(62 days)
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No
The document describes image segmentation software but does not mention AI, ML, deep learning, or any related concepts. The description of the device and its function is consistent with traditional image processing techniques.
No
The device is a software interface and image segmentation system used for processing medical scanner data for CAD or rapid prototyping; it does not directly treat or diagnose.
No.
The device is described as a software interface and image segmentation system intended for transferring imaging information from a medical scanner to be used as input for CAD or Rapid Prototyping Systems. Its purpose is to process image data rather than to arrive at a diagnosis or provide diagnostic information.
Yes
The 510(k) summary explicitly states that the device "is confined solely to the software image segmentation system" and describes it as a "software interface and image segmentation system." It processes input data files from medical scanners and produces output data files for other systems, without mentioning any hardware components included in the device itself.
Based on the provided information, the Materialise CT-Modeller System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Intended Use: The intended use of the CT-Modeller System is to process medical imaging data (from MRI or CT scans) for use in CAD or Rapid Prototyping Systems. It's a software tool for image processing and segmentation, not for analyzing biological samples.
- Device Description: The description reinforces that it's a software system for handling imaging data.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
The system is clearly focused on processing and preparing medical imaging data for downstream applications like design and manufacturing, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Materialise CT-Modeller System 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 Magnetic Resonance imaging scanner or CT scanner. The input data file is processed by the CT-Modeller System and the result is an output data file which may then be used as input data for a CAD or Rapid Prototyping System. The CT-Modeller System which is the subject of this 510(k) premarket notification is confined solely to the software image segmentation system.
Product codes
90LLZ
Device Description
The Materialise CT-Modeller System 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 Magnetic Resonance imaging scanner or CT scanner. The input data file is processed by the CT-Modeller System and the result is an output data file which may then be used as input data for a CAD or Rapid Prototyping System.
Mentions image processing
System, Image Processing
Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance imaging scanner or CT scanner
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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SUMMARY OF SAFETY AND EFFECTIVENESS MATERIALISE CT-MODELLER SYSTEM
GENERAL INFORMATION I.
APR 2 1, 1997
| Classification Name: | System, Image Processing |
|---|---|
| Common Name: | Image Processing System |
| Device Trade Name: | Materialise CT-Modeller System |
| Classification Code: | 90LLZ |
| Submitter's Name & Address: | Materialise N.V. |
| Kapeldreef 60 | |
| B-3001 Leuven Belgium | |
| Establishment Registration No: | Applied for |
| Contact Person: | Wilfried Vancraen |
| Summary Preparation Date: | February 14, 1997 |
II. PREDICATE DEVICE
The CT-Modeller System is claimed to be substantially equivalent in material, design, and function to the SurgiCAD View System cleared by FDA under 510(k) K924630 on April 7, 1993.
III. Device Description
The Materialise CT-Modeller System 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 Magnetic Resonance imaging scanner or CT scanner. The input data file is processed by the CT-Modeller System and the result is an output data file which may then be used as input data for a CAD or Rapid Prototyping System.
STERILIZATION IV.
The CT-Modeller System is provided non-sterile.
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V. INDICATIONS FOR USE
The Materialise CT-Modeller System 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 Magnetic Resonance imaging scanner or CT scanner. The input data file is processed by the CT-Modeller System and the result is an output data file which may then be used as input data for a CAD or Rapid Prototyping System. The CT-Modeller System which is the subject of this 510(k) premarket notification is confined solely to the software image segmentation system.
VI. SUBSTANTIAL EQUIVALENCE
The CT-Modeller System is considered to be substantially equivalent to the SurgiCAD View System.
VII. CONCLUSION
The CT-Modeller System is considered to be substantially equivalent in design, material and function to the SurgiCAD View System and is believed to perform as well as the SurgiCAD System.
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