Xeleris 4.0 Processing and Review Workstation

K153355 · GE Healthcare · LLZ · Mar 16, 2016 · Radiology

Device Facts

• Record ID: K153355
• Device Name: Xeleris 4.0 Processing and Review Workstation
• Applicant: GE Healthcare
• Product Code: LLZ · Radiology
• Decision Date: Mar 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Pulmonary ventilation and perfusion quantification	—	—	—	—	—	—	—
Brain tracer uptake quantification	—	—	—	—	—	—	—
Myocardial blood flow and coronary flow reserve	—	—	—	—	—	—	—

Indications for Use

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 Story

Xeleris 4.0 is a software-only nuclear medicine processing/review workstation; operates on dedicated hardware or client-server configurations. Inputs: planar/tomographic NMI data (SPECT, PET), registered/fused CT/MR scans, physiological signals. Processing: image manipulation, enhancement, quantification, and co-registration. Outputs: processed images, quantitative indices (MBF, CFR, tracer uptake), and reports. Used by clinicians/radiologists in clinical settings to aid diagnosis of CAD, pulmonary deficiencies, neurodegenerative diseases, and brain injuries. Benefits: provides standardized quantification and visualization of functional data, assisting in clinical decision-making for treatment planning and diagnostic interpretation.

Clinical Evidence

Bench testing only. No clinical studies were required. Performance was substantiated using bench measurements on representative clinical datasets to verify software outputs, workflow tools, and clinical performance claims.

Technological Characteristics

Software-only device; runs on dedicated workstations or client-server architectures. Complies with DICOM (NEMA PS3.1-3.18) and IEC62304 standards. Features include image processing, co-registration, and quantification algorithms for SPECT/PET data. Developed under GE Healthcare QMS (ISO 13485, 21 CFR 820).

Indications for Use

Indicated for Nuclear Medicine/Radiology practitioners and referring physicians to process, display, and quantify NMI data (planar/tomographic) from gamma/PET cameras. Includes applications for: DaTQUANT (Parkinson's/dopaminergic neuron loss); Q.Lung (PE, COPD, emphysema, lung resection assessment); Q.Brain (epilepsy, dementia, inflammation, brain death, stroke, TBI); Alcyone CFR (coronary artery disease via MBF/CFR indices).

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Xeleris 3.1 Processing and Review workstation (K130884)

Reference Devices

• Thoracic VCAR (K103480)
• CortexID Suite (K141074)
• Corridor4DM v2010 (K101279)

Submission Summary (Full Text)

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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 [phone] or [phone] 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

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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)

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).

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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# 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 Imaging<br>4 Hayozma St.<br>TIRAT HACARMEL, 30200, ISRAEL |
| Primary Contact Person: | Efrat Hartog-David<br>Regulatory Affairs Manager<br>GE Healthcare, GE Medical Systems Israel, Functional Imaging<br>[phone] ext. 805<br>[phone] |
| Secondary Contact Person: | John Jaeckle<br>Chief Regulatory Affairs Strategist<br>GE Healthcare<br>262-424-9547 |
| Device Trade Name: | Xeleris 4.0 Processing and Review Workstation |
| Device Classification<br>Name: | 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 built<br>upon the existing technologies of the predicate device Xeleris<br>3.1 Processing and Review Workstation (K130884). It is of<br>comparable type and substantially equivalent to its predicate<br>device Xeleris 3.1.<br><br>In addition, the software has the same intended use as that of<br>the predicate device. The proposed device's indications for use<br>have been revised to add the software capabilities as<br>substantiated and verified in the bench and testing provided |
| Predicate Device: | K130884 - Xeleris 3.1 Processing and Review workstation |
| Reference Devices: | K103480 - Thoracic VCAR<br>K141074 - CortexID Suite<br>K101279 - Corridor4DM v2010 |
| Device Description: | The Xeleris 4.0 is a Nuclear Medicine software-only device<br>designed for general nuclear medicine processing & review<br>procedures for detection and quantification of radioisotope<br>tracer uptake in the patient body, using a variety of processing<br>modes for various clinical applications types defined by<br>anatomy and/or function of interest, radiopharmaceuticals,<br>NM system acquisition set-up, etc., and various features<br>designed to enhance image quality.<br><br>The Xeleris 4.0 is a modification of its predicate device Xeleris<br>3.1 (K130884) by introducing the following additional clinical<br>applications:<br><br>1. <b>Q.Lung</b> - Q.Lung application provides processing,<br>quantification, and multidimensional review for<br>pulmonary scintigraphy for display and quantification<br>of global and regional ventilation (V) and perfusion (P)<br>on SPECT and SPECT/CT studies.<br><br>2. <b>Q.Brain</b> - Q.Brain application features automated<br>analysis through quantification of tracer uptake and<br>comparison with the corresponding tracer uptake in<br>control subjects. The resulting quantification is<br>presented using volume of interests, voxel-based and<br>3D stereotactic surface projection maps of the brain.<br><br>Q.Brain image analysis standardizes individual brain<br>shapes into a standard atlas shape while preserving<br>the functional information measured by SPECT and<br>PET imaging.<br><br>SPECT/PET co-registration to MR and fusion display<br>capabilities allows functional findings to be related to<br>anatomy and offers visualization of structural<br>abnormalities.<br><br>3. <b>Alcyone CFR</b> – Alcyone CFR application allows for the<br>quantification of coronary vascular function by<br>deriving the Myocardial Blood Flow (MBF) and<br>Coronary Flow Reserve (CFR). These indices may add<br>information to physicians using Myocardial Perfusion<br>Imaging for the diagnosis of Coronary Artery Disease<br>(CAD). |
| Intended Use: | The system is intended for use by Nuclear Medicine (NM) or<br>Radiology practitioners and referring physicians'. The intended<br>use of the system is to provide digital processing, review and<br>reporting of medical images, including data display, quality<br>control, image manipulation and quantification analysis,<br>transfer, storage and printing capabilities. |
| | The system operates in a variety of configurations. The<br>hardware components may include computer<br>workstations, communications devices, video monitors, data<br>storage and hardcopy devices. |
| | Software components provide functions for performing<br>operations related to image display, manipulation,<br>enhancements, analysis and quantification and can operate<br>on dedicated workstations and client-server architectures. |
| Indications of Use: | The system is intended for use by Nuclear Medicine (NM) or<br>Radiology practitioners and referring physicians for display,<br>processing, archiving, printing, reporting and networking of<br>NMI data, including planar scans (Static, Whole Body,<br>Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated<br>SPECT, dedicated PET or Camera-Based-PET) acquired by<br>gamma cameras or PET scanners. The system can run on<br>dedicated workstation or in a server-client configuration. |
| | The NM or PET data can be coupled with registered and/or<br>fused CT or MR scans, and with physiological signals in orderradionuclide tracers and anatomical structures in scanned<br>body tissue for clinical diagnostic purposes. |
| | DaTQUANT optional application enables visual evaluation and<br>quantification of 123I-ioflupane (DaTscanTM) images.<br>DaTQUANT Normal Database option enables quantification<br>relative to normal population databases of 123I-ioflupane<br>(DaTscanTM) images. These applications may assist in<br>detection of loss of functional dopamninergic neuron<br>terminals in the striatum, which is correlated with Parkinson<br>disease. |
| | Q.Lung application may aid physicians in:<br>• Diagnosis of Pulmonary Embolism (PE), Chronic Obstructive<br>Pulmonary Disease (COPD), Emphysema and other lung<br>deficiencies.<br>• Assess the fraction of total lung function provided by a lobe<br>or whole lung for Lung cancer resection requiring removal<br>of an entire lobe, bilobectomy or pneumonectomy. |
| Q.Brain allows the user to visualize and quantify relative<br>changes in the brain's metabolic function or blood flow<br>activity between a subject's images and controls, when used<br>with radiopharmaceuticals approved by the regulatory<br>authority in the country of use, which may be resulting from<br>brain function alterations in:<br>• Epileptic seizures<br>• Dementia, such as Alzheimer's disease, Lewy body<br>dementia, Parkinson's disease with dementia, vascular<br>dementia, and frontotemporal dementia.<br>• Inflammation<br>• Brain death<br>• Cerebrovascular disease such as acute stroke, chronic<br>and acute ischemia<br>• Traumatic Brain Injury (TBI)<br>When integrated with the patient's clinical and diagnostic<br>information, Q.Brain application may aid the physician in the<br>interpretation of cognitive complaints, neuro-degenerative<br>disease processes and brain injuries.<br>The Alcyone CFR application allows for the quantification of<br>coronary vascular function by deriving Myocardial Blood<br>Flow (MBF) and then calculating Coronary Flow Reserve (CFR)<br>indices on data acquired on PET scanners and on stationary<br>SPECT scanners with the capacity for dynamic SPECT<br>imaging. These indices may add information to physicians<br>using Myocardial Perfusion Imaging for the diagnosis of<br>Coronary Artery Disease (CAD). |…