(197 days)
Not Found
No
The summary describes image processing and segmentation but does not mention AI, ML, or related terms like deep learning. The performance studies focus on accuracy of physical outputs and manufacturing processes, not on the performance of an AI/ML algorithm.
No
The VSP System is a software and image segmentation system used for surgical planning, creating anatomical models, templates, and surgical guides. It does not directly treat or diagnose a disease; rather, it aids in the preparation for surgical procedures.
No
The VSP® System is intended as a software system for image transfer and processing, creating digital and physical models/guides, and as a pre-operative software tool for simulating/evaluating surgical treatment options. It facilitates surgical planning and guide creation, rather than providing a medical diagnosis.
No
The device description explicitly states that the system produces "physical outputs including anatomical models, templates, and surgical guides" and mentions a "rapid prototyping portion of the system that produces physical outputs". It also includes performance studies related to the physical components (cleaning, sterilization, biocompatibility, mechanical performance, packaging). While it includes software, it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the VSP® System is for processing imaging information from medical scanners (like CT) to create digital models, physical outputs (anatomical models, templates, surgical guides), and for pre-operative surgical planning and simulation. This is focused on surgical planning and execution, not on analyzing biological samples or providing diagnostic information about a patient's health status.
- Device Description: The description reinforces that it manipulates 3D medical images to create tools and plans for reconstructive surgical procedures.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), detection of diseases or conditions, or providing diagnostic information based on laboratory tests.
IVDs are typically used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The VSP® System's function is entirely focused on utilizing imaging data for surgical planning and creating physical aids for surgery.
N/A
Intended Use / Indications for Use
The VSP® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the VSP® System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, templates, and surgical guides for use in maxillofacial surgery. The VSP® System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
Product codes (comma separated list FDA assigned to the subject device)
DZJ
Device Description
The VSP System utilizes a combination of Commercial Off-The-Shelf (COTS) and custom software to manipulate 3D medical images (CT based systems) to create virtual and physical anatomical models, templates, surgical guides, and surgical plans for reconstructive surgical procedures.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT based system
Anatomical Site
Maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained personnel, in a non-medical manufacturing or office environment, with active support from the 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
Non-clinical 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 System:
· Design Validation
Design validation was performed to ensure VSP System guide designs conform to the user needs and intended use of supporting maxillofacial surgeries. The test methods assessed accuracy of cutting location/trajectory, drilling location/trajectory, and bony segment length utilizing subject device guides on bone models. The results of the testing concluded that all acceptance criteria were met.
· Process Performance Qualification
A process performance qualification was conducted to assess the manufacturing process as well as operator repeatability within the digital workflow. Cases utilized for testing were representative of orthognathic and 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 10-6 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.
· Mechanical Performance Validation
Material testing was conducted on the subject device guide materials to compare performance against the predicate device. Flexural deformation testing per ASTM D790, ASTM E290, and ISO 178 was conducted on both subject and predicate devices and compared. The results of the testing concluded that subject devices perform equivalent or better than the predicate device.
· Packaging Validation
Packaging validation was performed on all packaging configurations of the VSP 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.
· Clinical Performance Data
Clinical testing was not necessary for the determination of substantial equivalence.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 26, 2020
3D Systems Kim Torluemke Vice President, Quality & Regulatory, Healthcare 5381 South Alkire Circle Littleton, Colorado 80127
Re: K192192
Trade/Device Name: VSP® System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ Dated: January 24, 2020 Received: January 28, 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
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,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192192
Device Name VSP® System
Indications for Use (Describe)
The VSP® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the VSP® System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, templates, and surgical guides for use in maxillofacial surgery. The VSP® System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
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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K192192 510(K) SUMMARY
1. Introduction
This document contains the 510(k) summary for the VSP® 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: | February 24, 2020 |
| DEVICE | |
| Trade Name: | VSP® System |
| Common Name: | Patient specific maxillofacial anatomical models, templates, guides, and |
| surgical plans. | |
| Classification Name: | Bone Cutting Instruments and Accessories. |
| System, Image Processing, Radiological | |
| Classification: | Class II, 21 CFR 872.4120 |
| Product Code: | DZJ |
4. PREDICATE DEVICES
Predicate device:
- · VSP® System, Medical Modeling a 3D Systems Company (K133907)
5. DESCRIPTION OF THE DEVICE
The VSP System utilizes a combination of Commercial Off-The-Shelf (COTS) and custom software to manipulate 3D medical images (CT based systems) to create virtual and physical anatomical models, templates, surgical guides, and surgical plans for reconstructive surgical procedures. The following table provides a list of VSP System outputs by material and function.
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| Category | Material | Guide Function |
|---|---|---|
| Marking Guide | • Duraform ProX PA | |
| • Ti-6Al-4V | Marking of maxillofacial bone | |
| Marking of graft bone | ||
| Cutting Guide | • Ti-6Al-4V | Cutting/drilling/marking of |
| maxillofacial bone | ||
| Cutting/drilling/marking of graft bone | ||
| Positioning Guide | • Duraform ProX PA | |
| • Ti-6Al-4V | Positioning of maxillofacial bone |
6. INTENDED USE
The VSP® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the VSP® System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, templates, and surgical guides for use in maxillofacial surgery. The VSP® System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The intended use and technological characteristics of the subject device are either identical or substantially equivalent to the predicate device (VSP System), differing only in the expansion of materials to include Polyamide for marking guides and Titanium Alloy for marking, cutting and drilling guides within the VSP System. The potential impact on substantial equivalence of each technological difference was addressed by risk analysis and verification and validation testing.
Similarities to Predicate
The inputs to the subject device are identical to those of the predicate device. System outputs of the subject and predicate device comprise both digital and physical outputs which can include patientspecific anatomical models, guides, and splints for the purpose of assisting the surgeon during maxillofacial surgeries. The subject device and the predicate device are both intended to be used by trained personnel, in a non-medical manufacturing or office environment, with active support from the surgeon. The subject device uses the same fundamental technologies as the predicate device. These include image transfer and manipulation via software that is subsequently used for 3D printing of anatomical models, guides, and splints and for surgical planning. The subject and predicate device use the same software components for the digital workflow. There has been no change to the sterilization process for the surgical guides, templates and anatomical models produced by the subject device. The subject device serves the same patient population as the predicate device.
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Differences to Predicate
Two new materials are presented in the modified system and make up the modification of this Traditional 510(k) submission. Two additional 3D printing technologies have been added to the system in support of the additional materials. The VSP System stainless steel cutting and drill guide tool accessories are not changing, however, these accessories will not be utilized with the polyamide and titanium alloy surgical guide materials. The polyamide guides will not include features that interface with cutting or drilling surgical tools. This presented no issues of safety and/or effectiveness during validation, and the data obtained demonstrated the system performed correctly and in accordance with its intended use without the use of the stainless steel accessories, noting the aforementioned limitation of the polyamide guides.
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. Non-clinical 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 System:
· Design Validation
Design validation was performed to ensure VSP System guide designs conform to the user needs and intended use of supporting maxillofacial surgeries. The test methods assessed accuracy of cutting location/trajectory, drilling location/trajectory, and bony segment length utilizing subject device guides on bone models. The results of the testing concluded that all acceptance criteria were met.
• Process Performance Qualification
A process performance qualification was conducted to assess the manufacturing process as well as operator repeatability within the digital workflow. Cases utilized for testing were representative of orthognathic and 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
6
acceptance criteria. The results of the testing adequately address biocompatibility for the output devices and their intended use.
• Mechanical Performance Validation
Material testing was conducted on the subject device guide materials to compare performance against the predicate device. Flexural deformation testing per ASTM D790, ASTM E290, and ISO 178 was conducted on both subject and predicate devices and compared. The results of the testing concluded that subject devices perform equivalent or better than the predicate device.
• Packaging Validation
Packaging validation was performed on all packaging configurations of the VSP 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.
• Clinical Performance Data
Clinical testing was not necessary for the determination of substantial equivalence.
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
The VSP System has the same intended use and similar technological characteristics as the predicate. Minor differences in the 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.