Who is the manufacturer of Spine Auto Views?

GE Medical Systems SCS filed the 510(k) submission for Spine Auto Views (K223424).

What is the FDA product code for Spine Auto Views?

JAK. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Spine Auto Views?

510(k) clearance (submission type: Traditional).

Does Spine Auto Views use AI or machine learning?

Yes. Spine Auto Views (K223424) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Spine Auto Views?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Spine Auto Views get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Spine Auto Views

K223424 · GE Medical Systems SCS · JAK · Jul 13, 2023 · Radiology

Device Facts

Record ID	K223424
Device Name	Spine Auto Views
Applicant	GE Medical Systems SCS
Product Code	JAK · Radiology
Decision Date	Jul 13, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

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.

Device Story

Spine Auto Views is a non-invasive software package for CT image analysis; automates generation of anatomically focused multi-planar reformats (oblique axial, curved coronal, curved sagittal) and vertebral/disc labeling. Input: CT image volumes. Processing: Deep learning algorithm detects vertebral bodies and intervertebral disc positions/orientations; generates reformats without manual user interaction. Output: DICOM-formatted image series exported to predetermined destinations (e.g., PACS). Used in clinical settings (trauma, oncology, routine body) by radiologists/clinicians. Benefits: Streamlines workflow by replacing manual reformat generation; provides consistent, ready-to-read anatomical views for interpretation.

Clinical Evidence

Reader study conducted on clinical CT images. Evaluated acceptance of automated oblique axial, curved coronal, and curved sagittal reformats. Results: Oblique axial reformats achieved >95% user acceptance rate across all readers. Curved reformats were assessed via comparison to standard coronal/sagittal views. Bench testing validated disc detection algorithm performance using a retrospective database of CT exams.

Technological Characteristics

Software-only device; operates on EHL platform. Employs deep learning algorithm for vertebral/disc detection and labeling. Outputs DICOM images. Complies with NEMA PS 3.1-3.20 (DICOM). Moderate level of concern software. No hardware components.

Indications for Use

Indicated for use with CT images to aid in automatic generation of anatomically focused multiplanar reformats and automatic export to DICOM destinations. Assists clinicians by providing anatomically focused spine reformats, including anatomical labeling of vertebral bodies and intervertebral disc spaces. Applicable to multiple care areas including trauma, oncology, and routine body exams; not specific to any disease state.

Regulatory Classification

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.

Predicate Devices

Bone VCAR (K183204)

Related Devices

K183204 — Bone VCAR (BVCAR) · GE Medical Systems SCS · Apr 8, 2019
K231955 — aprevo® Digital Segmentation · Carlsmed, Inc. · Nov 3, 2023
K222361 — AI-Rad Companion (Musculoskeletal) · Siemens Medical Solutions USA, Inc. · Oct 20, 2022
K233209 — uOmnispace.CT · Shanghai United Imaging Healthcare Co., Ltd. · May 17, 2024
K213944 — HealthOST · Nanoxai , Ltd. · Apr 22, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ K223424 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 | {4}------------------------------------------------ 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. {5}------------------------------------------------ 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. | {6}------------------------------------------------ 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. {7}------------------------------------------------ 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. {8}------------------------------------------------ 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 {9}------------------------------------------------ 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.