(97 days)
Not Found
No
The summary describes image processing and analysis techniques based on dual-energy CT data, but there is no mention of AI or ML algorithms being used. The focus is on material decomposition and visualization based on the physical properties of different materials at different energy levels.
No.
The device is a post-processing software that analyzes CT images to visualize and analyze information, aiding in diagnosis, rather than directly treating a condition.
Yes
Explanation: The device is described as combining images to "visualize and analyze information about anatomical and pathological structures" and enabling an "initial diagnosis" and "specific clinical tasks" like "Gout Evaluation." This indicates its purpose is to aid in identifying medical conditions, which is the definition of a diagnostic device.
Yes
The device is described as a "post processing application" that analyzes images from a CT scanner. The description focuses entirely on the software's functionality, image processing, and algorithms, with no mention of accompanying hardware components being part of the device itself. While it operates on CT images, the device is the software that performs the analysis.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The syngo® Single Source Dual Energy device processes and analyzes CT images taken directly from the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use describes analyzing information about anatomical and pathological structures based on the differences in attenuation coefficients within the body, not analyzing biological samples.
Therefore, since the device operates on images acquired directly from the patient and not on in vitro specimens, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
syngo® Single Source Dual Energy is designed to operate with CT images taken at the same anatomical region of a patient using two different kV levels. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures. The functionality of the syngo® Single Source Dual Energy applications are as follows: - Gout Evaluation - Monoenergetic.
Product codes
JAK, 901AK
Device Description
Dual Energy CT can be used to obtain intensity measurements with two different spectra and thus provides additional information when compared to single energy. This additional information is analyzed in the post processing application syngo Single Source Dual Energy and can be used to improve the visualization of various materials in the human body. After loading the reconstructed images corresponding to the two subsequent scans with different X-ray spectra into syngo® Single Source Dual Energy, the images are first registered to compensate for motion effects. They are then displayed using linear blending with selectable mixing ratio and color scale ("General Viewing"). Multiplanar reformations (MPR) of the volume are shown in 3 image segments, which are initialized as sagittal, coronal and axial view. After arriving at an initial diagnosis on the basis of the CT-images, the user can choose between application classes Monoenergetic or Gout Evaluation. These application classes are designed for specific clinical tasks, so that algorithms, additional tool buttons, the use of colored overlay images and image representation (for example MPR or maximum intensity projection) are optimized correspondingly. For Gout Evaluation a fourth image segment is used for volume rendering techniques (VRT). If is possible to adjust Gout Evaluation by using a configuration dialog. Special tools are available to remove the table or perform manual punching.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
the same anatomical region of a patient
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 verification and validation was performed for all newly developed components and the complete software package, according the following standards: DICOM, NEMA PS 3.1 - 3.18 (2008), IEC 60601-1-4: Ed. 1.1.2000 IEC 60601-1-6: 2004 IEC 62304 Ed. 1.0. 2006 IEC/ISO 14971 ( 2007 ). After completion of the test and comparison of the test results with the release acceptance criteria, Siemens is of the opinion, that syngo Single Source Dual Energy is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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SIEMENS
Special 510(k) Submission: syngo® Single Source Dual Energy
DEC 2 7 2012
510(K) SUMMARY FOR syngo® Single Source Dual Energy
Submitted by:
Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Malvern, PA 19355
September 14, 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Contact Person:
Mrs. Kimberly Mangum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D02 Malvern, PA 19355-1406 Phone: (610) 448-4912 Fax: (610) 448-1787 Email: kimberly.mangum@siemens.com
2. Device Name and Classification
Product Name: Propriety Trade Name: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:
syngo® Single Source Dual Energy syngo® Single Source Dual Energy Accessory to Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 901AK
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Substantial Equivalence: 3.
Siemens syngo® Single Source Dual Energy is substantially equivalent to the following medical device in commercial distribution:
| Predicate Device Name | FDA Clearance
Number | FDA Clearance
Date |
|---------------------------------------------------|-------------------------|-----------------------|
| syngo® Dual Energy with
extended functionality | K083524 | 04/01/2009. |
| syngo® Volume Perfusion - CT
Body | K073373 | 12/18/2007 |
4. Device Description:
Dual Energy CT can be used to obtain intensity measurements with two different spectra and thus provides additional information when compared to single energy.
This additional information is analyzed in the post processing application syngo Single Source Dual Energy and can be used to improve the visualization of various materials in the human body.
After loading the reconstructed images corresponding to the two subsequent scans with different X-ray spectra into syngo® Single Source Dual Energy, the images are first registered to compensate for motion effects. They are then displayed using linear blending with selectable mixing ratio and color scale ("General Viewing"). Multiplanar reformations (MPR) of the volume are shown in 3 image segments, which are initialized as sagittal, coronal and axial view.
After arriving at an initial diagnosis on the basis of the CT-images, the user can choose between application classes Monoenergetic or Gout Evaluation.
These application classes are designed for specific clinical tasks, so that algorithms, additional tool buttons, the use of colored overlay images and image representation (for example MPR or maximum intensity projection) are optimized correspondingly. For Gout Evaluation a fourth image segment is used for volume rendering techniques (VRT). If is possible to adjust Gout Evaluation by using a configuration dialog. Special tools are available to remove the table or perform manual punching.
2
Special 510(k) Submission: syngo® Single Source Dual Energy
SIEMENS
Summary of Technical Characteristics of the Subject Device as 5. Compared with the Predicate Device:
syngo® Single Source Dual Energy software package provides the same and unmodified application classes as the predicate devices. The unmodified algorithm for motion correction as used in syngo® Volume Perfusion Body was added to allow the evaluation of images achieved with single source scanners and reduce motion effects in images from dual source scanners.
syngo® Single Source Dual Energy does not have significant changes in materials, energy source, or technological characteristics when compared to the predicate devices. The intended use and fundamental scientific technology are similar to the predicate devices; therefore Siemens believes that they are substantially equivalent to the predicate devices.
Nonclinical Testing: 6.
syngo Single Source Dual Energy software package uses the same algorithm for non rigid registration as syngo® Volume Perfusion - CT Body. This algorithm is unmodified since the release of syngo® Volume Perfusion-CT Body and in clinical use since that time without any known problems.
The verification and validation was performed for all newly developed components and the complete software package, according the following standards:
DICOM, NEMA PS 3.1 - 3.18 (2008),
IEC 60601-1-4: Ed. 1.1.2000 IEC 60601-1-6: 2004 IEC 62304 Ed. 1.0. 2006 IEC/ISO 14971 ( 2007 )
After completion of the test and comparison of the test results with the release acceptance criteria, Siemens is of the opinion, that syngo Single Source Dual Energy is substantially equivalent to the predicate devices.
7. Indications for Use:
syngo® Single Source Dual Energy is designed to operate with CT images taken at the same anatomical region of a patient using two different kV levels. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to
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SIEMENS
Special 510(k) Submission: syngo® Single Source Dual Energy
visualize and analyze information about anatomical and pathological structures.
The functionality of the syngo Single Source Dual Energy applications are as follows:
- Gout Evaluation .
- Monoenergetic .
8. General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
In summary Siemens is of the opinion, that syngo Single Source Dual Energy software package does not introduce any new potential safety risks and is substantially equivalent to the predicate devices.
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Image /page/4/Picture/0 description: The image shows the text 'DEPARTMENT OF HEALTH & HUMAN SERVICES'. The text is in bold and is in all caps. The text is centered in the image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Siemens Medical Systems, Inc. Kimberly Magnum 51 Valley Stream Parkway MALVERN PA 19355-1406
December 27, 2012
Re: K122909
Trade/Device Name: syngo Single Source Dual Energy Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: Class II Product Code: JAK Dated: Nov. 30, 2012 Received: Dec. 7, 2012
Dear Ms. Mangum:
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.
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
5
Page 2 -- Ms. Mangum
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,
Michael D. O'Hara
Janine M. Morris 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): K122909
Device Name: syngo® Single Source Dual Energy
Indications For Use:
syngo® Single Source Dual Energy is designed to operate with CT images taken at the same anatomical region of a patient using two different kV levels. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures.
The functionality of the syngo® Single Source Dual Energy applications are as follows:
- Gout Evaluation
- Monoenergetic .
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michal D'Hara
(Division Sign Off)
Office of In Vitro Diagnostics and Radiological Health
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