(136 days)
Not Found
No
The summary describes a standard CT system with software updates focused on user interface, workflow improvements, and basic image processing features like MIP and 3D alignment. There is no mention of AI, ML, or related concepts like deep learning, training data, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as an X-ray Computed Tomography System intended to produce cross-sectional images for diagnostic purposes, not for treating any condition.
Yes
The device is a CT system intended to produce cross-sectional images of the body. These images are used for medical assessment, which is a diagnostic purpose.
No
The device description clearly states that the SOMATOM Emotion 6 and 16 are "whole body X-ray Computed Tomography Systems," which are hardware devices. While the submission discusses software modifications, the core device is a CT scanner, not software alone.
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 device is used to "produce cross-sectional images of the body by computer reconstruction of x-ray transmission data". This describes an imaging device that works directly on the patient's body, not on samples taken from the body.
- Device Description: The description reinforces that it is a "whole body X-ray Computed Tomography System".
- Lack of mention of biological samples: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.), which is a defining characteristic of IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device is an imaging system that directly interacts with the patient's body.
N/A
Intended Use / Indications for Use
SOMATOM Emotion 6/16 CT 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.)
Product codes
JAK
Device Description
The SOMATOM Emotion 6 and the SOMATOM Emotion 16 are whole body X-ray Computed Tomography Systems. The SOMATOM Emotion 6 and the SOMATOM Emotion 16 produce CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors.
The system software is a command-based program used for patient management, X-ray scan control, image reconstruction, and image archive/evaluation. The new version of system software, SOMARIS/5 VC30 supports the following modifications: 1) Localized language support of scan protocols, 2) Easy UI improvement, 3) Study Split Improvement, 4) FAST kV, 5) syngo. via client, 6) online help based on knowledge gateway, 7) new software field update concept 8) Temporal-MIP, 9) TrueD-4D viewer, 10) FAST 3D Align, 11) Tube Protection.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray transmission data / Computed Tomography X-ray System
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
Performance tests were conducted to test the functionality of the SOMATOM Emotion 6/16 configured with software version syngo® CT VC30-easyIQ version. 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted for the SOMATOM Emotion 6/16 configured with software version syngo® VC30-easyIQ version 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.
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.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2015
Siemens Medical Solutions USA, Inc. % Mr. John Urtz Regulatory Affairs Specialist 40 Liberty Boulevard, Mail Code 65-1A MALVERN PA 19355
Re: K151752
Trade/Device Name: SOMATOM Emotion 6/16 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 23, 2015 Received: October 23, 2015
Dear Mr. Urtz:
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 Oakes
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Indications for Use
Image /page/2/Picture/5 description: The image shows the text "510(k) Number (if known)" followed by empty boxes. The text indicates that the image is part of a form or document where the 510(k) number, if known, should be entered. The empty boxes suggest that the user should write the number in the provided spaces.
Image /page/2/Picture/6 description: The image shows the text "K151752" above the words "Device Name". There is a line separating the text from the words below. The text is in a simple, sans-serif font and is easy to read. The image is likely a label or identifier for a device.
SOMATOM Emotion 6/16
Indications for Use (Describe)
SOMATOM Emotion 6/16 CT 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.)
| 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:
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
.
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510(K) SUMMARY FOR SOMATOM Emotion 6/16 Systems
Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
November 9, 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.
1. General Information:
Importer/Distributor Establishment:
Registration Number: 2240869 Siemens Medical Solutions, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
Manufacturing Facility (1):
SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD 278 Zhou Zhu Rd Shanghai, CHINA, 201318 Establishment Registration Number: 3003202425
Manufacturing Facility (2):
Siemens AG; Medical Solutions Siemensstrasse 1 91301 Forchheim, GERMANY Establishment Registration Number: 3004977335
2. Contact Person:
John Urtz Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355-1406 Phone: (610) 448-6002 Fax: (610) 640-4481 Email: john.urtz@siemens.com
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3. Device Name and Classification
| Product Name: | SOMATOM Emotion 6 |
|---|---|
| Propriety Trade Name: | SOMATOM Emotion 6 (with syngo® CT VC30-easyIQ version) |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
Device Name and Classification
| Product Name: | SOMATOM Emotion 16 |
|---|---|
| Propriety Trade Name: | SOMATOM Emotion 16 (with syngo® CT VC30-easyIQ version) |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
Legally Marketed Primary Predicate Device:
| Product Name: | SOMATOM Emotion 6/16 |
|---|---|
| Propriety Trade Name: | SOMATOM Emotion 6/16 (with syngo® CT 2013A ((SOMARIS/5 VC20)) |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Clearance Number: | K133424 |
Legally Marketed Secondary Predicate Device:
| 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: | JAK |
| Clearance Number: | K143401 |
4. Substantial Equivalence:
Siemens SOMATOM Emotion 6 and SOMATOM Emotion 16 configured with software version syngo® CT VC30-easyIQ version (SOMARIS/5 VC30) is substantially equivalent to the following medical devices in commercial distribution:
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Table 1 Predicate Devices
| Manufacturer | Primary Predicate Device | 510(k)
Number | Clearance Date |
|--------------|-----------------------------------------------------------------------------------------------------------------|------------------|----------------|
| Siemens | syngo® CT 2013A (SOMARIS/5 VC20B) system
software for SOMATOM Emotion 6 CT and
SOMATOM Emotion 16 sysyems | K133424 | 01/17/2014 |
| Manufacturer | Secondary Predicate Device | 510(k)
Number | Clearance Date |
| Siemens | SOMATOM Definition Edge with SOMARIS/7 VA48 | K143401 | 04/06/2015 |
ട. Device Description:
The SOMATOM Emotion 6 and the SOMATOM Emotion 16 are whole body X-ray Computed Tomography Systems. The SOMATOM Emotion 6 and the SOMATOM Emotion 16 produce CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors.
The system software is a command-based program used for patient management, X-ray scan control, image reconstruction, and image archive/evaluation. The new version of system software, SOMARIS/5 VC30 supports the following modifications: 1) Localized language support of scan protocols, 2) Easy UI improvement, 3) Study Split Improvement, 4) FAST kV, 5) syngo. via client, 6) online help based on knowledge gateway, 7) new software field update concept 8) Temporal-MIP, 9) TrueD-4D viewer, 10) FAST 3D Align, 11) Tube Protection.
6. Indications for Use
The SOMATOM Emotion 6/16 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.)
7. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
SOMATOM Emotion 6/16 configured with software version syngo® VC30-easyIQ version 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 remain unchanged from 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.
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Table 2 Predicate Device Comparison
| Subject Device Feature | Predicate Device Feature | |
|---|---|---|
| New Software version syngo® CT | ||
| VC30-easyIQ version | System scanner software | |
| syngo® CT 2013A | ||
| K133424 | System scanner software | |
| syngo® CT VA48 | ||
| K143401 | ||
| Temporally MIP (t-MIP) | N/A | Temporally MIP (t-MIP) |
| FAST 3D Align | N/A | FAST 3D Align |
| TrueD-4D Viewer | N/A | TrueD-4D Viewer |
| Fast kV | N/A | N/A |
| Localized Language Support of | ||
| Scan Protocols | N/A | N/A |
| Easy UI Improvement | Easy UI | Easy UI |
| Study Split Improvement | Study Split | Study Split |
| syngo.via client | N/A | syngo.via client |
| Online Help Based on Knowledge | ||
| Gateway | Online help available | Online help available |
| New Software Field Update | ||
| Concept | N/A | N/A |
| Tube Protection | N/A | N/A |
8. Nonclinical Testing:
SOMATOM Emotion 6/16 configured with software version syngo® VC30-easyIQ version 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. 3.1
- 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 - 3.14: 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, 2005 .
- IEC 60601-1-3: 2008, Medical electrical equipment Part 11-3: General requirements for radiation . protection in diagnostic X-ray equipment
- IEC 60601-1-6: 2010; Medical electrical equipment Part 1-6: General requirements for basic safety . and essential performance -- Collateral Standard: Usability
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- 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 .
- NEMA XR-26: Access Controls for Computed Tomography—Identification, Interlocks, and Logs ●
- IEC/ISO 10918: Information Technology Digital Compression and Coding of Continuous-Tone Still . Images: Requirements and Guidelines [Including: Technical Corrigendum (2005)]
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 Emotion 6/16 configured with software version syngo® VC30-easyIQ version 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.
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 Emotion 6/16 configured with software version syngo® CT VC30-easyIQ version. 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.
9. 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.
10. Conclusion as to Substantial Equivalence:
The SOMATOM Emotion 6/16 configured with software version syngo® CT VC30-easyIQ version 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 syngo® CT 2013A (SOMARIS/5 VC20B) system software for SOMATOM Emotion 6 CT systems and SOMATOM Emotion 16 (K133424) 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.