(77 days)
Not Found
No
The summary mentions image processing and segmentation but does not explicitly mention AI, ML, or related terms, nor does it describe training or test sets typically associated with such technologies.
No
The device is described as a software system and image segmentation system used for processing imaging information to create digital models, physical outputs (anatomical models, surgical guides), and for pre-operative simulation. It does not directly provide therapy or treatment to a patient.
No
The device is intended for pre-operative planning, simulation, and the creation of physical models and surgical guides, not for diagnosing a condition.
No
The device description explicitly states that the system produces "physical outputs including anatomical models, and surgical guides" and mentions a "rapid prototyping portion of the system that produces physical outputs". The performance studies also include validation for cleaning, sterilization, and biocompatibility, which are relevant to physical devices that come into contact with patients.
Based on the provided information, the VSP® System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The VSP® System's intended use and device description clearly state that it processes imaging information from medical scanners (like CT) and produces digital or physical models and surgical guides. It does not analyze biological samples like blood, urine, or tissue.
- The purpose of an IVD is to provide information for diagnosis, monitoring, or screening. The VSP® System is a pre-operative planning tool for simulating and evaluating surgical treatment options and creating physical aids for surgery. While it uses medical imaging data, its output is not a diagnostic result in the traditional sense of an IVD.
The VSP® System falls under the category of medical devices used for surgical planning and guidance, which are distinct from IVDs.
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 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.
Product codes
DZJ, LLZ
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
medical scanner such as a CT based system. DICOM file from Medical Scanner (CT, CBCT)
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
Not Found
Summary of Performance Studies
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.
Testing performed:
- 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 10-6 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. 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 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
| 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.