(14 days)
No
The summary does not mention AI, ML, deep learning, or any related terms. The described functionality focuses on standard image processing, quantification, and database comparison, which are not inherently AI/ML technologies.
No
The device is a Nuclear Medicine Workstation system used for displaying, processing, archiving, and reporting NM data for diagnostic purposes, not for treating or preventing disease.
Yes
The system is intended for "clinical diagnostic purposes" and "may assist in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease."
No
The device description explicitly lists hardware components: "operation console, monitor and peripherals."
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The described device, Xeleris 3.1, is a Nuclear Medicine Workstation system. Its primary function is to process, display, archive, and analyze medical images acquired from gamma cameras and PET scanners. These images are generated by detecting the distribution of radionuclide tracers within the patient's body.
- Input Data: The input data is imaging data (NM, PET, CT, MR scans) and physiological signals, not biological samples taken from the body.
- Intended Use: The intended use is for practitioners to display, process, and analyze imaging data for clinical diagnostic purposes, specifically related to the distribution of radionuclide tracers and anatomical structures in scanned body tissue.
While the device assists in clinical diagnosis, it does so by processing and analyzing in vivo imaging data, not by performing tests on in vitro biological samples.
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 NM 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 order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes.
DaTQUANT optional application enables visual evaluation and quantification of 131ioflupane (DaTscan) images. DaTQUANT Normal Database option enables quantification relative to normal population databases of 1231-ioflupane (DaTscan) images.
These applications may assist in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The Xeleris 3.1 is a Nuclear Medicine Workstation system intended for general nuclear medicine processing & review procedures for detection of radioisotope tracer uptake in the patient body, using a variety of processing modes supported by various clinical applications types and various features designed to enhance image quality. The components of the Xeleris 3.1 NM Workstation system are: operation console, monitor and peripherals.
The Xeleris 3.1 is a modification of its predicate device Xeleris 3 while providing enhanced workflow to existing operations and enabling broader access to Xeleris applications in supporting PACS and GE AW Server and in offline client server configuration. Xeleris 3.1 also enables the use of normal data base comparison together with the quantification analysis of 123I-ioflupane brain NM images. Similar functionality for NM/PET brain image analysis also resides in the predicate devices K021656 and K123528.
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, Gated SPECT, dedicated PET or Camera-Based-PET), CT, MR scans
Anatomical Site
Body tissue, striatum (brain)
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
- Testing the accuracy of using the DaTQUANT application by comparing DaTQUANT analysis results to manual analysis results. The data that was used for comparison was taken from brain phantoms injected symmetrically and asymmetrically, thus simulating normal and abnormal uptakes in the left and right striatum. Different contrast levels were used to simulate different signal to noise ratio levels.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
The Xeleris 3.1 and its applications have been successfully tested to comply with voluntary standards (DICOM Standard NEMA PS3.1 - 3.18; IEC60601-1-4; IEC62304) as detailed in Section 9, of this premarket submission. The modifications from the predicate Xeleris 3 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 (Module verification) Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation)
In addition to the verification and validation testing successfully completed as required by GE Healthcare's quality system, additional engineering and clinical performance 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 workflow and tool improvements
- Testing of Advanced Connectivity capabilities
- Testing of the Volumetrix MI enhancements related to attenuation correction.
- Testing the accuracy of using the DaTQUANT application by comparing DaTQUANT analysis results to manual analysis results. The data that was used for comparison was taken from brain phantoms injected symmetrically and asymmetrically, thus simulating normal and abnormal uptakes in the left and right striatum. Different contrast levels were used to simulate different signal to noise ratio levels. DaTQUANT results were found to be as accurate as manual results.
- Clinical scenario testing performed on phantoms simulating clinical applications and situations.
Clinical Tests:
The subject of this premarket submission, XELERIS 3.1, did not require clinical studies to support substantial equivalence. However, clinical scenario testing was performed on the bench.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
DaTQUANT results were found to be as accurate as manual results.
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.
K093982- Xeleris 3 Processing and Review workstation, K021656- HERMES HDAQ Acquisition Station and HERMES Workstation, Ver. 3.4, K123528- Scenium 3.0
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.
Not Found
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).
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APR 1 2 2013
Section 5: 510(k) Summary
Xeleris 3.1 Processing and Review Workstation
Throughout of this document the Xeleris 3.1 Processing and Review Workstation is mention also in the relevant documents as project names: Xeleris Skyline, Skyline or Xeleris 3.1. All names are equivalent.
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | March 21 2013 |
|---|---|
| Submitter: | GE Healthcare, GE Medical Systems Israel, Functional |
| Imaging | |
| 4 Hayozma St | |
| TIRAT HACARMEL, 30200, ISRAEL | |
| Primary Contact Person: | Eli Werner |
| Regulatory Affairs Leader | |
| GE Healthcare, GE Medical Systems Israel, Functional | |
| Imaging | |
| +972-4-8563666 | |
| +972-4-8577664 | |
| Secondary Contact | |
| Person: | John Jaeckle |
| Chief Regulatory Affairs Strategist | |
| GE Healthcare | |
| 262-424-9547 | |
| Device Trade Name: | Xeleris 3.1 Processing and Review Workstation |
| Common/Usual Name: | Nuclear Medicine Workstation |
| Classification Names: | System, Image Processing, Radiological |
| Product Code: | Class II ;21CFR 892.2050 |
| LLZ | |
| Predicate Device(s): | K093982- Xeleris 3 Processing and Review workstation |
| K021656- HERMES HDAQ Acquisition Station and | |
| HERMES Workstation, Ver. 3.4 | |
| K123528- Scenium 3.0 | |
| Device Description: | The Xeleris 3.1 is a Nuclear Medicine Workstation system |
| intended for general nuclear medicine processing & review | |
| procedures for detection of radioisotope tracer uptake in the | |
| patient body, using a variety of processing modes supported | |
| by various clinical applications types and various features | |
| designed to enhance image quality. The components of the | |
| Xeleris 3.1 NM Workstation system are: operation console, | |
| monitor and peripherals. | |
| The Xeleris 3.1 is a modification of its predicate device | |
| Xeleris 3 while providing enhanced workflow to existing | |
| operations and enabling broader access to Xeleris | |
| applications in supporting PACS and GE AW Server and in | |
| offline client server configuration. Xeleris 3.1 also | |
| enables the use of normal data base comparison together | |
| with the quantification analysis of 123I-ioflupane brain NM | |
| images. Similar functionality for NM/PET brain image | |
| analysis also resides in the predicate devices K021656 and | |
| K123528. | |
| 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. | |
| Indication 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 NM 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 order to depict, localize, and/or quantify the | |
| distribution of radionuclide tracers and anatomical | |
| structures in scanned body tissue for clinical diagnostic | |
| purposes. | |
| DaTQUANT optional application enables visual | |
| evaluation and quantification of 1231-ioflupane | |
| (DaTscan 100) images. DaTQUANT Normal Database | |
| option enables quantification relative to normal | |
| population databases of 1231-ioflupane (DaTscan™) | |
| images. | |
| These applications may assist in detection of loss of | |
| functional dopaminergic neuron terminals in the striatum, | |
| which is correlated with Parkinson disease. | |
| Technology: | The Xeleris 3.1 Processing and Review Workstation employs |
| the same fundamental scientific technology as its predicate | |
| devices Xeleris 3. | |
| Determination of | |
| Substantial Equivalence: | Summary of Non-Clinical Tests: |
| [The Xeleris 3.1 and its applications have been successfully | |
| tested to comply with voluntary standards (DICOM Standard | |
| NEMA PS3.1 - 3.18; IEC60601-1-4; IEC62304) as detailed | |
| in Section 9, of this premarket submission. The modifications | |
| from the predicate Xeleris 3 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 (Module verification) Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation) | |
| In addition to the verification and validation testing | |
| successfully completed as required by GE Healthcare's | |
| quality system, additional engineering and clinical | |
| performance 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 workflow and tool improvements |
- Testing of Advanced Connectivity capabilities
- Testing of the Volumetrix MI enhancements related to
attenuation correction. - Testing the accuracy of using the DaTQUANT application
by comparing DaTQUANT analysis results to manual
analysis results. The data that was used for comparison was |
| | taken from brain phantoms injected symmetrically and
asymmetrically, thus simulating normal and abnormal
uptakes in the left and right striatum. Different contrast levels |
| | were used to simulate different signal to noise ratio levels.
DaTQUANT results were found to be as accurate as manual
results. - Clinical scenario testing performed on phantoms simulating
clinical applications and situations. |
| | Summary of Clinical Tests:
The subject of this premarket submission, XELERIS 3.1, did
not require clinical studies to support substantial equivalence. |
| | However, clinical scenario testing was performed on the
bench. |
| Conclusion: | Based on the conformance to standards, development under
our quality system, and the extensive engineering testing
provided, GE Healthcare believes that the Xeleris 3.1
Processing and Review Workstation is as safe and effective,
and performs in a substantially equivalent manner to the
predicate devices. The device and the predicate devices are
image post processing workstations devices and provide
similar features of visualization and quantitative analysis. |
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510(k) Premarket Notification Submission
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510(k) Premarket Notification Submission
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510(k) Premarket Notification Submission
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510(k) Premarket Notification Submission
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
April 12, 2013
GE Healthcare, GE Medical System % Ned Devine Sr. Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, IL 60062
Re: K130884
Trade/Device Name: Xelaris 3.1 Processing and Review Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: March 28, 2013 Received: March 29, 2013
Dear Mr. Devine:
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. 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.
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); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
MichaFDA'Hara for
Janine M. Morris Director Division Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
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510(k) Number (if known): K130884
Device Name:
Xeleris 3.1 Processing and Review Workstation
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 NM 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 order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes.
DaTQUANT optional application enables visual evaluation and quantification of 131ioflupane (DaTscan™)) images. DaTQUANT Normal Database option enables quantification relative to normal population databases of 1231-ioflupane (DaTscan TM) images.
These applications may assist in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease.
AND/OR Prescription Use X
Over-The-Counter Use
(Part 21 CFR 801 Sub part D)
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)
Mehmood Hara
Division Sign-Off Office of In Vitro Devices and Radiologic Health
510(k) K130884