(377 days)
Not Found
Unknown
The document mentions a "model-based algorithm" for phase identification, which could potentially be an ML model, but it doesn't explicitly state that AI or ML is used. The description of the algorithm is not detailed enough to confirm the use of AI/ML.
No.
The device is described as an "aiding tool for the clinician to review multi-phase liver CT images" and "designed to help analyzing liver lesions". It provides a LI-RADS score and assists with assessment, but it does not directly perform any therapy or treatment.
Yes
The device is described as an "aiding tool for the clinician to review multi-phase liver CT images following LI-RADS® guidelines" and is "designed to help analyzing liver lesions in patients with known or suspected hepatocellular carcinoma (HCC)". It provides a "guided workflow to assess relevant clinical features...to enable computation of a LI-RADS score." The "Automated calculation of LI-RADS score (per LI-RADS v2018 guidelines) from user assessment of major and ancillary features" directly contributes to a diagnostic process, even though the clinician remains ultimately responsible for the final diagnosis.
Yes
The device description explicitly states "Liver Suite is a medical software" and details its functions as processing input CT series and providing a guided workflow and calculations. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device 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.
- Device Function: The Liver Suite software processes medical images (CT scans) of the liver. It does not analyze biological samples taken from the patient.
- Intended Use: The intended use is to aid clinicians in reviewing and analyzing liver CT images and applying LI-RADS guidelines. This is an image analysis and interpretation tool, not a diagnostic test performed on a biological sample.
Therefore, the Liver Suite software falls under the category of medical imaging software or a clinical decision support tool, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Liver Suite is an aiding tool for the clinician to review multi-phase liver CT images following LI-RADS® guidelines. Liver Suite is designed to help analyzing liver lesions in patients with known or suspected hepatocellular carcinoma (HCC). It provides optimized series display and a guided workflow to assess relevant clinical features for user-defined observations, to enable computation of a LI-RADS score. It is intended for use by healthcare professionals. The clinician remains ultimately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of liver images or quantitative data.
Product codes (comma separated list FDA assigned to the subject device)
JAK, LLZ
Device Description
Liver Suite is a medical software that offers a guided workflow for the review and assessment of multi-phase CT liver exams per LI-RADS® v2018 guidelines. It is designed to help analyze liver lesions in patients with known or suspected hepatocellular carcinoma (HCC) by providing optimized image display and assessment of intensity metrics related to the 3 major imaging features for LI-RADS scoring.
Liver Suite takes phased contrast CT series as input. It only processes one exam at a time (no longitudinal analysis).
Liver Suite guided workflow includes:
- Automatic phase identification of the four hepatic imaging phases: unenhanced, arterial, portal venous and delayed
- Semi-automatic lesion contouring based on an initial deposition from the user, user selects applicable appropriate score (LRNC, LR-TIV, LR-1, LR-2 or LR-M) based on image review
- -A user interface to guide the user in the application of LI-RADS scoring guidelines v2018
- -User sets the features - non-rim APHE (Yes/No), Enhancing Capsule (Yes/No), Non-peripheral washout (Yes/No), Threshold growth (Yes/No/Not Applicable), Ancillary Features
- Automated computation of intensity metrics to help characterize Arterial Phase -Hyper Enhancement (APHE), Washout and Capsule
- Automated calculation of LI-RADS score (per LI-RADS v2018 guidelines) from user assessment of major and ancillary features
- Display of all measurements in a table for review and export
Identification of hepatic phases is based on a model-based algorithm or can be set manually by the user. Semi-automatic contouring of the lesion is based on the Auto Contour feature and user input. The Auto Contour feature is already part of Volume Viewer (K041521).
User sets LI-RADS major and ancillary features and compute associated LI-RADS score. To assist with the assessment of Arterial Phase Hyper Enhancement (APHE), Washout and Capsule, intensity metrics based on enhancement characteristics around the lesion are automatically computed.
LI-RADS score is computed based on LI-RADS features using LI-RADS diagnostic table. User can edit the major features, add ancillary features or manually choose a different score.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering bench testing for the Liver Suite Phase Identification algorithm demonstrated the capabilities to identify automatically the two, three or four phases acquired on multi-phases CT images for LI-RADS scoring.
APHE. Washout and Capsule intensity metric calculation was verified through testing on synthetic images and validated by comparing intensity metric distribution on a set of expert-annotated lesions.
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
May 2, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
GE Medical Systems SCS % Peter Uhlir Regulatory Affairs Leader 283, rue de la Minière Buc. 78530 FRANCE
Re: K211180
Trade/Device Name: Liver Suite Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, LLZ Dated: April 25, 2022 Received: April 26, 2022
Dear Peter Uhlir:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,
Laurel Burk Assistant Director Diagnostic X-ray Systems Team DHT 8B: 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)
Device Name
Liver Suite
Indications for Use (Describe)
Liver Suite is an aiding tool for the clinician to review multi-phase liver CT images following LI-RADS® guidelines. Liver Suite is designed to help analyzing liver lesions in patients with known or suspected hepatocellular carcinoma (HCC). It provides optimized series display and a guided workflow to assess relevant clinical features for user-defined observations, to enable computation of a LI-RADS score. It is intended for use by healthcare professionals. The clinician remains ultimately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of liver images or quantitative data.
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) |
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."
C)
3
K211180
Image /page/3/Picture/2 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. The circle has a decorative, swirling design around the letters, giving it a distinctive and recognizable appearance. The logo is simple, yet elegant, and is widely recognized as the symbol of the General Electric company.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | May 2, 2022 |
|---|---|
| Submitter: | GE Medical Systems SCS |
| Establishment Registration Number - 9611343 | |
| 283 rue de la Minière | |
| 78530 Buc, France | |
| Primary Contact: | Peter Uhlir |
| Regulatory Affairs Leader | |
| GE Healthcare, (GE Medical Systems SCS) | |
| Phone: +36 70 436 9317 | |
| Email: peter.uhlir@ge.com | |
| Secondary Contact: | Camille Vidal |
| Director, Regulatory Strategy | |
| Phone: (240) 280-5356 | |
| Email: camille.vidal@ge.com | |
| Proposed Device: | |
| Device Name: | Liver Suite |
| Common/Usual Name: | Liver Suite |
| Regulation number/ Product Code: | 21 CFR 892.1750 Computed tomography x-ray system / JAK |
| 21 CFR 892.2050 Medical image management and processing system / LLZ | |
| Classification: | Class II |
| Predicate Device: | |
| Device Name: | Hepatic VCAR |
| 510(k) number: | K193281 cleared on March 20, 2020 |
| Regulation number/ Product Code: | 21 CFR 892.1750 Computed tomography x-ray system / JAK |
| 21 CFR 892.2050 Picture archiving and communication system / LLZ | |
| Classification: | Class II |
| Manufacturer: | GE Medical Systems SCS |
| Device Name: | PROView |
| 510(k) number: | K193306 cleared on November 17, 2020 |
| Regulation number/ Product Code: | 21 CFR 892.2050 Picture archiving and communication system / LLZ |
| Classification: | Class II |
| Manufacturer: | GE Medical Systems SCS |
4
Image /page/4/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background. The logo is simple, recognizable, and represents the brand identity of General Electric.
Reference Device:
Liver Suite is a medical software that offers a guided workflow for the review and Device Description: assessment of multi-phase CT liver exams per LI-RADS® v2018 guidelines. It is designed to help analyze liver lesions in patients with known or suspected hepatocellular carcinoma (HCC) by providing optimized image display and assessment of intensity metrics related to the 3 major imaging features for LI-RADS scoring.
Liver Suite takes phased contrast CT series as input. It only processes one exam at a time (no longitudinal analysis).
Liver Suite guided workflow includes:
- Automatic phase identification of the four hepatic imaging phases: unenhanced, arterial, portal venous and delayed
- Semi-automatic lesion contouring based on an initial deposition from the user, user selects applicable appropriate score (LRNC, LR-TIV, LR-1, LR-2 or LR-M) based on image review
- -A user interface to guide the user in the application of LI-RADS scoring guidelines v2018
- -User sets the features - non-rim APHE (Yes/No), Enhancing Capsule (Yes/No), Non-peripheral washout (Yes/No), Threshold growth (Yes/No/Not Applicable), Ancillary Features
- Automated computation of intensity metrics to help characterize Arterial Phase -Hyper Enhancement (APHE), Washout and Capsule
- Automated calculation of LI-RADS score (per LI-RADS v2018 guidelines) from user assessment of major and ancillary features
- Display of all measurements in a table for review and export
Identification of hepatic phases is based on a model-based algorithm or can be set manually by the user. Semi-automatic contouring of the lesion is based on the Auto Contour feature and user input. The Auto Contour feature is already part of Volume Viewer (K041521).
User sets LI-RADS major and ancillary features and compute associated LI-RADS score. To assist with the assessment of Arterial Phase Hyper Enhancement (APHE), Washout and Capsule, intensity metrics based on enhancement characteristics around the lesion are automatically computed.
LI-RADS score is computed based on LI-RADS features using LI-RADS diagnostic table. User can edit the major features, add ancillary features or manually choose a different score.
5
Image /page/5/Picture/1 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 border. There are three water droplet-like shapes evenly spaced around the outside of the circle. The logo is colored in a light blue hue.
- Liver Suite is a medical diagnostic software that provides the clinician with tools to Intended Use: efficiently process, analyze, review and communicate to peers findings from liver CT image data. The combination of acquired images, reconstructed images, annotations and measurements performed by the clinician are intended to provide the referring physician with clinically relevant information that may aid in diagnosis and patient management.
- Indication for Use: Liver Suite is an aiding tool for the clinician to review multi-phase liver CT images following LI-RADS® guidelines. Liver Suite is designed to help analyzing liver lesions in patients with known or suspected hepatocellular carcinoma (HCC). It provides optimized series display and a guided workflow to assess relevant clinical features for user-defined observations, to enable computation of a LI-RADS score. It is intended for use by healthcare professionals. The clinician remains ultimately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of liver images or quantitative data.
- Technology: Liver Suite software provides a workflow to assess hepatocellular carcinoma following LI-RADS guidelines using multi-phase liver CT images which are routine acquisitions, systematically done by the clinician for liver cancer assessment in case of hepatocellular carcinoma, as it is part of LI-RADS guidelines.
Liver Suite is a post processing application option that is intended for the analysis of CT liver images. It is embedded in Volume Viewer (K041521). Volume Viewer is a platform of 3D applications that provides at the same time an autonomous set of layouts, protocols and tools for the user and common framework to build other specialty 3D applications on top of Volume Viewer, such as proposed application Liver Suite. Liver Suite and Volume Viewer run on AW VolumeShare Workstation (K110834) and AW Server (K081985) platforms, Cloud or PACS stations
- The table below summarizes the feature/technological comparison between the predicate Comparison: device and the proposed device:
| Specification | Predicate Device:
Hepatic VCAR (K193281) | Proposed Device:
Liver Suite |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Targeted clinical
condition,
anatomy and
imaging
modality | Clinical condition: patient
with suspected or known
liver lesions. Anatomy:
Liver; Imaging modality:
CT | Clinical condition: patient with
suspected or known HCCs,
which are a type of liver
lesions. Anatomy: Liver;
Imaging modality: CT |
| Lesion
characterization | Automatic characterization
of the lesion volume based
on maximum 2D diameter
given manually by the user. | Automatic characterization of
the lesion volume based on
maximum 2D diameter given
manually by the user. |
| | User can review and edit
the contour. Once accepted,
the following statistics are
available: | User can review and edit the
contour. Once accepted, the
following statistics are
available: |
| | - lesion volume | - lesion volume |
| | - lesion 2D max and short
axis | |
6
Image /page/6/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 three white swirls around the outside of the circle. The logo is simple and recognizable.
| - lesion HU values (min,
max, average, standard
deviation) | - lesion 2D max and short axis
- lesion HU values (min, max,
average, standard deviation) - 3 intensity metrics: Arterial
Phase Hyper Enhancement
(APHE), Washout and Capsule
based on analysis of intensity
enhancement differences
between the lesion and
adjacent parenchyma.
User sets LI-RADS major and
ancillary features in workflow
panel to enable computation of
the associated LI-RADS score. | |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Automatic phase
identification | Automatic detection of portal
phase based on image
information.
User can modify series
display if needed. | Automatic detection of
uncontrasted, arterial, portal and
delayed phase based on a
statistical model using image
and acquisition information.
User can modify series display if
needed. |
| Summary Report
Content | Organ type bookmarks:
• Liver
• Portal Vein
• Hepatic Artery
• Segment
Lesion type bookmarks:
• Lesion | For each lesion Observation
Analysis finding:
• Observation size
• Observation major
features
• Observation ancillary
features
• Observation LI-RADS
score |
| Specification | Reference Device:
PROView (K193306) | Proposed Device:
Liver Suite |
|------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Computation of
PI/LI-RADS score | Based on user input on
location and assessment
Following PI-RADS™ v2.1
guidelines | Based on user input on major
and ancillary features
Following LI-RADS® v2018
guidelines |
Determination of
Substantial Equivalence:
The proposed device, Liver Suite, has successfully completed the required design control testing per GE Healthcare Quality Management System. Liver Suite was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO
7
Image /page/7/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. The circle has small, white, droplet-like shapes around its perimeter, giving it a dynamic and fluid appearance.
13485:2016. 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 have been applied to the development of the system:
- . Risk Analysis
- . Required Reviews
- . Design Reviews
- . Software Development Lifecycle
- Performance testing (Verification)
- . Safety testing (Verification)
- Algorithm Qualification (Validation)
Liver Suite has been verified on AW workstation (K110834) and AW Server (K081985) platforms. The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.
Engineering bench testing for the Liver Suite Phase Identification algorithm demonstrated the capabilities to identify automatically the two, three or four phases acquired on multi-phases CT images for LI-RADS scoring.
APHE. Washout and Capsule intensity metric calculation was verified through testing on synthetic images and validated by comparing intensity metric distribution on a set of expert-annotated lesions.
- Conclusion: GE Healthcare considers the Liver Suite software application to be as safe, as effective, and performance is substantially equivalent to the predicate device.