(255 days)
Yes
The document explicitly states the incorporation of a deep learning neural network for segmentation prediction.
No
The device is described as pre-operative software for surgical planning and for producing physical replicas for adjunctive use in diagnosis, patient management, and/or treatment selection. It does not directly provide therapy.
No.
Explanation: The "Intended Use / Indications for Use" states that the physical replica output by the software "may be used for adjunctive use along with other diagnostic tools and expert clinical judgement for diagnosis". This indicates that the device itself is not a diagnostic tool but rather provides input for other diagnostic processes. Additionally, the "Device Description" section notes "Seamless integration with Virtual Reality visualization for non-diagnostic use," reinforcing its non-diagnostic classification.
Yes
The device is described as a "stand-alone modular software package" and its functions are purely software-based (DICOM viewing, segmentation, editing, integration with other software/printers). While it facilitates the creation of physical replicas, the device itself is the 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 software is for pre-operative surgical planning and the output file (physical replica) is for adjunctive use along with other diagnostic tools and expert clinical judgement for diagnosis, patient management, and/or treatment selection. This indicates the device is used in conjunction with diagnostic information, not as a primary diagnostic tool itself.
- Device Description: The description focuses on image processing, visualization, segmentation, and integration with 3D printing and other software. These are functions related to surgical planning and creating physical models, not analyzing biological samples or providing diagnostic results directly from patient specimens.
- Lack of IVD Characteristics: An IVD device typically involves the examination of specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
While the device uses medical imaging data and aids in the diagnostic process by providing a physical replica for better understanding, its role is supportive and pre-operative, not directly diagnostic in the sense of an IVD.
No
The provided input states "Control Plan Authorized (PCCP) and relevant text: Not Found", which does not include any explicit language indicating FDA review, approval, or clearance of a PCCP for this device.
Intended Use / Indications for Use
The D2P software is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also intended as pre-operative software for surgical planning. For this purpose, the output file may be used to produce a physical replical replica is intended for adjunctive use along with other diagnostic tools and expert clinical judgement for diagnosis, patient management, and/or treatment selection of cardiovascular, craniofacial, genitourinary, neurological, and/or musculoskeletal applications.
Product codes
LLZ
Device Description
The D2P software is a stand-alone modular software package that provides advanced visualization of DICOM imaging data. This modular package includes, but is not limited to the following functions:
- DICOM viewer and analysis
- Automated segmentation
- · Editing and pre-printing
- Seamless integration with 3D Systems printers
- · Seamless integration with 3D Systems software packages
- Seamless integration with Virtual Reality visualization for non-diagnostic use.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Incorporation of a deep learning neural network used to create the prediction of the segmentation.
Input Imaging Modality
DICOM imaging data
Anatomical Site
cardiovascular, craniofacial, genitourinary, neurological, and/or musculoskeletal applications.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 D2P application has been validated for its intended use to determine substantial equivalence to the predicate device. A measurement accuracy and calculation 3D study, usability study, and decimation study were performed and confirmed to be within specification. Validation of printing of physical replicas was performed and demonstrated that anatomic models for cardiovascular, craniofacial, gastrointestinal, genitourinary, neurological, and/or musculoskeletal cases can be printed accurately when using any of the compatible 3D printers and materials.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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August 28, 2019
3D Systems, Inc. % Kim Torluemke VP Quality & Regulatory, Healthcare 5381 South Alkire Circle LITTLETON, CO 80127
Re: K183489
Trade/Device Name: D2P Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: July 16, 2019 Received: July 18, 2019
Dear Kim Torluemke:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 (OS) 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
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183489
Device Name D2P
Indications for Use (Describe)
The D2P software is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also intended as pre-operative software for surgical planning. For this purpose, the output file may be used to produce a physical replical replica is intended for adjunctive use along with other diagnostic tools and expert clinical judgement for diagnosis, patient management, and/or treatment selection of cardiovascular, craniofacial, genitourinary, neurological, and/or musculoskeletal applications.
| 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 3D Systems logo. On the left is a 3D cube with the letters '3D' on its faces. To the right of the cube is the text '3D SYSTEMS' in a simple, sans-serif font. The logo has a modern and corporate feel.
510(K) SUMMARY
1. INTRODUCTION
This document contains the 510(k) summary for the D2P software. The content of this summary is based on the requirements of 21 CFR 807.92.
2. SUBMITTER
| Name: | Simbionix LTD a 3D Systems Company |
|---|---|
| Address: | Beit Golan |
| Corner of Golan and Hanegev St. | |
| Airport City, 70151, Israel | |
| Phone: +972-3-9114444 | |
| Fax: +972-3-9114455 | |
| Official Contact: | Kim Torluemke |
| Vice President, Quality and Regulatory, Healthcare | |
| Date Prepared: | July 16, 2019 |
| DEVICE | |
| Trade Name: | D2P |
| Common Name: | Image processing system |
| Classification Name: | System, Image Processing, Radiological |
| Classification: | Class II, 21 CFR 892.2050 |
| Product Code: | LLZ |
4. PREDICATE DEVICE
The D2P software is claimed to be substantially equivalent to the following legally marketed predicate device:
-
D2P, Simbionix LTD a 3D Systems Company (K161841)
Reference device: -
InPrint, Materials N.V. (K173619)
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Image /page/4/Picture/0 description: The image shows the 3D Systems logo. On the left is a 3D cube with the letters "3D" on the sides. To the right of the cube is the word "3DSYSTEMS" in a sans-serif font. The logo is in a gray color scheme.
5. DEVICE DESCRIPTION
The D2P software is a stand-alone modular software package that provides advanced visualization of DICOM imaging data. This modular package includes, but is not limited to the following functions:
- DICOM viewer and analysis
- Automated segmentation
- · Editing and pre-printing
- Seamless integration with 3D Systems printers
- · Seamless integration with 3D Systems software packages
- Seamless integration with Virtual Reality visualization for non-diagnostic use.
INDICATIONS FOR USE 6.
The D2P software is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also intended as pre-operative software for surgical planning. For this purpose, the output file may be used to produce a physical replica. The physical replica is intended for adjunctive use along with other diagnostic tools and expert clinical judgement for diagnosis, patient management, and/or treatment selection of cardiovascular, craniofacial, gastrointestinal, genitourinary, neurological, and/or musculoskeletal applications.
The Indications for Use statement for the D2P software is nearly identical to the predicate device. The primary difference, confirmed through bench testing, includes the ability to utilize the electronic output to print physical anatomic models on qualified 3D Printing technologies and materials for diagnostic use. Both the subject and predicate devices have the same intended use for visualization, analysis and segmentation of medical images and rendering 3D objects.
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The D2P software employs the same fundamental technologies as the identified predicate devices, including:
- Viewing of medical imaging data in the axial, coronal and sagittal views
- Ability to process, review and analyze medical imaging data;
- Image transfer and manipulation via software used for the creation of a 3D object;
The following technological differences exist between the subject and predicate devices:
- Incorporation of a deep learning neural network used to create the prediction of the segmentation.
- The ability to remove images from a DICOM dataset.
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- The addition of a measurement tool into VR visualization.
- The subject device's intended use explicitly reflects 3D printing of the output file which can be used for diagnostic purposes in cardiovascular, craniofacial, gastrointestinal, genitourinary, neurological, and/or musculoskeletal applications.
8. PERFORMANCE DATA
Non-clinical tests
The D2P application has been validated for its intended use to determine substantial equivalence to the predicate device. A measurement accuracy and calculation 3D study, usability study, and decimation study were performed and confirmed to be within specification. Validation of printing of physical replicas was performed and demonstrated that anatomic models for cardiovascular, craniofacial, gastrointestinal, genitourinary, neurological, and/or musculoskeletal cases can be printed accurately when using any of the compatible 3D printers and materials.
Summary
All performance 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 were established in order to demonstrate device performance and substantial equivalence of the software to the predicate device.
9. CONCLUSIONS
Based on a comparison of the intended use and technological characteristics, the D2P software is substantially equivalent to the identified predicate device. Minor differences in technological and performance characteristics did 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.