(90 days)
The 360CAS is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided surgical procedures.
The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure, such as the pelvis, femur, or tibia, can be identified.
The 360CAS Knee is indicated for the following surgical procedures:
- Total Knee Arthroplasty (TKA)
- For conditions of the knee joint in which the use of computer assisted surgery may be appropriate
The 360CAS Hip is indicated for the following surgical procedures:
- Total Hip Arthroplasty (THA) e.g., open or minimally invasive, where a posterior or anterior approach is used
- For conditions of the hip joint in which the use of computer assisted surgery may be appropriate
The 360 Computer Assisted Surgery (360CAS) is a stereotaxic surgical navigation system for orthopaedic surgical procedures. The 360CAS is intended to be used as a planning and intraoperative quidance system with any manufacturers implant in open or percutaneous orthopaedic surgical procedures. The 360CAS uses optical tracking technology that allows surgeons to map a patient's morphology, navigate surgical instruments and implants and assess the state of the joint throughout the surgery. The system consists of four main components: 360CAS navigation software, which consists of two modules: 360CAS Knee and 360CAS Hip, surgical instruments, spatial tracking components and a navigation cart. 360CAS Knee is a 360CAS navigation software for knee replacement surgery. 360CAS Hip is a 360CAS navigation software for hip replacement surgery. The navigation software interfaces with the optical trackers which are attached to navigation instruments (e.g. pointer, bone fixator(s)).
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| System Accuracy (Knee) | The system enables the determination of the mechanical axes of the lower limb as well as cut and component alignment with a mean translational error of < ±2 mm and a mean rotational error of < ±1°. |
| System Accuracy (Hip) | The system enables the determination of the mechanical axes of the lower limb as well as cut and component alignment with a mean translational error of < ±2 mm and a mean rotational error of < ±1°. (Note: The predicate device for Hip had a rotational error of < ±2°, making the subject device's performance superior or at least equivalent if the "less than" applies to the absolute value.) |
| Electrical Safety | Conducted in accordance with AS/NZS 3551:2012 and IEC 60601-1-2:2014. |
| Electromagnetic Compatibility | Conducted in accordance with IEC 60601-1-2:2014. |
| Software Verification/Validation | Performed according to FDA guidance (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005) and Off-the-Shelf Use in Medical Devices (2019)). Considered a "MAJOR" level of concern. |
| Functional Testing | All functional requirements are fulfilled. |
| Safety Testing | Effectiveness of all risk controls determined in the device risk analysis was verified. |
| Clinical Workflow | Verified that all system components (application, computer platform and accessories) are compatible through complete knee and hip arthroplasty procedures simulated using Sawbones mimicking the patient's anatomy and cadaver laboratories. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing and cadaveric laboratory testing. Specific sample sizes for each test are not explicitly provided, but the types of materials used are:
- ASTM accuracy testing: Not specified, but uses a standardized test procedure according to ASTM F2554-18.
- System accuracy testing: Sawbones mimicking patient's anatomy.
- Clinical accuracy testing: Not specified, but states "in a cadaveric laboratory."
- Clinical workflow testing: Sawbones mimicking the patient's anatomy and cadaver laboratory.
The data provenance is from laboratory and cadaveric studies, not real-world patient data. The country of origin of the data is not explicitly stated, but the applicant company is located in Australia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document describes verification and validation activities but does not detail how ground truth was established for these tests or the experts involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. The document describes accuracy and workflow testing but does not mention any adjudication method for establishing ground truth or evaluating disagreements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The device is a surgical navigation system, and the performance testing focuses on its accuracy and functionality, not its impact on human reader performance. No AI-assistance claims are made that would necessitate such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, standalone performance testing was done for the device's accuracy. The "System Accuracy" and "Clinical Accuracy" testing (translational and rotational error) are examples of standalone performance evaluations for the navigation system's output. The entire performance data section (bench testing, software V&V) implicitly describes standalone performance, as it assesses the device's inherent characteristics. The design of the device as a "planning and intraoperative guidance system" suggests it assists a human surgeon, but the accuracy metrics are for the system itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance testing appears to be based on:
- Standardized test procedures and physical measurements: ASTM F2554-18 for spatial tracking accuracy.
- Engineered or known physical values: Sawbones mimicking patient anatomy and cadaveric laboratories are used to assess the device's ability to measure and guide with specified accuracy (±2mm and ±1°). The "specified accuracy" itself serves as the benchmark for evaluation.
8. The sample size for the training set
This information is not applicable/not provided. The document describes a "stereotaxic surgical navigation system" and "optical tracking technology." While it includes "360CAS navigation software," it does not explicitly mention machine learning or AI models that would require a distinct "training set" in the context of deep learning. The software verification and validation, along with functional testing, imply that the software's performance was evaluated against its design specifications, not through a machine learning training/validation split.
9. How the ground truth for the training set was established
This information is not applicable/not provided as there is no mention of a machine learning training set. The software's "ground truth" would be its design requirements and specifications, validated through standard software V&V processes and functional testing.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 11, 2022
Kico Knee Innovation Company Pty Limited Stefanie Auf Der Mauer Head of RA/QA Suite 3, Building 1, 20 Bridge Street Pymble, New South Wales 2073 Australia
Re: K213380
Trade/Device Name: 360cas Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 8, 2021 Received: October 13, 2021
Dear Stefanie Mauer:
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.
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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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213380
Device Name 360CAS
Indications for Use (Describe)
The 360CAS is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided surgical procedures.
The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure, such as the pelvis, femur, or tibia, can be identified.
The 360CAS Knee is indicated for the following surgical procedures:
-
Total Knee Arthroplasty (TKA)
-
For conditions of the knee joint in which the use of computer assisted surgery may be appropriate
The 360CAS Hip is indicated for the following surgical procedures:
-
Total Hip Arthroplasty (THA) e.g., open or minimally invasive, where a posterior or anterior approach is used
-
For conditions of the hip joint in which the use of computer assisted surgery may be appropriate
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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/1 description: The image is a logo for "360 Med Care". The logo features the number "360" in a bold, sans-serif font, with the words "MED CARE" stacked below it in a smaller font. The logo is encircled by a dotted line that transitions from black to blue to gray, suggesting a full circle or a comprehensive approach. The upper right portion of the circle is a solid gray arc with an arrow at the end, further emphasizing the "360" concept.
510(k) Summary
A 510(k) summary has been prepared in accordance with the requirements of 21 CFR 807.92 Content and Format of a 510(k) Summary.
Applicant Details
| Name: | Kico Knee Innovation Company PtyLimited |
|---|---|
| Address: | Suite 3, Building 1, 20 Bridge StreetPymble, New South Wales 2073Australia |
| Contact Person /Prepared By: | Emma HayesRegulatory Affairs Manager+64 221 188 373 (phone)emma@360med.care |
| Date Prepared: | January 11, 2022 |
Device Details and Substantial Equivalence Claim
| Device Common Name: | Orthopedic Stereotaxic Instrument |
|---|---|
| Device Trade Name: | 360CAS |
| Regulation Number: | 21 CFR 882.4560 |
| Regulation Name: | Stereotaxic Instrument |
| Regulatory Class: | II |
| Panel: | Orthopedic |
| Product Code: | OLO |
| Predicate Devices:(Primaries for Knee and Hip) | Stryker OrthoMap Precision Knee System (K162341)Stryker OrthoMap Versatile Hip System (K162937) |
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Device Description
The 360 Computer Assisted Surgery (360CAS) is a stereotaxic surgical navigation system for orthopaedic surgical procedures. The 360CAS is intended to be used as a planning and intraoperative quidance system with any manufacturers implant in open or percutaneous orthopaedic surgical procedures. The 360CAS uses optical tracking technology that allows surgeons to map a patient's morphology, navigate surgical instruments and implants and assess the state of the joint throughout the surgery. The system consists of four main components: 360CAS navigation software, which consists of two modules: 360CAS Knee and 360CAS Hip, surgical instruments, spatial tracking components and a navigation cart. 360CAS Knee is a 360CAS navigation software for knee replacement surgery. 360CAS Hip is a 360CAS navigation software for hip replacement surgery. The navigation software interfaces with the optical trackers which are attached to navigation instruments (e.g. pointer, bone fixator(s)).
Indications for Use
The 360CAS is intended to be used as a planning and intraoperative quidance system to enable open or percutaneous image quided surgical procedures.
The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure, such as the pelvis, femur, or tibia, can be identified.
The 360CAS Knee is indicated for the following surgical procedures:
- Total Knee Arthroplasty (TKA) .
- For conditions of the knee joint in which the use of computer . assisted surgery may be appropriate
The 360CAS Hip is indicated for the following surgical procedures:
- Total Hip Arthroplasty (THA) e.g., open or minimally invasive, . where a posterior or anterior approach is used
- For conditions of the hip joint in which the use of computer assisted . surgery may be appropriate
Performance Data
The following performance data was provided in support of substantial equivalence decision:
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Electrical Safety and Electromagnetic Compatibility (EMC) Testing
Electrical safety and EMC testing were conducted on the subject device in accordance with the following standards:
- AS/NZS 3551:2012 Management Programs for Medical Equipment .
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: . General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests (FDA Recognition #: 19-8)
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by:
- Guidance for Industry and Food and Drug Administration Staff: ● Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued 11-May-2005
- Guidance for Industry and Food and Drug Administration Staff: Off-. the-Shelf Use in Medical Devices issued 27-Sep-2019
The 360CAS Navigation Software was considered as a "MAJOR" level of concern.
Performance Testing - Bench
The following design verification and validation activities have been performed to ensure the correct functionality of the system as it has been specified :
- . ASTM accuracy testing verifying the accuracy performance of the spatial tracking technology using the standardized test procedure according to ASTM F2554-18.
- . System accuracy testing verifying the specified accuracy of ±2mm and ±1º using Sawbones mimicking patient's anatomy.
- . Clinical accuracy testing verifying the specified accuracy of ±3mm and ±3º in a cadaveric laboratory.
- . Clinical workflow verifying that all system components (application, computer platform and accessories) are compatible. Complete knee and hip arthroplasty procedures were simulated using Sawbones mimicking the patient's anatomy and cadaver laboratory.
- Functional testing to ensure that all functional requirements are . fulfilled.
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- Safety testing verifying the effectiveness of all risk controls . determined in the device risk analysis.
This strategy ensures the verification of the accuracy, system integration, software algorithms, system functionality, and correct implementation of the risk control measures. All tests have been successfully completed.
Animal Study
No animal studies were performed to support substantial equivalence.
Clinical Studies
No clinical studies were performed to support substantial equivalence.
Substantial Equivalence Rationale - 360CAS Knee
The 360CAS Knee is considered substantially equivalent to the Stryker OrthoMap Precision Knee System regarding clinical, technical, and biological characteristics. The 360CAS Knee and the Stryker OrthoMap Precision Knee System are both intended to be used as planning and intraoperative quidance systems to enable open and percutaneous surqical procedures. Both systems are indicated for knee conditions where the use of CAS is appropriate (e.q., TKA) and where reference to a rigid anatomical structure can be identified. The 360CAS Knee and the Stryker OrthoMap Precision Knee System are intended to be used by trained orthopaedic surqeons and operators in an equivalent fashion, following equivalent registration and navigation workflows. Both systems comprise equivalent components (computer platform, navigation software, instruments, tracking components) to achieve the same purpose. The 360CAS Knee and Stryker OrthoMap Precision Knee System both require AC power to power the computer, monitor and camera. The Stryker OrthoMap Precision Knee System requires additional external enerqy sources (batteries) to power their smart instruments, whereas the 360CAS Knee does not require additional external energy sources for its instruments. Both systems use optical tracking technology where a tracker is sensed by a camera to compute spatial information. Surgical navigation in both systems is enabled through similar software platforms developed by each manufacturer. The 360CAS Knee passive optical trackers and instruments do not require infrared (IR), wireless connection or external energy sources for operation. Such passive instruments are commonly used and have been successfully integrated in other marketed devices such as the K102251 BrainLAB DASH Knee. The 360CAS Knee and the Stryker OrthoMap Precision Knee System are measuring devices
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with identical accuracy of ±2 mm and ±1°. Therefore, it is concluded that the 360CAS Knee is substantially equivalent to the Stryker OrthoMap Precision Knee System.
| Characteristic | 360CAS Knee(Subject Device) | Stryker OrthoMapPrecision Knee System(Predicate Device) |
|---|---|---|
| Trade Name: | 360CAS Knee | Stryker OrthoMap PrecisionKnee System |
| 510(k)Submitter: | Kico Knee InnovationCompany Pty Limited | Stryker Leibinger GmbH & Co.KG |
| 510(k)Number: | K213380 | K162341 |
| RegulationNumber: | 882.4560 – StereotaxicInstrument | 882.4560 – StereotaxicInstrument |
| Product Code: | OLO | OLO |
| Product Class: | II | II |
| Indications forUse | The 360CAS is intended to beused as a planning andintraoperative guidancesystem to enable open orpercutaneous image guidedsurgical procedures.The 360CAS is indicated forpatients undergoingorthopaedic surgery andwhere reference to a rigidanatomical structure, such asthe pelvis, femur, or tibia,can be identified.The 360CAS Knee is indicatedfor the following surgicalprocedures:• Total Knee Arthroplasty(TKA)• For conditions of theknee joint in which the | The Stryker OrthoMapPrecision Knee system, whichis comprised of the OrthoMapPrecision Knee 5.0 softwareand a platform of the NAV3iplatform family, is intendedas a planning andintraoperative guidancesystem to enable open orpercutaneous image guidedsurgery.The system can be used forintraoperative guidancewhere a reference to a rigidanatomical structure can beidentified. The system isindicated for conditions of theknee joint in which the use ofcomputer assisted surgerymay be appropriate. |
| Characteristic | 360CAS Knee(Subject Device) | Stryker OrthoMapPrecision Knee System(Predicate Device) |
| use of computerassisted surgery maybe appropriate | ||
| Anatomy | Knee | Knee |
| PatientPopulation | Patients with medicalconditions where use ofcomputer-assisted surgerymay be appropriate. | Patients with conditions of theknee joint where use ofcomputer-assisted surgerymay be appropriate. |
| End-Users | Trained orthopaedic surgeonand system operators | Trained orthopaedic surgeonand system operators |
| ClinicalWorkflow | Clinical workflow testingverifying that all systemcomponents are compatible.Complete total kneearthroplasty procedures aresimulated using Sawbonesmimicking the patient'sanatomy and cadaverlaboratory. | Clinical workflow testingverifying that all systemcomponents (application,computer platform andaccessories) are compatible.Complete total kneearthroplasty procedures aresimulated using Sawbonesmimicking the patient'sanatomy. |
| Main SystemComponents | Computer PlatformNavigation Cart360CAS Navigation Software- 360CAS KneeSurgical InstrumentsSpatial Tracking Components | Computer PlatformOrthoMap Precision Knee 5.0SoftwareSmart InstrumentsPatient Tracker FixationNavigated ManualInstrumentsInstrument Battery, Trays |
| Energy Source | Computer - AC Power | Computer - AC PowerSmart Instruments – Battery1. Pointer2. nGenius® Tibia Tracker |
| Characteristic | 360CAS Knee(Subject Device) | Stryker OrthoMapPrecision Knee System(Predicate Device) |
| 3. nGenius® FemurTracker | ||
| TrackingTechnology | Passive optical trackingtechnology | Infrared optical active sensingtechnology: Infrared lightemitted by diodes placed in aknown fashion on navigatedsurgical instruments is sensedby a camera array (navigationcamera) on the computerplatform, thus allowing forcomputation of the spatialinformation. |
| Image Display | Monitor | Monitor |
| SystemAccuracy | The system enables thedetermination of themechanical axes of the lowerlimb as well as cut andcomponent alignment with amean translational error of <$±2$ mm and a mean rotationalerror of < $±1$ °. | The system enables thedetermination of themechanical axes of the lowerlimb as well as cut andcomponent alignment with amean translational error of <$±2$ mm and a mean rotationalerror of < $±1$ °. |
| Software | 360CAS Navigation Software- 360CAS Knee | OrthoMap Precision Knee 5.0Software |
| Patient /InstrumentTrackers | Patient/Instrument Trackers• Femur Tracker• Tibia Tracker• Resection Guide ToolPointer• Pointer | Patient/Instrument Trackers• Universal Tracker• Tibia/Pelvic Tracker• Femoral Tracker• nGenius UniversalTracker• nGenius Tibial Tracker• nGenius Femur Tracker• Hip Femur Tracker |
| Characteristic | 360CAS Knee(Subject Device) | Stryker OrthoMapPrecision Knee System(Predicate Device) |
| Patient TrackerFixation | Bone Fixator | Hip Tibia/Pelvis TrackerPointers Pointer, Knee Navigation Ortho Grip Knee Pointer OrthoLock with OrthoLockNavigation Pin orOrthoLock EX-PinsAnchoring Pins and InsertionTool |
| NavigatedManualInstruments | Resection Guide ToolThe resection tool is capableof being used with anymanufacturers cutting blocks.The resection guide tool iscompatible with 1.3mm thicksaw blades. | Dedicated Mini Jig (whichconsists of): Adjustment Component Tracker Adapter Mini Cutting Guide Mini Fixation Plate MIS Jig (which consists of): Navigated MIS Jig-A Navigated MIS Jig-B Tracker Adapter Plane Probes (Resection PlanProbes and a Posterior PlaneProbe) |
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Substantial Equivalence Rationale - 360CAS Hip
The 360CAS Hip is considered substantially equivalent to the Stryker OrthoMap Versatile Hip System regarding clinical, technical and biological characteristics. The 360CAS and the Stryker OrthoMap Versatile Hip System are both intended to be used as planning and intraoperative guidance systems to enable open and percutaneous surgical procedures. Both systems are indicated for hip conditions where the use of CAS is appropriate (e.q., THA) and reference to a rigid anatomical structure can be identified. The 360CAS Hip and the Stryker OrthoMap Versatile Hip System are intended to be used by trained orthopaedic surgeons and operators in an equivalent fashion, following equivalent registration and navigation workflows. Both systems comprise equivalent components (computer platform, navigation software, instruments, tracking components) to achieve the same purpose. The 360CAS Hip and Stryker OrthoMap Versatile Hip System both require AC power to power the computer, monitor and camera. The Stryker OrthoMap Versatile Hip System requires additional external energy sources (batteries) to power smart instruments, whereas the 360CAS Hip does not require additional external energy sources for its instruments. Both systems use optical tracking technology where a tracker is sensed by a camera to compute spatial information. The 360CAS Hip passive optical trackers and instruments do not require infrared (IR), wireless connection or external energy sources for operation. Such passive instruments are commonly used and have been successfully integrated in other marketed devices such as the K102251 BrainLAB DASH Knee. Surgical navigation in both systems is enabled through similar software platforms developed by each manufacturer. The 360CAS Hip and the Stryker OrthoMap Versatile Hip System are measuring devices where the 360CAS Hip provides greater accuracy of with mean translational error of <±2 mm and mean rotational error of <±1°. Therefore, it is concluded that the 360CAS Hip is substantially equivalent to the Stryker OrthoMap Versatile Hip System.
| Characteristic | 360CAS Hip(Subject device) | Stryker OrthoMap VersatileHip System(Predicate device) |
|---|---|---|
| Trade Name: | 360CAS Hip | Stryker OrthoMap Versatile HipSystem |
| Characteristic | 360CAS Hip(Subject device) | Stryker OrthoMap VersatileHip System(Predicate device) |
| 510(k)Submitter: | Kico Knee Innovation CompanyPty Limited | Stryker Leibinger GmbH & Co.KG |
| 510(k)Number: | K213380 | K162937 |
| RegulationNumber: | 882.4560 - StereotaxicInstrument | 882.4560 - StereotaxicInstrument |
| Product Code: | OLO | OLO |
| Product Class: | II | II |
| Indications forUse | The 360CAS is intended to beused as a planning andintraoperative guidance systemto enable open or percutaneousimage guided surgicalprocedures.The 360CAS is indicated forpatients undergoing orthopaedicsurgery and where reference toa rigid anatomical structure,such as the pelvis, femur, ortibia, can be identified.The 360CAS Hip is indicated forthe following surgicalprocedures:Total Hip Arthroplasty(THA) e.g., open orminimally invasive, wherea posterior or anteriorapproach is usedFor conditions of the hipjoint in which the use ofcomputer assisted surgerymay be appropriate | The Stryker OrthoMap VersatileHip System, which is comprisedof the OrthoMap Versatile Hip2.0 Software and a platform ofthe NAV3i platform family, isintended as a planning andintraoperative guidance systemto enable open or percutaneousimage guided surgery.The system can be used forintraoperative guidance where areference to a rigid anatomicalstructure such as but not limitedto the pelvis, or femur, can beidentified.The system is indicated forconditions of the hip joint inwhich the use of image guidedsurgery may be appropriate.The Stryker OrthoMap VersatileHip system is indicated for thefollowing surgical procedures:Total Hip Athroplasty (THA),e.g. open or minimally-invasivePrecisely positioninstruments, implants andbony tissue during |
| Characteristic | 360CAS Hip(Subject device) | Stryker OrthoMap VersatileHip System(Predicate device) |
| • Revisions. | ||
| Anatomy | Hip | Hip |
| PatientPopulation | Patients with conditions of thehip joint where use ofcomputer-assisted surgery maybe appropriate. | Patients with conditions of thehip joint where use ofcomputer-assisted surgery maybe appropriate. |
| End-Users | Trained orthopaedic surgeonsand system operators | Trained orthopaedic surgeonsand system operators |
| ClinicalWorkflow | Clinical workflow testingverifying that all systemcomponents are compatible.Complete total hip arthroplastyprocedures are simulated usingSawbones mimicking thepatient's anatomy and cadaverlaboratory. | Clinical workflow testingverifying that all systemcomponents (application,computer platform andaccessories) are compatible.Complete total hip arthroplastyprocedures are simulated usingSawbones mimicking thepatient's anatomy. |
| Main Systemcomponents | Computer PlatformNavigation Cart360CAS Navigation Software- 360CAS Hip | Computer PlatformOrthoMap Versatile Hip 2.0Software |
| Surgical Instruments | Smart InstrumentsPatient Tracker FixationNavigated Manual Instruments | |
| Spatial Tracking Components | Instrument Battery, Trays | |
| Energy Source | Computer - AC Power | Computer - AC PowerSmart Instruments – Battery1. Pointer2. Patient Tracker, blue(Pelvis)3. Pelvis Tracker, green(Femur)4. Instrument Tracker |
| Characteristic | 360CAS Hip(Subject device) | Stryker OrthoMap VersatileHip System(Predicate device) |
| TrackingTechnology | Passive optical trackingtechnology | Infrared optical active sensingtechnology: Infrared lightemitted by diodes placed in aknown fashion on navigatedsurgical instruments is sensedby a camera array (navigationcamera) on the computerplatform, thus allowing forcomputation of the spatialinformation. |
| Image Display | Monitor | Monitor |
| SystemAccuracy | The system enables thedetermination of the mechanicalaxes of the lower limb as well ascut and component alignmentwith a mean translational errorof $< \pm 2$ mm and a meanrotational error of $< \pm 1^\circ$ . | The system enables thedetermination of the mechanicalaxes of the leg as well as cutand component alignment witha mean translational error of $<$ 2 mm and a mean rotationalerror of $<$ 2°. |
| Software | 360CAS Navigation Software | OrthoMap Precision Hip 2.0Software |
| Patient /InstrumentTrackers | Patient/Instrument TrackersPelvis Tracker Femur Tracker Tracker Universal Grip Pointer Pointer | Patient/Instrument Trackers Hip Femur Tracker Hip Tibial/Pelvic Tracker Instrument Tracker Backup Trackers Universal Tracker Tibial/Pelvic Tracker Femoral Tracker Pointers Pointer, Knee Navigation Ortho Grip Knee Pointer Hip Pointer, Straight |
| Characteristic | 360CAS Hip(Subject device) | Stryker OrthoMap VersatileHip System(Predicate device) |
| Patient TrackerFixation | Bone Fixator | OrthoLock with OrthoLockNavigation Pin or OrthoLock EX-Pins |
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Substantial Equivalence Conclusion
Based on the comparison of intended use and technological characteristics, each of the 360CAS Knee and 360CAS Hip are similar to the predicate device. The hardware and software verification and validation testing demonstrate that the subject devices meet their performance specifications and will perform as intended in the specified use conditions and that any differences between the subject devices and predicate devices do not raise new questions of safety and effectiveness. Therefore, the subject devices, 360CAS Knee and 360CAS Hip, can be found substantially equivalent to the predicate devices, Stryker OrthoMap Precision Knee System and Stryker OrthoMap Precision Hip System.
§ 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).