(188 days)
Not Found
No
The document mentions "Automated segmentation" but does not explicitly mention AI, ML, or related terms, nor does it describe training or test sets typically associated with AI/ML development. The performance studies focus on software verification, validation, phantom studies, and usability, without mentioning AI/ML-specific metrics or methodologies.
No.
The D2P software is used for transferring imaging information and pre-operative surgical planning, generating 3D models for visual, non-diagnostic use, training, education, and pre-operative surgical planning. It does not directly diagnose, treat, or prevent a disease or condition, which are characteristics of a therapeutic device.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states that "3D printed models generated from the output file are meant for visual, non-diagnostic use." While the software processes medical imaging, its output is intended for non-diagnostic purposes like surgical planning and creating models for visual use, not for diagnosing conditions.
Yes
The device description explicitly states it is a "stand-alone modular software package" and its functions are purely software-based (DICOM viewing, segmentation, editing, integration). While it interacts with medical scanners and can lead to 3D printed models, the device itself is the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the 3D printed models generated from the output file are meant for visual, non-diagnostic use. The software itself is for image segmentation and pre-operative surgical planning, which are not diagnostic activities in the sense of analyzing biological samples or providing a diagnosis.
- Device Description: The description reinforces the non-diagnostic nature by mentioning uses such as training, education, and pre-operative surgical planning. While it processes medical images, the output is not intended for making a diagnosis.
- Lack of Diagnostic Claims: There are no claims or indications that the software or the resulting models are used to diagnose a disease, condition, or state of health.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The D2P software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for surgical planning.
3D printed models generated from the output file are meant for visual, non-diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The D2P software is a stand-alone modular software package that allows easy to use and quick digital 3D model preparation for printing or use by third party applications. The software is aimed at usage by medical staff, technicians, nurses, researchers or lab technicians that wish to create patient specific digital anatomical models for variety of uses such as training, education, and pre-operative surgical planning. The patient specific digital anatomical models may be further used as an input to a 3D printer to create physical models for visual, non-diagnostic use. 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 .
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
medical scanner such as a CT scanner
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical staff, technicians, nurses, researchers or lab technicians
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the patient. Software verification and validation included:
- Verification of each independent software subsystem against defined requirements
- Verification of interfaces between software subsystems against defined interface requirements
- Validation of fully integrated system including all subsystems against overall system requirements.
Phantom Study: The purpose of the study was to evaluate, measure and compare the correlations between a physical phantom model with segmentations that were created using the subject and predicate device from a CT scan of the phantom model. Comparison between the physical phantom and both software systems revealed that all measurements fell within the set acceptance criteria.
Usability Study - System Measurements: The purpose of the study was to evaluate, measure and compare the inter and intra user variability between measurements taken by multiple users in the subject device. Comparison of the inter and intra user measurements showed that all measurements fell within the set acceptance criteria.
Usability Study – Segmentation: The purpose of the study was to visually and quantitatively compare segmentation models created by representative users. The comparison showed similarity in all models.
Segmentation Study: The purpose of the study was to visually and quantitatively compare segmentation models created by both the subject and predicate devices. The comparison showed similarity in all models.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2017
3D Systems, Inc. % Ms. Kim Torluemke VP Quality & Regulatory, Healthcare 5381 South Alkire Circle LITTLETON CO 80127
Re: K161841 Trade/Device Name: D2P Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 23, 2016 Received: December 27, 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 device-related 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/Resourcesfor You/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,
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161841
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 imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for surgical planning.
3D printed models generated from the output file are meant for visual, non-diagnostic use.
| 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 stylized cube made up of the letters "3D" on the left, followed by the words "3D SYSTEMS" in a bold, sans-serif font. The cube is in shades of gray, while the text is in a darker gray or black color.
510(K) SUMMARY
INTRODUCTION 1.
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.
-
- SUBMITTER
| Name: | 3D Systems, Inc. (Simbionix) |
|---|---|
| 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: | January 5, 2017 |
| DEVICE | |
| Trade Name: | D2P |
| Common Name: | Image processing system and preoperative software for simulating |
| /evaluating surgical treatment options. | |
| Classification Name: | System, Image Processing, Radiological |
| Classification: | Class II, 21 CFR 892.2050 |
| Product Code: | LLZ |
PREDICATE DEVICE 4.
The D2P software is claimed to be substantially equivalent to the following legally marketed predicate device:
- · Mimics, Materialise N.V (K073468)
5. DEVICE DESCRIPTION
The D2P software is a stand-alone modular software package that allows easy to use and quick digital 3D model preparation for printing or use by third party applications. The software is aimed at usage by medical staff, technicians, nurses, researchers or lab technicians that wish to create patient specific digital anatomical models for variety of uses such as training, education, and pre-operative surgical planning. The patient specific digital anatomical models may be further used as an input to a 3D printer to create physical models for visual, non-diagnostic use. This modular package includes, but is not limited to the following functions:
4
Image /page/4/Picture/0 description: The image shows the logo for 3D Systems. The logo consists of a stylized cube made up of the letters "3D" on the left, followed by the words "3D SYSTEMS" in a sans-serif font. The cube is in shades of gray, while the text is in a darker gray color.
- DICOM viewer and analysis
- Automated segmentation
- Editing and pre-printing .
- Seamless integration with 3D Systems printers .
- Seamless integration with 3D Systems software packages .
INDICATIONS FOR USE 6.
The D2P software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for surgical planning.
3D printed models generated from the output file are meant for visual, non-diagnostic use.
The Indications for Use statement for the D2P software is nearly identical to the predicate device. The subtle differences do not alter the intended clinical use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for visualization, analysis and segmentation of medical images and rendering 3D objects.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 7.
The D2P software employs similar 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:
- The inputs to the subject device are equivalent to a subset of the inputs of the predicate device
- The outputs of the subject device are equivalent to a subset of the outputs of the predicate device
8. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the patient. Software verification and validation included:
- Verification of each independent software subsystem against defined requirements
- Verification of interfaces between software subsystems against defined interface requirements
- Validation of fully integrated system including all subsystems against overall system requirements.
5
Image /page/5/Picture/0 description: The image shows the logo for 3D Systems. The logo consists of a stylized cube made up of the letters "3D" on the left, followed by the words "3D SYSTEMS" in a sans-serif font. The cube is in shades of gray, while the text is in black.
Phantom Study
The purpose of the study was to evaluate, measure and compare the correlations between a physical phantom model with segmentations that were created using the subject and predicate device from a CT scan of the phantom model. Comparison between the physical phantom and both software systems revealed that all measurements fell within the set acceptance criteria.
Usability Study - System Measurements
The purpose of the study was to evaluate, measure and compare the inter and intra user variability between measurements taken by multiple users in the subject device. Comparison of the inter and intra user measurements showed that all measurements fell within the set acceptance criteria.
Usability Study – Segmentation
The purpose of the study was to visually and quantitatively compare segmentation models created by representative users. The comparison showed similarity in all models.
Segmentation Study
The purpose of the study was to visually and quantitatively compare segmentation models created by both the subject and predicate devices. The comparison showed similarity in all models.
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 characteristics did not raise new or different questions of safety and effectiveness. Additionally, the validation data supports that the system performs in accordance with its intended use and is substantially equivalent to the predicate device.