(88 days)
Not Found
No
The description focuses on spectral imaging, material decomposition, and post-processing visualization tools based on physical principles of x-ray attenuation. There is no mention of AI, ML, training data, or algorithms typically associated with these technologies.
No
The device is a post-processing visualization tool that displays and analyzes medical images to provide diagnostic information (e.g., chemical composition of kidney stones, fat percentage in the liver), rather than directly treating or preventing a disease or condition.
Yes
The device aids in the characterization of kidney stones (uric acid vs. non-uric acid) and provides an approximation of fat percentage in the liver by analyzing the chemical composition of body materials from CT images. This information is used to provide additional details beyond standard methods, which is a diagnostic function.
Yes
The device is described as a "post processing visualization tool" that accepts images from a CT system. It performs analysis and generates images and data based on the input images. There is no mention of any hardware component being part of the device itself; it operates on data acquired by a separate CT system.
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 and analyzes images acquired from a CT system. It does not perform tests on biological samples.
- Intended Use: The intended use describes the analysis of anatomical and pathological structures based on image data, and the characterization of renal calculi and liver fat percentage based on image processing. This is not consistent with the definition of an IVD.
The device is a medical image processing and analysis software that aids in the interpretation of CT scans.
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 (comma separated list FDA assigned to the subject device)
JAK
Device Description
The unmodified device GSI Viewer with VUE option (K121827) 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 monochromatic spectral images using a projection based reconstruction algorithm.
GSI Viewer is a post processing visualization tool 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. With VUE option, it also produces a material suppressed image at a given monochromatic energy in the conventional CT Hounsfield Units.
The modification being introduced is the Fat option that produces an approximation of a Fat percentage in the liver.
This modification is based on the existing capability of the predicate device that generates material separated images in the Material Density (MD) space and VUE algorithm which is based upon Multi-Material Decomposition (MMD) a technique that allows for material separation and is the subject of this pre-market notification.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
renal calculi
liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Summary of Non-Clinical Tests:
The GSI Viewer with GSI Fat Option software complies with NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard.
The GSI Viewer with GSI Fat Option software employs the same fundamental scientific technology as its predicate device, GSI Viewer with VUE Option.
This modification is based on the existing capability of the predicate device that generates material separated images in the Material Density (MD) space and VUE algorithm which is based upon Multi-Material Decomposition (MMD) a technique that allows for material separation and is the subject of this pre-market notification.
The following quality assurance measures were applied to the development of the system:
■ Risk Analysis
■ Requirements Reviews
■ Design Reviews
■ Integration testing (System verification)
■ Performance testing (Bench testing, validation)
■ Safety testing (Verification)
The substantial equivalence determination is based on the software documentation for a MODERATE level of concern device.
The substantial equivalence is established with performance testing involving:
■ testing of accuracy based on different levels of fat using anthropomorphic and non-anthropomorphic (cylindrical with varying diameter) phantoms,
■ testing confounding variable of iodinated contrast agent from clinical acquisition using comparison between contrasted and non-contrasted phases,
testing confounding variable of hepatic iron based on different levels of fat and iron concentration using non-anthropomorphic phantom with accuracy comparison to MR.
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.
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
§ 892.1750 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.
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April 24, 2018
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
GE Medical Systems SCS % Kristine Schraufnagel Senior Regulatory Affairs Manager GE Medical Systems, LLC 3000 North Grandview Blvd. WAUKESHA WI 53188
Re: K180225
Trade/Device Name: GSI Viewer with GSI Fat Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 26, 2018 Received: January 29, 2018
Dear Kristine Schraufnagel:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. 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) K180225
Device Name GSI Viewer with GSI Fat Option
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | April 12, 2018 |
|---|---|
| Submitter: | GE Medical Systems SCS |
| 283, rue de la Minière | |
| 78530 Buc, France | |
| Primary Contact Person: | Peter Uhlir |
| Regulatory Affairs Leader | |
| Tel: 00 36 1 4793318 | |
| Fax: (262) 548 2317 | |
| Secondary Contact Person: | Kristine Schraufnagel |
| Senior Regulatory Affairs Manager | |
| Tel: (262) 269-4273 | |
| Fax: (262) 548 2317 | |
| Device Trade Name: | GSI Viewer with GSI Fat Option |
| Common/Usual Name: | GSI Viewer with GSI Fat Option |
| Regulation Number: | 21CFR 892.1750 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Regulatory Class: | Class II |
| Product Code: | JAK |
| Predicate Device: | K121827 – GSI Viewer with VUE Option |
| Regulation Number: | 21CFR 892.1750 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Regulatory Class: | Class II |
| Product Code: | JAK |
| Device Description / | |
| Intended Use: | The unmodified device GSI Viewer with VUE option (K121827) 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 monochromatic spectral | |
| images using a projection based reconstruction algorithm. | |
| GSI Viewer is a post processing visualization tool 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. With VUE option, it | |
| also produces a material suppressed image at a given monochromatic | |
| energy in the conventional CT Hounsfield Units. | |
| The modification being introduced is the Fat option that produces an | |
| approximation of a Fat percentage in the liver. | |
| This modification is based on the existing capability of the predicate | |
| device that generates material separated images in the Material | |
| Density (MD) space and VUE algorithm which is based upon Multi- | |
| Material Decomposition (MMD) a technique that allows for material | |
| separation and is the subject of this pre-market notification. | |
| 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. | |
| The Indications for Use are identical to that of the predicate device. | |
| Technology: | The GSI Viewer with GSI Fat Option software employs the same |
| fundamental scientific technology as its predicate device. | |
| The GSI Viewer with GSI Fat Option relies on the predicate device's | |
| ability to generate material separated images in the material density | |
| (MD) space. Additionally, while the predicate device provides the | |
| ability to create fat as one of the material decomposed basis pairs | |
| (typically with iodine or calcium as the other basis) in units of | |
| voluminal mass (mg/ml or μg/ml), the GSI Viewer with GSI Fat Option | |
| adds the ability to provide a liver fat fraction. | |
| Determination of Substantial | |
| Equivalence: | Summary of Non-Clinical Tests: |
| The GSI Viewer with GSI Fat Option software complies with NEMA PS | |
| 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine | |
| (DICOM) Set (Radiology) standard. | |
| The GSI Viewer with GSI Fat Option software employs the same | |
| fundamental scientific technology as its predicate device, GSI Viewer | |
| with VUE Option. | |
| This modification is based on the existing capability of the predicate | |
| device that generates material separated images in the Material | |
| Density (MD) space and VUE algorithm which is based upon Multi- | |
| Material Decomposition (MMD) a technique that allows for material | |
| separation and is the subject of this pre-market notification. | |
| The following quality assurance measures were applied to the | |
| development of the system: | |
| ■ Risk Analysis | |
| ■ Requirements Reviews | |
| ■ Design Reviews | |
| ■ Integration testing (System verification) | |
| ■ Performance testing (Bench testing, validation) | |
| ■ Safety testing (Verification) | |
| The substantial equivalence determination is based on the software | |
| documentation for a MODERATE level of concern device. | |
| The substantial equivalence is established with performance testing involving: | |
| ■ testing of accuracy based on different levels of fat using | |
| anthropomorphic and non-anthropomorphic (cylindrical with | |
| varying diameter) phantoms, | |
| ■ testing confounding variable of iodinated contrast agent from | |
| clinical acquisition using comparison between contrasted and | |
| non-contrasted phases, | |
| testing confounding variable of hepatic iron based on different | |
| ■ | |
| levels of fat and iron concentration using non-anthropomorphic | |
| phantom with accuracy comparison to MR. | |
| Conclusion: | GE Healthcare considers the GSI Viewer with GSI Fat Option software |
| application to be as safe, as effective, and performance is substantially | |
| equivalent to the predicate device. |
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