(241 days)
Not Found
Yes
The device description explicitly mentions a "state-of-the-art deep learning algorithm" and a "new deep learning Disc detection algorithm." Deep learning is a subset of machine learning.
No
This device is an image analysis software designed to process CT images and generate anatomically focused reformats of the spine. It aids clinicians in diagnosis and review and does not directly provide therapy.
No
The device is an image analysis software that aids in the generation of anatomically focused multi-planar reformats and applies labels, but it explicitly states it "is not specific to any disease state" and "assists clinicians by providing anatomically focused reformats of the spine" and "The automated reformats may help in providing a consistent output of anatomically orientated images, labeled, and presented to the interpreting physician ready to read." It does not provide a diagnosis or aid in the diagnosis of a specific condition.
Yes
The device description explicitly states "Spine Auto Views is a software analysis package" and describes its function as processing existing CT images and generating reformats and labels, without mentioning any accompanying hardware components.
No, 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.
- Spine Auto Views function: Spine Auto Views is a software package that processes medical images (CT scans) to generate reformats and labels. It does not analyze biological samples from the body.
- Intended Use: The intended use clearly states it's for "image analysis software package which may be used in conjunction with CT images to aid in the automatic generation of anatomically focused multi-planar reformats and automatically export results to predetermined DICOM destinations." This is image processing, not in vitro testing.
The description focuses entirely on image manipulation and presentation, not on analyzing biological specimens.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this device, and the "Control Plan Authorized (PCCP) and relevant text" section is marked as "Not Found."
Intended Use / Indications for Use
Spine Auto Views is a non-invasive image analysis software package which may be used in conjunction with CT images to aid in the automatic generation of anatomically focused multi-planar reformats and automatically export results to predetermined DICOM destinations.
Spine Auto Views assists clinicians by providing anatomically focused reformats of the spine, with the ability to apply anatomical labels of the vertebral bodies and intervertebral disc spaces.
Spine Auto Views may be used for multiple care areas and is not specific to any disease state. It can be utilized for the review of various types of exams including trauma, oncology, and routine body.
Product codes
JAK, QIH
Device Description
Spine Auto Views is a software analysis package designed to generate batch reformats and apply labels to the spine. It is intended to streamline the process of generating clinically relevant batch reformat outputs that are requested for many CT exam types.
Spine Auto Views can generate, automatically, patient specific, anatomically focused spine reformats. Spine Auto Views brings a state-of-the-art deep learning algorithm that generates oblique axial reformats, appropriately angled through each disc space without the need for a user interface and human interaction. 3D curved coronal and curved sagittal views of the spine as well as traditional reformat planes can all be generated with Spine Auto Views, no manual interaction required. Vertebral bodies and disc spaces can be labeled, and all series networked to desired DICOM destination(s), ready to read. The automated reformats may help in providing a consistent output of anatomically orientated images, labeled, and presented to the interpreting physician ready to read.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Spine Auto Views brings a state-of-the-art deep learning algorithm that generates oblique axial reformats, appropriately angled through each disc space without the need for a user interface and human interaction.
Spine Auto Views introduces a new deep learning Disc detection algorithm which can detect discs positions, planes/orientations and generate disc labels.
Input Imaging Modality
CT images
Anatomical Site
Spine
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
Engineering has validated Spine Auto Views algorithm capability to automatically detect the position and orientation of intervertebral discs using a database of retrospective CT exams. This database of exams is representative of the clinical scenarios where Spine Auto Views is intended to be used, with consideration of acquisition parameters and patient characteristics. The result of the algorithm validation showed that the algorithm successfully passed the defined acceptance criteria.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A reader study evaluation was performed with a sample of clinical CT images which were processed with the Spine Auto Views software. The purpose of this study was to assess the acceptance of spine automated reformats generated in the oblique axial, curved coronal and curved sagittal planes as these orientations traditionally require users to manually generate each of them. The reader evaluation concluded that Spine Auto Views oblique axial reformats generates user acceptable results greater than 95% of the time for all readers. Additionally, the batch reformats of curved coronal and curved sagittal views were also assessed by the readers by comparing the automatically generated curved batch reformats with the corresponding standard coronal and standard sagittal views.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
user acceptable results greater than 95% of the time for all readers (for oblique axial reformats)
Predicate Device(s)
Reference Device(s)
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.
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July 13, 2023
Image /page/0/Picture/1 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GE Medical Systems SCS % Yonghui Han Senior Regulatory Affairs Leader 283, rue de la Miniere BUC, 78530 FRANCE
Re: K223424
Trade/Device Name: Spine Auto Views Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, QIH Dated: June 9, 2023 Received: June 12, 2023
Dear Yonghui Han:
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/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.
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223424
Device Name Spine Auto Views
Indications for Use (Describe)
Spine Auto Views is a non-invasive image analysis software package which may be used in conjunction with CT images to aid in the automatic generation of anatomically focused multi-planar reformats and automatically export results to predetermined DICOM destinations.
Spine Auto Views assists clinicians by providing anatomically focused reformats of the spine, with the ability to apply anatomical labels of the vertebral bodies and intervertebral disc spaces.
Spine Auto Views may be used for multiple care areas and is not specific to any disease state. It can be utilized for the review of various types of exams including trauma, oncology, and routine body.
| 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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Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The circle has a swirling design around the letters, giving the impression of motion or energy. The logo is simple, recognizable, and associated with a well-known multinational corporation.
GE HealthCare 510(k) Premarket Notification Submission -Spine Auto Views
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | July 7, 2023 |
|---|---|
| Submitter: | GE Medical Systems SCS |
| Establishment Registration Number - 9611343 | |
| 283 rue de la Miniere | |
| 78530 Buc, France | |
| Primary Contact Person: | Yonghui Han |
| Senior Regulatory Affairs Leader | |
| GE HealthCare | |
| (+1) (262)225-1914 | |
| Yonghui.Han@ge.com | |
| Secondary Contact Person: | Elizabeth Mathew |
| Senior Regulatory Affairs Manager | |
| GE HealthCare | |
| Tel: (+1) (262)424-7774 | |
| Email: Elizabeth.Mathew@ge.com | |
| Device Trade Name: | Spine Auto Views |
| Common/Usual Name: | Spine Auto Views |
| Primary Regulation Number: | Computed Tomography X-Ray System (21 CFR 892.1750) |
| Primary Product Code: | JAK |
| Secondary Product Code: | QIH |
| Classification: | Class II |
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Image /page/4/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. There are white swirls around the letters, giving the impression of movement or energy. The logo is simple and recognizable, and it is often used to represent the company's products and services.
| Predicate Device | |
|---|---|
| Device name: | Bone VCAR |
| Manufacturer: | GE Medical Systems SCS |
| 510(k) number: | K183204 |
| Regulation Number: | 21 CFR 892.1750 Computed tomography X-Ray System |
| Primary Product Code: | JAK |
| Secondary Product Code: | LLZ |
| Classification: | Class II |
Device Description:
Spine Auto Views is a software analysis package designed to generate batch reformats and apply labels to the spine. It is intended to streamline the process of generating clinically relevant batch reformat outputs that are requested for many CT exam types.
Spine Auto Views can generate, automatically, patient specific, anatomically focused spine reformats. Spine Auto Views brings a state-of-the-art deep learning algorithm that generates oblique axial reformats, appropriately angled through each disc space without the need for a user interface and human interaction. 3D curved coronal and curved sagittal views of the spine as well as traditional reformat planes can all be generated with Spine Auto Views, no manual interaction required. Vertebral bodies and disc spaces can be labeled, and all series networked to desired DICOM destination(s), ready to read. The automated reformats may help in providing a consistent output of anatomically orientated images, labeled, and presented to the interpreting physician ready to read.
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Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. There are decorative swirls around the circle, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, representing the brand identity of General Electric.
Intended Use:
Spine Auto Views is a non-invasive image analysis software package which may be used in conjunction with CT images to aid in the automatic generation of anatomically focused multiplanar reformats.
Indication for Use:
Spine Auto Views is a non-invasive image analysis software package which may be used in conjunction with CT images to aid in the automatic generation of anatomically focused multiplanar reformats and automatically export results to pre-determined DICOM destinations.
Spine Auto Views assists clinicians by providing anatomically focused reformats of the spine, with the ability to apply anatomical labels of the vertebral bodies and intervertebral disc spaces.
Spine Auto Views may be used for multiple care areas and is not specific to any disease state. It can be utilized for the review of various types of exams including trauma, oncology, and routine body.
Technology:
The proposed device Spine Auto Views employs the same fundamental scientific technology as its predicate device.
Comparison:
The table below summarizes the key feature/technological differences and similarities between the predicate device and the proposed device:
Table 5.1: Comparison
| Specification | Predicate Device:
Bone VCAR (K183204) | Subject Device:
Spine Auto Views | Comparison |
|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CT Spine Labeling
algorithm
(Vertebrae
Detection and
Vertebrae Labels) | Yes | Yes | Identical |
| Specification | Predicate Device:
Bone VCAR (K183204) | Subject Device:
Spine Auto Views | Comparison |
| Disc Detection
algorithm
(Disc Position, Disc
Orientation & Disc
Labels) | Not available | Yes | Substantially
Equivalent.
Spine Auto Views
introduces a new deep
learning Disc detection
algorithm which can
detect discs positions,
planes/orientations
and generate disc
labels. |
| Image Display
Formats | Traditional reformat
orientations (axial, coronal,
sagittal) | Traditional reformat orientations
(axial, coronal, sagittal) | Identical |
| | Curved coronal and curved
sagittal views of the spine
as well as oblique axial
views perpendicular to the
3D curved trace. | Curved coronal and curved sagittal
views of the spine as well as oblique
axial views through the
intervertebral spaces. | Substantially
Equivalent
Both the subject device
and predicate device
can output curved
coronal and curved
sagittal views and
oblique axial view.
However, the
methodology in which
these reformat series
are generated are
different between the
subject device and
predicate device.
For the curved
reformats, Bone VCAR
uses the centerline
traced through the
vertebrae centers;
Spine Auto Views use
the centerline traced |
| Specification | Predicate Device:
Bone VCAR (K183204) | Subject Device:
Spine Auto Views | Comparison |
| | | | edge of the disc
centers.
For oblique axial views
generation, the oblique
axial of Bone VCAR is
perpendicular to its
centerline. Spine Auto
Views uses the
computed position and
orientation of the discs. |
| Field of View | Bone VCAR uses input
volume field of view and
manually adjusted by the
user. | Spine Auto Views uses input volume
field of view and additionally has an
option to automatically set the field
of view to focus on the spine | Substantially
Equivalent
The subject device has
two configurations:
input series field of
view, or automated
field of view focused
on the spine. |
| Export | Manual | Automated | Substantially
Equivalent
In the subject device,
all generated series can
be automatically
exported to DICOM
destinations, such as
PACS, ready for review
and interpretation. |
| Measurement Tool | Access to all standard
Volume Viewer tools for
measuring distances, areas,
Hounsfield unit values and
annotating within the
images | Not available | Subject device doesn't
have a user interface
and doesn't include
measurement tools.
Subject device provides
DICOM reformat
images for export. |
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Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. There are decorative swirls or droplets surrounding the circle, giving it a dynamic and recognizable appearance.
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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. The frame is adorned with three droplet-like shapes evenly spaced around the circle. The logo is presented in a blue color.
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Image /page/8/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 script inside. There are three water droplet shapes around the outside of the circle.
Determination of Substantial Equivalence:
Summary of Non-Clinical, Design Control Testing
Spine Auto Views has successfully completed the design control testing per GE's quality system. It was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. No additional hazards were identified, and no unexpected test results were observed. The proposed device complies with NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard.
The following quality assurance measures were applied to the development of the device:
- Requirements Definition
- Risk Analysis
- Technical Design Reviews ●
- Formal Design Reviews
- Software Development Lifecycle ●
- Performance testing (Verification, Validation)
- Safety Testing (Verification)
The proposed Spine Auto Views has been successfully verified on the EHL platform. All the testing and results did not raise new or different questions of safety and effectiveness other than those already associated with predicate device. Software documentation is for a MODERATE level of concern.
In addition, Engineering has validated Spine Auto Views algorithm capability to automatically detect the position and orientation of intervertebral discs using a database of retrospective CT exams. This database of exams is representative of the clinical scenarios where Spine Auto Views is intended to be used, with consideration of acquisition parameters and patient
characteristics. The result of the algorithm validation showed that the algorithm successfully passed the defined acceptance criteria.
Summary of Clinical Testing
A reader study evaluation was performed with a sample of clinical CT images which were processed with the Spine Auto Views software. The purpose of this study was to assess the acceptance of spine automated reformats generated in the oblique axial, curved coronal and curved sagittal planes as these orientations traditionally require users to manually generate each of them. The reader evaluation concluded that Spine Auto Views oblique axial reformats generates user acceptable results greater than 95% of the time for all readers. Additionally, the batch reformats of curved coronal and curved sagittal views were also assessed by the readers by comparing the automatically generated curved batch reformats with the corresponding standard coronal and standard sagittal views.
Conclusion:
Spine Auto Views has the same intended use as its predicate device but differs in technological characteristics. Specifically Spine Auto Views automatically generates spine reformat DICOM
5 б
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Image /page/9/Picture/1 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. There are white swirls around the edge of the circle. The logo is simple and recognizable.
images by detecting the vertebras and discs in the scan while the predicate requires more manual interactions.
GE HealthCare's quality system's design, verification, and risk management processes did not identify any new questions of safety or effectiveness, hazards, unexpected results, or adverse effects stemming from the changes to the predicate.
Based on development under GE HealthCare's quality system, successful design verification, software documentation for a "Moderate" level of concern, along with the engineering bench testing and reader study, GE HealthCare determines that the proposed device is as safe and effective as its predicate device.