Who is the manufacturer of VSP System?

3D Systems filed the 510(k) submission for VSP System (K210347).

What is the FDA product code for VSP System?

DZJ. It is classified under 21 CFR 872.4120 as a Class 2 device in the Dental panel.

What is the regulatory pathway for VSP System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like VSP System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VSP System

K210347 · 3D Systems · DZJ · Apr 26, 2021 · Dental

Device Facts

Record ID	K210347
Device Name	VSP System
Applicant	3D Systems
Product Code	DZJ · Dental
Decision Date	Apr 26, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4120
Device Class	Class 2

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, 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.

Device Story

VSP System processes DICOM files from medical scanners (CT/CBCT) to create virtual and physical anatomical models, surgical guides, and templates for maxillofacial surgery. System utilizes COTS and custom software for image segmentation, manipulation, and 3D surgical planning. Physician provides input for planning and approves final designs. Physical outputs are manufactured via rapid prototyping (3D printing) using various materials (e.g., Accura ClearVue, Ti-6Al-4V, Polyamide). Device used in non-medical manufacturing or office environments by trained personnel with surgeon oversight. Output aids surgeons in reconstructive procedures by providing patient-specific anatomical references and surgical guides, potentially improving surgical accuracy and planning efficiency.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including operational qualification, performance qualification, cleaning validation (AAMI TIR 30), steam sterilization validation (ISO 17665-1:2006, SAL 10^-6), and biocompatibility testing (ISO 10993-1) for the new Accura ClearVue material.

Technological Characteristics

Software/hardware system for image segmentation and 3D printing. Materials: Accura ClearVue, Accura SL 7810M, Somos BioClear, Accura Y-C 9300M (all photopolymers), Ti-6Al-4V (Direct Metal Printing), Polyamide (Selective Laser Sintering). Manufacturing: Stereolithography (SLA), Direct Metal Printing, Selective Laser Sintering. Sterilization: Steam sterilization (1 x 10^-6 SAL). Connectivity: DICOM input from CT/CBCT scanners.

Indications for Use

Indicated for use in maxillofacial surgery as a software and image segmentation tool to process CT/CBCT imaging data for the creation of digital models, anatomical models, surgical guides, and templates, and for pre-operative surgical simulation and planning.

Regulatory Classification

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.

Predicate Devices

VSP® System, Medical Modeling a 3D Systems Company (K192192)

Related Devices

K192192 — VSP System · 3D Systems · Feb 26, 2020
K120956 — VSP SYSTEM · Medical Modeling, Inc. · Dec 12, 2012
K133907 — VSP SYSTEM · Medical Modeling, Inc. · Jan 22, 2014
K210731 — KLS Martin Individual Patient Solutions · KLS-Martin L.P. · Jul 18, 2022
K181813 — ImmersiveView Surgical Plan (IVSP®) · Immersivetouch · Jun 9, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words. April 26, 2021 3D Systems Scott Brewer Director, Regulatory Affairs, Healthcare 5381 South Alkire Circle Littleton, Colorado 80127 Re: K210347 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, LLZ Dated: February 5, 2021 Received: February 8, 2021 Dear Scott Brewer: 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 {1}------------------------------------------------ 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 mediation-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 Michael Adjodha Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210347 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 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, 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) | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) SUMMARY - K210347 # 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 3. | Name: | 3D Systems | |--------------------------|------------------------------------------------------------------------------------------------------| | Address: | 5381 South Alkire Circle Littleton, CO 80127, USA Phone: (720) 643-1001 Fax: (720) 643-1009 | | Official Contact: | Scott Brewer Director, Regulatory Affairs, Healthcare | | Date Prepared: | April 23, 2021 | | DEVICE | | | Trade Name: | VSP® System | | Common Name: | Patient specific maxillofacial anatomical models, templates, guides, and surgical plans. | | Classification Name: | Bone Cutting Instruments and Accessories | | Classification: | 21 CFR 872.4120 | | Class: | Class II | | Product Code: | DZJ | | Subsequent Product Code: | LLZ | # 4. PREDICATE DEVICES Predicate device: - · VSP® System, Medical Modeling a 3D Systems Company (K192192) # 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. # 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 {4}------------------------------------------------ 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 included within the VSP® System for anatomic models to include Accura® ClearVue™. The potential impact on substantial equivalence of each technological difference was addressed by risk analysis and verification and validation testing. | Specification / Characteristic | Subject Device, VSP® System, Medical Modeling a 3D Systems Company | Predicate Device, VSP® System, Medical Modeling Inc. (K192192) | Comparison | |-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Classification | 21 CFR 872.4120, 21 CFR 892.2050 | 21 CFR 872.4120, 21 CFR 892.2050 | Substantially Equivalent | | Class | II | II | Substantially Equivalent | | Product Code | DZJ, LLZ | DZJ, LLZ | Substantially Equivalent | | 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 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. | 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. | Substantially Equivalent | | Technological Description | Software / Hardware based device that incorporates image manipulation software to transfer, segment and modify images with input from the physician that are further used to manufacture, via rapid prototyping, anatomical models and surgical guides. Additional system outputs include digital files and surgical case planning reports. Device includes image processing software, hardware for rapid prototyping of physical outputs, and the resulting anatomical models and surgical guides. | Software / Hardware based device that incorporates image manipulation software to transfer, segment and modify images with input from the physician that are further used to manufacture, via rapid prototyping, anatomical models and surgical guides. Additional system outputs include digital files and surgical case planning reports. Device includes image processing software, hardware for rapid prototyping of physical outputs, and the resulting anatomical models and surgical guides. | Substantially Equivalent | | Specification / Characteristic | Subject Device, VSP® System, Medical Modeling a 3D Systems Company | Predicate Device, VSP® System, Medical Modeling Inc. (K192192) | Comparison | | Software Technologies | Image transformation into 3D models, Computer Aided Design, Surgical planning / simulation | Image transformation into 3D models, Computer Aided Design, Surgical planning / simulation | Substantially Equivalent | | Hardware Technologies | 3D Printing to produce physical output devices | 3D Printing to produce physical output devices | Substantially Equivalent | | System Inputs | DICOM file from Medical Scanner (CT, CBCT), patient contoured and standard implant .STL files; input from physician | DICOM file from Medical Scanner (CT, CBCT), patient contoured and standard implant .STL files; input from physician | Substantially Equivalent | | Technologies Employed | Software, 3D Printing | Software, 3D Printing | Substantially Equivalent | | Materials | - Accura ClearVue Epoxy/Resin Acrylic (photopolymer): Stereolithography (SLA) - Accura SL 7810M Epoxy/Resin, Acrylic (photopolymer): Stereolithography (SLA) - Somos BioClear Epoxy/Resin, Acrylic (photopolymer): Stereolithography (SLA) - Accura Y-C 9300M Epoxy/Resin, Acrylic (photopolymer): Stereolithography (SLA) - Ti-6Al-4V: Direct Metal Printing - Polyamide: Selective Laser Sintering | - Accura SL 7810M Epoxy/Resin, Acrylic (photopolymer): Stereolithography (SLA) - Somos BioClear Epoxy/Resin, Acrylic (photopolymer): Stereolithography (SLA) - Accura Y-C 9300M Epoxy/Resin, Acrylic (photopolymer): Stereolithography (SLA) - Ti-6Al-4V: Direct Metal Printing - Polyamide: Selective Laser Sintering | Substantially Equivalent | | Method of Sterilization | Steam sterilization 1 x 10-6 SAL | Steam sterilization 1 x 10-6 SAL | Substantially Equivalent | | Physician Interaction with Planning and Physician Model / Guide Approval | Yes | Yes | Substantially Equivalent | Table 1: Substantial Equivalence Comparison {5}------------------------------------------------ # 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 are comprised of both digital outputs, which can include patient-specific 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 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 and templates produced by the subject device. The subject device serves the same patient population as the predicate device. {6}------------------------------------------------ # Differences to Predicate One new material is presented in the modified system and makes up the changes presented within this Traditional 510(k) submission. The material, SLA printing resin Accura ClearVue, is being added to the system for anatomic models. # 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: # · Operational Qualification A process operational qualification was performed to assess the manufacturing process over the range of allowable process parameters. All test method acceptance criteria were met. # • Performance Qualification A process performance qualification was conducted to assess the manufacturing process repeatability at nominal parameters. All test method acceptance criteria were met. # · Cleaning Validation A cleaning validation was performed in accordance with AAMI TIR 30. Following soiling and cleaning of the subject device, bioburden, protein levels, and hemoglobin levels were exampled. 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. Sensitization, irritation, and acute systemic toxicity testing conducted on the subject device manufactured from Accura ClearVue are within the pre-defined acceptance criteria. The results of the testing adequately address biocompatibility for the output device and its intended use. # • Clinical Performance Data Clinical testing was not necessary for the determination of substantial equivalence. All process and 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. Therefore, the subject device is substantial equivalence to the predicate device.