(129 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on software updates for image reconstruction and system operation, not AI/ML capabilities.
No
The device is described as an imaging system (Computed Tomography X-ray) intended to produce cross-sectional images of the body for diagnostic purposes, not for treating any condition.
Yes
The device is intended to "produce cross-sectional images of the body by computer reconstruction of x-ray transmission data," which indicates its role in obtaining information for diagnosis.
No
The device description explicitly states that the software is a new version for the SOMATOM Definition Edge Computed Tomography X-ray systems, which are hardware devices. The software is either delivered with new systems or offered as an upgrade for existing hardware systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for producing cross-sectional images of the body using x-ray transmission data. This is a diagnostic imaging device, not a device that performs tests on biological samples (like blood, urine, or tissue) outside of the body.
- Device Description: The description focuses on the software version for a Computed Tomography X-ray system. CT systems are imaging modalities, not IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
In summary, the Siemens SOMATOM Definition Edge system is a medical imaging device used for diagnostic purposes through the creation of images, not through the analysis of biological samples in vitro.
N/A
Intended Use / Indications for Use
The Siemens SOMATOM Definition Edge (Project P46F) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultancous translation of the patient.)
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
Siemens intends to market a new software version, syngo® VA48 (SOMARIS/7 VA48) for its SOMATOM Definition Edge Computed Tomography X-ray systems. The subject device SOMATOM Definition Edge will be delivered with software version syngo® VA48 (SOMARIS/7 VA48). Additionally software version synqo® VA48 (SOMARIS/7 VA48 will be offered as an optional upgrade for existing SOMATOM Definition Edge systems. syngo® VA48 (SOMARIS/7 VA48) is a further development to the SOMARIS/7 operating software cleared as part of the predicate devices. A listing of device modifications is as follows:
- New software version syngo® VA48 (SOMARIS/7 VA48) to support the following additional features:
- TwinBeam Scanning
- Adaptive Spiral (zig-zag scan) for Sliding Gantry Configuration
- Respiratory Analysis of Respiratory Rate & Pitch Adjustment
- FAST 3D Reconstruction (Auto 3D Recon FAST 3D Align)
- Multiphase Reconstruction with extended Field of View
- FAST DE Results (Dual Energy PACS ready images)
- FAST Contact
- Iterative Reconstruction with Extended Field of View
- OEM Varian RGSc Online Mode
- Full 4D Lung Scan
- Applications at CT syngo.via client
- Temporal MIP (t-MIP)
- TrueD 4D Viewer
- HD Field of View Pro (HD FoV 2.0)
- ADMIRE Iterative Reconstruction (option)
- iMAR Improved Metal Artifact Correction (option)
- MARIS (Metal Artifact Reduction in Image Space) Option
- HandCARE Quantitative Dose Reduction Option
- CARE Dose4D Dose Reduction Option
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography x-ray
Anatomical Site
Body
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)
Performance tests were conducted to test the functionality of the SOMATOM Definition Edge configured with software version syngo® VA48. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 6, 2015
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 51 Valley Stream Parkway MALVERN PA 19355
Re: K143401
Trade/Device Name: SOMATOM Definition Edge Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 10, 2015 Received: February 13, 2015
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. The word is displayed horizontally and is the main focus of the image.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K143401
Device Name
SOMATOM Definition Edge
Indications for Use (Describe)
The Siemens SOMATOM Definition Edge (Project P46F) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultancous translation of the patient.)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
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Image /page/3/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a light blue or teal. The letters are evenly spaced and appear to be a solid color with no gradients or shadows.
510(K) SUMMARY FOR
SOMATOM Definition Edge Computed Tomography Systems
Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355 Date Prepared: January 29, 2015
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.
-
- General Information: Importer/Distributor Establishment: Registration Number: 2240869 Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355
Manufacturing Facility: Siemens AG: Medical Solutions Siemensstrasse 1
- General Information: Importer/Distributor Establishment: Registration Number: 2240869 Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355
91301 Forchheim, GERMANY Establishment Registration Number: 3004977335
2. Contact Person:
Ms. 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
3. Device Name and Classification
Product Name: SOMATOM Definition Edge Propriety Trade Name: SOMATOM Definition Edge Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: 90JAK
-
- Legally Marketed Primary Predicate Device: Product Name: SOMATOM Definition Edge
4
SIEMENS
Propriety Trade Name: SOMATOM Definition Edge Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: 90 JAK
Legally Marketed Secondary Predicate Device: Name: SOMATOM Definition AS Open Propriety Trade Name: SOMATOM Definition AS Open Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: 90 JAK
5. Indications for Use
The Siemens SOMATOM Definition Edge (Project P46F) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
6. Substantial Equivalence:
Siemens SOMATOM Definition Edge Computed Tomography Systems with software version syngo® VA48 (SOMARIS/7 VA48) is substantially equivalent to the following medical devices in commercial distribution as listed in Table 1:
| Manufacturer | Predicate Device | 510(k) # | Clearance Date |
|---|---|---|---|
| Siemens | SOMATOM Definition Edge | K120579 | May 23, 2012 |
| Manufacturer | Secondary Device | 510(k) # | Clearance Date |
| Siemens | SOMATOM Definition AS Open | K130901 | January 2, 2014 |
Table 1: Predicate Devices
7. Device Description:
Siemens intends to market a new software version, syngo® VA48 (SOMARIS/7 VA48) for its SOMATOM Definition Edge Computed Tomography X-ray systems. The subject device SOMATOM Definition Edge will be delivered with software version syngo® VA48 (SOMARIS/7 VA48). Additionally software version synqo® VA48 (SOMARIS/7 VA48 will be offered as an optional upgrade for existing SOMATOM Definition Edge systems. syngo® VA48 (SOMARIS/7 VA48) is a further development to the SOMARIS/7 operating software cleared as part of the predicate devices. A listing of device modifications is as follows:
5
SIEMENS
-
- New software version syngo® VA48 (SOMARIS/7 VA48) to support the following additional features:
- TwinBeam Scanning ●
- Adaptive Spiral (zig-zag scan) for Sliding Gantry Configuration .
- Respiratory Analysis of Respiratory Rate & Pitch Adjustment ●
- FAST 3D Reconstruction (Auto 3D Recon FAST 3D Align) .
- Multiphase Reconstruction with extended Field of View ●
- FAST DE Results (Dual Energy PACS ready images) ●
- FAST Contact ●
- Iterative Reconstruction with Extended Field of View ●
- OEM Varian RGSc Online Mode
- Full 4D Lung Scan ●
- Applications at CT syngo.via client ●
- Temporal MIP (t-MIP) .
- TrueD 4D Viewer .
- . HD Field of View Pro (HD FoV 2.0)
-
- ADMIRE Iterative Reconstruction (option)
-
- iMAR Improved Metal Artifact Correction (option)
-
- MARIS (Metal Artifact Reduction in Image Space) Option
-
- HandCARE Quantitative Dose Reduction Option
-
- CARE Dose4D Dose Reduction Option
8. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
SOMATOM Definition Edge configured with software version syngo® VA48 does not have significant changes in materials, energy source, or technological characteristics when compared to the predicate devices. Both the subject device and predicate devices are computed tomography scanners that support various visualization and evaluation tools. 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. Table 2 below provides a comparison of the primary features of the subject device in comparison to the predicate device.
| Subject Device Feature | Predicate Device Comparable Feature |
|---|---|
| New software version syngo® VA48 | |
| (SOMARIS/7 VA48) with supported | |
| software options | System scanner software syngo® |
| VA44 (SOMARIS/7 VA44) with | |
| supported software options | |
| ADMIRE Iterative Reconstruction | |
| (option) | Optional Iterative Reconstruction |
| (option) | |
| iMAR Iterative Reconstruction (option) | Optional Iterative Reconstruction |
| (option) | |
| MARIS (option) | MARIS (option) |
| HandCARE with Quantitative Dose | HandCARE with Quantitative Dose |
Table 2: Predicate Device Comparison
6
| Subject Device Feature | Predicate Device Comparable Feature |
|---|---|
| Reduction Option | Reduction Option |
| CARE Dose4D Quantitative Dose | |
| Reduction Option | CARE Dose4D Quantitative Dose |
| Reduction Option |
9. Nonclinical Testing:
SOMATOM Definition Edge configured with software version syngo® VA48 is designed to fulfill the requirements of the following standards:
- IEC 60601-2-44: Medical electrical equipment Part 2-44: Particular . requirements for the safety of X-ray equipment for computed tomography - Ed. 2.1
- IEC 61223-3-5: Evaluation and routine testing Evaluation and routine ● testing in medical imaging departments - Part 3-5: Acceptance tests -Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1
- NEMA XR-25: Computed Tomography Dose Check ●
- IEC 61223-2-6: Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
- NEMA PS 3.1 3.18: Digital Imaging and Communications in Medicine ● (DICOM) Set
- IEC 62304 Ed. 1.0: Medical device software software life cycle ● processes
- . IEC 60601-1: Medical electrical equipment - Part 1: General requirements for Safety, 1988, Amendment 1, 1991-11, Amendment 2, 1995
- ISO 14971: Medical devices Application of risk management to medical ● devices
- NEMA XR-29: Standard Attributes on CT Equipment Related to Dose ● Optimization and Management
This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests were conducted for the SOMATOM Definition Edge configured with software version syngo® VA48 during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.
The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
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SIEMENS
Software Verification and Validation
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.
Summary
Performance tests were conducted to test the functionality of the SOMATOM Definition Edge configured with software version syngo® VA48. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
General Safety and Effectiveness Concerns: 10.
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.
11. Conclusion as to Substantial Equivalence:
The SOMATOM Definition Edge configured with software version syngo® VA48 has the same intended use and comparable indication for use as the predicate devices. The technological characteristics such as image acquisition, operating platform, and image manipulation are similar to the predicate devices
The predicate devices were cleared based on non-clinical supportive information and clinical images. The results of these tests demonstrate that the SOMATOM Definition Edge (K120579) and SOMATOM Definition AS Open (K130901) are adequate for the intended use. The comparison of technological characteristics, non-clinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate devices that are currently marketed for the same intended use.