(498 days)
Not Found
No
The document describes image segmentation and processing but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML models.
No
The device is described as software that assists in surgical planning and the creation of physical outputs (models, templates, guides) for surgery, rather than directly treating a condition or performing a therapeutic function itself.
No
The device is described as a collection of software that processes CT imaging data to produce outputs like anatomical models, templates, and surgical guides for cranial surgery planning. It does not state that it analyzes medical images to provide a diagnosis of a patient's condition.
Yes
The device description explicitly states it is a "collection of Commercial Off-The-Shelf (COTS) software, third party medical device software, and custom software" and its intended use is to "provide image segmentation and transfer of imaging information". While the output can be used to create physical objects, the device itself is described solely as software.
Based on the provided information, the 3D Systems, Inc. VSP Cranial System is not an In Vitro Diagnostic (IVD) device.
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, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease or conditions.
- VSP Cranial System's Intended Use: The VSP Cranial System's intended use is focused on processing medical imaging data (CT scans) to create digital models, templates, and surgical guides for use in cranial surgery. It does not involve the analysis of biological specimens.
- Device Description: The device description confirms it's a software system that manipulates patient images for surgical planning and execution, producing physical outputs like anatomical models and surgical guides. This aligns with surgical planning and guidance, not in vitro testing.
Therefore, the VSP Cranial System falls under the category of medical devices used for surgical planning and guidance based on imaging data, rather than an IVD device.
N/A
Intended Use / Indications for Use
The 3D Systems, Inc. VSP Cranial System is intended for use as a collection of software to provide image segmentation and transfer of imaging information from a CT based medical scanner. The is processed by the VSP Cranial System and the result is an output data file that may then be provided as digital models or used as input in the production of physical outputs including anatomical models, templates, and surgical guides for use in the marking of cranial bone in cranial surgery.
Product codes (comma separated list FDA assigned to the subject device)
PPT
Device Description
The 3D Systems VSP® Cranial System is a collection of Commercial Off-The-Shelf (COTS) software, third party medical device software, and custom software intended to provide a variety of outputs to support cranial reconstructive surgery. The system uses CT based imaging data of the patient's anatomy with input from the physician, to manipulate original patient images for planning and executing surgery. The system produces a variety of patient specific outputs including, anatomical models (physical and digital), surgical templates / guides, and patient specific case reports.
3D Systems employees utilize a combination of Commercial Off-The-Shelf (COTS) software, third party medical device software, and custom software to manipulate CT based imaging data to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during planning and prior to delivery of the final outputs. While the process and data-flow can vary somewhat based on the particular requirements of a given patient and physician, the following description outlines the functions of key sub-components of the system, and how they interact to produce the defined system outputs. It should be noted that the system is operated only by trained 3D Systems employees, and the physician does not directly input information. The physician only provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the engineer during the planning session.
The VSP® Cranial System is made up of 10 individual pieces of software and additional manufacturing equipment integrated to provide a range of anatomical models (physical and digital), surgical templates / guides and patient-specific case reports for reconstructive surgery in the cranial region.
The VSP® Cranial System also contains Stainless Steel Cutting and Drill Inserts (VSP® Cranial System Accessories) which are intended to be used by the physician to guide cutting and drilling activities during the surgical procedure. The inserts fit into a standard slot / hole in the cutting / drill guides, and can be used across all VSP® Cranial System guides and templates.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT based medical scanner / CT based imaging systems
Anatomical Site
Cranial region / cranial bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained 3D Systems employees in a non-medical manufacturing or office environment. The physician provides input and review.
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 planning/design process, materials, manufacturing process, cleaning methods and sterilization methods for VSP® Cranial System are identical to those used for the predicate device. Therefore, the following testing was leveraged from the predicate device:
- Biocompatibility testing
- Cleaning and sterilization testing
- Software verification and validation testing
- Performance testing
- Process validation (IQ/OQ/PQ)
- Simulated Use (Planning session)
- Mechanical testing
VSP® Cranial System output guides and templates differ from the predicate device only in size and shape to accommodate the anatomical region for which they are intended. To address any concerns with the similar performance of the VSP® Cranial System, the following performance data were provided in addition to the leveraged testing to support the substantial equivalence determination:
Test: Packaging Validation
Test Method Summary: Product packaging and labels were tested according to ASTM D4577, ASTM D642, Method A, ASTM D4728, ASTM D3580, ASTM D5276, ASTM D6179, ASTM D880, ASTM D6179, ASTM D6653, and National Motor Freight Classification Rule 180.
Results: All packaging and labeling met the required acceptance criteria.
Test: Sterilization Compatibility
Test Method Summary: To ensure VSP® Cranial System outputs are compatible with the validated sterilization method, outputs were subjected to a single sterilization cycle and visually/dimensionally inspected.
Results: All acceptance criteria was met.
Test: Dimensional Analysis
Test Method Summary: Sizes and shapes of VSP® Cranial System templates and guides were selected to challenge the system and were dimensionally inspected to verify conformance to the product requirements.
Results: All acceptance criteria was met.
Test: Bioburden
Test Method Summary: Bioburden testing was conducted on VSP® Cranial System templates, guides, anatomical models, and metal accessories per ISO 11737-1, USP and USP .
Results: All acceptance criteria was met.
Test: Pyrogenicity testing
Test Method Summary: Pyrogenicity testing was conducted on VSP® Cranial System templates, guides, anatomical models, and metal accessories per AAMI ST72, USP , and USP .
Results: All samples met the acceptance criteria of ≤ 2.15 EU/device.
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.
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
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three heads, representing the department's focus on health, human services, and the well-being of the population. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 23, 2016
3D Systems Corporation Ms. Kim Torluemke Vice President, Quality & Regulatory, Healthcare 5381 South Alkire Circle Littleton, Colorado 80127
Re: K151285
Trade/Device Name: VSP Cranial System Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories Regulatory Class: Class II Product Code: PPT Dated: September 21, 2016 Received: September 22, 2016
Dear Ms. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151285
Device Name VSP Cranial System
Indications for Use (Describe)
The 3D Systems, Inc. VSP Cranial System is intended for use as a collection of software to provide image segmentation and transfer of imaging information from a CT based medical scanner. The is processed by the VSP Cranial System and the result is an output data file that may then be provided as digital models or used as input in the production of physical outputs including anatomical models, templates, and surgical guides for use in the marking of cranial bone in cranial surgery.
| 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/0 description: The image shows the logo for 3D Systems. The logo consists of a geometric shape on the left and the text "3D SYSTEMS" on the right. The geometric shape is a stylized cube with the letters "3D" integrated into its design. The text "3D SYSTEMS" is written in a bold, sans-serif font.
510(K) SUMMARY
1. INTRODUCTION
This document contains the 510(k) summary for the VSP® Cranial System. The content of this summary is based on the requirements of 21 CFR 807.92.
2. APPLICANT NAME AND ADDRESS
| 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: September 23, 2016
3. DEVICE NAME AND CLASSIFICATION
| Trade Name: | VSP® Cranial System |
|---|---|
| Common Name: | System for the creation of patient specific anatomical models, templates, |
| guides, and surgical plans. | |
| Classification Name: | Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories |
| Classification: | Class II, 21 CFR 882.4310 |
| Product Code: | PPT |
4. PREDICATE DEVICE
- · VSP® System, 3D Systems (K133907)
5. DESCRIPTION OF THE DEVICE
The 3D Systems VSP® Cranial System is a collection of Commercial Off-The-Shelf (COTS) software, third party medical device software, and custom software intended to provide a variety of outputs to support cranial reconstructive surgery. The system uses CT based imaging data of the patient's anatomy with input from the physician, to manipulate original patient images for planning and executing surgery. The system produces a variety of patient specific outputs including, anatomical models (physical and digital), surgical templates / guides, and patient specific case reports.
4
Image /page/4/Picture/0 description: The image shows the logo for 3D Systems. The logo consists of a geometric shape on the left and the text "3D SYSTEMS" on the right. The geometric shape is a cube-like structure with the letters "3D" integrated into its design. The text "3D SYSTEMS" is written in a bold, sans-serif font.
3D Systems employees utilize a combination of Commercial Off-The-Shelf (COTS) software, third party medical device software, and custom software to manipulate CT based imaging data to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during planning and prior to delivery of the final outputs. While the process and data-flow can vary somewhat based on the particular requirements of a given patient and physician, the following description outlines the functions of key sub-components of the system, and how they interact to produce the defined system outputs. It should be noted that the system is operated only by trained 3D Systems employees, and the physician does not directly input information. The physician only provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the engineer during the planning session.
The VSP® Cranial System is made up of 10 individual pieces of software and additional manufacturing equipment integrated to provide a range of anatomical models (physical and digital), surgical templates / guides and patient-specific case reports for reconstructive surgery in the cranial region.
The VSP® Cranial System requires an input 3D image file from CT based imaging systems. This input is then used, with support from the prescribing physician, to provide the following categories of outputs to support reconstructive surgery. Each system output is designed with physician input, and reviewed by the physician prior to finalization and distribution. All outputs are used only with direct physician involvement to reduce the criticality of the outputs.
System Outputs:
- Anatomical Models
- Surgical Positioning Templates / Guides
- Osteotomy Templates / Guides
- Patient Specific Case Reports
The VSP® Cranial System also contains Stainless Steel Cutting and Drill Inserts (VSP® Cranial System Accessories) which are intended to be used by the physician to guide cutting and drilling activities during the surgical procedure. The inserts fit into a standard slot / hole in the cutting / drill guides, and can be used across all VSP® Cranial System guides and templates.
6. INDICATIONS FOR USE
The 3D Systems, Inc. VSP® Cranial System is intended for use as a collection of software to provide image segmentation and transfer of imaging information from a CT based medical scanner. The input data file is processed by the VSP® Cranial System and the result is an output data file that may then be provided as digital models or used as input in the production of physical outputs including anatomical models, templates, and surgical guides for use in the marking or cutting of cranial bone in cranial surgery.
The Indications for Use statement for the VSP® Cranial System is nearly identical to the predicate device, differing only in anatomical region. The anatomical region for which the predicate device is
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Image /page/5/Picture/0 description: The image shows the logo for 3D Systems. The logo consists of a geometric shape on the left and the text "3D SYSTEMS" on the right. The geometric shape is a cube-like structure with the letters "3D" embedded within it. The text "3D SYSTEMS" is written in a bold, sans-serif font.
intended is listed as maxillofacial, indicating that the device may be used only for maxillofacial applications. The VSP® Cranial System is specific to only the cranial region, and excludes maxillofacial applications. The change in anatomical region presented in the Indications for Use statement of the VSP® Cranial System as compared to the predicate device do not change the therapeutic effects of the device.
Both the subject and predicate devices have the same intended use for providing image segmentation for the transfer of imaging information from a medical scanner, pre-operative software tools for simulating / evaluating surgical treatment options, and patient specific outputs for use in reconstructive surgery.
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The intended use and technological characteristics of the subject device (VSP® Cranial System) are either identical or substantially equivalent to the predicate device (VSP® System), differing only in the anatomical region for which they are intended. The potential impact on substantial equivalence of each technological difference was addressed by extensive risk analysis and verification and validation testing.
The VSP® Cranial System employs identical fundamental technologies as the predicate device:
- The VSP Cranial System uses a subset of the software previously cleared in the predicate device.
- Hardware for rapid manufacturing of patient-specific anatomical models, guides and templates is identical to the previously cleared predicate device.
The principles of operation and technological characteristics are all either identical or substantially equivalent between the VSP® Cranial System and the predicate device.
The VSP® Cranial System has the following identical technological characteristics:
- System Inputs: Images from CT based medical scanners
- System Outputs: Physical and digital outputs such as patient-specific anatomical models, cutting and drill guides, and templates
- Materials: Biocompatible polymers and surgical instrument grade stainless steel
- Sterility Assurance Level: 1 x 10-6
The intended use of the VSP® Cranial System is similar to the predicate device, differing only in the anatomical region in which the device is intended for:
- Both devices are intended to provide tools and accessories (software for image manipulation, anatomical models, guides and templates) for use in reconstructive surgery.
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Image /page/6/Picture/0 description: The image shows the logo for 3D Systems. The logo consists of a geometric shape on the left and the text "3D SYSTEMS" on the right. The geometric shape is a stylized cube with the letters "3D" and "S" incorporated into its design. The text "3D SYSTEMS" is written in a bold, sans-serif font.
- The VSP® Cranial System and its 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 VSP® Cranial System and its predicate device are both intended for use on surgical candidates undergoing complex reconstructive surgery.
The VSP® Cranial System and its predicate's accessories are manufactured to ASTM F899-11 and are sterilized by the healthcare facility with the same cycle as the other system outputs.
8. SUMMARY OF PERFORMANCE TESTING
The planning/design process, materials, manufacturing process, cleaning methods and sterilization methods for VSP® Cranial System are identical to those used for the predicate device. Therefore, the following testing was leveraged from the predicate device:
- Biocompatibility testing
- Cleaning and sterilization testing
- Software verification and validation testing
- · Performance testing
- o Process validation (IQ/OQ/PQ)
- Simulated Use (Planning session) o
- o Mechanical testing
VSP® Cranial System output guides and templates differ from the predicate device only in size and shape to accommodate the anatomical region for which they are intended. To address any concerns with the similar performance of the VSP® Cranial System, the following performance data were provided in addition to the leveraged testing to support the substantial equivalence determination:
| Test | Test Method Summary | Results |
|---|---|---|
| Packaging Validation | Product packaging and labels were tested | |
| according to ASTM D4577, ASTM D642, Method | ||
| A, ASTM D4728, ASTM D3580, ASTM D5276, | ||
| ASTM D6179, ASTM D880, ASTM D6179, ASTM | ||
| D6653, and National Motor Freight Classification | ||
| Rule 180 | All packaging and labeling | |
| met the required | ||
| acceptance criteria | ||
| Sterilization | ||
| Compatibility | To ensure VSP® Cranial System outputs are | |
| compatible with the validated sterilization | ||
| method, outputs were subjected to a single | ||
| sterilization cycle and visually/dimensionally | ||
| inspected | All acceptance criteria was | |
| met |
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Image /page/7/Picture/0 description: The image shows the logo for 3D Systems. The logo consists of a geometric shape on the left and the text "3D SYSTEMS" on the right. The geometric shape is a stylized cube with the letters "3D" incorporated into its design. The text "3D SYSTEMS" is written in a bold, sans-serif font.
| Test | Test Method Summary | Results |
|---|---|---|
| Dimensional Analysis | Sizes and shapes of VSP® Cranial System | |
| templates and guides were selected to challenge | ||
| the system and were dimensionally inspected to | ||
| verify conformance to the product requirements | All acceptance criteria was | |
| met | ||
| Bioburden | Bioburden testing was conducted on VSP® | |
| Cranial System templates, guides, anatomical | ||
| models, and metal accessories per ISO 11737-1, | ||
| USP and USP | All acceptance criteria was | |
| met | ||
| Pyrogenicity testing | Pyrogenicity testing was conducted on VSP® | |
| Cranial System templates, guides, anatomical | ||
| models, and metal accessories per AAMI ST72, | ||
| USP , and USP | All samples met the | |
| acceptance criteria of ≤ 2.15 | ||
| EU/device |
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® Cranial System is substantially equivalent to the identified predicate device. Minor differences in the indications for use do not raise new or different questions of safety and effectiveness. Validation data supports that the system performs in accordance with its intended use and is substantially equivalent to the predicate device.