(92 days)
Not Found
No
The description focuses on automated highlighting, bookmarking, measurement, and propagation based on user-defined settings and algorithms, not on learning from data or making predictions based on complex patterns typically associated with AI/ML. The "automatic reference region VOI placement algorithm" mentioned in the performance studies also suggests a rule-based or algorithmic approach rather than a learned model.
No
The device is a software package that assists clinicians in diagnosis, staging, treatment planning, and monitoring treatment response by processing PET/CT images and providing measurements, but it does not directly administer or influence a therapy. Its role is analytical and informative, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software "can be used by the clinician to assist in diagnosis."
Yes
The device is explicitly described as a "PET/CT software package" and a "PET/CT post processing software package," with no mention of accompanying 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 description clearly states that PET VCAR is a software package that processes PET/CT images. Images are not considered specimens derived from the human body in the context of IVD regulation.
- The intended use is focused on image analysis and visualization. The software assists clinicians in interpreting images, measuring values (SUV, volume), and tracking changes over time. This is distinct from performing tests on biological samples to diagnose or monitor conditions.
- There is no mention of analyzing blood, urine, tissue, or any other biological sample. The entire process described revolves around the manipulation and analysis of medical images.
Therefore, PET VCAR falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user-defined settings. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy using multi exam comparison. The software is designed to measure Standard Uptake Value (SUV) and volume for any PET defined metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow, which is designed to allow clinicians to make informed follow-up decisions in an efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure or function.
Product codes
KPS, LLZ
Device Description
PET VCAR (Volume Computer Assisted Reading) is a PET/CT post processing software package which can be used by the trained clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user defined threshold settings. Bookmarks are any highlighted item including 2D or 3D region of interests and their associated measurements and annotations on the images. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy using multi exam comparison. It is designed to measure PET Standard Uptake Value (SUV) and volume for any PET defined metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow. Bookmark propagating is the feature that allows all bookmarks from the baseline exam of the patient to be automatically populated to subsequent exams of the same patient to facilitate the analysis of changes between the exams.
PET VCAR offers a tool called Summary Table that compiles and manages all the analytical information in an organized and interactive design. The Summary Table is synchronized with the image display layouts offering quick measurement / image visual validation. PET VCAR's workflow is designed to allow clinicians to make informed follow-up decisions in an efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure, or function.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET/CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained clinician
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)
Bench testing was performed to evaluate the performance of the automatic reference region VOI placement algorithm and the algorithm passed the defined acceptance criteria.
The proposed PET VCAR has been successfully verified on the AW VolumeShare workstation and AW Server platforms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
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July 27, 2021
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GE Medical Systems SCS % Ms. Elizabeth Mathew Senior Regulatory Affairs Manager 283, rue de la Miniere Buc, 78530 FRANCE
Re: K211247
Trade/Device Name: PET VCAR Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS. LLZ Dated: July 12, 2021 Received: July 13, 2021
Dear Ms. 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/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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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)
K211247
Device Name
PET VCAR
Indications for Use (Describe)
PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment plannitoring treatment response. PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user-defined settings. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy using multi exam comparison. The software is designed to measure Standard Uptake Value (SUV) and volume for any PET defined metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow, which is designed to allow clinicians to make informed follow-up decisions in an efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure or function.
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/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by a series of swirling, wave-like lines, also in blue, that give the impression of motion or energy.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided. K211247
| Date: | July 22, 2021 |
|---|---|
| Submitter: | GE Medical Systems SCS |
| Establishment Registration Number - 9611343 | |
| 283, rue de la Minière | |
| 78530 Buc, France | |
| Primary Contact: | Elizabeth Mathew |
| Senior Regulatory Affairs Manager | |
| GE Healthcare | |
| Tel: (262)424-7774 | |
| Email: Elizabeth.Mathew@ge.com | |
| Secondary Contact | Helen Peng |
| Senior Regulatory Affairs Director | |
| Tel: (262)424-8222 | |
| Email: Hong.Peng@ge.com | |
| Device Trade Name: | PET VCAR |
| Common/Usual Name: | PET VCAR |
| Primary Regulation Number: | 21 CFR 892.1200 Emission computed tomography system |
| Primary Product Code: | KPS |
| Secondary Product Code: | LLZ |
| Classification: | Class II |
| Predicate Device: | |
| Device Name: | PET VCAR |
| Manufacturer: | GE Medical Systems SCS |
| 510(k) number: | K063324 |
| Regulation Number: | 21 CFR 892.1750 Computed tomography X-Ray system |
| 21 CFR 892.1200 Emission computed tomography system | |
| Product Code: | JAK |
| KPS | |
| Classification: | Class II |
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Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. Three curved, white shapes surround the circle, giving the impression of motion or energy.
Device Description and Marketed Devices:
PET VCAR (Volume Computer Assisted Reading) is a PET/CT post processing software package which can be used by the trained clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user defined threshold settings. Bookmarks are any highlighted item including 2D or 3D region of interests and their associated measurements and annotations on the images. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy using multi exam comparison. It is designed to measure PET Standard Uptake Value (SUV) and volume for any PET defined metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow. Bookmark propagating is the feature that allows all bookmarks from the baseline exam of the patient to be automatically populated to subsequent exams of the same patient to facilitate the analysis of changes between the exams.
PET VCAR offers a tool called Summary Table that compiles and manages all the analytical information in an organized and interactive design. The Summary Table is synchronized with the image display layouts offering quick measurement / image visual validation. PET VCAR's workflow is designed to allow clinicians to make informed follow-up decisions in an efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure, or function.
Intended Use:
PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response.
Indication for Use:
PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user-defined threshold settings. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy using multi exam comparison. The software is designed to measure Standard Uptake Value (SUV) and volume for any PET defined metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow, which is designed to allow clinicians to make informed follow-up decisions in an efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure or function.
Technology:
The proposed device PET VCAR employs the same fundamental scientific technology as its predicate device.
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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. The circle is surrounded by a decorative pattern of swirling lines, also in blue. The logo is simple, recognizable, and represents the General Electric brand.
Comparison:
The table below summarizes the key feature/technological differences and similarities between the predicate device and the proposed device:
| Specification | Predicate Device:
PET VCAR (K063324) | Proposed Device:
PET VCAR | Comparison |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | PET VCAR (Volume
Computer Assisted
Reading) is a
PET/CT software
package which can
be used by the
clinician to assist in
diagnosis, staging,
treatment planning
and monitoring
treatment
response. PET VCAR
automatically
highlights and
bookmarks PET
defined regions of
interest based on
user-defined
threshold settings.
The software can
be used for
visualization and
analytical
monitoring of
disease progression
or response to
treatment or
therapy using multi
exam comparison.
The software is
designed to
measure Standard
Uptake Value (SUV)
and volume for any
PET defined
metabolic activity.
The software
automatically
propagates
bookmarks from
one time point to
another for the | PET VCAR (Volume
Computer Assisted
Reading) is a
PET/CT software
package which can
be used by the
clinician to assist in
diagnosis, staging,
treatment planning
and monitoring
treatment
response. PET VCAR
automatically
highlights and
bookmarks PET
defined regions of
interest based on
user-defined
threshold settings.
The software can
be used for
visualization and
analytical
monitoring of
disease progression
or response to
treatment or
therapy using multi
exam comparison.
The software is
designed to
measure Standard
Uptake Value (SUV)
and volume for any
PET defined
metabolic activity.
The software
automatically
propagates
bookmarks from
one time point to
another for the | Substantially Equivalent.
The Proposed Device's
Indications for Use is simplified
by removing the underlined text
from those of the predicate. We
also changed the name of
"Interactive Data Analysis (IDA)
spreadsheet "to the “summary
table".
These minor changes do not
change the clinical meaning of
the indications and are made for
improved clarity and simplicity. |
| Specification | Predicate Device:
PET VCAR (K063324) | Proposed Device:
PET VCAR | Comparison |
| | improving analysis
and workflow. PET
VCAR offers a tool
called Interactive
Data Analysis (IDA)
spreadsheet that
compiles and
manages all the
analytical
information in an
organized and
interactive design.
The IDA is
synchronized with
the image display
layouts offering
quick measurement
/ image visual
validation. PET
VCAR's workflow is
designed to allow
clinicians to make
informed follow-up
decisions in an
efficient manner.
PET VCAR does not
provide or claim
any automatic
detection or
automatic
diagnosis of
abnormal anatomy,
structure or
function. | improving analysis
and workflow,
which is designed
to allow clinicians
to make informed
follow-up decisions
in an efficient
manner. PET VCAR
does not provide or
claim any
automatic
detection or
automatic
diagnosis of
abnormal anatomy,
structure or
function. | |
| PET lesion
Segmentation | Yes | Yes | Substantially Equivalent
The subject device additionally
provides user flexibility to manually
edit the bookmarks if desired. |
| Automatic VOI
placement in the
liver | Not Available | Yes | Substantially Equivalent
Subject device places an initial VOI
in the liver for user convenience. |
| Deauville Score | Not Available | Yes | Substantially Equivalent
Subject device implements
Deauville Score |
| Specification | Predicate Device:
PET VCAR (K063324) | Proposed Device:
PET VCAR | Comparison |
| PERCIST | Not Available | Yes | Substantially equivalent
Subject device implements PERCIST
evaluation Criteria |
| EORTC | Yes
(customer defined
threshold) | Yes
(automated) | Substantially Equivalent |
| Bone lesion
identification and
lesion extent
calculation | Manual bone
segmentation &
PET Lesion
Segmentation | Automated Bone
Segmentation &
PET Lesion
Segmentation | Substantially Equivalent |
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Image /page/6/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. The color of the logo is a light blue.
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Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue, and the background is white.
Determination of Substantial Equivalence:
Summary of Non-Clinical, Design Control Testing
PET VCAR 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)
In addition, bench testing was performed to evaluate the performance of the automatic reference region VOI placement algorithm and the algorithm passed the defined acceptance criteria.
The proposed PET VCAR has been successfully verified on the AW VolumeShare workstation and AW Server platforms. 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 for a MODERATE level of concern.
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Image /page/8/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The circle has small, wave-like embellishments around its perimeter, giving it a slightly decorative appearance. The logo is simple, recognizable, and associated with the multinational conglomerate corporation.
Substantial Equivalence Conclusion:
PET VCAR has identical or equivalent technological characteristics as its predicate device.
GE'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, GE Healthcare believes that the proposed PET VCAR is substantially equivalent to, and hence as safe and as effective for its Intended Use as the legally marketed predicate device.