(77 days)
Not Found
No
The document explicitly states the system is "image-free" and relies on optical tracking of anatomical landmarks for planning and execution. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms. The description focuses on robotic assistance for precise execution based on surgeon-defined plans and real-time compensation for movement, which are not inherently AI/ML functions.
No.
The device is described as an image-free robotic-assisted surgery system designed to aid surgeons in identifying anatomical structures, planning implant positions, and executing bone preparation during total knee arthroplasty. It is a surgical tool that facilitates a medical procedure, rather than directly providing therapy.
No
Explanation: The device is described as a surgical assistance system for planning and executing bone preparation during total knee arthroplasty. Its functions relate to identifying anatomical positions, planning implant placement, and guiding bone resections, rather than diagnosing conditions or identifying diseases. It aids in surgical procedures, not diagnosis.
No
The device description explicitly states that the system includes a "Robotic-Assisted Device" which is a physical component that constrains the saw handpiece and blade. It also mentions an "optical tracking device" and a "touchscreen and footswitch" for user interaction, all of which are hardware components. While the system incorporates software subsystems, it is not solely software.
Based on the provided text, the VELYS™ Robotic-Assisted Solution is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "stereotaxic surgery to help the surgeon... plan the position of the femoral and tibial implant components intraoperatively and prepare the bones during total knee arthroplasty." This describes a surgical assistance system, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description focuses on the robotic arm, optical tracking, software for surgical planning and execution, and bone preparation. It does not mention any components or processes related to analyzing biological samples (blood, tissue, etc.).
- Image Processing: While it uses optical tracking to acquire anatomical landmarks, it explicitly states it's an "image-free" system in the context of traditional medical imaging like X-rays or CT scans used for diagnosis. The optical tracking is for navigation and positioning during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on biological specimens.
In summary, the VELYS™ Robotic-Assisted Solution is a surgical robotic system designed to assist surgeons during total knee replacement surgery. It does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VELYS™ Robotic-Assisted Solution is intended for stereotaxic surgery to help the surgeon to identify the relative position and orientation of anatomical structures, plan the position of the femoral and tibial implant components intraoperatively and prepare the bones during total knee arthroplasty.
The VELYS™ Robotic-Assisted Solution is indicated for use with the ATTUNE™ Total Knee System and its cleared indications for use.
Product codes
OLO
Device Description
The VELYS™ Robotic-Assisted Solution is an image-free robotic-assisted surgery system for Total Knee Arthroplasty (TKA). It is intended for stereotaxic surgery to aid the surgeon in identifying the relative position of anatomical structures and landmarks, planning the position of the femoral and tibial implant components intraoperatively, and preparing total knee arthroplasty.
The image-free system uses a dedicated optical tracking device to acquire anatomical landmarks are then used to plan the femoral and tibial implant locations based on the surgeon's preferred surgical technique and placement preferences. Following the planning step, the VELYS™ Robotic-Assisted Solution helps the surgeon to execute the bone preparation according to the plan.
The system includes a Robotic-Assisted Device that constrion and orientation of the saw handpiece and blade inside each plane corresponding to each resection on the patient's femur and tibia. The surgeon actuates the saw handpiece, within the planned resection plane, to execute the bone resection. This is analogous to using manual instruments in TKA. If the patient's leg moves during the resection, the Robotic-Assisted Device compensates for such movement in real-time.
The Robotic-Assisted Device is assembled with a Robotic-Assisted Device arm, mounted on the Operating Room (OR) bed rail, for a minimal footprint.
The VELYS® Robotic-Assisted Solution incorporates several software subsystems, including applications responsible for general operation of the system and a Clinical Application dedicated to the surgery workflow.
The users interact with the Clinical Application via a touchscreen and footswitch to navigate through the surgery steps. Case Reports including key surgical procedure information are stored on the system and can be retrieved by the surgeon for future use. Cases Reports including PHI are only available to the surgeon who performed the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical tracking device
Anatomical Site
femur and tibia during total knee arthroplasty
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon / Operating Room (OR)
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)
The following tests were performed on the VELYS Robotic-Assisted Solution to demonstrate substantial equivalence of safety and efficacy with the predicate device:
• Functional System Integration Test
· Full software verification test campaign, including unit, integration, and software systeml-evel testing
· Cybersecurity testing, including penetration testing
No clinical tests were conducted to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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December 14, 2023
DePuy Ireland UC Bastien Michel D'annoville Senior Regulatory Affairs Specialist Loughbeg Ringaskiddy, Co. Cork Munster Ireland
Re: K233227
Trade/Device Name: VELYSTM Robotic-Assisted Solution Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 29, 2023 Received: November 16, 2023
Dear Bastien Michel D'annoville:
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 (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.
1
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" (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 QS 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.
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 by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tejen D. Soni -S
For Shumaya Ali, MPH Assistant Director
2
DHT6C: Stereotaxic, Bone Growth Stimulators, and Fracture Fixation Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
VELYS™ Robotic-Assisted Solution
Indications for Use (Describe)
The VELYS™ Robotic-Assisted Solution is intended for stereotaxic surgery to help the surgeon to identify the relative position and orientation of anatomical structures, plan the position of the femoral and tibial implant components intraoperatively and prepare the bones during total knee arthroplasty.
The VELYS™ Robotic-Assisted Solution is indicated for use with the ATTUNE™ Total Knee System and its cleared indications for use.
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)
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| 510(k) #: | K233227 | 510(k) Summary | Prepared on: 2023-11-16 |
|---|---|---|---|
| ----------- | --------- | ---------------- | ------------------------- |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| ----------------- | --------------------- |
| Applicant Name | DePuy Ireland UC |
|---|---|
| Applicant Address | Loughbeg Ringaskiddy Ireland |
| Applicant Contact Telephone | +33(0)679888395 |
| Applicant Contact | Mr. Bastien Michel d'Annoville |
| Applicant Contact Email | bdannovi@its.jnj.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| ------------- | --------------------- |
| Device Trade Name | VELYS TM Robotic-Assisted Solution |
|---|---|
| Common Name | Stereotaxic instrument |
| Classification Name | Orthopedic Stereotaxic Instrument |
| Regulation Number | 882.4560 |
| Product Code | OLO |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K202769 | VELYS ™ Robotic-Assisted Solution | OLO |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|---|---|
| ---------------------------- | --------------------- |
The VELYST™ Robotic-Assisted Solution is an image-free robotic-assisted surgery system for Total Knee Arthroplasty (TKA). It is intended
lobotic-Assisted Solution is an image-free robotic-assisted surgery system for Total Knee Arthroplasty (TKA). I for stereotaxic surgery to aid the surgeon in identifying the relative position of anatomical structures and landmarks, planning the position of the femoral and tibial implant components intraoperatively, and preparing total knee arthroplasty.
The image-free system uses a dedicated optical tracking device to acquire anatomical landmarks are then used to plan the femoral and tibial implant locations based on the surgeon's preferred surgical technique and placement preferences. Following the planning step, the VELYS™ Robotic-Assisted Solution helps the surgeon to execute the bone preparation according to the plan.
The system includes a Robotic-Assisted Device that constrion and orientation of the saw handpiece and blade inside each plane corresponding to each resection on the patient's femur and tibia. The surgeon actuates the saw handpiece, within the planned resection plane, to execute the bone resection. This is analogous to using manual instruments in TKA. If the patient's leg moves during the resection, the Robotic-Assisted Device compensates for such movement in real-time.
The Robotic-Assisted Device is assembled with a Robotic-Assisted Device arm, mounted on the Operating Room (OR) bed rail, for a minimal footprint
The VELYS® Robotic-Assisted Solution incorporates several software subsystems, including applications responsible for general operation of the system and a Clinical Application dedicated to the surgery workflow.
The users interact with the Clinical Application via a touchscreen and footswitch to navigate through the surgery steps. Case Reports including key surgical procedure information are stored on the system and can be retrieved by the surgeon for future use. Cases Reports
5
including PHI are only available to the surgeon who performed the procedure.
Intended Use/Indications for Use
The VELYS™ Robotic-Assisted Solution is intended for stereotaxic surgeon to identify the relative position and orientation of anatomical structures, plan the femoral and tibial implant components intraoperatively and prepare the bones during total knee arthroplasty.
The VELYS™ Robotic-Assisted Solution is indicated for use with the ATTUNE™ Total Knee System and its cleared indications for use.
Indications for Use Comparison
The proposed device has the same indications for use as the predicate device.
Technological Comparison
The subject device and predicate device have intended use, classification and principles of operation.
The subject device and predicate device have Surgical Workflow, including preoperative setup steps, anatomical registration, joint balance assessment, implant positioning and bone resection. They also have the same technological characteristics, and the same patient contact materials and energy source.
The subject device shows some differences regarding the network connectivity during non-clinical use.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following tests were performed on the VELYS Robotic-Assisted Solution to demonstrate substantial equivalence of safety and efficacy with the predicate device:
• Functional System Integration Test
· Full software verification test campaign, including unit, integration, and software systeml-evel testing
· Cybersecurity testing, including penetration testing
No clinical tests were conducted to demonstrate substantial equivalence.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)