(28 days)
Not Found
No
The summary describes a stereotaxic surgical navigation system using optical tracking technology for guidance, without mentioning any AI or ML components in the device description, performance studies, or key metrics.
No
The device is a computer-assisted surgical navigation system and not designed to treat a medical condition.
No
Explanation: The device is described as a "stereotaxic surgical navigation system for orthopaedic surgical procedures" and an "intraoperative guidance system." Its intended use is for planning and guiding surgical procedures, not for diagnosing conditions.
No
The device description explicitly states that the system consists of "360CAS navigation software, surgical instruments, spatial tracking components and a navigation cart." This indicates the presence of hardware components beyond just the software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The 360CAS is described as a "stereotaxic surgical navigation system for orthopaedic surgical procedures." It uses optical tracking to guide surgeons during surgery.
- Intended Use: The intended use is for guiding surgeons during orthopaedic procedures like Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA).
- No mention of samples: There is no mention of the device analyzing samples taken from the patient's body.
The 360CAS is a surgical navigation system, which falls under a different category of medical devices than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure can be identified.
The 360CAS Knee is indicated for the following surgical procedures:
- · Any form of 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:
· Any form of 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
Product codes (comma separated list FDA assigned to the subject device)
OLO
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 subject's morphology, navigate surgical instruments and implants and assess state of the joint throughout the surgery. The system consists of 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)).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained orthopaedic surgeon and system operators
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)
Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Electrical safety and EMC testing were conducted on the subject device in accordance with IEC 60601-1-2:2014.
Software Verification and Validation Testing: Software verification and validation testing were conducted, and summary information was provided as recommended by FDA guidance documents. 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 and ASTM F2554-22.
- System accuracy testing verifying the specified accuracy of ±2mm and ±1º using Sawbones mimicking patient's anatomy.
- 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.
- Functional testing to ensure that all functional requirements are fulfilled.
- Safety testing verifying the effectiveness of all risk controls determined in the device risk analysis.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
mean translational error of
§ 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
January 27, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is 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.
Kico Knee Innovation Company Pty Limited Danyon Munro Head of Regulatory Affairs and Quality Assurance Suite 3, Building 1, 20 Bridge Street, Pymble NSW Sydney, New South Wales 2073 Australia
Re: K223927
Trade/Device Name: 360CAS Knee, 360CAS Hip Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 30, 2022 Received: December 30, 2022
Dear Danyon Munro:
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
1
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 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,
Jesse Muir-S
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) K223927
Device Name 360CAS Knee and 360CAS Hip
Indications for Use (Describe)
The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure can be identified.
The 360CAS Knee is indicated for the following surgical procedures:
- · Any form of 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:
· Any form of 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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3
Image /page/3/Picture/0 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" in a smaller font size underneath. The logo also includes a circular design element that wraps around the number "360". The circular design is made up of a combination of gray and blue dots, with a gray arrow at the top of the circle.
4. 510(k) Summary - K223927
4.1 INTRODUCTION
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,
- . Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] issued 28-Jul-2014,
- . Guidance for Industry and Food and Drug Administration Staff: The Special 510(k) Program issued 13-Sep-2019.
- . Guidance for Industry and Food and Drug Administration: Bundling Multiple Devices or Multiple Indications in a Single Submission issued 22-Jun-2007, and
- . Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy for 510(k)s issued 13-Sep-2019.
4.2 510(K) Summary
4.2.1 Applicant Details
| Name: | Kico Knee Innovation Company Pty
Limited |
|----------------------------------|-------------------------------------------------------------|
| Address: | Suite 3, Building 1, 20 Bridge Street |
| | Pymble, New South Wales 2073 |
| | Australia |
| Contact Person /
Prepared By: | Danyon Munro |
| | Head of Regulatory Affairs and Head of
Quality Assurance |
| | +61 435 677 481 (phone) |
| | danyon.munro@360med.care |
4
Date Prepared:
December 30, 2022
4.2.2 Device Details and Substantial Equivalence Claim
| Device Common Name: | Orthopedic Stereotaxic Instrument | |
|---|---|---|
| Device Trade Name: | 360CAS Knee | 360CAS Hip |
| Regulation Number: | 21 CFR 882.4560 | |
| Regulation Name: | Stereotaxic Instrument | |
| Regulatory Class: | II | |
| Panel | Orthopedic | |
| Classification Product | ||
| Code | OLO | |
| Predicate Devices | 360CAS Knee | |
| (K213380) | 360CAS Hip | |
| (K213380) |
Device Description 4.2.3
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 subject's morphology, navigate surgical instruments and implants and assess state of the joint throughout the surgery. The system consists of 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)).
The subject device is predicated on submission (K213380). The modification driving the subject device submission relates to the change of the spatial tracking component sub-system. The previously cleared device incorporated a tracking camera manufactured by Metria Innovation Inc., whereas the subject device will utilise a tracking camera manufactured by Atracsys LLC.
5
Image /page/5/Picture/1 description: The image shows a navigation system for medical procedures. The system includes a navigation camera, navigation software, trackers, and a navigation cart. The navigation camera is used to track the position of the trackers, which are attached to the patient's body. The navigation software uses this information to create a 3D model of the patient's anatomy, which the surgeon can use to guide the procedure.
Figure 4-1 - 360CAS Navigation System (Metria)
Image /page/5/Figure/3 description: The image shows a navigation system for medical procedures. On the left is a navigation cart with a navigation camera and software. On the right is a model of a pelvis with trackers attached to it.
Figure 4-2 - 360CAS Navigation System (Atracsys)
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Image /page/6/Picture/1 description: The image shows two panels related to medical imaging. The left panel, titled "Register Femur," displays a 3D model of a femur with several points marked, along with a checklist of anatomical features such as "Hip Centre," "Femoral Centre," and "Medial Epicondyle." The right panel, titled "Cup Orientation," presents two views of a pelvis model, accompanied by measurements for "Inclination" and "Anteversion," with values of 40 degrees and 20 degrees, respectively. The interface includes buttons for actions like "Transfer," "Revert," "Confirm," and "Delete."
Figure 4-3 - 360CAS Knee Software
Figure 4-4 – 360CAS Hip Software
4.2.4 Indications for Use for 360CAS
The Indications for Use for 360CAS remains unchanged from the cleared device. It has been included below for clarity.
The 360CAS is intended to be used as a planning and intraoperative guidance 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.
4.2.5 Performance Data
The following performance data was provided in support of substantial equivalence decision:
Electrical Safety and Electromagnetic Compatibility (EMC) Testing
7
Electrical safety and EMC testing were conducted on the subject device in accordance with the following standards:
- 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 summary information 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: Offthe-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 and ASTM F2554-22.
- . System accuracy testing verifying the specified accuracy of ±2mm and ±1º using Sawbones mimicking patient's anatomy.
- . 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.
- . Functional testing to ensure that all functional requirements are fulfilled.
- . 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.
8
Animal Study
No animal studies were performed to support substantial equivalence.
Clinical Studies
No clinical studies were performed to support substantial equivalence.
Comparison with the Predicates 4.2.6
Substantial Equivalence Rationale - 360CAS Knee
The 360CAS Knee is considered substantially equivalent to the previously cleared 360CAS Knee regarding clinical, technical, and biological characteristics. The 360CAS Knee and the previously cleared 360CAS Knee are both intended to be used as planning and intraoperative guidance systems to enable open and percutaneous surgical procedures. Both systems are indicated for knee conditions where the use of CAS is appropriate (e.g., TKA) and where reference to a rigid anatomical structure can be identified. The 360CAS Knee and the previously cleared 360CAS Knee are intended to be used by trained orthopedic 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 Knee and previously cleared 360CAS Knee both require AC power to power the computer, monitor and camera. 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 the same software platform developed by Kico Knee Innovation Company Pty Limited. The 360CAS Knee and the previously cleared 360CAS Knee are measuring devices with identical accuracy of ±2 mm and ±1º. Therefore, it is concluded that the 360CAS Knee is substantially equivalent to the previously cleared 360CAS Knee.
| Characteristic | 360CAS Knee
(Subject Device) | 360CAS Knee
(Predicate Device) |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Unchanged from previous
submission. | 360CAS Knee |
| 510(k)
Submitter: | Unchanged from previous
submission. | Kico Knee Innovation
Company Pty Limited |
| Characteristic | 360CAS Knee
(Subject Device) | 360CAS Knee
(Predicate Device) |
| 510(k) Number: | Under Review | K213380 |
| Regulation Number: | Unchanged from previous submission. | 882.4560 - Stereotaxic Instrument |
| Product Code: | Unchanged from previous submission. | OLO |
| Product Class: | Unchanged from previous submission. | II |
| Indications
for Use | Unchanged from previous submission. | 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 can be identified.
The 360CAS Knee is indicated for the following surgical procedures:
Any form of Total Knee Arthroplasty (TKA)For conditions of the knee joint in which the use of computer assisted surgery may be appropriate |
| Anatomy | Unchanged from previous submission. | Knee |
| Patient Population | Unchanged from previous submission. | Patients with medical conditions where use of |
| Characteristic | 360CAS Knee
(Subject Device) | 360CAS Knee
(Predicate Device) |
| | | computer-assisted surgery
may be appropriate. |
| End-Users | Unchanged from previous
submission. | Trained orthopaedic surgeon
and system operators |
| Clinical
Workflow | Unchanged from previous
submission. | Clinical workflow testing
verifying that all system
components are compatible.
Complete total knee
arthroplasty procedures are
simulated using Sawbones
mimicking the patient's
anatomy and cadaver
laboratory. |
| Main System
Components | Unchanged from previous
submission. | Computer Platform
Navigation Cart
360CAS Navigation Software
- 360CAS Knee
Surgical Instruments
Spatial Tracking Components |
| Energy
Source | Unchanged from previous
submission. | Computer - AC Power |
| Tracking
Technology | Passive Optical tracking
technology
Retroreflective markers
placed in a specified
configuration. | Passive optical tracking
technology. |
| Image
Display | Unchanged from previous
submission. | Monitor |
| System
Accuracy | Unchanged from previous
submission. | 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