(14 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Xeleris 3.1 Processing and Review Workstation, specifically focusing on the DaTQUANT application:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria with specific numerical thresholds for the DaTQUANT application's accuracy. Instead, it describes a
The study for the DaTQUANT application compared "DaTQUANT analysis results to manual analysis results." The reported performance is that "DaTQUANT results were found to be as accurate as manual results."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| DaTQUANT analysis results are accurate compared to manual analysis results. | DaTQUANT results were found to be as accurate as manual results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions that the data used for testing was "taken from brain phantoms injected symmetrically and asymmetrically." It does not specify the number of phantoms or the number of acquisitions/images used.
- Data Provenance: The data was derived from "brain phantoms injected symmetrically and asynchronously," simulating normal and abnormal uptakes, with "different contrast levels used to simulate different signal to noise ratio levels." This indicates a controlled, artificial data set (phantoms) rather than human clinical data. It is a retrospective analysis of phantom data. The country of origin for the phantom data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth in this specific test was established by "manual analysis results," which inherently implies human expert involvement. However, the document does not specify the number of experts who performed the manual analysis, nor their specific qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It simply states that the DaTQUANT results were compared to "manual analysis results," implying a direct comparison without detailing how discrepancies in manual analysis (if multiple experts were involved) would have been resolved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned for the DaTQUANT application in this document. The testing described focuses on comparing the algorithm's output to manual analysis, not on how human readers' performance might improve with or without AI assistance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Yes, a standalone performance test was done for the DaTQUANT application. The description, "Testing the accuracy of using the DaTQUANT application by comparing DaTQUANT analysis results to manual analysis results," indicates that the algorithm's output (DaTQUANT results) was directly evaluated against a ground truth (manual analysis) without an explicit human-in-the-loop interaction for the DaTQUANT itself during this specific accuracy test.
7. Type of Ground Truth Used
The ground truth used for the DaTQUANT accuracy testing was expert consensus / manual analysis results derived from phantom data.
8. Sample Size for the Training Set
The document does not specify the sample size or details regarding a training set for the DaTQUANT application. The description focuses solely on the accuracy testing using phantom data.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not mentioned, the method for establishing its ground truth is also not provided in this document.
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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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K130884
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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, FunctionalImaging |
| 4 Hayozma St | |
| TIRAT HACARMEL, 30200, ISRAEL | |
| Primary Contact Person: | Eli Werner |
| Regulatory Affairs Leader | |
| GE Healthcare, GE Medical Systems Israel, FunctionalImaging | |
| +972-4-8563666 | |
| +972-4-8577664 | |
| Secondary ContactPerson: | John Jaeckle |
| Chief Regulatory Affairs StrategistGE Healthcare262-424-9547 | |
| 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 andHERMES Workstation, Ver. 3.4 | |
| K123528- Scenium 3.0 | |
| Device Description: | The Xeleris 3.1 is a Nuclear Medicine Workstation systemintended for general nuclear medicine processing & reviewprocedures for detection of radioisotope tracer uptake in thepatient body, using a variety of processing modes supported |
| by various clinical applications types and various featuresdesigned to enhance image quality. The components of theXeleris 3.1 NM Workstation system are: operation console,monitor and peripherals.The Xeleris 3.1 is a modification of its predicate deviceXeleris 3 while providing enhanced workflow to existingoperations and enabling broader access to Xelerisapplications in supporting PACS and GE AW Server and inoffline client server configuration. Xeleris 3.1 alsoenables the use of normal data base comparison togetherwith the quantification analysis of 123I-ioflupane brain NMimages. Similar functionality for NM/PET brain imageanalysis also resides in the predicate devices K021656 andK123528. | |
| Intended Use: | The system is intended for use by Nuclear Medicine (NM) orRadiology practitioners and referring physicians'. Theintended use of the system is to provide digital processing,review and reporting of medical images, including datadisplay, quality control, image manipulation andquantification analysis, transfer, storage and printingcapabilities.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 operate ondedicated workstations and client-server architectures. |
| Indication of Use | The system is intended for use by Nuclear Medicine(NM) or Radiology practitioners and referringphysicians for display, processing, archiving, printing,reporting and networking of NM data, including planarscans (Static, Whole Body, Dynamic, Multi-Gated) andtomographic scans (SPECT, Gated SPECT, dedicatedPET or Camera-Based-PET) acquired by gamma camerasor PET scanners.The system can run on dedicated workstation or in aserver-client configuration.The NM or PET data can be coupled with registered |
| and/or fused CT or MR scans, and with physiologicalsignals in order to depict, localize, and/or quantify thedistribution of radionuclide tracers and anatomicalstructures in scanned body tissue for clinical diagnosticpurposes.DaTQUANT optional application enables visualevaluation and quantification of 1231-ioflupane(DaTscan 100) images. DaTQUANT Normal Databaseoption enables quantification relative to normalpopulation databases of 1231-ioflupane (DaTscan™)images.These applications may assist in detection of loss offunctional dopaminergic neuron terminals in the striatum,which is correlated with Parkinson disease. | |
| Technology: | The Xeleris 3.1 Processing and Review Workstation employsthe same fundamental scientific technology as its predicatedevices Xeleris 3. |
| Determination ofSubstantial Equivalence: | Summary of Non-Clinical Tests:[The Xeleris 3.1 and its applications have been successfullytested to comply with voluntary standards (DICOM StandardNEMA PS3.1 - 3.18; IEC60601-1-4; IEC62304) as detailedin Section 9, of this premarket submission. The modificationsfrom the predicate Xeleris 3 system were completed inaccordance with GE's quality management system anddesign controls per 21CFR 820 and ISO 13485. Engineeringtesting and standards compliance testing were successfullyconducted and did not raise any new safety questions oridentify any new risks. The following quality assurancemeasures 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 testingsuccessfully completed as required by GE Healthcare'squality system, additional engineering and clinicalperformance testing was performed to provide the requisitedata 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 toattenuation correction.- Testing the accuracy of using the DaTQUANT applicationby comparing DaTQUANT analysis results to manualanalysis results. The data that was used for comparison was | |
| taken from brain phantoms injected symmetrically andasymmetrically, thus simulating normal and abnormaluptakes 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 manualresults.- Clinical scenario testing performed on phantoms simulatingclinical applications and situations. | |
| Summary of Clinical Tests:The subject of this premarket submission, XELERIS 3.1, didnot require clinical studies to support substantial equivalence. | |
| However, clinical scenario testing was performed on thebench. | |
| Conclusion: | Based on the conformance to standards, development underour quality system, and the extensive engineering testingprovided, GE Healthcare believes that the Xeleris 3.1Processing and Review Workstation is as safe and effective,and performs in a substantially equivalent manner to thepredicate devices. The device and the predicate devices areimage post processing workstations devices and providesimilar features of visualization and quantitative analysis. |
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K130884
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GE Healthcare
510(k) Premarket Notification Submission
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GE Healthcare
510(k) Premarket Notification Submission
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510(k) Premarket Notification Submission
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K130884
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GE Healthcare
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
§ 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).