(140 days)
Not Found
Yes
The device description explicitly states that it utilizes a "deep learning technique," which is a subset of machine learning and artificial intelligence.
No
The device is a post-processing application that assists clinicians in visualizing and analyzing CT images of the spine to improve reading efficiency and reporting. It does not directly treat or diagnose any disease.
No.
The device is a post-processing application designed to assist clinicians in visualizing and labeling the spine from CT images, optimizing display settings, and improving reporting efficiency. It does not provide a medical diagnosis or treatment decision.
Yes
The device is described as a "software analysis package" and a "post processing application option" that runs on existing hardware platforms (AW, CT Scanner, Cloud, PACS stations). It processes existing CT images and does not include any new hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that Bone VCAR is a post-processing application for analyzing CT images. CT images are generated from the human body, but they are not biological specimens themselves.
- IVDs are used to provide information about a physiological or pathological state. While Bone VCAR assists clinicians in reviewing images that may contain information about a patient's condition (trauma, oncology, etc.), its primary function is to process and display images to improve visualization and efficiency. It does not directly analyze biological samples to diagnose or monitor a disease state.
- The description focuses on image processing, visualization tools, and labeling. The core functionalities described are related to manipulating and presenting image data (MPR, display settings, labeling, measurements), not analyzing biological markers or substances.
In summary, Bone VCAR is an image processing and visualization tool for medical images, not a device that analyzes biological specimens to provide diagnostic information.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The prompt explicitly states "Control Plan Authorized (PCCP) and relevant text Not Found".
Intended Use / Indications for Use
Bone VCAR is a post processing application for use in the analysis of CT images. The software is intended to support clinicians in the review of images that include the spine by providing tools to label the spine and optimize the display of anatomy within the CT image.
Bone VCAR is designed to support the clinician in visualization of the spine, by providing initial identification of vertebrae to assist in report dictation.
The software also assists the user by providing optimized display settings for easier identification of anatomy to facilitate fast image review and reporting of findings. Bone VCAR may be used for multiple care areas and is not specific to any disease state. It can be utilized during the review of exams including trauma, oncology, and routine body.
Product codes (comma separated list FDA assigned to the subject device)
JAK, LLZ
Device Description
Bone VCAR is a software analysis package utilizing a deep learning technique that assists in the analysis and visualization of CT data. It is intended to provide clinicians with an optimized display and quick access to tools that improve the reading experience and efficiency for anatomy. Bone VCAR is a post processing application option for the Advantage Workstation (AW) platform, CT Scanner, Cloud or PACS stations which can be used in the analysis of CT images.
Bone VCAR is designed to support the clinician in easy visualization of spine and to provide identification of those structures to assist in report dictation. This post processing solution combines the following tools and functionality:
· Multiplanar Reconstruction (MPR) displays of axial, sagittal, coronal, oblique, x-section and curved views which can be displayed in thin/thick, Average, Maximum Intensity Projection (MIP), Minimum intensity Projection (MinIP), Volume Rendering (VR) modes
· Display of anatomical labels automatically with editing capability of all labels such as the spine.
• Display of curved views automatically and editing capability of curved views through anatomical regions such as the spine for enhanced display options
· Access to all standard volume viewer tools for measuring distances, areas, Hounsfield unit values and annotating within the images
· Synchronization of views when multiple series are loaded with spine labeling for all series loaded.
The software will assist the user by providing optimized display settings to enable fast review of the images along with easy identification of anatomy to ease reporting of findings. Bone VCAR may be used for multiple care areas and is not specific to any disease state. It can be utilized during the review of various types of exams including trauma, oncology, and routine body.
Bone VCAR is compatible with both single energy and Gemstone Spectral Imaging (GSI) acquisition methods.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT images
Anatomical Site
Spine / vertebrae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians, multiple care areas.
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
A representative set of clinical sample images was assessed by three board certified radiologists using 5-point Likert scale.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering has validated Bone VCAR algorithm's capability of using deep learning technique to automatically label spine using a dataset of CT exams. This database of exams is considered as a representative of the clinical scenarios where Bone VCAR is intended to be used, with consideration of acquisition parameters, image quality, pathologies and anatomy variations. The result of the algorithm validation provided a success rate greater than 90% for the capability of automatically labeling the spine.
A representative set of clinical sample images was assessed by three board certified radiologists using 5-point Likert scale. The assessment demonstrated that the capability of automatic labeling of spine by Bone VCAR is faster than manually labeling and it also increases reading and reporting efficiency whilst providing accurate identification of vertebra.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
April 8, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two distinct elements: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized depiction of an eagle, while the FDA portion includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
GE Medical Systems SCS % Ms. Elizabeth Mathew Senior Regulatory Affairs Manager 283 rue de la Miniere Buc. 78530 FRANCE
Re: K183204
Trade/Device Name: Bone VCAR (BVCAR) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, LLZ Dated: March 18, 2019 Received: March 19, 2019
Dear Elizabeth Mathew:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D'Hara
For
Thalia T. Mills, 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) K183204
Device Name
Bone VCAR
Indications for Use (Describe)
Bone VCAR is a post processing application for use in the analysis of CT images. The software is intended to support clinicians in the review of images that include the spine by providing tools to label the spine and optimize the display of anatomy within the CT image.
Bone VCAR is designed to support the clinician in visualization of the spine, by providing initial identification of vertebrae to assist in report dictation.
The software also assists the user by providing optimized display settings for easier identification of anatomy to facilitate fast image review and reporting of findings. Bone VCAR may be used for multiple care areas and is not specific to any disease state. It can be utilized during the review of exams including trauma, oncology, and routine body.
| 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 General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle is surrounded by a decorative pattern of swirls and dots. The logo is simple and recognizable, and it is associated with a well-known and established company.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | April 8, 2019 |
|---|---|
| Submitter: | GE Medical Systems SCS |
| Establishment Registration Number - 9611343 | |
| 283 rue de la Miniere | |
| 78530 Buc, France | |
| Primary Contact | |
| Person: | Elizabeth Mathew |
| Senior Regulatory Affairs Manager | |
| Phone: (262) 424-7774 | |
| Email: Elizabeth.Mathew@ge.com | |
| Secondary Contact | |
| Person: | Helen Peng |
| Regulatory Affairs Director | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| 3000 N Grandview Blvd., | |
| Waukesha, WI - 53188 | |
| Phone: 262-424-8222 | |
| Email: Hong.Peng@ge.com | |
| Proposed Device: | |
| Device Name: | Bone VCAR |
| Common/Usual | |
| Name: | BVCAR |
| Primary Regulation | |
| number: | 21 CFR 892.1750 Computed tomography x-ray system |
| Primary Product | |
| Code: | JAK |
| Secondary Product | |
| Code: | LLZ |
| Classification: | Class II |
4
Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has decorative swirls or wave-like elements emanating from it, giving the logo a distinctive and recognizable appearance. The logo is simple, clean, and uses a consistent color scheme.
Predicate Device:
| Device Name: | Syngo.CT Bone Reading |
|---|---|
| 510(k) number: | K123584 cleared on May 12, 2013 |
| Regulation number/ | |
| Product Code: | 21 CFR 892.1750 Computed tomography x-ray system / |
| JAK | |
| Classification: | Class II |
| Manufacturer: | Siemens Medical Solutions, USA |
Device Description/
Technology:
Bone VCAR is a software analysis package utilizing a deep learning technique that assists in the analysis and visualization of CT data. It is intended to provide clinicians with an optimized display and quick access to tools that improve the reading experience and efficiency for anatomy. Bone VCAR is a post processing application option for the Advantage Workstation (AW) platform, CT Scanner, Cloud or PACS stations which can be used in the analysis of CT images.
Bone VCAR is designed to support the clinician in easy visualization of spine and to provide identification of those structures to assist in report dictation. This post processing solution combines the following tools and functionality:
· Multiplanar Reconstruction (MPR) displays of axial, sagittal, coronal, oblique, x-section and curved views which can be displayed in thin/thick, Average, Maximum Intensity Projection (MIP), Minimum intensity Projection (MinIP), Volume Rendering (VR) modes
· Display of anatomical labels automatically with editing capability of all labels such as the spine.
• Display of curved views automatically and editing capability of curved views through anatomical regions such as the spine for enhanced display options
· Access to all standard volume viewer tools for measuring distances, areas, Hounsfield unit values and annotating within the images
· Synchronization of views when multiple series are loaded with spine labeling for all series loaded.
The software will assist the user by providing optimized display settings to enable fast review of the images along with easy identification of anatomy to ease reporting of findings. Bone VCAR may be used for multiple care areas and is not specific to any disease state. It can be utilized during the review of various types of exams including trauma, oncology, and routine body.
Bone VCAR is compatible with both single energy and Gemstone Spectral Imaging (GSI) acquisition methods.
5
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The frame is made up of swirling, wave-like elements, giving it a dynamic and fluid appearance. The color of the logo is a bright, vibrant blue.
GE Healthcare 510(k) Premarket Notification Submission
| The labeling tool can be activated and deactivated by the user at any time during
the image review. Multiple volumes of data can be processed with the Bone
VCAR tool at the same time. Volumes can be from the same or different exams.
| All labels can be moved, edited, hidden or deleted. | ||
|---|---|---|
| The dedicated display layout should assist in easy review of the anatomy. Users | ||
| have the flexibility for using all or a subset of the features within this application | ||
| as they find suitable. | ||
| Intended Use: | Bone VCAR is a non-invasive image analysis software package which may be | |
| used in conjunction with CT images to aid in the assessment and reporting | ||
| efficiency of images that include the spine. | ||
| Indication for Use: | Bone VCAR is a post processing application for use in the analysis of CT images. | |
| The software is intended to support clinicians in the review of images that include | ||
| the spine by providing tools to label the spine and optimize the display of | ||
| anatomy within the CT image. | ||
| Bone VCAR is designed to support the clinician in visualization of the spine, by | ||
| providing initial identification of vertebrae to assist in report dictation. | ||
| The software also assists the user by providing optimized display settings for | ||
| easier identification of anatomy to facilitate fast image review and reporting of | ||
| findings. Bone VCAR may be used for multiple care areas and is not specific to | ||
| any disease state. It can be utilized during the review of various types of exams | ||
| including trauma, oncology, and routine body. | ||
| Technological | ||
| Characteristic: | The goal of the Bone VCAR software algorithm is to extract from a CT scan the | |
| positions and labels of the patient vertebrae in the image. The algorithm takes as | ||
| input a CT scan acquisition and is compatible with a wide range of acquisitions | ||
| for dedicated spine work, trauma, oncology and routine exam. Bone VCAR | ||
| automated vertebra detection algorithm returns the list of detected vertebrae | ||
| position in 3D coordinates and associated labels. | ||
| Comparison: | The table below summarizes the feature/technological comparison between the | |
| predicate device and the proposed device: | ||
| Specification | Syngo CT Bone Reading | |
| (K123584) | Proposed Device: | |
| Bone VCAR | ||
| Spine Labeling | ||
| Tool | Automated labeling with | |
| manual editing capability | Automated labeling with | |
| manual editing capability | ||
| Display of | ||
| curved spine | ||
| structures | Yes | Yes |
| Measurement | ||
| Tool | geometric | |
| measurement | ||
| tools (distance line, | ||
| polyline, marker, arrow, | ||
| angle), HU measurement | ||
| tools (Pixel lens, ROI | ||
| circle, ROI polygonal, ROI | ||
| freehand, VOI sphere) | Access to all standard | |
| Volume Viewer tools for | ||
| measuring distances, areas, | ||
| Hounsfield unit values and | ||
| annotating within the images | ||
| Image Display | ||
| formats | Multiplanar reconstruction | |
| (MPR) thin/thick, | ||
| maximum intensity | ||
| projection (MIP) thin/thick, | ||
| inverted MIP thin/thick, | ||
| volume rendering technique | ||
| (VRT) | Multiplanar Reconstruction | |
| (MPR) displays of axial, | ||
| sagittal, coronal, oblique, x- | ||
| section and curved views | ||
| which can be displayed in | ||
| thin/thick, Average, | ||
| Maximum Intensity | ||
| Projection (MIP), Minimum | ||
| intensity Projection (MinIP), | ||
| Volume Rendering (VR) | ||
| modes. |
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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue, and the background is white.
GE Healthcare 510(k) Premarket Notification Submission
Determination of Substantial Equivalence:
Engineering has validated Bone VCAR algorithm's capability of using deep learning technique to automatically label spine using a dataset of CT exams. This database of exams is considered as a representative of the clinical scenarios where Bone VCAR is intended to be used, with consideration of acquisition parameters, image quality, pathologies and anatomy variations. The result of the algorithm validation provided a success rate greater than 90% for the capability of automatically labeling the spine.
A representative set of clinical sample images was assessed by three board certified radiologists using 5-point Likert scale. The assessment demonstrated that the capability of automatic labeling of spine by Bone VCAR is faster than
7
Image /page/7/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle has a decorative border with swirling lines. The logo is simple and recognizable, and it is associated with a well-known company.
manually labeling and it also increases reading and reporting efficiency whilst providing accurate identification of vertebra.
Bone VCAR has successfully completed the required design control testing per GE's quality system. Bone VCAR was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. The following quality assurance measures have been applied to the development of the device:
- Risk Analysis
- Requirements Reviews
- . Design Reviews
- Performance testing (Verification, Validation)
- Safety testing (Verification)
The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.
Conclusion:
GE Healthcare considers Bone VCAR to be as safe, as effective, and performance is substantially equivalent to the predicate device.