(117 days)
No
The summary describes standard image processing, quantification, and comparison to databases, but does not mention AI, ML, or related terms.
No.
The devices are used for display, processing, archiving, printing, reporting, and networking of data for clinical diagnostic purposes; they do not apply therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system's purpose is to "depict, localize, and/or quantify the distribution of radionuclical structures in scanned body tissue for clinical diagnostic purposes." Furthermore, it lists specific diagnostic applications like "detection of loss of functional dopamninergic neuron terminals in the striatum, which is correlated with Parkinson disease," "Diagnosis of Pulmonary Embolism (PE), Chronic Obstructive Pulmonary Disease (COPD), Emphysema and other lung deficiencies," aiding in the interpretation of "cognitive complaints, neuro-degenerative disease processes and brain injuries", and adding information for "diagnosis of Coronary Artery Disease (CAD)".
Yes
The device description explicitly states "The Xeleris 4.0 is a Nuclear Medicine software-only device".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device, Xeleris 4.0, is a software-only system that processes and analyzes medical images (NMI, PET, CT, MR) acquired from imaging scanners. It works with data from the patient's body, but it does not perform tests on samples taken from the body.
- Intended Use: The intended use clearly states that the system is for "display, processing, archiving, printing, reporting and networking of NMI data... acquired by gamma cameras or PET scanners." It also mentions coupling this data with CT or MR scans and physiological signals. While the system aids in diagnosis by providing processed and quantified image data, it does not perform the diagnostic test itself on a biological sample.
- Device Description: The device is described as 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." This further reinforces that it's an image processing and analysis tool, not an IVD.
The applications like DaTQUANT, Q.Lung, Q.Brain, and Alcyone CFR are all focused on analyzing and quantifying information derived from medical images, not from in vitro samples. They provide information that may aid physicians in diagnosis, but they are not the diagnostic test itself.
N/A
Intended Use / 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.
Q.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).
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
planar scans (Static, Whole Body, Dynamic, Multi-Gated), tomographic scans (SPECT, dedicated PET or Camera-Based-PET), CT, MR
Anatomical Site
Body tissue, striatum, lung, brain, heart (myocardium)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Nuclear Medicine (NM) or Radiology practitioners and referring physicians
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
Bench measurements on representative clinical datasets for substantiation of clinical performance. The subject of this premarket submission, XELERIS 4.0, did not require clinical studies to support substantial equivalence. However, bench measurements on representative clinical datasets were used to demonstrate the outputs of the software applications, and to substantiate their clinical performance.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Xeleris 4.0 and its applications have been successfully tested to verify conformance to standards (DICOM Standard NEMA PS3.1 - 3.18; IEC62304). The modifications from the predicate Xeleris 3.1 system were completed in accordance with GE's quality management system and design controls per 21CFR 820 and ISO 13485. Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or identify any new risks. The following quality assurance measures were applied to the development 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 required by GE Healthcare's quality system, additional engineering testing was performed to provide the requisite data to substantiate performance claims, revised indications, safety and efficacy, and ultimately substantial equivalence. This testing included:
- Demonstration of clinical outputs, workflow and tools.
- Scientific measurements for substantiation of technical claims.
- Bench measurements on representative clinical datasets for substantiation of clinical performance.
The subject of this premarket submission, XELERIS 4.0, did not require clinical studies to support substantial equivalence. However, 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 has been performed with results demonstrating the Xeleris 4.0 Processing and Review Workstation software met its design inputs and clinical performance requirements. No new hazards were introduced and all existing hazards residual risks remain ALARP.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K130884 - Xeleris 3.1 Processing and Review workstation
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K103480 - Thoracic VCAR, K141074 - CortexID Suite, K101279 - Corridor4DM v2010
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 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).
0
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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."
4
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 Imaging |
| 4 Hayozma St. | |
| TIRAT HACARMEL, 30200, ISRAEL | |
| Primary Contact Person: | Efrat Hartog-David |
| Regulatory Affairs Manager | |
| GE Healthcare, GE Medical Systems Israel, Functional Imaging | |
| +972-4-8563666 ext. 805 | |
| +972-4-8577662 | |
| Secondary Contact Person: | John Jaeckle |
| Chief Regulatory Affairs Strategist | |
| GE Healthcare | |
| 262-424-9547 | |
| Device Trade Name: | Xeleris 4.0 Processing and Review Workstation |
| Device Classification | |
| 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 |
| upon the existing technologies of the predicate device Xeleris | |
| 3.1 Processing and Review Workstation (K130884). It is of | |
| comparable type and substantially equivalent to its predicate | |
| device Xeleris 3.1. |
In addition, the software has the same intended use as that of
the predicate device. The proposed device's indications for use
have been revised to add the software capabilities as
substantiated and verified in the bench and testing provided |
| Predicate Device: | K130884 - Xeleris 3.1 Processing and Review workstation |
| Reference Devices: | K103480 - Thoracic VCAR
K141074 - CortexID Suite
K101279 - Corridor4DM v2010 |
| 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). |
| Intended Use: | The system is intended for use by Nuclear Medicine (NM) or
Radiology practitioners and referring physicians'. The intended
use of the system is to provide digital processing, review and
reporting of medical images, including data display, quality
control, image manipulation and quantification analysis,
transfer, storage and printing capabilities. |
| | The system operates in a variety of configurations. The
hardware components may include computer
workstations, communications devices, video monitors, data
storage and hardcopy devices. |
| | Software components provide functions for performing
operations related to image display, manipulation,
enhancements, analysis and quantification and can operate
on dedicated workstations and client-server architectures. |
| Indications of 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, Gated
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 orderradionuclide tracers and anatomical structures in scanned
body tissue for clinical diagnostic purposes. |
| | DaTQUANT optional application enables visual evaluation and
quantification of 123I-ioflupane (DaTscanTM) images.
DaTQUANT Normal Database option enables quantification
relative to normal population databases of 123I-ioflupane
(DaTscanTM) 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. |
| Q.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, Q.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). | |
| Technology: | The Xeleris 4.0 Processing and Review Software employs the
same fundamental scientific technology as that of its
predicate device. The software was developed, verified, and
validated under GE Healthcare's QMS including software
development lifecycle. |
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Tests: |
| | The Xeleris 4.0 and its applications have been successfully
tested to verify conformance to standards (DICOM Standard
NEMA PS3.1 - 3.18; IEC62304). The modifications from the
predicate Xeleris 3.1 system were completed in accordance
with GE's quality management system and design controls per |
| | 21CFR 820 and ISO 13485. Engineering testing and standards
compliance testing were successfully conducted and did not
raise any new safety questions or identify any new risks. The
following quality assurance measures were applied to the
development 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 required
by GE Healthcare's quality system, additional engineering
testing was performed to provide the requisite data to
substantiate performance claims, revised indications, safety
and efficacy, and ultimately substantial equivalence. |
| | This testing included: |
| | Demonstration of clinical outputs, workflow and tools.
– |
| | –
Scientific measurements for substantiation of
technical 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 not
require clinical studies to support substantial equivalence.
However, bench measurements on representative clinical
datasets were used to demonstrate the outputs of the
software applications, and to substantiate their clinical
performance. |
| Conclusion: | 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 has been performed with results demonstrating the
Xeleris 4.0 Processing and Review Workstation software met |
| | |
| its design inputs and clinical performance requirements. No
new hazards were introduced and all existing hazards residual
risks remain ALARP. | |
| The system and its development process comply with
International standards. | |
| The Xeleris 4.0 Processing and Review Workstation Software is
developed under the same design controls processes and
software development life cycle, as other GE healthcare
software post-processing system as the predicate device.
Based in the established verification testing GE has
determined that Xeleris 4.0 is of comparable type and
substantially equivalent to the currently marketed workstation
software and to its predicate device described in Xeleris 3.1
(K130884). | |
| Based on the conformance to standards, development under
our quality system, and the extensive engineering testing
provided, GE Healthcare believes that the Xeleris 4.0
Processing and Review Workstation is as safe and effective,
and performs in a substantially equivalent manner to the
predicate device. | |
5
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
6
Image /page/6/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized, 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.
7
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.
8
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.
9
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.