(21 days)
Not Found
Yes
The summary explicitly states that the preoperative planning platform uses "Al-based automatic image segmentation and landmarking algorithms."
No
The device is a navigation system that assists surgeons in positioning and aligning implants during shoulder arthroplasty; it does not directly treat a disease or condition.
No
The device is a computer-controlled navigation system for surgical assistance in total shoulder arthroplasty, not a diagnostic device. It aids in positioning and alignment of implants and intraoperative measurements, based on preoperative imaging and real-time tracking, but it does not diagnose a medical condition.
No
The device description explicitly states that the system consists of "software, electronic hardware and surgical instruments." It also describes specific hardware components like the ARVIS® Eyepiece and Belt Pack.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ARVIS® Shoulder system is a computer-controlled navigation system used during surgery to assist the surgeon in positioning and aligning implants. It uses pre-operative imaging (CT scans) and intraoperative tracking to guide the surgeon.
- Lack of Biological Sample Analysis: The device does not analyze biological samples from the patient. Its function is based on image processing, tracking, and surgical guidance.
Therefore, the ARVIS® Shoulder system falls under the category of a surgical navigation system or medical device for surgical guidance, not an in vitro diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
ARVIS® Shoulder is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery.
The system aids the surgeon in making intraoperative measurements and locating anatomical structures of the shoulder joint based on the patient's preoperative imaging.
The system is intended to be used with the head mounted ARVIS® Eyepiece display for augmented reality visualization and information, such as visualization of the preoperative plan and display of instrument and implant alignment information. The augmented/ virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information.
ARVIS® Shoulder is indicated for total shoulder arthroplasty using the Enovis AltiVate, LimaCorporation PRIMA, and LimaCorporation SMR implant systems.
Product codes
SBF, LLZ, QIH
Device Description
ARVIS® Shoulder is a computer-controlled navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joint based on the patient's preoperative imaging to assist with selection and positioning of orthopedic implant components. The system consists of software, electronic hardware and surgical instruments.
The ARVIS® Eyepiece is mounted on the surgeon's head and contains tracking cameras that locate the positions of trackers on the patient and instruments. All system measurements, instructions, prompts, and alerts are shown to the surgeon on the Eyepiece display. The Eyepiece communicates with the Belt Pack which is worn by the surgeon around their waist and houses the computer module that runs the ARVIS® Shoulder application software.
The device's workflow involves CT based preoperative planning followed by intraoperative navigation and execution. The preoperative planning software enables 3D virtual implant positioning based on the patient's CT reconstructed digital bone model and bony landmarks. The shoulder navigation software then matches the patient's digital bone model and landmarks to the intraoperative landmarks reqistered by the surgeon, allowing an image-based navigation to follow. The surgeon uses the plan data as guidance to navigate and help position shoulder instruments and implants.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT
Anatomical Site
Shoulder joint
Indicated Patient Age Range
Patient ages ranged from 36 to 89 years (mean age of 70)
Intended User / Care Setting
Surgeon, stereotaxic orthopedic surgery
Description of the training set, sample size, data source, and annotation protocol
The training dataset consisted of 240 CT scans (from 240 patients). Patient ages ranged from 36 to 89 years (mean age of 70), with 46% male and 54% female. All CT scans were acquired using FDA cleared CT scanners. The data used to train the algorithms was labeled and validated in advance by trained experts.
Description of the test set, sample size, data source, and annotation protocol
The test dataset consisted of 60 CT scans (from 60 patients). All CT scans were acquired using FDA cleared CT scanners. The data used to test the algorithms was labeled and validated in advance by trained experts.
Summary of Performance Studies
Software Verification and Validation. Clinical testing was not required to demonstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of "ADMINISTRATION".
January 13, 2025
Kico Knee Innovation Company Pty Ltd % Stefanie Auf Der Mauer Regulatory Affairs Consultant Stefanie Michele Auf der Mauer Asmuss 22 Monfield Rochestown, Cork T12C65D Ireland
Re: K243950
Trade/Device Name: ARVIS® Shoulder Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: SBF. LLZ. OIH Dated: December 20, 2024 Received: December 23, 2024
Dear Stefanie Auf Der 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali -S
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
3
Indications for Use
510(k) Number (if known) K243950
Device Name ARVIS® Shoulder
Indications for Use (Describe)
ARVIS® Shoulder is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery.
The system aids the surgeon in making intraoperative measurements and locating anatomical structures of the shoulder joint based on the patient's preoperative imaging.
The system is intended to be used with the head mounted ARVIS® Eyepiece display for augmented reality visualization and information, such as visualization of the preoperative plan and display of instrument and implant alignment information. The augmented/ virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information.
ARVIS® Shoulder is indicated for total shoulder arthroplasty using the Enovis AltiVate, LimaCorporation PRIMA, and LimaCorporation SMR implant systems.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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."
4
510(k) Summary
2025-01-08 Prepared:
1. Submitter Information
| Submitter: | Kico Knee Innovation Company Pty Ltd
Unit 1, 25 Frenchs Forest Rd E
Frenchs Forest NSW 2086
Australia |
|--------------------|--------------------------------------------------------------------------------------------------------------------------|
| Submitter Contact: | Matthew Ryan
VP R&D Surgical Automation and Visualization
Email: matthew.ryan@enovis.com
Phone: +1 949-290-8210 |
| Correspondent: | Stefanie Auf der Mauer
Email: stefanie.aufdermauer@enovis.com
Phone: +353 85 759 1774 |
2. Subject Device
| Trade Name: | ARVIS® Shoulder |
|---|---|
| Regulation: | 21 CFR 882.4560 – Stereotaxic Instrument |
| Classification Name: | Orthopedic Augmented Reality |
| Product Code: | SBF, LLZ, QIH |
3. Predicate Device
| 510(k) Number: | K240062 |
|---|---|
| Trade Name: | ARVIS® Shoulder |
| Submitter: | Insight Medical Systems, Inc. |
| Product Code: | OLO, LLZ, QIH |
Device Description Summary 4.
ARVIS® Shoulder is a computer-controlled navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joint based on the patient's preoperative imaging to assist with selection and positioning of orthopedic implant components. The system consists of software, electronic hardware and surgical instruments.
The ARVIS® Eyepiece is mounted on the surgeon's head and contains tracking cameras that locate the positions of trackers on the patient and instruments. All system measurements, instructions, prompts, and alerts are shown to the surgeon on the Eyepiece display. The Eyepiece communicates with the Belt Pack which is worn by the surgeon around their waist and houses the computer module that runs the ARVIS® Shoulder application software.
5
The device's workflow involves CT based preoperative planning followed by intraoperative navigation and execution. The preoperative planning software enables 3D virtual implant positioning based on the patient's CT reconstructed digital bone model and bony landmarks. The shoulder navigation software then matches the patient's digital bone model and landmarks to the intraoperative landmarks reqistered by the surgeon, allowing an image-based navigation to follow. The surgeon uses the plan data as guidance to navigate and help position shoulder instruments and implants.
The preoperative planning platform uses Al-based automatic image segmentation and landmarking algorithms. The algorithms and the data used to train and test these remain unchanged from the original submission. The data used to train and test the algorithms was labeled and validated in advance by trained experts. The total data consisted of 300 CT scans (from 300 patients) acquired from candidates for shoulder joint replacement surgery. The cohort was partitioned into two disjoint subsets through random sampling, with 80% producing a training dataset and 20% constituting the test dataset. The training dataset consisted of 240 CT scans (from 240 patients). Patient ages ranged from 36 to 89 years (mean age of 70), with 46% male and 54% female. All CT scans were acquired using FDA cleared CT scanners.
5. Indications for Use
ARVIS® Shoulder is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery.
The system aids the surgeon in making intraoperative measurements and locating anatomical structures of the shoulder joint based on the patient's preoperative imaging.
The system is intended to be used with the head mounted ARVIS® Eyepiece display for augmented reality visualization and information, such as visualization of the preoperative plan and display of instrument and implant alignment information. The augmented/ virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displaved stereotaxic information.
ARVIS® Shoulder is indicated for total shoulder arthroplasty using the Enovis AltiVate, LimaCorporation PRIMA, and LimaCorporation SMR implant systems.
6. Indications for Use Comparison
The Indications for Use of the predicate device are maintained in the subject device. The subject device expands the implant compatibility to include LimaCorporate shoulder implant systems.
This compatibility difference does not result in a new intended use; the subject device with extended compatibility is intended to be used in the same manner as the predicate device. The difference in the Indications for Use does not affect the safety and effectiveness of the subject device as demonstrated by testing.
6
In line with the primary product code change, the subject device Indications for Use were updated to include the system's use with the head mounted augmented reality display.
7. Technological Comparison
The subject device ARVIS® Shoulder is the same as the predicate (K240062) in operating principle, main system components, materials, and navigation tracking technology and accuracy.
The technological difference between the subject device and predicate is that the subject device is compatible with additional implant systems. The device compatibility has been verified with existing well-established methods. The results demonstrate that the subject device is substantially equivalent to the previously cleared ARVIS® Shoulder.
Non-Clinical Tests Summary and Conclusions 8.
The following performance tests were completed to demonstrate substantial equivalence of safety and effectiveness with the predicate device:
- Software Verification and Validation
Clinical testing was not required to demonstrate substantial equivalence.
Risk analysis and performance data provided in this submission demonstrate that ARVIS® Shoulder is as safe, effective, and performs as well as its predicate device.