(30 days)
Not Found
No
The description focuses on patient-specific guides derived from CT data for surgical planning and instrumentation, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as patient-specific surgical planning and instrumentation to assist in positioning total ankle replacement components and guiding bone cutting, not to directly treat or alleviate a medical condition.
No
The device is described as surgical planning and instrumentation to assist in the positioning of components and guiding bone cutting during surgery, not for diagnosing a condition.
No
The device description explicitly states that the system produces physical surgical guides and anatomic models made from biocompatible nylon, which are hardware components.
Based on the provided information, the Vantage 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 intra-operatively, and in guiding bone cutting." This describes a surgical planning and guidance tool used during a surgical procedure, not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: The device description focuses on patient-specific guides and models created from imaging data to facilitate surgical procedures. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
Therefore, the Vantage PSI System falls under the category of surgical planning and guidance devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Vantage PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intra-operatively, and in guiding bone cutting. The Vantage PSI System is intended for use with Exactech's Vantage Total Ankle System and its cleared indications for use.
Product codes
OYK
Device Description
3D System's Vantage PSI System is patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides and models are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The surgical guides in combination with Exacted Vantage Total Ankle reusable instruments, facilitate the positioning of Vantage Total Ankle Implants. 3D System s Vantage PSI System produces a variety of patient specific outputs including surgical quides, anatomic models, and case reports.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
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
Cadaveric comparison testing was performed between the subject and Exactech instrumentation. Accuracy and functionality were shown to be substantially equivalent across all devices and instruments.
Key Metrics
Accuracy and functionality
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/0 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 the FDA logo, which 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.
June 30, 2023
3D Systems, Inc. Ashley Dawson Director, Regulatory Affairs 5381 South Alkire Circle Littleton, Colorado 80127
Re: K231585
Trade/Device Name: Vantage 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: May 31, 2023 Received: May 31, 2023
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 (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
1
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,
Image /page/1/Picture/5 description: The image shows the name "Lixin Liu -S" in a simple, sans-serif font. The text is black and stands out against a light background. The name appears to be a title or heading, possibly indicating a person's name or a project title. The overall impression is clean and straightforward.
Lixin Liu, Ph.D. 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Vantage PSI System
Indications for Use (Describe)
The Vantage PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intra-operatively, and in guiding bone cutting. The Vantage PSI System is intended for use with Exactech's Vantage Total Ankle 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Contact Details
Prepared on: 2023-05-31 21 CFR 807.92(a)(1)
| Applicant Name | 3D Systems, Inc. |
|---|---|
| Applicant Address | 5381 South Alkire Circle Littleton CO 80127 United States |
| Applicant Contact Telephone | +1 803-326-3908 |
| Applicant Contact | Dr. Ashley Dawson |
| Applicant Contact Email | ashley.dawson@3dsystems.com |
Device Name 21 CFR 807.92(a)(2)
| Device Trade Name | Vantage PSI System |
|---|---|
| Common Name | Ankle joint metal/polymer semi-constrained cemented prosthesis |
| Classification Name | Ankle Arthroplasty Implantation System |
| Regulation Number | 888.3110 |
| Product Code | OYK |
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K193432 | Vantage PSI System | OYK |
Device Description Summary 21 CFR 807.92(a)(4)510(k) Summarv
3D System's Vantage PSI System is patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides and models are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The surgical guides in combination with Exacted Vantage Total Ankle reusable instruments, facilitate the positioning of Vantage Total Ankle Implants. 3D System s Vantage PSI System produces a variety of patient specific outputs including surgical quides, anatomic models, and case reports.
Intended Use/Indications for Use
The Vantage PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intra-operatively, and in guiding bone cutting. The Vantage PSI System is intended for use with Exactech's Vantage Total Ankle System and its cleared indications for use.
Indications for Use Comparison
The indications for use is the same as the predicate device: The Vantage to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement intra-operatively, and in guiting bone cutting. The Vantage PSI System is intended for use with Exacted 's Vantage Total Ankle System and its cleared indications for use.
Technological Comparison
The principles of operation and technological characteristics are substantially equivalent between the subject Vantage PSI System and the predicate Vantage PSI System (K193432). Both the predicate and the subject devices are designed with CT-based methods to produce a patient specific instrument. Vantage PSI System Guides are manufactured using SLS technology with DuraForm®
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
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K231585 Page 2 of 2
ProX PA (polyamide) material. Both the subject and predicate devices guide the placement of pins and talar anatomies for total ankle arthroplasties intended for use with Exactech's Vantage Total Ankle System and its cleared indications for use. The differences between the subject Vantage PSI System and the predicate Vantage PSI System are additional fixation options, addition of corner drill features, and an optional decoupled talus guide. The reason for the changes is to align with updates to the Exactech Vantage Total Ankle System. The changes included in the subject Vantage PSI System are not technologically different from the predicate Vantage PSI System.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Cadaveric comparison testing was performed between the subject and Exactech instrumentation. Accuracy and functionality were shown to be substantially equivalent across all devices and instruments.