(224 days)
No
The summary describes a system for pre-operative planning and surgical guidance using physical and digital outputs, but there is no mention of AI or ML in the device description, intended use, or performance studies. The process relies on physician input and review.
No.
This device is a surgical instrument system intended to assist pre-operative planning and guide surgical instruments, not to treat or alleviate a disease or condition directly.
No
Explanation: The device is described as a surgical instrument and system for preoperative planning and guiding surgical procedures, not for diagnosing conditions or diseases.
No
The device description explicitly states that the system contains "several physical and digital outputs including patient-specific anatomical models, and guides (physical outputs)" and also includes "Stainless Steel Drill Inserts (VSP® Orthopedics System Accessories)". This indicates the system includes physical components in addition to digital ones.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- VSP® Orthopedics System Function: The VSP® Orthopedics System is a surgical instrument used for preoperative planning and guiding surgical procedures directly on the patient's body during surgery. It does not involve the analysis of specimens taken from the body.
The description clearly states its purpose is to assist surgeons in planning and executing osteotomies (bone cuts) in specific anatomical locations. This is a surgical aid, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The VSP® Orthopedics System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the distal femur, tibia, and non-sacrum pelvis.
Product codes
PBF
Device Description
The VSP® Orthopedics System is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in orthopedic procedures. The system contains several physical and digital outputs including patient-specific anatomical models, and guides (physical outputs); and patient-specific surgical plans and digital files (digital or documentation outputs).
Outputs of the VSP® Orthopedics System are designed with physician input and reviewed by the physician prior to finalization and distribution.
The VSP® Orthopedics System also contains Stainless Steel Drill Inserts (VSP® Orthopedics System Accessories) which are intended to be used by the physician to guide drilling activities during the surgical procedure. The inserts fit into a standard hole in the cutting / drill guides and can be used across all VSP® Orthopedics System guides and templates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal femur, tibia, and non-sacrum pelvis
Indicated Patient Age Range
adult patients
Intended User / Care Setting
surgeon
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 for the VSP® Orthopedics System:
- · Equipment Qualification (IQ/OQ/PQ)
- · Process Qualification (PQ)
- · Mechanical Testing
- Software Validation
- · Cleaning Validation
- Sterilization Validation
- Biocompatibility Validation
- Packaging Validation
- Shelf Life Validation
- Drop Test Validation
- Debris Validation
- · Cadaver Study
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
August 21, 2019
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, Inc. Kim Torluemke Vice President, Quality & Regulatory 5381 South Alkire Circle Littleton, Colorado 80127
Re: K190044
Trade/Device Name: VSP® Orthopedics System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: PBF Dated: July 23, 2019 Received: July 24, 2019
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 (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,
For, Shumaya Ali, MPH Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190044
Device Name VSP® Orthopedics System
Indications for Use (Describe)
The VSP® Orthopedics System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the distal femur, tibia, and non-sacrum pelvis.
| 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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Image /page/3/Picture/1 description: The image shows the 3D Systems logo. The logo consists of a 3D cube-like shape on the left and the text "3D SYSTEMS" on the right. The cube is silver and has a modern, geometric design. The text is also silver and in a sans-serif font.
Medical Modeling™
510(K) SUMMARY
1. Introduction
This document contains the 510(k) summary for the VSP® Orthopedics 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: | Kim Torluemke |
| Vice President, Quality and Regulatory, Healthcare | |
| Date Prepared: | July 23, 2019 |
| DEVICE | |
| Trade Name: | VSP® Orthopedics System |
| Common Name: | Patient specific orthopedic anatomical models, templates, guides, and surgical |
| plans. | |
| Classification Name: | Orthopaedic Surgical Planning and Instrument Guides |
| Classification: | Class II, 21 CFR 888.3030 |
| Product Code: | PBF |
| PREDICATE DEVICES |
Predicate device:
-
· SurgiCase Orthopaedics System, Materialise N.V. (K163156)
Reference devices: -
VSP® Cranial System, 3D Systems Inc. (K151285)
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Image /page/4/Picture/1 description: The image shows the 3D Systems logo. The logo consists of a stylized cube with the number "3" on each visible face. To the right of the cube is the text "3D SYSTEMS" in a modern, sans-serif font. The overall design is clean and corporate, suggesting a technology-focused company.
Medical Modeling™
5. DESCRIPTION OF THE DEVICE
The VSP® Orthopedics System is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in orthopedic procedures. The system contains several physical and digital outputs including patient-specific anatomical models, and guides (physical outputs); and patient-specific surgical plans and digital files (digital or documentation outputs).
Outputs of the VSP® Orthopedics System are designed with physician input and reviewed by the physician prior to finalization and distribution.
The VSP® Orthopedics System also contains Stainless Steel Drill Inserts (VSP® Orthopedics System Accessories) which are intended to be used by the physician to guide drilling activities during the surgical procedure. The inserts fit into a standard hole in the cutting / drill guides and can be used across all VSP® Orthopedics System guides and templates.
6. INDICATIONS FOR USE
The VSP® Orthopedics System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the distal femur, tibia, and nonsacrum pelvis.
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The intended use and technological characteristics of the subject device (VSP® Orthopedics System) are either identical or substantially equivalent to the predicate device (Surgicase Orthopaedics System), differing only in the expansion of anatomical regions included within the VSP® Orthopedics System. The potential impact on substantial equivalence of each technological difference was addressed by risk analysis and verification and validation testing.
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 for the VSP® Orthopedics System:
- · Equipment Qualification (IQ/OQ/PQ)
- · Process Qualification (PQ)
- · Mechanical Testing
- Software Validation
- · Cleaning Validation
- Sterilization Validation
5
Image /page/5/Picture/1 description: The image shows the 3D Systems logo. On the left is a 3D cube-like shape with the number 3 on its side. To the right of the shape is the company name "3D SYSTEMS" in a sans-serif font. The logo is clean and modern, with a focus on the company's name and its association with 3D technology.
Medical Modeling™
- Biocompatibility Validation
- Packaging Validation
- Shelf Life Validation
- Drop Test Validation
- Debris Validation
- · Cadaver Study
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 VSP® Orthopedics 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.