(72 days)
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No
The summary mentions "3D image processing" but does not explicitly mention AI, ML, or related terms like deep learning, neural networks, or algorithms that are typically associated with AI/ML in medical imaging. The performance studies section also lacks details about training or test sets, which are common in AI/ML device submissions.
No
The device is described as software for creating 3D images from CT or MRI scans, which is a diagnostic imaging function, not a therapeutic one. It processes images, but does not provide treatment or alleviate a condition.
No
This device processes existing CT and MRI diagnostic images to create 3D visualizations, rather than directly diagnosing conditions itself.
Yes
The device description explicitly states "ADV is software used for 3D image processing of CT and MR diagnostic images," and there is no mention of any accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "create 3D images of the anatomy from a set of CT or MRI images." This describes a process of image manipulation and visualization, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description reinforces this, stating it's "software used for 3D image processing."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely related to processing and visualizing medical images.
N/A
Intended Use / Indications for Use
ADV is intended to create 3D images of the anatomy from a set of CT or MRI images.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
ADV is software used for 3D image processing of CT and MR diagnostic images.
Mentions image processing
ADV is software used for 3D image processing of CT and MR diagnostic images.
Mentions AI, DNN, or ML
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Input Imaging Modality
CT, MRI
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests: ADV has been developed in a manner consistent with accepted standards for software development, including testing protocols.
Clinical data have not been submitted as part of this premarket notification.
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.
VoxelView® 2.5 (K953259)
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.
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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).
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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).
0
Appendix K - Class II 510(k) Summary ADV®
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
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Predicate Device VoxelView® 2.5 (K953259).
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Device Description
ADV is software used for 3D image processing of CT and MR diagnostic images.
- Intended Use
ADV is intended to create 3D images of the anatomy from a set of CT or MRI images.
- Comparison with Predicate Device
The products have substantially equivalent features for processing CT/MR imaging data in a three-dimensional format. The ADV software renders a 3D image which exhibits great faithfulness to the original and does so with great speed. Relative to VV2.5. ADV is a more convenient software package to use.
5. Nonclinical Tests
ADV has been developed in a manner consistent with accepted standards for software development, including testing protocols.
- Clinical Data
Clinical data have not been submitted as part of this premarket notification.
- Conclusions Drawn from Nonclinical and Clinical Tests
We conclude from these tests that ADV is substantially equivalent to the predicate device in its ability to render accurate 3D images for use in medical diagnosis.
End of Class II 510(k) Summary