(335 days)
No
The summary describes patient-specific guides created from CT data, but there is no mention of AI or ML being used in the design or manufacturing process. The focus is on traditional image processing and 3D printing.
No
The device is intended for surgical planning and instrumentation to assist in positioning total ankle replacement components and guiding bone cutting, not for direct therapeutic treatment of a disease or condition.
No
The device is intended for surgical planning and instrumentation to assist in positioning components and guiding bone cutting, not for diagnosing medical conditions.
No
The device description explicitly states that the system produces physical outputs, including surgical guides and anatomic models, which are made from biocompatible nylon. The performance studies also include validation for cleaning, sterilization, biocompatibility, packaging, shelf life, and debris, all of which are relevant to physical devices, not software alone.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states 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 planning and guidance tool used during a surgical procedure, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description focuses on patient-specific guides and models created from imaging data to facilitate surgical procedures. It doesn't mention analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies described are related to the physical properties of the device (cleaning, sterilization, biocompatibility, packaging, shelf life, debris) and its performance in guiding surgical procedures (bench and cadaveric testing). There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with IVDs.
- Predicate and Reference Devices: The listed predicate and reference devices are also surgical planning and guidance systems, not IVDs.
In summary, the Vantage PSI System is a surgical planning and guidance system, not a device used for in vitro diagnostic testing.
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 intraoperatively, 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 (comma separated list FDA assigned to the subject device)
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 Exactech 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 guides, anatomic models, and case reports for use with Exactech's Vantage Total Ankle System (K152217 and K183343).
Mentions image processing
Found: "The Vantage PSI System uses the same fundamental technologies as its predicate device. These include image transformation and manipulation via software that is subsequently used for 3D printing of anatomical models and guides and for surgical planning, only potentially differing in the software applications."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient imaging data (CT)
Anatomical Site
patient's distal tibial and proximal talar anatomy (ankle)
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)
The testing outlined below was intended to show that the output of the design and development process demonstrated compliance with the device specifications. Bench and cadaveric testing was conducted to prove the subject device performs in accordance with its intended use and is substantially equivalent to the listed predicate device.
The following testing was conducted in accordance with the listed consensus standards for the Vantage PSI System:
- Process Qualification: Process qualification was conducted to assess the manufacturing process as well as operator repeatability within the digital workflow. Cases utilized for testing were representative of ankle reconstruction procedures within the subject device's intended use. Both digital and physical outputs from all manufacturing processes were verified against design specifications. All test method acceptance criteria were met.
- Cleaning Validation: Cleaning validations were performed in accordance with AAMI TIR 30. Following soiling and cleaning of the subject devices, bioburden, protein levels, and hemoglobin levels were examined. All test method acceptance criteria were met.
- Sterilization Validation: Steam sterilization validations were performed for the dynamic-air-removal cycle in accordance with ISO 17665-1:2006 to a sterility assurance level (SAL) of 10* using the biological indicator (BI) overkill method. All test method acceptance criteria were met.
- Biocompatibility Validation: Biocompatibility endpoints were evaluated in accordance with ISO 10993-1. The battery of cytotoxicity, sensitization, irritation, and acute systemic toxicity testing conducted on the subject devices manufactured from polyamide and titanium alloy are within the pre-defined acceptance criteria. The results of the testing adequately address biocompatibility for the output devices and their intended use.
- Packaging Validation: Packaging validation was performed on all packaging configurations of the system. Testing was performed in accordance with the 3D Systems Transportation Test Standard (based on ASTM and National Motor Freight Classification standards). All test method acceptance criteria were met.
- Shelf Life Validation: Shelf life validation was conducted in accordance with ASTM F1980-16 to verify the stated shelf life duration. All test method acceptance criteria were met.
- Debris Validation: Debris generation validation was performed utilizing standard orthopedic instrumentation. Debris generation was evaluated and compared to published data. The results of the testing perform equivalent or better than the values found in literature.
- Cadaver Study / Design Validation: Cadaveric and design validation studies were performed to compare the subject device to Vantage Total Ankle standard instrumentation. The cadaver and design validation studies utilized three surgeon users. 2D analysis was conducted by measuring AP tibia varus/valgus, bearing-to-bearing, and lateral tibia from intra-operative fluoroscopic images, and compared to the pre-operative plan. 3D analysis was conducted by comparing final implant placement to pre-operative implant placement. The 3D analysis consisted of post-operative CT image segmentation, STL alignments, and measurements. Translations were analyzed across three axis (medial/lateral, anterior/posterior, and distal/proximal) and rotations were analyzed across three axis (varus/valgus, plantarflexion/dorsiflexion, and internal/external). The results of both 2D and 3D analysis demonstrate the subject device performing equivalent or better than the Vantage Total Ankle standard instrumentation.
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.
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
§ 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
November 9, 2020
Image /page/0/Picture/1 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.
3D Systems Kim Torluemke Vice President, Quality & Regulatory, Healthcare 5381 South Alkire Circle Littleton, Colorado 80127
Re: K193432
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: November 5, 2020 Received: November 6, 2020
Dear Kim Torluemke:
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 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
1
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 (OS) 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,
Ting Song, PhD, RAC 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
510(k) 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 intraoperatively, 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) |
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510(K) SUMMARY
1. INTRODUCTION
This document contains the 510(k) summary for the Vantage™ PSI System. The content of this summary is based on the requirements of 21 CFR 807.92.
2. SUBMITTER
| Name: | Medical Modeling - A 3D Systems Company |
|---|---|
| Address: | 5381 South Alkire Circle |
| Littleton, CO 80127, USA | |
| Phone: (720) 643-1001 | |
| Fax: (720) 643-1009 | |
| Official Contact: | Kim Torluemke |
| Vice President, Quality and Regulatory, Healthcare | |
| Date Prepared: | November 5, 2020 |
| DEVICE | |
| Trade Name: | Vantage PSI System |
| Common Name: | Ankle surgical guide system |
| Classification Name: | Ankle Arthroplasty Implantation System |
| Classification: | Class II, 21 CFR 888.3110 |
Product Code: ОУК
4. PREDICATE DEVICES
Predicate device:
-
· PROPHECY® INVISION® Preoperative Navigation Alignment Guides, Wright Medical Technology, Inc.(K170968)
Reference devices: -
VSP® Orthopedics System, 3D Systems Inc. (K190044)
5. DESCRIPTION OF THE DEVICE
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 Exactech Vantage Total Ankle reusable instruments, facilitate the positioning of
4
Image /page/4/Picture/0 description: The image shows the 3D Systems logo. The logo consists of a stylized cube with the number "3D" on its faces, followed by the text "3D SYSTEMS" in a simple, sans-serif font. The cube is rendered in a metallic silver color, giving it a modern and technological appearance. The text is in a similar color, creating a cohesive and professional brand identity.
Vantage Total Ankle Implants. 3D System's Vantage PSI System produces a variety of patient specific outputs including surgical guides, anatomic models, and case reports for use with Exactech's Vantage Total Ankle System (K152217 and K183343).
6. INTENDED 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 intraoperatively, 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.
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The intended use and technological characteristics of the subject device (Vantage PSI System) are either identical or substantially equivalent to the predicate device (PROPHECY® Preoperative Navigation Alignment System):
The principles of operation and technological characteristics are all substantially equivalent between the Vantage PSI System and the identified predicate device. Specifically, the predicate device includes 3D printing of patient specific anatomical models and surgical guides with polyamide materials. Both have stainless steel accessories produced from a common subtractive manufacturing process.
The Vantage PSI System uses the same fundamental technologies as its predicate device. These include image transformation and manipulation via software that is subsequently used for 3D printing of anatomical models and guides and for surgical planning, only potentially differing in the software applications.
The outputs of the Vantage PSI System include materials commonly used in surgical instruments (stainless steel) and for surgical guides and anatomical models (biocompatible polyamide). These materials are substantially equivalent to those employed by the predicate, which also uses a polyamide material and stainless steel surgical instruments.
The Vantage PSI System Accessories are standardized stainless steel fluoroscopic inserts that are inserted into patient-specific guides to assist in alignment operations. The accessories are similar to those included with the predicate device, but differ in shape. The predicate device utilizes standard surgical pins. The subject device includes a specific single use tool to be used exclusively with the system. These accessories are sterilized by the healthcare facility with the same cycle as the other system outputs. The minor differences in accessory geometry does not change the intended use of the system, and does not raise new questions of safety and effectiveness.
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8. SUMMARY OF PERFORMANCE TESTING
The testing outlined below was intended to show that the output of the design and development process demonstrated compliance with the device specifications. Bench and cadaveric testing was conducted to prove the subject device performs in accordance with its intended use and is substantially equivalent to the listed predicate device.
The following testing was conducted in accordance with the listed consensus standards for the Vantage PSI System:
· Process Qualification
Process qualification was conducted to assess the manufacturing process as well as operator repeatability within the digital workflow. Cases utilized for testing were representative of ankle reconstruction procedures within the subject device's intended use. Both digital and physical outputs from all manufacturing processes were verified against design specifications. All test method acceptance criteria were met.
· Cleaning Validation
Cleaning validations were performed in accordance with AAMI TIR 30. Following soiling and cleaning of the subject devices, bioburden, protein levels, and hemoglobin levels were examined. All test method acceptance criteria were met.
• Sterilization Validation
Steam sterilization validations were performed for the dynamic-air-removal cycle in accordance with ISO 17665-1:2006 to a sterility assurance level (SAL) of 10* using the biological indicator (BI) overkill method. All test method acceptance criteria were met.
• Biocompatibility Validation
Biocompatibility endpoints were evaluated in accordance with ISO 10993-1. The battery of cytotoxicity, sensitization, irritation, and acute systemic toxicity testing conducted on the subject devices manufactured from polyamide and titanium alloy are within the pre-defined acceptance criteria. The results of the testing adequately address biocompatibility for the output devices and their intended use.
• Packaging Validation
Packaging validation was performed on all packaging configurations of the system. Testing was performed in accordance with the 3D Systems Transportation Test Standard (based on ASTM and National Motor Freight Classification standards). All test method acceptance criteria were met.
• Shelf Life Validation
Shelf life validation was conducted in accordance with ASTM F1980-16 to verify the stated shelf life duration. All test method acceptance criteria were met.
• Debris Validation
Debris generation validation was performed utilizing standard orthopedic instrumentation. Debris generation was evaluated and compared to published data. The results of the testing perform equivalent or better than the values found in literature.
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Image /page/6/Picture/0 description: The image shows the 3D Systems logo. The logo consists of a stylized 3D cube on the left and the text "3D SYSTEMS" on the right. The text is in a sans-serif font and is gray in color. The logo is clean and modern in appearance.
• Cadaver Study / Design Validation
Cadaveric and design validation studies were performed to compare the subject device to Vantage Total Ankle standard instrumentation. The cadaver and design validation studies utilized three surgeon users. 2D analysis was conducted by measuring AP tibia varus/valgus, bearing-to-bearing, and lateral tibia from intra-operative fluoroscopic images, and compared to the pre-operative plan. 3D analysis was conducted by comparing final implant placement to pre-operative implant placement. The 3D analysis consisted of post-operative CT image segmentation, STL alignments, and measurements. Translations were analyzed across three axis (medial/lateral, anterior/posterior, and distal/proximal) and rotations were analyzed across three axis (varus/valgus, plantarflexion/dorsiflexion, and internal/external). The results of both 2D and 3D analysis demonstrate the subject device performing equivalent or better than the Vantage Total Ankle standard instrumentation.
Summary
All design, process, and other verification and validation testing, which were conducted as a result of risk analyses and design impact assessments, showed conformity to pre-established specifications and acceptance criteria. The acceptance criteria was established in support of device performance, and testing demonstrated substantial equivalence of the system to the predicate device.
9. CONCLUSION
Based on a comparison of the intended use and technological characteristics, the Vantage PSI System is substantially equivalent to the identified predicate device. Minor differences in the indications for use, technological and performance characteristics do not raise new or different questions of safety and effectiveness. 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.