(84 days)
No
The document describes image processing and analysis techniques based on spectral CT data, but there is no mention of AI or ML algorithms being used for these processes. The technology is described as based on material density data and projection-based reconstruction.
No.
The device is described as a "post processing visualization tool" that provides information to "visualize and analyze information about anatomical and pathological structures" and to "aid in the characterization of uric acid versus non-uric acid stones." This indicates a diagnostic rather than therapeutic function.
Yes
The device "provides additional information to aid in the characterization of uric acid versus non-uric acid stones" and helps "evaluating stone etiology and composition," which are all diagnostic purposes.
No
The device is described as a "post processing visualization tool on the Discovery CT750 HD system". While it performs software functions (image processing, visualization, analysis), it is explicitly stated to be part of a larger hardware system (Discovery CT750 HD) and relies on images acquired by that system. It is not a standalone software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
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.
- Device function: The GSI Viewer processes images acquired directly from a CT scan of a patient's body. It analyzes the attenuation of X-rays through the body to provide information about the chemical composition of materials within the body (specifically renal calculi).
- No sample analysis: The device does not analyze samples taken from the patient. It works directly with the imaging data generated by the CT scanner.
The device is a post-processing visualization tool for medical images, providing additional information to aid in diagnosis and characterization of conditions within the body. This falls under the category of medical imaging software or a component of a medical imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GSI Viewer accepts images from a CT System that can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.
GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus non-uric acid stones. It is intended to be used on non-contrast studies as an adjunct to current standard methods for evaluating stone etiology and composition.
Product codes
JAK
Device Description
The unmodified device Discovery CT750 HD (K120833) offers the Gemstone Spectral Imaging (GSI) capability that uses rapid kV switching to acquire the dual energy samples almost simultaneously. This enables generation of material density data that can be used for the separation of materials and derivation of GSI Viewer is a post processing visualization tool on the Discovery CT750 HD system that allows users to view and process spectral images acquired by the GSI scan modes. It allows for the review of monochromatic energy images at user selectable energy levels, detailed analysis using material decomposed images (such as water-iodine, water calcium, etc.), and complementary information using the Effective-Z images by providing an estimate of the protons' effective atomic number in a voxel.
The modification being introduced is the VUE (Virtual Unenhanced Exam) option that produces a material suppressed image at a given monochromatic energy in the conventional CT Hounsfield Units.
This modification is based on the existing capability of the predicate device that generates material separated images in the Material density (MD) space and is the subject of this pre-market notification.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT System
Anatomical Site
Renal calculi (kidney stone characterization)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, GSI Viewer with VUE option, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K120833 Discovery CT750 HD
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
.510K Summary
K12/827
1 3 2012
GE Healthcare GSI Viewer with VUE Option 510(k) Premarket Notification
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | June 20th, 2012 |
|---|---|
| Submitter: | GE Medical Systems SCS |
| 283, rue de la Minière | |
| 78530 Buc Cedex - FRANCE | |
| Primary Contact Person: | Helen Peng, RAC |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| TEL: 262-548-5091 | |
| FAX: 262-364-2506 | |
| Secondary Contact Person: | Stephen G. Slavens, RAC |
| Regulatory Affairs Director | |
| GE Healthcare | |
| TEL: (262) 548-4992 | |
| FAX: (262) 364-2506 | |
| Device: | |
| Trade Name: | GSI Viewer with VUE Option |
| Common/Usual Name: | GSI Viewer with MSI Option |
| Classification Name: | 21CFR 892.1750 Computed Tomography X-Ray system |
| Product Code: | JAK |
| Predicate Devices: | K120833 Discovery CT750 HD |
| Device Description: | The unmodified device Discovery CT750 HD (K120833) offers the |
| Gemstone Spectral Imaging (GSI) capability that uses rapid kV | |
| switching to acquire the dual energy samples almost | |
| simultaneously. This enables generation of material density data | |
| that can be used for the separation of materials and derivation o |
reconstruction algorithm.
GSI Viewer is a post processing visualization tool on the Discovery CT750 HD system that allows users to view and process spectral images acquired by the GSI scan modes. It allows for the review of monochromatic energy images at user selectable energy levels, detailed analysis using material decomposed images (such as water-iodine, water calcium, etc.), and complementary information using the Effective-Z images by providing an estimate of the protons' effective atomic number in a voxel.
monochromatic spectral images using a projection based
The modification being introduced is the VUE (Virtual Unenhanced Exam) option that produces a material suppressed image at a given
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The logo is black and white.
GE Healthcare GSI Viewer with VUE Option 510(k) Premarket Notification
monochromatic energy in the conventional CT Hounsfield Units.
This modification is based on the existing capability of the predicate device that generates material separated images in the Material density (MD) space and is the subject of this pre-market notification.
Indication for Use:
The GSI Viewer accepts images from a CT System that can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the eneray dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.
GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus non-uric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition.
The GSI Viewer with VUE option employs the same technology as the Technology: that of the GSI Viewer on its predicate device.
Determination of Substantial Summary of Non-Clinical Tests: Equivalence:
The GSI Viewer with VUE Option complies with voluntary standards as detailed in Section 9, 11 and 16 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis .
- Requirements Reviews .
- . Design Reviews
- Performance testing (Verification) .
- Safety testing (Verification) .
- Final acceptance testing (Validation) .
Summary of Clinical Tests:
The subject of this premarket submission, GSI Viewer with VUE option, did not require clinical studies to support substantial
2
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GE Healthcare GSI Viewer with VUE Option 510(k) Premarket Notification
equivalence.
GE Healthcare considers the GSI Viewer with VUE Option software Conclusion: application to be as safe, as effective, and its performance is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
GE Medical Systems SCS % Ms. Helen Peng Regulatory Affairs Leader GE Medical Systems, LLC dba GE Healthcare 3000 N Grandview. W1140 WAUKESHA WI 53188
SEP 13 2012
Re: K121827
Trade/Device Name: GSI Viewer with VUE Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 18, 2012 Received: June 21, 2012
Dear Ms. Peng:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use saled in the encrosule) is regarry manet date of the Medical Device Amendments, or to conimeres prior to May 20, 1978, the eccordance with the provisions of the Federal Food, DNAA devices that have been recuire approval of a premarket approval application (PMA). alla Cosment Act (Act) that do not require approvince to the general controls provisions of the Act. The 1 ou may, merciole, market the act include requirements for annual registration, listing of general condols provisions of the fiel labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (see asor regulations affecting your device can be found in Title 21, additional controls. Existing major regulations and to 895. In addition, FDA may publish further Sode of Pourial concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a succession in other requirements of the Act that FDA has made a determination that your steered by other Federal agencies. You must of any Federal Statutes and regulations animatives but not limited to: registration and listing (21 comply with all the Act 3 requirements, theraung, Surnet Called of the Parting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device related adverses viality systems (QS) regulation (21 CFR Part 820). This letter requirents as set form in are quarty -device as described in your Section 510(k) premarket with anow you to begal mading of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and If you desire speedile ad ree for your viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 9 120. Thise note 1000 in 100.000. 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 Tou may 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,
Janine M. Morris
Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
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GE Healthcare GSI Viewer with VUE Option 510(k) Premarket Notification
Indications for Use
510(k) Number (if known):
GSI Viewer with VUE Option Device Name:
Indications for Use:
The GSI Viewer accepts images from a CT System that can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.
GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus non-uric acid stones. It is intended to be used on non-contrast studies as an adjunct to current standard methods for evaluating stone etiology and composition.
AND/OR Prescription Use X {Part 21 CFR 801 Subpart D}
Over-The-Counter Use (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 Diagnostic Devices (OIVD)
Mund D. Phm
Division S Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K121827