(263 days)
The SOMATOM Scope and SOMATOM Scope Power 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.
The Siemens SOMATOM Scope/Scope Power are Computed Tomography X- ray Systems which feature a continuously rotating tube-detector system and function according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.
The new version of system software, SOMARIS/5 VC30 supports 1) Localized language support of scan protocols, 2) Easy UI Improvement, 3) iMAR, 4) Study Split Improvement, 5) FAST kV, 6) e-Sleep Improvement, 7) syngo. via client, 8) Touch Panel (FAST Positioning), 9) online help based on knowledge gateway, 10) FAST Wizard, 11) new software field update concept, 12) Temporal-MIP, 13) TrueD-4D viewer, 14) RTP Enhancement 15) Adaptive Signal Boost Improvement, 16) FAST 3D Align, 17) Dual Spiral Dual Energy, 18) FAST DE Results (for Mono-energetic), 19) Tube Protection, 20) SAFIRE, 21) Modified Patient Table 22) Interleaved Volume Reconstruction (IVR)
The provided text describes a 510(k) summary for the Siemens SOMATOM Scope/Scope Power Computed Tomography X-ray Systems. This document focuses on demonstrating the substantial equivalence of a new software version (SOMARIS/5 VC30 syngo® CT VC30-easylQ version) to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and study information provided, noting the limitations of the document for some specific requests:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with specific quantitative targets for "device performance" in the way one might expect for a new diagnostic algorithm's sensitivity, specificity, or accuracy. Instead, it focuses on demonstrating conformance to established standards and the successful verification and validation of software functionalities.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Conformance to Regulatory Standards | Fulfilled requirements of: - IEC 60601-2-44: Safety of X-ray equipment for CT- IEC 61223-3-5: Acceptance tests - Imaging performance of CT X-ray equipment CORRIGENDUM 1- NEMA XR-25: Computed Tomography Dose Check- IEC 61223-2-6: Constancy tests - Imaging performance of CT X-ray equipment- NEMA PS 3.1 3.20 (2011): DICOM Set- IEC 62304 Ed. 1.0: Medical device software life cycle processes- IEC 60601-1: General requirements for Safety, 2005- IEC 60601-1-6 : 2010; Usability- ISO 14971: Application of risk management to medical devices- NEMA XR-29: Dose Optimization and Management- NEMA XR-26: Access Controls- IEC/ISO 10918: Digital Compression and Coding- 60601-1-2 (2007): Electromagnetic Compatibility |
| Software Verification/Validation | Accepted results for:- All software specifications met acceptance criteria.- Testing for verification and validation of the device was found acceptable to support claims of substantial equivalence.- Performance tests demonstrate the subject device performs as intended for included features. |
| Risk Analysis and Control | Risk analysis was completed, and risk control implemented to mitigate identified hazards. |
| General Safety and Effectiveness (Labeling) | Device labeling contains instructions for use and necessary cautions/warnings for safe and effective use. |
| Substantial Equivalence | The proposed device has the same intended use and comparable indication for use as predicate devices. Technological characteristics (image acquisition, operating platform, image manipulation) are similar. The results of non-clinical tests and software validation demonstrate the subject device is as safe and effective as predicate devices. |
Note: This is a 510(k) for a software update to an existing CT system. The primary goal is to show substantial equivalence, not necessarily to prove efficacy for new clinical claims with extensive performance metrics like sensitivity/specificity. The focus is on ensuring the new software features do not introduce new safety or effectiveness concerns and maintain the performance of the cleared predicate device.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "sample size" in terms of patient cases or imaging data used for a test set for clinical performance evaluation. The testing described is primarily non-clinical verification and validation of software functionalities and adherence to technical and electrical safety standards.
- Sample Size for Test Set: Not specified in terms of patient data or images. The testing seems to be functional and engineering-level.
- Data Provenance: Not specified, as it's primarily non-clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The document describes non-clinical software and system performance testing, not a clinical study involving ground truth established by medical experts.
4. Adjudication Method for the Test Set
Not applicable, as it's not a clinical study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance
No MRMC study was mentioned or performed. This document is for a CT system software update, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a Computed Tomography X-ray System. While it has extensive software, it is not an "algorithm only" device in the AI sense. Its "standalone performance" refers to its ability to acquire and reconstruct images according to its specifications and regulatory standards, which was tested non-clinically. The document confirms that "performance tests were conducted to test the functionality of the SOMATOM Scope/Scope Power configured with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ version."
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of clinical ground truth. The "ground truth" for the non-clinical testing would be the engineering specifications and expected behavior of the software and hardware components.
8. The Sample Size for the Training Set
Not applicable. This is a 510(k) for a CT system's software update, not a machine learning algorithm that requires a separate training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for a machine learning algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2016
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Technical Specialist, Regulatory Submissions 40 Liberty Boulevard, Mail Code 65-1A MALVERN PA 19355
Re: K151749
Trade/Device Name: SOMATOM Scope/Scope Power Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 7, 2016 Received: March 9, 2016
Dear Ms. Mangum:
This letter corrects our substantially equivalent letter of March 18, 2016.
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
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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.
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Oels
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
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Indications for
Image /page/2/Picture/6 description: The image shows the 510(k) number, which is K151749. The text "510(k) Number (if known)" is above the number. The number is in a large, bold font.
Device Name SOMATOM Scope/Scope Power
Indications for Use (Describe)
The SOMATOM Scope and SOMATOM Scope Power 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 SCOPE SYSTEMS
Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355 Date Prepared: October 30, 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 Mail code: 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 Business Unit CR Siemensstrasse 1 DE-91301 Forchheim, Germany Establishment Registration Number: 3004977335
Contact Person: 2.
Kimberly Mangum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 40 Liberty Boulevard, 65-1A Malvern, PA 19355-1406 Phone: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com
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| 3. Device Name and Classification | |
|---|---|
| Product Name: | SOMATOM Scope |
| Propriety Trade Name: | SOMATOM Scope (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 Scope Power |
| Propriety Trade Name: | SOMATOM Scope Power (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 Scope/Scope Power |
|---|---|
| Propriety Trade Name: | SOMATOM Scope/Scope Power |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| 510(k) #: | K140912 |
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 |
| 510(k)#: | K143401 |
Substantial Equivalence: 4.
Siemens SOMATOM Scope/Scope Power with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ version is substantially equivalent to the following medical devices in commercial distribution.
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Table 1 Predicate Devices
| Predicate Device Name andManufacturer | 510(k)number | Clearance Date |
|---|---|---|
| Primary Predicate Device:Siemens SOMATOM Scope/Scope Powerwith SOMARIS/5 VC28 | K140912 | 09/15/2014 |
| Secondary Predicate Device:Siemens SOMATOM Definition Edge withSOMARIS/7 VA48 | K143401 | 04/06/2015 |
5. Device Description:
The Siemens SOMATOM Scope/Scope Power are Computed Tomography X- ray Systems which feature a continuously rotating tube-detector system and function according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.
The new version of system software, SOMARIS/5 VC30 supports 1) Localized language support of scan protocols, 2) Easy UI Improvement, 3) iMAR, 4) Study Split Improvement, 5) FAST kV, 6) e-Sleep Improvement, 7) syngo. via client, 8) Touch Panel (FAST Positioning), 9) online help based on knowledge gateway, 10) FAST Wizard, 11) new software field update concept, 12) Temporal-MIP, 13) TrueD-4D viewer, 14) RTP Enhancement 15) Adaptive Signal Boost Improvement, 16) FAST 3D Align, 17) Dual Spiral Dual Energy, 18) FAST DE Results (for Mono-energetic), 19) Tube Protection, 20) SAFIRE, 21) Modified Patient Table 22) Interleaved Volume Reconstruction (IVR)
6. Indications for Use
The SOMATOM Scope 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 xray tube, and the simultaneous translation of the patient.)
-
- Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
SOMATOM Scope/Scope Power configured with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ version do 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
- Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
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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.
| Predicate Device Comparable Feature | |||
|---|---|---|---|
| Subject DeviceFeature | Subject DeviceSOMATOM Scope/ScopePower | Primary PredicateDeviceSOMATOM Scope/ScopePower | SOMATOMDefinition Edge(K143401) |
| Localized languagesupport of scan protocols | Localized language support ofscan protocols | N/A | N/A |
| Easy UI Improvement | Easy UI Improvement | Easy UI | Easy UI |
| iMAR | iMAR | N/A | iMAR |
| Study Split Improvement | Study Split Improvement | Study Split | Study SplitImprovement |
| FAST kV | FAST kV | N/A | N/A |
| e-Sleep Improvement | e-Sleep Improvement | e-Sleep | N/A |
| syngo.via client | syngo.via client | N/A | syngo.via client |
| FAST Positioning | FAST Positioning | N/A | N/A |
| Online help based onknowledge gateway | Online help based onknowledge gateway | Online help available | Online helpavailable |
| FAST Wizard | FAST Wizard | N/A | N/A |
| New software fieldupdate concept | New software field updateconcept | N/A | N/A |
| Temporal MIP (t-MIP) | Temporal MIP (t-MIP) | N/A | Temporal MIP (t-MIP) |
| True-D-4D Viewer | True-D-4D Viewer | N/A | True-D-4DViewer |
| RTP Enhancement | RTP enhancement | RTP supported | RTP supported |
| Adaptive Signal BoostImprovement (SDFImprovement) | Adaptive Signal BoostImprovement (SDFImprovement) | Adaptive Signal Boost | N/A |
| FAST 3D Align | FAST 3D Align | N/A | FAST 3D Align |
| Dual Spiral Dual Energy | Dual Spiral Dual Energy | N/A | Dual Spiral DualEnergy |
| FAST 3D Results forMono-Energetic | FAST 3D Results for Mono-Energetic | N/A | FAST 3D Resultsfor Mono-Energetic |
| SAFIRE | SAFIRE | N/A | SAFIRE |
| Modified Patient Table | Modified Patient Table | Normal table load | N/A |
| Tube Protection | Tube Protection | N/A | N/A |
| Interleaved VolumeReconstruction (IVR) | Interleaved VolumeReconstruction (IVR) | N/A | N/A |
Table 2 Predicate Device Comparison
Nonclinical Testing: 8.
SOMATOM Scope/Scope Power configured with software version syngo® CT VC30-easylQ version is designed to fulfill the requirements of the following standards:
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- . 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 3.20 (2011): 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 60601-1-6 : 2010; Medical electrical equipment Part 1-6: General ● requirements for basic safety and essential performance -- Collateral Standard: Usability
- 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)]
- 60601-1-2 (2007): Medial Electrical Equipment Part 1-2: General ● requirements for basic safety and essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
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 Scope/Scope Power configured with software version SOMARIS/5 VC30 syngo® CT VC30easylQ version during product development. The modifications described in this Premarket Notification were supported with verification/validation and performance 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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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 Scope/Scope Power configured with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ 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 Scope/Scope Power configured with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ 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 the SOMATOM Scope/Scope Power (K140912) is 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.
§ 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.