(25 days)
No
The description focuses on patient-specific surgical planning and instrumentation based on CT scans, without mentioning any AI/ML algorithms for image analysis, planning, or guide generation. The performance testing also focuses on cadaveric comparison of guide usability and implant alignment accuracy, not on the performance of an AI/ML model.
No
The device is described as surgical planning and instrumentation to assist in the positioning of total ankle replacement components and guiding bone cutting, rather than directly treating a condition.
No
The device is described as "patient specific surgical planning and instrumentation" used to "assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting." It creates surgical guides and models based on patient imaging for surgical assistance, not for diagnosing conditions.
No
The device description explicitly states that the system consists of patient specific outputs including surgical guides and anatomical models, which are physical components made from biocompatible nylon and surgical grade stainless steel.
Based on the provided information, the Cadence Ankle PSI System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting." This describes a surgical aid used during a surgical procedure on a patient's body.
- Device Description: The device consists of "surgical guides, anatomical models, and case reports" made from biocompatible materials. These are physical tools used in the operating room.
- Lack of Diagnostic Function: The system does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a disease or condition. Its purpose is to facilitate a surgical procedure based on pre-existing imaging.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cadence Ankle PSI System does not fit this definition.
N/A
Intended Use / Indications for Use
The Cadence Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Cadence Ankle PSI System is intended for use with Smith + Nephew's Cadence Total Ankle System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.
Product codes
OYK
Device Description
3D Systems' Cadence Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Cadence Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Cadence Total Ankle System instruments, facilitate the positioning of Cadence Total Ankle Prostheses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
distal tibial and proximal talar anatomy (for total ankle replacement)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical performance testing on the Cadence Ankle PSI System included cadaveric comparison testing in order to compare Implant Alignment Accuracy and Guide Usability between the subject device and reference device. Accuracy and functionality were shown to be similar to that of the standard instrumentation used for the Cadence Total Ankle System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K241326 Cadence Ankle PSI System, Product Code OYK
Reference Device(s)
K201507 Cadence Total Ankle System, Produce Code HSN
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
October 25, 2024
3D Systems, Inc. Ashley Dawson Director, Regulatory Affairs 5381 South Alkire Circle Littleton, Colorado 80127
Re: K243174
Trade/Device Name: Cadence Ankle PSI System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: OYK Dated: September 30, 2024 Received: September 30, 2024
Dear Ashley Dawson:
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.
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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.
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 Rule"). 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-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 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-regulatory
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assistance/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,
Image /page/2/Picture/3 description: The image shows the name "Lixin Liu -S" in a large, bold, sans-serif font. The name is written in black and is centered on a white background. The letters are evenly spaced and the name is easy to read. The background has a faint watermark.
Lixin Liu, PhD Assistant Director DHT6A: Division of Joint Arthroplasty 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
Submission Number (if known)
Device Name
Cadence Ankle PSI System
Indications for Use (Describe)
The Cadence Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Cadence Ankle PSI System is intended for use with Smith + Nephew's Cadence Total Ankle System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.
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) SUMMARY
1. INTRODUCTION
This document contains the 510(k) summary for the Cadence Ankle PSI System. The content of this summary is based on the requirements of 21 CFR 807.92.
| 2. SUBMITTER | |
|---|---|
| Name: | 3D Systems, Inc. |
| Address: | 5381 South Alkire Circle |
| Littleton, CO 80127, USA | |
| Phone: (720) 643-1001 | |
| Fax: (720) 643-1009 | |
| Official Contact: | Dr. Ashley Dawson |
| Director of Regulatory Affairs | |
| ashley.dawson@3dsystems.com | |
| Date Prepared: | October 23, 2024 |
| 3. DEVICE | |
| Trade Name: | Cadence Ankle PSI System |
| Common Name: | Ankle Arthroplasty Implantation System |
| Classification Name: | Ankle joint metal/polymer semi-constrained cemented prosthesis |
| Classification: | Class II, 21 CFR 888.3110 |
| Product Code: | OYK |
| 4. PREDICATE DEVICE | |
| Predicate Device: | K241326 Cadence Ankle PSI System, Product Code OYK |
5. REFERENCE DEVICE
Reference Device: K201507 Cadence Total Ankle System, Produce Code HSN
6. DESCRIPTION OF THE DEVICE
3D Systems' Cadence Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Cadence Ankle PSI System guides are made
5
from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Cadence Total Ankle System instruments, facilitate the positioning of Cadence Total Ankle Prostheses.
7. INTENDED USE/INDICATIONS FOR USE
The Cadence Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Cadence Ankle PSI System is intended for use with Smith + Nephew's Cadence Total Ankle System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.
8. INDICATIONS FOR USE COMPARISON
The indications for use are the same as the predicate device: The Cadence Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Cadence Ankle PSI System is intended for use with Smith + Nephew's Cadence Total Ankle System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.
9. TECHNOLOGICAL COMPARISON
The principles of operation and technological characteristics are substantially equivalent between the subject Cadence Ankle PSI System and the predicate (K241326). Both the predicate and the subject devices are designed with CT-based methods to produce patientspecific instrumentation. Both the subject and predicate Cadence Ankle PSI System guides are manufactured using SLS technology with DuraForm® ProX PA (polyamide) material and surgical stainless steel components. Both the subject and predicate devices guide the placement of pins and resections of tibial and talar anatomies for total ankle arthroplasties. The difference between the subject device and the predicate device is that the subject device is designed to guide the accurate placement of the Smith+Nephew Cadence Total Ankle System with a flat cut talar prosthesis and the predicate device is designed to guide the accurate placement of the Smith+Nephew Cadence Total Ankle System with a chamfer cut talar prosthesis.
10. NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY
Previous testing for biocompatibility, cleaning, sterilization, debris generation, mechanical stability, and packaging are applicable to the subject device.
Non-clinical performance testing on the Cadence Ankle PSI System included cadaveric comparison testing in order to compare Implant Alignment Accuracy and Guide Usability between the subject device and reference device. Accuracy and functionality were shown to be similar to that of the standard instrumentation used for the Cadence Total Ankle System.
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11. CONCLUSION
Based on a comparison of the intended use, indications for use, and technological characteristics, the Cadence Ankle PSI System is substantially equivalent to the identified predicate device. Additionally, the non-clinical testing supports that the system performs in accordance with its intended use and is as safe, as effective, and performs as well as the predicate device.