(119 days)
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of X-ray transmission data.
The images delivered by the system can be used by a trained physician as an aid in diagnosis.
This CT system can be used for low dose lung cancer screening in high risk populations. *
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011: 365:395-409) and subsequent literature. for further information.
The Siemens SOMATOM Drive is a Computed Tomography X- ray System, which features two continuously rotating tube-detector systems and functions according to the fan beam principle. The SOMATOM Drive produces CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors. The computer system delivered with the CT scanner is able to run the post processing applications optionally. syngo CT VA62A (SOMARIS/7 VA62A) is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation available on the SOMATOM Drive CT system.
Here's a breakdown of the acceptance criteria and supporting studies for the SOMATOM Drive, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria in a dedicated table for the SOMATOM Drive (the new device being reviewed). Instead, it focuses on demonstrating that the SOMATOM Drive meets software specifications and performs comparably to predicate devices. The "reported device performance" is largely implicitly stated by concluding that "all of the software specifications have met the acceptance criteria" and "the SOMATOM Drive performs as intended."
However, we can infer some "acceptance criteria" through the lens of what was tested and compared to predicate devices:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Conformance to recognized standards. | Claims conformance to IEC 60601-1/A2: 2005; IEC 60601-2-44:2009 +A1:2012; XR-29: 2013; ISO/IEC 14971:2007; IEC 62304: Ed. 1.0 2006, IEC 61223-2-6: 2006, 61223-3-5: 2004, XR 25, ISO/IEC 10918-1: 1994, DICOM NEMA PS 3.1 - PS 3.20. Risk analysis completed, hazards mitigated, and risk control implemented. |
| Software Functionality: All software specifications met. | "The test results show that all of the software specifications have met the acceptance criteria." "Verification and validation testing of the device was found acceptable to support the claim of substantial equivalence." "The performance data demonstrates continued conformance with special controls for medical devices containing software." |
| Image Performance: Comparable to predicate devices. | "Non-clinical tests (integration and functional), including phantom test were conducted during the SOMATOM Drive product development." "The non-clinical test data demonstrates that the SOMATOM Drive performance is comparable to the predicate devices that are currently marketed for the same intended use." |
| Dosimetry: Met during product development. | "Non clinical tests, including dosimetry and image performance, were conducted for the SOMATOM Drive during product development." |
| New Features (X-ray Tube/kV Steps): Function as intended. | Higher mA at lower kV levels (70kV, 80kV). Consistent 10kV steps (70-140kV), adding 90kV, 110kV, 130kV. Implied to function correctly based on overall software/performance claims. |
| New Features (Tube Collimator): Function as intended. | Includes Tin Filter on collimator of both X-ray tubes (vs. one on predicate). Implied to function correctly. |
| New Features (Dual Power Mode): Function as intended. | Allows use of both tubes at same kV with routine pitch and full detector width, doubling mA. Implied to function correctly, compared to predicate which only allowed half detector width. |
| Clinical Performance for Dual Source Dual Power mode: Demonstrated. | "Clinical images were evaluated to demonstrate performance for Dual Source Dual Power mode." |
| Effectiveness: Supported by clinical literature for lung cancer screening. | Refers to the National Lung Screening Trial (NLST) for low-dose lung cancer screening. (This is for the indication for use, not the device's technical performance itself). |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for specific non-clinical tests. The document mentions "clinical images were evaluated" for Dual Source Dual Power mode, but the number of images/patients is not provided.
- Data Provenance:
- Non-clinical/Software Testing: Conducted "during product development." This implies controlled, in-house testing, likely in Germany where the manufacturing site is located (Siemens Healthcare GmbH, Forchheim, Germany).
- Clinical Images: "Clinical images were evaluated" suggests retrospective or newly acquired images for validation. No specific country of origin is mentioned.
- National Lung Screening Trial (NLST): A multi-center randomized controlled trial conducted in the United States. The study started in August 2002 and completed in October 2010.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- For the device's technical performance (non-clinical tests, software evaluation):
- No information is provided about expert involvement for establishing ground truth for the test set used in non-clinical or software testing. These typically rely on defined engineering specifications and quantitative measurements.
- For the clinical images evaluated for Dual Source Dual Power mode:
- No information provided on experts or their qualifications for evaluating these images.
- For the NLST reference:
- The NLST involved multiple radiologists at participating centers. The interpretation task for CT was to detect lung nodules of 4mm diameter or greater. The expertise of these radiologists would be broad, as it was a large-scale clinical trial. The document doesn't detail their specific years of experience or sub-specialties beyond being "trained physicians" in the general indications.
4. Adjudication Method for the Test Set:
- No specific adjudication method (e.g., 2+1, 3+1) is mentioned for any of the tests conducted for the SOMATOM Drive itself.
- The NLST, as a large clinical trial, would have had its own established protocols for interpretation, consensus, and potentially adjudication to establish ground truth for its primary endpoints, but this is not detailed in the 510(k) summary regarding the device's performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done regarding human readers improving with AI vs. without AI assistance.
- The SOMATOM Drive is a CT scanner, not an AI-assisted diagnostic tool. The document focuses on the hardware and reconstruction software performance, not on AI for interpretation.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop):
- Yes, a standalone performance assessment was conducted for the device's capabilities. The document states:
- "Nonclinical tests, including dosimetry and image performance, were conducted for the SOMATOM Drive during product development."
- "The test results show that all of the software specifications have met the acceptance criteria."
- "Non-clinical tests (integration and functional), including phantom test were conducted during the SOMATOM Drive product development."
- These tests assess the system's output (images, dose measurements) directly against specified criteria, effectively evaluating its "standalone" algorithmic and hardware performance.
7. Type of Ground Truth Used:
- For non-clinical/software performance:
- Ground truth was based on engineering specifications and phantom measurements. These are objective, quantifiable standards for image quality, dose, and system functionality.
- For clinical images for Dual Source Dual Power mode:
- Not explicitly defined, but implied to be based on clinical evaluation of the images by unstated evaluators.
- For the NLST reference (supporting the Indication for Use for lung cancer screening):
- The NLST's ground truth for lung cancer detection and mortality reduction would have been based on pathology results for confirmed cancers and long-term outcomes data (mortality).
8. Sample Size for the Training Set:
- Not applicable / Not provided. The SOMATOM Drive is a CT imaging system. While it uses complex algorithms for image reconstruction (e.g., ADMIRE, iMAR), these are typically engineered using physics-based models and iterative refinement, not "trained" on large datasets in the way modern deep learning AI models are. Therefore, there isn't a "training set" in the context of machine learning. The algorithms are part of the system's core functionality.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, the system uses algorithms that are largely model-based and optimized through engineering principles, rather than being trained on a labeled dataset with a "ground truth" in the AI sense.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 24, 2016
Siemens Medical Solutions USA, Inc. Kimberly Mangum Regulatory Affairs Specialist 65 Valley Stream Parkway Malvern, Pennsylvania 19355
Re: K161196
Trade/Device Name: SOMATOM Drive Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: July 22, 2016 Received: July 25, 2016
Dear Kimberly 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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" (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 vours.
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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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) K161196
Device Name
SOMATOM Drive
Indications for Use (Describe)
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of X-ray transmission data.
The images delivered by the system can be used by a trained physician as an aid in diagnosis.
This CT system can be used for low dose lung cancer screening in high risk populations. *
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011: 365:395-409) and subsequent literature. for further information.
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)
Page 1 of 1
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SIEMENS
510(k) Summary: SOMATOM Drive
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Date Prepared: July 20, 2016
This 510(k) summary of 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: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number: 2240869
Location of Manufacturing Site
Siemens Healthcare GmbH Siemensstrasse 1 D-91301 Forchheim. Germany Establishment Registration Number: 3004977335
Contact Person:
Kimberly Mangum Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com
2. Device Name and Classification:
| Product Name: | SOMATOM Drive |
|---|---|
| Trade Name: | SOMATOM Drive |
| Classification Name: | Computed Tomography X-Ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
3. Legally Marketed Predicate Devices
SOMATOM Definition Flash Trade Name: 510(k) #: K143416 Clearance Date: April 16, 2015 Computed Tomography X-ray System Classification Name: Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Class II Device Class: Product Code: JAK
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| Recall Information: | This predicate device has not been the subject of any design related recalls. |
|---|---|
| Trade Name: | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/Scope Power |
| 510(k) #: | K142955 |
| Clearance Date: | November 24, 2015 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | This predicate device has not been the subject of any design related recalls |
| Reference Device Trade Name: | SOMATOM Force |
| 510(k) #: | K133589 |
| Clearance Date: | April 17, 2014 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | This reference device has not been the subject of any design related recalls |
4. Device Description:
The Siemens SOMATOM Drive is a Computed Tomography X- ray System, which features two continuously rotating tube-detector systems and functions according to the fan beam principle. The SOMATOM Drive produces CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors. The computer system delivered with the CT scanner is able to run the post processing applications optionally. syngo CT VA62A (SOMARIS/7 VA62A) is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation available on the SOMATOM Drive CT system.
5. Indication for Use:
This computed tomography system is intended to generate and process crosssectional images of patients by computer reconstruction of X-ray transmission data.
The images delivered by the system can be used by a trained physician as an aid in diagnosis.
This CT system can be used for low dose lung cancer screening in high risk populations.*
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SIEMENS
*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
6. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Devices:
The SOMATOM Drive provides the same technological characteristics in terms of materials, energy source and control mechanisms when compared to the predicate devices. The performance data of the X-ray tube and software features for the subject device SOMATOM Drive have been improved in comparison to the predicate device as described below:
X-Ray Tube/kV Steps Improvements:
The SOMATOM Drive includes two STRATON MX Sigma X-ray tubes, which are a modification of the X-ray tube to the predicate device (SOMATOM Definition Flash). This modification enables higher mA at lower kV levels. 70 kV and 80 kV (High Power 70 and High Power 80) in comparison to predicate device (SOMATOM Definition Flash).
The STRATON MX Sigma also enables consistent 10 kV steps from 70 to 140 kV, which were introduced as part of the predicate device (SOMATOM Force) and adds 90 kV. 110 kV and 130 kV steps in comparison to the predicate device (SOMATOM Definition Flash).
Tube Collimator Improvement
The SOMATOM Drive includes the Tin Filter (selective photon shield) as cleared in the predicate device (SOMATOM Definition Flash) on the collimator of both X-ray tubes, whereas the predicate device (SOMATOM Definition Flash) only had this on one X-ray tube.
Dual Power (full detector width)
The SOMATOM Drive allows the use of both tubes at the same kV with a routine pitch and full detector width, providing a doubling of the mA available in the examination (Dual Power Mode). The predicate device (SOMATOM Definition Flash) allows the use of both tubes at the same kV with a routine pitch only at half detector width.
Comparison of the technological characteristics
A tabular comparison of the technological characteristics between the subject device and predicate devices is provided as Table 1 below:
| Property | Subject Device:SOMATOM Drive | Primary PredicateDevice: SOMATOMDefinition FlashK143416 | Secondary PredicateDevice: SOMATOMForce cleared as part ofK142955 and ReferenceDevice K133589 |
|---|---|---|---|
| Generator | high voltage generatorwith max power100kW | high voltage generatorwith max power 100kW | high voltage generatorwith max power 120kW |
| User Interface | Touch based HumanMachine Interface | LCD Front gantrydisplay | LCD Front gantry display |
| Table 1: Subject Device Comparable Properties | |
|---|---|
| ------------------------------------------------ | -- |
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| Property | Subject Device:SOMATOM Drive | Primary PredicateDevice: SOMATOMDefinition FlashK143416 | Secondary PredicateDevice: SOMATOMForce cleared as part ofK142955 and ReferenceDevice K133589 |
|---|---|---|---|
| Patient tables | standard patient table(PHS4n)OPTIONALMultipurpose Table(MPT2n) | standard patient table(PHS4)OPTIONALMultipurpose Table(MPT2) | standard patient table(PHS5)OPTIONAL MultipurposeTable (MPT4) |
| x-ray tube | STRATON MX Sigma | STRATON MX P | Vectron |
| kV Steps | 70 kV, 80kV, 90kV,100kV, 110kV, 120kV,130kV, 140kV | 70kV, 80kV,100kV,120kV, 140kV | 70kV, 80kV, 100kV,120kV, 140kV |
| tubecollimator | including movable tinfilters for both tubes | including movable tinfilters only for tube B | including movable tinfilters for both tubes |
| Software | Windows basedSOMARIS/7 VA62A | Windows basedSOMARIS/7 VA48A | Windows basedSOMARIS/7 VA50 |
| Adjustable kVSettings | support of additionalkV steps | Support of adjustablekV settings | Support of adjustable kVsettings |
| Post-processingapplicationCalciumScoring | support for CalciumScoring with SN 100kVtube power setting | Support of CalciumScoring Post-Processing Application | Support of CalciumScoring Post-ProcessingApplication |
| iterativereconstructionmethods | ADMIREiMAR | SAFIREADMIREiMAR | SAFIREADMIRE |
The intended use and fundamental scientific technology remain unchanged from the predicate devices. The Indication for Use and technological characteristics are similar for the subject and predicate devices. Any differences in technological characteristics between the subject device and predicate devices do not raise different questions of safety and effectiveness. As such, Siemens believes that the subject device is substantially equivalent to the predicate devices.
7. Nonclinical Testing
The features described in this premarket notification are supported with verification and validation testing. Non clinical tests, including dosimetry and image performance, were conducted for the SOMATOM Drive during product development. The risk analysis was completed and risk control implemented to mitigate identified hazards. The test results show that all of the software specifications have met the acceptance criteria. Verification and validation testing of the device was found acceptable to support the claim of substantial equivalence.
Siemens claims conformance to the following standards: IEC 60601-1/A2: 2005; IEC 60601-2-44:2009 +A1:2012; XR-29: 2013; ISO/IEC 14971:2007; IEC 62304: Ed. 1.0 2006, IEC 61223-2-6: 2006, 61223-3-5: 2004, XR 25, ISO/IEC 10918-1: 1994, DICOM NEMA PS 3.1 - PS 3.20.
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SIEMENS
The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional). including phantom test were conducted during the SOMATOM Drive product development. The Risk analysis was completed, and risk control implemented, to mitigate identified hazards. The test results show that all of the software specifications have met the acceptance criteria.
Additional provided supporting data
The National Lung Screening Trial (NLST), sponsored by the National Cancer Institute, is used to support the additional lung cancer screening Indications for Use. The study was a randomized trial of screening with the use of low-dose CT compared to chest radiography to determine whether screening with low-dose CT could reduce mortality from lung cancer. The study start date was August. 2002 and the completion date was October. 2010. The interpretation task with CT for this study was to detect lung nodules of 4mm diameter or greater.
8. Clinical Testing
Clinical images were evaluated to demonstrate performance for Dual Source Dual Power mode. Clinical experience phrased in peer reviewed articles support the performance and effectiveness of several features provided with SOMATOM Drive.
9. General Safety and Effectiveness Concerns:
The device labeling contains instructions for use as well as 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. In order to minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
10.Conclusion as to Substantial Equivalence:
The subject device non-clinical data similarly supports the safety of the software with verification and validation testing. Verification and validation testing demonstrates that the SOMATOM Drive performs as intended. The non-clinical test data demonstrates that the SOMATOM Drive performance is comparable to the predicate devices that are currently marketed for the same intended use.
For SOMATOM Drive, Siemens used the same testing with the same workflows as was used to clear the predicate devices. Since both devices were tested using the same methods. Siemens believes that the data generated from the SOMATOM Drive testing supports a finding of substantial equivalence.
§ 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.