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.

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.

AI/ML Overview

Acceptance Criteria and Study for PET VCAR

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria	Reported Performance (Study Result)
Automatic Reference Region VOI Placement Algorithm	Passed defined acceptance criteria (specific criteria not detailed in document)	Algorithm passed the defined acceptance criteria
Overall Software Performance	No new or different questions of safety and effectiveness compared to predicate	No new or different questions of safety and effectiveness (verified on AW VolumeShare and AW Server platforms)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set. It mentions "bench testing" to evaluate the automatic reference region VOI placement algorithm and "verification on the AW VolumeShare workstation and AW Server platforms" for overall software performance. The data provenance (e.g., country of origin, retrospective/prospective) is not specified.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device through software verification and bench testing, rather than comparing human reader performance with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted in the form of "bench testing" to evaluate the "automatic reference region VOI placement algorithm." The document states that "the algorithm passed the defined acceptance criteria." Additionally, the overall software performance was verified on "AW VolumeShare workstation and AW Server platforms."

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated. Given the nature of the device (assistive software for image analysis) and the testing described (bench testing for an algorithm, software verification), it likely involved:

Bench testing for the VOI algorithm: Comparison against a pre-defined "correct" placement based on established anatomical landmarks or manual expert placement.
Overall software performance: Verification against expected output and functionality, implying internal reference data or pre-defined outcomes for various operations.

8. Sample Size for the Training Set

The document does not provide information about a training set since the study described is focused on verification and validation of the device's performance against pre-defined criteria, rather than training a new algorithm or AI model from scratch.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for the studies described, the method for establishing its ground truth is not applicable or provided in the document.

Summary

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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

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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 SCSEstablishment Registration Number - 9611343283, rue de la Minière78530 Buc, France
Primary Contact:	Elizabeth MathewSenior Regulatory Affairs ManagerGE HealthcareTel: (262)424-7774Email: Elizabeth.Mathew@ge.com
Secondary Contact	Helen PengSenior Regulatory Affairs DirectorTel: (262)424-8222Email: 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 system21 CFR 892.1200 Emission computed tomography system
Product Code:	JAKKPS
Classification:	Class II

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Device Description and Marketed Devices:

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 (VolumeComputer AssistedReading) is aPET/CT softwarepackage which canbe used by theclinician to assist indiagnosis, staging,treatment planningand monitoringtreatmentresponse. PET VCARautomaticallyhighlights andbookmarks PETdefined regions ofinterest based onuser-definedthreshold settings.The software canbe used forvisualization andanalyticalmonitoring ofdisease progressionor response totreatment ortherapy using multiexam comparison.The software isdesigned tomeasure StandardUptake Value (SUV)and volume for anyPET definedmetabolic activity.The softwareautomaticallypropagatesbookmarks fromone time point toanother for the	PET VCAR (VolumeComputer AssistedReading) is aPET/CT softwarepackage which canbe used by theclinician to assist indiagnosis, staging,treatment planningand monitoringtreatmentresponse. PET VCARautomaticallyhighlights andbookmarks PETdefined regions ofinterest based onuser-definedthreshold settings.The software canbe used forvisualization andanalyticalmonitoring ofdisease progressionor response totreatment ortherapy using multiexam comparison.The software isdesigned tomeasure StandardUptake Value (SUV)and volume for anyPET definedmetabolic activity.The softwareautomaticallypropagatesbookmarks fromone time point toanother for the	Substantially Equivalent.The Proposed Device'sIndications for Use is simplifiedby removing the underlined textfrom those of the predicate. Wealso changed the name of"Interactive Data Analysis (IDA)spreadsheet "to the “summarytable".These minor changes do notchange the clinical meaning ofthe indications and are made forimproved clarity and simplicity.
Specification	Predicate Device:PET VCAR (K063324)	Proposed Device:PET VCAR	Comparison
	improving analysisand workflow. PETVCAR offers a toolcalled InteractiveData Analysis (IDA)spreadsheet thatcompiles andmanages all theanalyticalinformation in anorganized andinteractive design.The IDA issynchronized withthe image displaylayouts offeringquick measurement/ image visualvalidation. PETVCAR's workflow isdesigned to allowclinicians to makeinformed follow-updecisions in anefficient manner.PET VCAR does notprovide or claimany automaticdetection orautomaticdiagnosis ofabnormal anatomy,structure orfunction.	improving analysisand workflow,which is designedto allow cliniciansto make informedfollow-up decisionsin an efficientmanner. PET VCARdoes not provide orclaim anyautomaticdetection orautomaticdiagnosis ofabnormal anatomy,structure orfunction.
PET lesionSegmentation	Yes	Yes	Substantially EquivalentThe subject device additionallyprovides user flexibility to manuallyedit the bookmarks if desired.
Automatic VOIplacement in theliver	Not Available	Yes	Substantially EquivalentSubject device places an initial VOIin the liver for user convenience.
Deauville Score	Not Available	Yes	Substantially EquivalentSubject device implementsDeauville Score
Specification	Predicate Device:PET VCAR (K063324)	Proposed Device:PET VCAR	Comparison
PERCIST	Not Available	Yes	Substantially equivalentSubject device implements PERCISTevaluation Criteria
EORTC	Yes(customer definedthreshold)	Yes(automated)	Substantially Equivalent
Bone lesionidentification andlesion extentcalculation	Manual bonesegmentation &PET LesionSegmentation	Automated BoneSegmentation &PET LesionSegmentation	Substantially Equivalent

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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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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.

Regulation Number and Section

§ 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.