The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NMI data, including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, dedicated PET or Camera-Based-PET) acquired by gamma cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration.

The NM or PET data can be coupled with registered and/or fused CT or MR scans, and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclical structures in scanned body tissue for clinical diagnostic purposes.

DaTQUANT optional application enables visual evaluation and quantification of 1371-iofflupane (DaTscan™) images. DaTQUANT Normal Database option enables quantification relative to normal population databases of 271-ioflupane (DaTscan™) images. These applications may assist in detection of loss of functional dopamninergic neuron terminals in the striatum, which is correlated with Parkinson disease.

Q.Lung application may aid physicians in:

· Diagnosis of Pulmonary Embolism (PE), Chronic Obstructive Pulmonary Disease (COPD), Emphysema and other lung deficiencies.
Assess the fraction of total lung function provided by a lobe or whole lung for Lung cancer resection requiring removal of an entire lobe. bilobectomy or pneumonectomy.

O.Brain allows the user to visualize and quantify relative changes in the brain's metabolic function or blood flow activity between a subject's images and controls, when used with radiopharmaceuticals approved by the regulatory authority in the country of use, which may be resulting from brain function alterations in:

· Epileptic seizures
· Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, vascular dementia, and frontotemporal dementia.
Inflammation
Brain death
· Cerebrovascular disease such as acute stroke, chronic and acute ischemia
· Traumatic Brain Injury (TBI)

When integrated with the patient's clinical and diagnostic information, O.Brain application may aid the physician in the interpretation of cognitive complaints, neuro-degenerative disease processes and brain injuries.

The Alcyone CFR application allows for the quantification of coronary vascular function by deriving Myocardial Blood Flow (MBF) and then calculating Coronary Flow Reserve (CFR) indices on data acquired on PET scanners and on stationary SPECT scanners with the capacity for dynamic SPECT imaging. These indices may add information to physicians using Myocardial Perfusion Imaging for the diagnosis of Coronary Artery Disease (CAD).

Device Description

The Xeleris 4.0 is a Nuclear Medicine software-only device designed for general nuclear medicine processing & review procedures for detection and quantification of radioisotope tracer uptake in the patient body, using a variety of processing modes for various clinical applications types defined by anatomy and/or function of interest, radiopharmaceuticals, NM system acquisition set-up, etc., and various features designed to enhance image quality.

The Xeleris 4.0 is a modification of its predicate device Xeleris 3.1 (K130884) by introducing the following additional clinical applications:

Q.Lung - Q.Lung application provides processing, quantification, and multidimensional review for pulmonary scintigraphy for display and quantification of global and regional ventilation (V) and perfusion (P) on SPECT and SPECT/CT studies.
Q.Brain - Q.Brain application features automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in control subjects. The resulting quantification is presented using volume of interests, voxel-based and 3D stereotactic surface projection maps of the brain.

Q.Brain image analysis standardizes individual brain shapes into a standard atlas shape while preserving the functional information measured by SPECT and PET imaging.

SPECT/PET co-registration to MR and fusion display capabilities allows functional findings to be related to anatomy and offers visualization of structural abnormalities.

Alcyone CFR – Alcyone CFR application allows for the quantification of coronary vascular function by deriving the Myocardial Blood Flow (MBF) and Coronary Flow Reserve (CFR). These indices may add information to physicians using Myocardial Perfusion Imaging for the diagnosis of Coronary Artery Disease (CAD).

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the GE Healthcare Xeleris 4.0 Processing and Review Workstation. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with explicit performance metrics.

Therefore, the requested information (acceptance criteria, specific performance metrics, sample sizes for test/training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not explicitly available in the provided text for the Xeleris 4.0 device.

The document states that:

The Xeleris 4.0 is a modification of its predicate device Xeleris 3.1 (K130884) by introducing additional clinical applications such as Q.Lung, Q.Brain, and Alcyone CFR.
Clinical studies were not required to support substantial equivalence for Xeleris 4.0.
"Bench measurements on representative clinical datasets were used to demonstrate the outputs of the software applications, and to substantiate their clinical performance."
"Development and testing of the new features included use of clinically acquired data-sets to ensure the intended clinical outputs were achieved."
Verification, including hazard mitigation, was performed with "results demonstrating the Xeleris 4.0 Processing and Review Workstation software met its design inputs and clinical performance requirements."

Without a detailed clinical study report, which is not part of this 510(k) summary, it's impossible to create the table and answer the specific questions about acceptance criteria and study details.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 16, 2016

GE Healthcare GE Medical Systems Israel. Functional Imaging % Efrat Hartog-David, Ph.D. Regulatory Affairs Manager 4 Hayozma Street Tirat Hacarmel 30200 ISRAEL

Re: K153355

Trade/Device Name: Xeleris 4.0 Processing and Review Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 28, 2016 Received: March 1, 2016

Dear Dr. Hartog-David:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara
For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K153355

Device Name

Xeleris 4.0 Processing and Review Workstation

Indications for Use (Describe)

Q.Lung application may aid physicians in:

· Diagnosis of Pulmonary Embolism (PE), Chronic Obstructive Pulmonary Disease (COPD), Emphysema and other lung deficiencies.
Assess the fraction of total lung function provided by a lobe or whole lung for Lung cancer resection requiring removal of an entire lobe. bilobectomy or pneumonectomy.

· Epileptic seizures
· Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, vascular dementia, and frontotemporal dementia.
Inflammation
Brain death
· Cerebrovascular disease such as acute stroke, chronic and acute ischemia
· Traumatic Brain Injury (TBI)

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.

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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."

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Image /page/4/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 blue circle. There are decorative swirls around the outer edge of the circle, giving it a classic and recognizable appearance.

510(k) Summary of Safety and Effectiveness

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).

Date:	February 9, 2016
Submitter:	GE Healthcare, GE Medical Systems Israel, Functional Imaging4 Hayozma St.TIRAT HACARMEL, 30200, ISRAEL
Primary Contact Person:	Efrat Hartog-DavidRegulatory Affairs ManagerGE Healthcare, GE Medical Systems Israel, Functional Imaging+972-4-8563666 ext. 805+972-4-8577662
Secondary Contact Person:	John JaeckleChief Regulatory Affairs StrategistGE Healthcare262-424-9547
Device Trade Name:	Xeleris 4.0 Processing and Review Workstation
Device ClassificationName:	System, Image Processing, Radiological
Regulation number:	21CFR 892.2050
Class:	Class II
Product Code:	LLZ
Marketed devices:	The Xeleris 4.0 is a new Processing and Review Software builtupon the existing technologies of the predicate device Xeleris3.1 Processing and Review Workstation (K130884). It is ofcomparable type and substantially equivalent to its predicatedevice Xeleris 3.1.In addition, the software has the same intended use as that ofthe predicate device. The proposed device's indications for usehave been revised to add the software capabilities assubstantiated and verified in the bench and testing provided
Predicate Device:	K130884 - Xeleris 3.1 Processing and Review workstation
Reference Devices:	K103480 - Thoracic VCARK141074 - CortexID SuiteK101279 - Corridor4DM v2010
Device Description:	The Xeleris 4.0 is a Nuclear Medicine software-only devicedesigned for general nuclear medicine processing & reviewprocedures for detection and quantification of radioisotopetracer uptake in the patient body, using a variety of processingmodes for various clinical applications types defined byanatomy and/or function of interest, radiopharmaceuticals,NM system acquisition set-up, etc., and various featuresdesigned to enhance image quality.The Xeleris 4.0 is a modification of its predicate device Xeleris3.1 (K130884) by introducing the following additional clinicalapplications:1. Q.Lung - Q.Lung application provides processing,quantification, and multidimensional review forpulmonary scintigraphy for display and quantificationof global and regional ventilation (V) and perfusion (P)on SPECT and SPECT/CT studies.2. Q.Brain - Q.Brain application features automatedanalysis through quantification of tracer uptake andcomparison with the corresponding tracer uptake incontrol subjects. The resulting quantification ispresented using volume of interests, voxel-based and3D stereotactic surface projection maps of the brain.Q.Brain image analysis standardizes individual brainshapes into a standard atlas shape while preservingthe functional information measured by SPECT andPET imaging.SPECT/PET co-registration to MR and fusion displaycapabilities allows functional findings to be related toanatomy and offers visualization of structuralabnormalities.3. Alcyone CFR – Alcyone CFR application allows for thequantification of coronary vascular function byderiving the Myocardial Blood Flow (MBF) andCoronary Flow Reserve (CFR). These indices may addinformation to physicians using Myocardial PerfusionImaging for the diagnosis of Coronary Artery Disease(CAD).
Intended Use:	The system is intended for use by Nuclear Medicine (NM) orRadiology practitioners and referring physicians'. The intendeduse of the system is to provide digital processing, review andreporting of medical images, including data display, qualitycontrol, image manipulation and quantification analysis,transfer, storage and printing capabilities.
	The system operates in a variety of configurations. Thehardware components may include computerworkstations, communications devices, video monitors, datastorage and hardcopy devices.
	Software components provide functions for performingoperations related to image display, manipulation,enhancements, analysis and quantification and can operateon dedicated workstations and client-server architectures.
Indications of Use:	The system is intended for use by Nuclear Medicine (NM) orRadiology practitioners and referring physicians for display,processing, archiving, printing, reporting and networking ofNMI data, including planar scans (Static, Whole Body,Dynamic, Multi-Gated) and tomographic scans (SPECT, GatedSPECT, dedicated PET or Camera-Based-PET) acquired bygamma cameras or PET scanners. The system can run ondedicated workstation or in a server-client configuration.
	The NM or PET data can be coupled with registered and/orfused CT or MR scans, and with physiological signals in orderradionuclide tracers and anatomical structures in scannedbody tissue for clinical diagnostic purposes.
	DaTQUANT optional application enables visual evaluation andquantification of 123I-ioflupane (DaTscanTM) images.DaTQUANT Normal Database option enables quantificationrelative to normal population databases of 123I-ioflupane(DaTscanTM) images. These applications may assist indetection of loss of functional dopamninergic neuronterminals in the striatum, which is correlated with Parkinsondisease.
	Q.Lung application may aid physicians in:• Diagnosis of Pulmonary Embolism (PE), Chronic ObstructivePulmonary Disease (COPD), Emphysema and other lungdeficiencies.• Assess the fraction of total lung function provided by a lobeor whole lung for Lung cancer resection requiring removalof an entire lobe, bilobectomy or pneumonectomy.
Q.Brain allows the user to visualize and quantify relativechanges in the brain's metabolic function or blood flowactivity between a subject's images and controls, when usedwith radiopharmaceuticals approved by the regulatoryauthority in the country of use, which may be resulting frombrain function alterations in:• Epileptic seizures• Dementia, such as Alzheimer's disease, Lewy bodydementia, Parkinson's disease with dementia, vasculardementia, and frontotemporal dementia.• Inflammation• Brain death• Cerebrovascular disease such as acute stroke, chronicand acute ischemia• Traumatic Brain Injury (TBI)When integrated with the patient's clinical and diagnosticinformation, Q.Brain application may aid the physician in theinterpretation of cognitive complaints, neuro-degenerativedisease processes and brain injuries.The Alcyone CFR application allows for the quantification ofcoronary vascular function by deriving Myocardial BloodFlow (MBF) and then calculating Coronary Flow Reserve (CFR)indices on data acquired on PET scanners and on stationarySPECT scanners with the capacity for dynamic SPECTimaging. These indices may add information to physiciansusing Myocardial Perfusion Imaging for the diagnosis ofCoronary Artery Disease (CAD).
Technology:	The Xeleris 4.0 Processing and Review Software employs thesame fundamental scientific technology as that of itspredicate device. The software was developed, verified, andvalidated under GE Healthcare's QMS including softwaredevelopment lifecycle.
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Tests:
	The Xeleris 4.0 and its applications have been successfullytested to verify conformance to standards (DICOM StandardNEMA PS3.1 - 3.18; IEC62304). The modifications from thepredicate Xeleris 3.1 system were completed in accordancewith GE's quality management system and design controls per
	21CFR 820 and ISO 13485. Engineering testing and standardscompliance testing were successfully conducted and did notraise any new safety questions or identify any new risks. Thefollowing quality assurance measures were applied to thedevelopment of the system:
	Risk Analysis•
	Requirements Reviews•
	Design Reviews•
	Testing on unit level•
	Integration testing•
	Performance testing•
	Safety testing•
	Simulated use testing•
	In addition to the testing successfully completed as requiredby GE Healthcare's quality system, additional engineeringtesting was performed to provide the requisite data tosubstantiate performance claims, revised indications, safetyand efficacy, and ultimately substantial equivalence.
	This testing included:
	Demonstration of clinical outputs, workflow and tools.–
	–Scientific measurements for substantiation oftechnical claims.
	Bench measurements on representative clinical–datasets for substantiation of clinical performance.
	Summary of Clinical Tests:
	The subject of this premarket submission, XELERIS 4.0, did notrequire clinical studies to support substantial equivalence.However, bench measurements on representative clinicaldatasets were used to demonstrate the outputs of thesoftware applications, and to substantiate their clinicalperformance.
Conclusion:	Development and testing of the new features included use ofclinically acquired data-sets to ensure the intended clinicaloutputs were achieved. Verification including hazardmitigation has been performed with results demonstrating theXeleris 4.0 Processing and Review Workstation software met

its design inputs and clinical performance requirements. Nonew hazards were introduced and all existing hazards residualrisks remain ALARP.
The system and its development process comply withInternational standards.
The Xeleris 4.0 Processing and Review Workstation Software isdeveloped under the same design controls processes andsoftware development life cycle, as other GE healthcaresoftware post-processing system as the predicate device.Based in the established verification testing GE hasdetermined that Xeleris 4.0 is of comparable type andsubstantially equivalent to the currently marketed workstationsoftware and to its predicate device described in Xeleris 3.1(K130884).
Based on the conformance to standards, development underour quality system, and the extensive engineering testingprovided, GE Healthcare believes that the Xeleris 4.0Processing and Review Workstation is as safe and effective,and performs in a substantially equivalent manner to thepredicate device.

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The letters are stylized and connected, and the circle has white accents that give it a dynamic, swirling appearance.

GE Healthcare 510(k) Premarket Notification Submission

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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, cursive font in the center. The letters are also blue, and there are small white swirls around the letters, giving the logo a dynamic and recognizable appearance. The logo is simple, yet distinctive, and is a well-known symbol of the company.

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Image /page/7/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 also three white teardrop shapes around the outside of the circle. The logo is simple and recognizable, and it is often used to represent the company's brand.

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Image /page/8/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 blue circle. There are also four water droplet-like shapes surrounding the circle, positioned at the top, bottom, left, and right sides.

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Image /page/9/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized, cursive font in the center. There are two white swirls on either side of the letters. The logo is simple and recognizable, and it is often used to represent the company's brand.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).