8±0.8° and a tibial slope of 0.1±1.7°. Data on post-operative x-rays obtained from 53 patients operated with Perseus and compared with 52 patients operated with conventional technique have been obtained. Results show and average post-operative deviation of HKA alignment of 0.7° with a range of 0-2°. ### 5.8 Conclusion The comparison performed between the proposed device PERSEUS, the predicate device K163380 and the reference device K141601, is able to demonstrates that the device PERSEUS has similar technical features and clinical performance of the devices previously marketed in US. Particularly, even if the user interface is slightly different from the one proposed by the predicate device, this difference does not raise any new concern in terms of safety and effectiveness, as demonstrated through electrical safety, EMC, sterilization, packaging, shelf life and performance test reports. In light of evidence summarized above and based on classification, intended use, technological characteristics, and performance data, the subject device PEPRSEUS may be found substantially equivalent to the predicate device KneeAlign 2 System (K163379) and the reference device iASSIST™ Knee System (K141601).