(90 days)
No
The summary describes a stereotaxic surgical navigation system using optical tracking technology. There is no mention of AI, ML, or related terms, nor any description of training or test data sets typically associated with AI/ML development. The performance studies focus on accuracy testing of the tracking system and workflow, not on the performance of an AI/ML algorithm.
No
The device is a surgical navigation system intended for planning and intraoperative guidance during orthopedic surgical procedures, not for therapy itself.
No
This device is described as a "planning and intraoperative guidance system" for surgical procedures. It is used to navigate surgical instruments and implants, not to diagnose a condition.
No
The device description explicitly states that the system consists of four main components, including surgical instruments, spatial tracking components, and a navigation cart, in addition to the software. This indicates it is a system with hardware components, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the 360CAS is a "planning and intraoperative guidance system to enable open or percutaneous image guided surgical procedures." It is used during surgery to guide the surgeon, not to perform tests on samples taken from the body in vitro (outside the body).
- Device Description: The description reinforces this by calling it a "stereotaxic surgical navigation system for orthopaedic surgical procedures." It uses optical tracking to navigate instruments and assess the joint during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases or conditions through in vitro testing, or providing diagnostic information based on such tests.
The device is a surgical navigation system, which falls under the category of medical devices used for surgical planning and guidance.
N/A
Intended Use / Indications for Use
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
Product codes
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 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)).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis, femur, or tibia, 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)
Performance Data:
Electrical Safety and Electromagnetic Compatibility (EMC) Testing were conducted on the subject device in accordance with AS/NZS 3551:2012 and IEC 60601-1-2:2014.
Software Verification and Validation Testing were conducted 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 and 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 included:
- 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.
- Safety testing verifying the effectiveness of all risk controls determined in the device risk analysis.
All tests have been successfully completed.
No animal studies or clinical studies were performed.
Key results:
- 360CAS Knee system accuracy: 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
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.
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 (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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3
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 Pty
Limited |
|----------------------------------|-----------------------------------------------------------------------------------------|
| Address: | Suite 3, Building 1, 20 Bridge Street
Pymble, New South Wales 2073
Australia |
| Contact Person /
Prepared By: | Emma Hayes
Regulatory 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) |
4
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:
5
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.
6
- 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
7
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 OrthoMap
Precision Knee System
(Predicate Device) |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | 360CAS Knee | Stryker OrthoMap Precision
Knee System |
| 510(k)
Submitter: | Kico Knee Innovation
Company Pty Limited | Stryker Leibinger GmbH & Co.
KG |
| 510(k)
Number: | K213380 | K162341 |
| Regulation
Number: | 882.4560 – Stereotaxic
Instrument | 882.4560 – Stereotaxic
Instrument |
| Product Code: | OLO | OLO |
| Product Class: | II | II |
| Indications for
Use | 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 | The Stryker OrthoMap
Precision Knee system, which
is comprised of the OrthoMap
Precision Knee 5.0 software
and a platform of the NAV3i
platform family, is intended
as a planning and
intraoperative guidance
system to enable open or
percutaneous image guided
surgery.
The system can be used for
intraoperative guidance
where a reference to a rigid
anatomical structure can be
identified. The system is
indicated for conditions of the
knee joint in which the use of
computer assisted surgery
may be appropriate. |
| Characteristic | 360CAS Knee
(Subject Device) | Stryker OrthoMap
Precision Knee System
(Predicate Device) |
| | use of computer
assisted surgery may
be appropriate | |
| Anatomy | Knee | Knee |
| Patient
Population | Patients with medical
conditions where use of
computer-assisted surgery
may be appropriate. | Patients with conditions of the
knee joint where use of
computer-assisted surgery
may be appropriate. |
| End-Users | Trained orthopaedic surgeon
and system operators | Trained orthopaedic surgeon
and system operators |
| Clinical
Workflow | 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. | Clinical workflow testing
verifying that all system
components (application,
computer platform and
accessories) are compatible.
Complete total knee
arthroplasty procedures are
simulated using Sawbones
mimicking the patient's
anatomy. |
| Main System
Components | Computer Platform
Navigation Cart
360CAS Navigation Software
- 360CAS Knee
Surgical Instruments
Spatial Tracking Components | Computer Platform
OrthoMap Precision Knee 5.0
Software
Smart Instruments
Patient Tracker Fixation
Navigated Manual
Instruments
Instrument Battery, Trays |
| Energy Source | Computer - AC Power | Computer - AC Power
Smart Instruments – Battery
- Pointer
- nGenius® Tibia Tracker |
| Characteristic | 360CAS Knee
(Subject Device) | Stryker OrthoMap
Precision Knee System
(Predicate Device) |
| | | 3. nGenius® Femur
Tracker |
| Tracking
Technology | Passive optical tracking
technology | Infrared optical active sensing
technology: Infrared light
emitted by diodes placed in a
known fashion on navigated
surgical instruments is sensed
by a camera array (navigation
camera) on the computer
platform, thus allowing for
computation of the spatial
information. |
| Image Display | Monitor | Monitor |
| System
Accuracy | 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