(316 days)
Not Found
Yes
The document explicitly mentions an "AI bone segmentation algorithm" and describes its training and validation.
No
The device aids in diagnosis and treatment planning by generating 3D models and facilitating the fabrication of physical replicas, but it does not directly treat or prevent a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Segment 3DPrint is intended to generate 3D models for diagnostic purposes".
Yes
The device description explicitly states "Segment 3DPrint is a software". While it processes images from medical scanners and its output can be used for physical fabrication, the device itself, as described, is solely the software component. The performance studies validate the software's output (digital models, AI segmentation) and the accuracy of physical replicas fabricated using the software's output, but the device under review is the software itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Segment 3DPrint's Function: Segment 3DPrint processes medical images from scanners and medical 3D models. It generates 3D models for visualization, measurement, and treatment planning. It does not analyze biological samples from the body.
- Intended Use: The intended use clearly states it's for "review and segmentation of images from a medical scanner as well as of medical 3D models" and to "generate 3D models for diagnostic purposes." This is distinct from analyzing biological samples.
While the software is used for diagnostic purposes and involves image processing, its core function is not the analysis of in vitro samples. Therefore, it falls outside the definition of an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
Segment 3DPrint is a software for review and segmentation of images from a medical scanner as well as of medical 3D models. Segment 3DPrint is intended to generate 3D models for diagnostic purposes in both paediativ and adult populations in the field of orthopaedic, maxillofacial, and cardiovascular applications. The models can be used for visualisation, measuring, and treatment planning. Output from Segment 3DPrint can be used to fabrical replical replical replical replical replical replical replical replical by use of additive manufacturing methods. Segment 3DPrint is intended to be used by trained professionals in conjunction with expert clinical judgement.
Product codes
LLZ
Device Description
Seqment 3DPrint is a software for review and segmentation of images from a medical scanner as well as of medical 3D models. Segment 3DPrint is intended to generate 3D models for diagnostic purposes. The models can be used for visualisation, measuring, and treatment planning. Output from Segment 3DPrint can be used to fabricate physical replicas, by use of additive manufacturing methods.
Medical images and 3D models may be imported from various sources, including images stored on portable media, network storage devices, and other vendor systems.
Segment 3DPrint meets the identification criteria LLZ 892.2050 - Picture archiving and communications system. Segment 3DPrint is a software with the capability to import and display medical images and to perform digital processing of a rendered 3D object. Segment 3DPrint is a support tool with the means of generating 3D models and should be used by medically trained professionals in conjunction with expert clinical judgement.
The user will interact with Seqment 3DPrint through a graphical user interface on a standard PC platform, using Windows operating system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
images from a medical scanner
Anatomical Site
Not Found
Indicated Patient Age Range
paediativ and adult populations
Intended User / Care Setting
trained professionals
Not Found
Description of the training set, sample size, data source, and annotation protocol
AI bone segmentation algorithm was trained on 20 data sets, and 21 data sets were used for its validation. There was no overlap of data between the two sets, and care was taken to include a great variety of data (such as scanner model, image quality, and anatomy). The maximum 95th percentile surface distance between the ground truth segmentation and the resulting image was
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medviso AB % Einar Heiberg, Ph.D. Founder, Vice President, CTO Griffelvägen 3 Lund. SE-22467 SWEDEN
May 6, 2022
Re: K211966
Trade/Device Name: Segment 3DPrint Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 30, 2022 Received: April 8, 2022
Dear Einar Heiberg:
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 801and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
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- 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
Thalia T. Mills, Ph.D. Director DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211966
Device Name Segment 3DPrint
Indications for Use (Describe)
Segment 3DPrint is a software for review and segmentation of images from a medical scanner as well as of medical 3D models. Segment 3DPrint is intended to generate 3D models for diagnostic purposes in both paediativ and adult populations in the field of orthopaedic, maxillofacial, and cardiovascular applications. The models can be used for visualisation, measuring, and treatment planning. Output from Segment 3DPrint can be used to fabrical replical replical replical replical replical replical replical replical by use of additive manufacturing methods. Segment 3DPrint is intended to be used by trained professionals in conjunction with expert clinical judgement.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
--- Over-The-Counter Use (21 CFR 801 Subpart C)
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510 (k) Summary 5
Submitter 5.1
Medviso AB Griffelvägen 3 SE-224 67 Lund, Sweden +46(0)761-836442
Date Prepared: May 4, 2022 Contact Person: Einar Heiberg, PhD, CTO, +46(0)761-836442, einar@medviso.com
5.2 Device
Device Trade Name: Segment 3DPrint Device Common Name: Image processing system Classification Name: Class II - System, Image Processing Regulation Number: 892.2050(Medical image management and processing system) Product Code: LLZ
Predicate Device 5.3
Mimics Medical (K183105) Materialise N.V. Technologielaan 15 3001 Leuven Belgium
5.4 Device Description
Device Description
Seqment 3DPrint is a software for review and segmentation of images from a medical scanner as well as of medical 3D models. Segment 3DPrint is intended to generate 3D models for diagnostic purposes. The models can be used for visualisation, measuring, and treatment planning. Output from Segment 3DPrint can be used to fabricate physical replicas, by use of additive manufacturing methods.
Image /page/3/Picture/14 description: The image shows the word "MEDVISO" in a light blue color. The word is surrounded by a pattern of small, light blue squares that form a semi-circular shape above and below the word. The squares are arranged in a grid-like pattern and appear to be fading out towards the edges of the semi-circle.
Page 5-1 of 5
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Medical images and 3D models may be imported from various sources, including images stored on portable media, network storage devices, and other vendor systems.
Segment 3DPrint meets the identification criteria LLZ 892.2050 - Picture archiving and communications system. Segment 3DPrint is a software with the capability to import and display medical images and to perform digital processing of a rendered 3D object. Segment 3DPrint is a support tool with the means of generating 3D models and should be used by medically trained professionals in conjunction with expert clinical judgement.
The user will interact with Seqment 3DPrint through a graphical user interface on a standard PC platform, using Windows operating system.
5.5 Intended Use
Segment 3DPrint is a software for review and segmentation of images from a medical scanner as well as of medical 3D models. Segment 3DPrint is intended to generate 3D models for diagnostic purposes in both paediatric and adult populations in the field of orthopaedic, maxillofacial, and cardiovascular applications. The models can be used for visualisation, measuring, and treatment planning. Output from Segment 3DPrint can be used to fabricate physical replicas, by use of additive manufacturing methods. Segment 3DPrint is intended to be used by trained professionals in conjunction with expert clinical judgement.
Comparison with Predicate Device
Both Segment 3DPrint and the predicate device Mimics Medical are support tools which provide the healthcare professional(s) with relevant clinical data to support clinical decisions by analyzing the generated 3D models.
Both Seament 3DPrint and Mimics Medical can be used for the fabrication of physical replicas of the output file using additive manufacturing methods.
The intended use for Segment 3DPrint is substantially equivalent to the intended use of the predicate device Mimics Medical.
Technological Characteristics 5.6
Seament 3DPrint and the predicate device are both software packages that can be used for visualization and segmentation of medical images. Both Segment 3DPrint and the predicate device provide a user interface with items for selecting images and adjusting image viewing and can be operated from a personal computer. The subject device and predicate device render segmentations of the region of interest either semiautomatically, manually, or in combination, providing digital 3D models. The technological difference between the subject device and the predicate device is that different algorithms are used for the semi-automatic segmentation approaches. There might be slight differences in features and menu, but these differences between the
Image /page/4/Picture/13 description: The image shows the word "MEDVISO" in a light blue color. The word is surrounded by a pattern of small, light blue squares that form a semi-circular shape above and below the word. The squares appear to be pixelated, giving the image a digital or technological feel. The background is white.
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predicate device and the proposed device are not significant since they do not raise any new or potential safety risks to the user or patient and questions of safety or effectiveness. Based on the results of software validation and verification tests, we conclude that Segment 3DPrint is substantially equivalent to the predicate device.
| System | Segment 3DPrint | Mimics Medical |
|---|---|---|
| Version | 3.2 | 23.0.2 |
| Manufacturer | Medviso AB | Materialise NV |
| 510(k) number | K211966 | K183105 |
| Classification | 892.2050 | |
| LLZ, Class II | 892.2050 | |
| LLZ, Class II | ||
| Intended use | same | same |
| Patient population | All with images from | |
| medical scanner. | Unspecified | |
| Graphical user interface | Yes | Yes |
| Platform | PC | PC |
| Operating system | MS Windows 10 | MS Windows 10 |
| Image display monitor | Unspecified | Resolution of 1280x1024 or |
| higher | ||
| Report display monitor | No | No |
| Patient demographics | Yes | Yes |
| Networking | TCP/IP | TCP/IP |
| DICOM compliant image | ||
| compression | Lossless | Lossless |
| Image communication | Yes | Yes |
| Image processing annotations | Yes | Yes |
| Linear measurement tools | Yes | Yes |
| Automatic and manual | ||
| segmentation of object | Yes | Yes |
| Automatic filling and | ||
| smoothing tools | Yes | Yes |
| Local and remote image | ||
| storage | Yes | Yes |
| Type of software – custom | ||
| integrated | Yes | Yes |
| Viewing | Yes | Yes |
| Safety - For use only by a | ||
| licensed professional | Yes | Yes |
Image /page/5/Picture/4 description: The image shows the word "MEDVISO" in a light blue color. The word is surrounded by a pattern of small, light blue squares that form a semi-circular shape above and below the word. The squares appear to be pixelated, giving the image a digital or technological feel. The overall design is simple and clean, with a focus on the text and the surrounding pattern.
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5.7 Performance Data
The following performance data were provided in support of the substantial equivalence determination.
The accuracy of the final 3D model generated by Segment 3DPrint is