(113 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. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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 subject device SOMATOM CT Scanner Systems with SOMARIS/7 syngo CT VB20 are Computed Tomography X-ray Systems which feature one (single source) or two (dual source) continuously rotating tubedetector system and function according to the fan beam principle. The SOMATOM CT Scanner Systems with Software SOMARIS/7 syngo CT VB20 produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.
The platform software for the SOMATOM CT Scanner Systems, SOMARIS/7 syngo CT VB20, is a commandbased program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.
Here's an analysis of the acceptance criteria and supporting study information based on the provided text, broken down by your requested points:
Acceptance Criteria and Study Information for SOMATOM CT Scanner Systems-Software Version SOMARIS/7 syngo CT VB20
The provided document (a 510(k) summary) describes an update to existing Computed Tomography (CT) scanner systems (SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Definition AS/AS+, SOMATOM Confidence, and SOMATOM Edge Plus) with new software version SOMARIS/7 syngo CT VB20. The primary goal of the submission is to demonstrate substantial equivalence to previously cleared predicate devices (K173630 and K173607).
The document does not explicitly list specific numerical acceptance criteria for device performance beyond stating that "all software specifications have met the acceptance criteria" and "the SOMATOM CT Scanner Systems perform comparably to the predicate devices." It focuses on confirming the updated device maintains the safety and effectiveness of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria are not presented in the document, I will infer the high-level acceptance criteria from the submission's focus on demonstrating substantial equivalence and list the general performance statements made.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence: Device maintains equivalent safety and effectiveness to predicate devices. | "The subject and predicate devices are based on the following same technological elements: Scanner Principle, System Acquisition, Iterative Reconstruction, Workplaces, Patient table, Patient table foot switch for movement, Tin filtration technology, Stellar detector technology." "Testing and validation is completed. Test results show that the subject devices, the SOMATOM CT Scanner Systems, are comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices." "The non-clinical data supports the device and the hardware and software verification and validation demonstrates that the subject device SOMATOM CT Scanner Systems should perform as intended in the specified use conditions." |
| Conformance to Standards: Device complies with relevant electrical safety, EMC, software, and risk management standards. | "Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the SOMATOM CT Scanner Systems in accordance with the following standards: 60601-2-44, and 60601-1-2. A list of recognized and general consensus standards considered for the subject devices is provided as Table 9." (Table 9 and 10 list numerous IEC, ANSI AAMI, NEMA, and ISO standards). "Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document... is also included... The Risk Analysis was completed and risk control implemented to mitigate identified hazards." |
| Software Specifications Met: All software features and updates function as intended. | "The test results show that all of the software specifications have met the acceptance criteria." |
| Verification and Validation: Comprehensive testing proves the device's claims. | "The modifications described in this Premarket Notification were supported with verification and validation testing." "Verification and validation testing of the device was found acceptable to support the claim of substantial equivalence." |
| Cybersecurity: Device meets cybersecurity requirements. | "Siemens conforms to the Cybersecurity requirementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient... is included within this submission." |
| Image Quality / Performance (Implicit): Image reconstruction and diagnostic aid functionality are maintained or improved. | "Non-clinical test (integration and functional) including phantom tests were conducted for the SOMATOM CT Scanner Systems during product development." "dosimetry and imaging performance, and analysis of phantom images to assess device and feature performance during product development." (The document implies these tests confirmed performance but doesn't provide specific numerical results). |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "phantom tests were conducted" and refers to "dosimetry and imaging performance, and analysis of phantom images to assess device and feature performance." However, no specific sample size for the test set (number of phantom scans, patient data, etc.) is provided.
Data Provenance: The tests are described as "non-clinical test (integration and functional) including phantom tests... during product development." This indicates that the testing was conducted internally by the manufacturer,Siemens, likely on prototypes or production units, using phantoms. There is no mention of human subject data, country of origin, or whether the tests utilized retrospective or prospective data. The nature of phantom studies typically makes them prospective in this context.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide information on the number of experts used to establish ground truth or their specific qualifications (e.g., number of radiologists, years of experience). Given the nature of this submission (software upgrade for a CT system, focusing on technical performance and substantial equivalence rather than a new diagnostic algorithm's clinical efficacy), it's less likely to involve extensive expert-driven ground truth establishment as would be seen for AI/CADe devices. The "ground truth" for technical performance is typically established via physical measurements and established phantom metrics.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1). As stated above, the testing appears to be primarily technical and phantom-based, where ground truth is often objectively measurable through physical properties or established methods, rather than subjective expert interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported in this document. The submission focuses on demonstrating substantial equivalence of the updated CT system to its predicates through technical and non-clinical testing, not on measuring improvements in human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
While the document focuses on the performance of the CT system and its software, it does not specifically describe a standalone algorithm-only performance study in the context of an AI/CADe device. The SOMARIS/7 syngo CT VB20 is a platform software update for CT scanners, enhancing system functionality and image reconstruction capabilities (e.g., "Enhanced FAST DE Results," "Precision Matrix," "DirectDensity™"). The "performance" being evaluated is the system's ability to generate cross-sectional images and support diagnostic tasks, as opposed to a specific AI algorithm. The performance evaluation discussed would inherently be of the "algorithm" integrated into the system, contributing to the overall image quality and functional capabilities.
7. Type of Ground Truth Used
The ground truth for the non-clinical testing appears to be based on:
- Physical Measurements and Phantom Readings: "Non-clinical test (integration and functional) including phantom tests were conducted." This implies that phantoms with known properties or simulated pathologies were used, and the system's output (image quality, dose metrics, etc.) was measured against these known values.
- Engineering Specifications / Reference Data: For software functional tests ("all software specifications have met the acceptance criteria"), the ground truth would be the defined engineering and design specifications for the software's intended behavior.
There is no mention of pathology, outcomes data, or expert consensus (in the typical sense of clinical ground truth for diagnostic accuracy) for establishing the ground truth described in this submission.
8. Sample Size for the Training Set
The document does not mention a training set sample size or the use of a separate training set. This is consistent with the nature of the submission, which describes a software update for a CT system rather than a machine learning or AI algorithm submission where training data sets are explicitly separated from test data. The software updates described are enhancements to the system's core functionality, reconstruction, and workflow, which are typically developed and verified through engineering processes rather than large-scale machine learning training.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in the context of typical AI/ML development, this information is not applicable based on the provided document. The "training" for such system software updates primarily refers to the iterative development and internal testing processes by the engineers, where specifications serve as the "ground truth."
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc % Ms. Maria Ebio Sr. Director, Regulatory Affairs 40 Liberty Blvd. MALVERN PA 19355
June 27, 2019.
Re: K190578
Trade/Device Name: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: May 15, 2019 Received: May 16, 2019
Dear Ms. Ebio:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K190578
Device Name SOMATOM Definition AS/AS+
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. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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) |
|---|
| ------------------------------------------------- |
X 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
{3}------------------------------------------------
510(k) Number (if known) K190578
Device Name SOMATOM Confidence
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. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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) | |
|---|---|
| ------------------------------------------------- | -- |
X 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
{4}------------------------------------------------
510(k) Number (if known) K190578
Device Name SOMATOM Definition AS Open
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. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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)|X 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
{5}------------------------------------------------
510(k) Number (if known) K190578
Device Name SOMATOM Definition Edge
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. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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) | |
|---|---|
| ------------------------------------------------- | -- |
X 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
{6}------------------------------------------------
510(k) Number (if known) K190578
Device Name SOMATOM Definition Flash
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. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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) | |
|---|---|
X 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
{7}------------------------------------------------
510(k) Number (if known) K190578
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. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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) |
|---|
| ------------------------------------------------- |
X 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
{8}------------------------------------------------
510(k) Number (if known) K190578
Device Name SOMATOM Edge Plus
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. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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) | |
|---|---|
| ------------------------------------------------- | -- |
X 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
{9}------------------------------------------------
510(k) Number (if known) K190578
Device Name SOMATOM Force
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. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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) | |
|---|---|
| ------------------------------------------------- | -- |
|X 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
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.
510(K) SUMMARY
FOR
SOMATOM CT SCANNER SYSTEMS-SOFTWARE VERSION SOMARIS/7 syngo CT VB20
Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: February 28, 2019
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.
I. Submitter
Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869
Location of Manufacturing Site (1)
Siemens Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany Establishment Registration Number 3004977335
Location of Manufacturing Site (2)
SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD 278 Zhou Zhu Rd Shanghai, CHINA, 201318 Establishment Registration Number: 3003202425
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
II. Device Name and Classification
Product Name: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code:
SOMATOM Force SOMATOM Force Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK
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Image /page/11/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a cluster of orange dots.
Product Name: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code:
Product Name: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code:
Product Name: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code:
Product Name: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code:
Product Name: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code:
Product Name: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code:
Product Name: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code:
SOMATOM Definition Flash SOMATOM Definition Flash Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK
SOMATOM Drive SOMATOM Drive Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK
SOMATOM Definition Edge SOMATOM Definition Edge Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK
SOMATOM Definition AS/AS+ SOMATOM Definition AS/AS+ Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK
SOMATOM Definition AS Open SOMATOM Definition AS Open Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK
SOMATOM Confidence SOMATOM Confidence Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK
SOMATOM Edge Plus SOMATOM Edge Plus Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK
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III. Predicate Device
Primary Predicate Device:
| Trade Name: | SOMATOM CT Scanner Systems |
|---|---|
| 510(k) Number: | K173630 |
| Clearance Date: | March 30, 2018 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | All predicate device recalls have been considered in the subject device design. |
Predicate Device:
| Trade Name: | SOMATOM Edge Plus |
|---|---|
| 510(k) Number: | K173607 |
| Clearance Date: | March 21, 2018 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | There are currently no recalls for this device |
IV. Device Description
Siemens intends to market a new software version, SOMARIS/7 syngo CT VB20 for the following SOMATOM Computed Tomography (CT) Scanner Systems:
Dual Source CT Systems:
- SOMATOM Force
- SOMATOM Drive
- . SOMATOM Definition Flash
Single Source CT Systems:
- SOMATOM Definition AS/AS+ ●
- SOMATOM Definition AS Open ●
- SOMATOM Definition Edge
- SOMATOM Confidence ●
- . SOMATOM Edge Plus
The subject device SOMATOM CT Scanner Systems with SOMARIS/7 syngo CT VB20 are Computed Tomography X-ray Systems which feature one (single source) or two (dual source) continuously rotating tubedetector system and function according to the fan beam principle. The SOMATOM CT Scanner Systems with Software SOMARIS/7 syngo CT VB20 produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.
The platform software for the SOMATOM CT Scanner Systems, SOMARIS/7 syngo CT VB20, is a commandbased program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The subject devices with software version SOMARIS/7 syngo CT VB20 will support the following modifications in comparison with the predicate devices:
1) New/Modified Hardware
- Table 1: Overview of Hardware modifications supported by software SOMARIS/7 syngo CT ● VB20
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Image /page/13/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.
2) Software version SOMARIS/7 syngo CT VB20
- Table 2: Overview Software modifications of Single Source CT System Scanner with syngo CT ● VB20
- . Table 3: Overview Software modifications of Dual Source CT System Scanner with syngo CT VB20
3) Update 510(k) Information
- Provided as Appendix H .
| Table 1: Hardware Modifications Supported by software SOMARIS/7 syngo VB20 | ||||
|---|---|---|---|---|
| # | SOMATOM CT SystemScanner withSOMARIS/7 syngo CTVB20hardware properties | Subject Devices(Single Source Systems) | Subject Devices(Dual Source Systems) | |
| SOMATOM Definition AS/AS+; SOMATOM Definition AS Open; | SOMATOM Definition Edge SOMATOM Confidence SOMATOM Edge Plus | SOMATOM Force SOMATOM Definition Flash SOMATOM Drive | ||
| 1 | Stellar Detector (HW) | Unmodified | Unmodified | Modified |
Table 1: Hardware Modifications Supported by software SQMARIS/7 syngo VB20
| Table 2: Overview Software Modifications of Single Source CT System Scanner with syngo CT VB20 | |||||
|---|---|---|---|---|---|
| Single Source Subject Devices | |||||
| # | SOMATOM CT System ScannerwithSOMARIS/7 syngo CT VB20property | • SOMATOMDefinitionAS/AS+;• SOMATOMDefinition ASOpen | SOMATOMDefinition Edge | • SOMATOM Confidence;• SOMATOM Edge Plus | |
| 1 | Enhanced FAST DE Results | Modified | Modified | Modified | |
| 2 | Precision Matrix | N/A | N/A | N/A | |
| 3 | DirectBreathhold™ | New | New | New | |
| 4 | IT Hardening | Modified | Modified | Modified | |
| 5 | HD FoV (modification 4.0) | Modified | Modified | Modified | |
| 6 | Extended i-Control Function | Enabled | Enabled | Enabled | |
| 7 | Respiratory Scan Post-processing | Modified | Modified | Modified | |
| 8 | Data Role Settings | Enabled | Enabled | Enabled | |
| 9 | Stellar Detector (Firmware) | N/A | Modified | Modified | |
| 10 | DirectDensity™(showing relativemass density) | Modified | Modified | Modified | |
| 11 | FAST 3D Camera | N/A | N/A | Modified | |
| 12 | Support of Additional Dual SpiralDual Energy Protocols | New | New | New | |
| 13 | Modified User Interface Display | Modified | Modified | Modified |
| Table 3: Overview Software modifications of Dual Source CT System Scanner with syngo CT VB20 | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | ---------------------------------------------------------------------------------------------- | -- |
| # | SOMATOM CT System Scannerwith | Subject Devices(Dual Source) | ||
|---|---|---|---|---|
| SOMARIS/7 syngo CT VB20property | SOMATOM Force | SOMATOM Drive | SOMATOM DefinitionFlash | |
| 1 | Enhanced FAST DE Results | Modified | Modified | Modified |
| 2 | Precision Matrix | Modified | N/A | N/A |
| 3 | DirectBreathhold™ | N/A | New | New |
| 4 | IT Hardening | Modified | Modified | Modified |
| 5 | HD FoV (modification 4.0) | Unmodified | Modified | Modified |
| 6 | Extended i-Control Function | Enabled | Enabled | Enabled |
| 7 | Respiratory Scan Post-processing | N/A | Modified | Modified |
| 8 | Data Role Settings | Enabled | Enabled | Enabled |
| 9 | Stellar Detector (Firmware) | N/A | Modified | N/A |
| 10 | DirectDensity™ (showing relativemass density) | Modified | Modified | Modified |
| 11 | FAST 3D Camera | Modified | Modified | N/A |
| 12 | Support of Additional Dual SpiralDual Energy Protocols | N/A | N/A | N/A |
| 13 | Modified User Interface Display | Modified | Modified | Modified |
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A comparison of these modifications with respect to the predicate devices is provided the "Comparison of Technological Characteristics with the Predicate Device" section below. Software version SOMARIS/7 syngo CT VB20 will be offered as an optional upgrade for the applicable existing SOMATOM CT Systems.
V. Indications for Use
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. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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.
VI. Comparison of Technological Characteristics with the Predicate Device
The SOMATOM CT Scanner Systems with VB20 Software provide the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software features of these scanners have been modified or improved in comparison to the predicate devices to support enhanced device functionality compared to the predicate devices. The hardware components of the subject devices have been modified to support a modified Stellar Technology detector.
Software version SOMARIS/7 syngo CT VB20 supports software features that are designed as Software Platform update including all new and modified features. The applicable features are depending on the SOMATOM CT Scanner Systems technological characteristics and are provided as optional features for updating the installed base and are designed features for the subject devices: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM AS Open, SOMATOM Confidence, SOMATOM Edge Plus which supporting the technological characteristics as Hardware precondition for its intended software usage.
The intended use and fundamental scientific technology for the SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Edge, SOMATOM Definition AS/AS+, SOMATOM AS Open, SOMATOM Confidence, SOMATOM Edge Plus remains unchanged from the predicate devices.
At a high level, the subject and predicate devices are based on the following same technological elements:
- Scanner Principle- Whole body X-Ray Computed Tomography Scanner
- System Acquisition - Continuously rotating tube detector system
- . Iterative Reconstruction - Support of various iterative reconstruction methods
- Workplaces - Support of workplaces that include reconstruction and image evaluation software
- . Patient table
- . Patient table foot switch for movement
- Tin filtration technology
- Stellar detector technology ●
The following technological differences exist between the subject device and predicate devices:
- Software version SOMARIS/7 syngo CT VB20 ●
- . Support of additional cybersecurity features
- . Precision Matrix function
- Respiratory Scan - Functions
- . i-Control Functions
- DirectDensity™ (showing relative mass density) .
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A tabular summary of the unmodified subject and predicate device comparable hardware properties is provided in Table 4 and Table 5 below:
Table 4: Unmodified hardware properties valid for the subject device and predicate device
| Subject and Predicate Device(Single Source Systems) | |||||
|---|---|---|---|---|---|
| Hardware Property | SOMATOMEdge Plus | SOMATOMDefinitionEdge | SOMATOMDefinition AS/AS+ | SOMATOMConfidence | SOMATOMDefinition ASOpen |
| Scan mode | single source, dual energy | ||||
| High voltage generator | 100kW | 80kW | |||
| Detector | 38.4mm (128 slice conf.) | 19.2mm (20/40/64slice conf.)38.4mm (128 sliceconf.) | 19.2mm | ||
| DetectorPerformance Technologie | Stellar | ||||
| Tube | STRATONMX Sigma | STRATON MX P | |||
| kV Steps | 70kV,80kV,100kV, 120kV, 140kV |
| Subject and Predicate Device(Dual Source Systems) | |||
|---|---|---|---|
| Hardware Property | SOMATOMForce | SOMATOM DefinitionFlash | SOMATOMDrive |
| Scan mode | single source, dual source, dual energy | ||
| High voltage generator | 120kW/120kW | 100kW/100kW | 100kW/100kW |
| Detector | 2 x 57.6mm | 2 x 38.4mm | 2 x 38.4mm |
| DetectorPerformance Technologie | Stellar | ||
| Tube | Vectron | STRATON MX P | STRATON MX Sigma |
| kV Steps | 70kV,80kV,90kV, 100kV,110 kV,120 kV,130 kV,140 kV,150 kV | 70kV,80kV, 100kV,120kV,140kV | 70kV,80kV,90kV,100kV,110kV,120kV,130kV,140kV |
The tabular summary of the software and hardware differences between the subject devices with software version SOMARIS/7 syngo CT VB20 and the predicate devices are listed in Table 6 - Table 7 below (in gray shaded sections).
Table 6: Device Hardware Comparison for Subject (Single Source CT System Scanner) and Predicate Devices
| # | hardware properties | Subject Devices(syngo CT VB20) | Predicate Device(K173630 / K173607) |
|---|---|---|---|
| 1 | Stellar Detector(HW) | Dual Source:• SOMATOM Force,• SOMATOM Definition Flash | • Siemens SOMATOM CTScanner System |
| Single Source• SOMATOM DefinitionAS/AS+• SOMATOM Definition ASOpen | • SOMATOM Edge Plus | ||
| Dual Source:• SOMATOM Drive | |||
| Single Source:• SOMATOM Definition Edge,• SOMATOM Confidence• SOMATOM Edge Plus | |||
| Stellar Detector based onSillian classic technologiesupported | Stellar Detector based onSillian M technologiesupported | ||
| Subject Device | Predicate Device | ||
| Properties software | Dual Source:• SOMATOM Force,• SOMATOM Drive,• SOMATOM Definition FlashSingle Source:• SOMATOM Definition Edge,• SOMATOM Definition AS/AS+• SOMATOM Definition AS Open,• SOMATOM Confidence• SOMATOM Edge Plus(syngo CT VB20) | • Siemens SOMATOM CT Scanner System (K173630)• SOMATOM Edge Plus (K173607)(K173630 / K173607) | |
| Windows based | Windows based | ||
| Operating System | SOMARIS/7 syngo CT VB20 | SOMARIS/7 syngo CT VB10A | |
| AcquisitionWorkplace | syngo Acquisition Workplace (AWP)optional 2nd console syngo RRWPsyngo Viewing, syngo Filming and syngoArchiving & NetworkingImage Reconstruction | syngo Acquisition Workplace (AWP)optional 2nd console syngo RRWPsyngo Viewing, syngo Filming and syngo Archiving& NetworkingImage Reconstruction | |
| Stellar Detector | Stellar detector firmware supported forsubject device stellar detector re-design(no redesign for SOMATOM Force,Definition Flash and Definition ASSystems) | Stellar detector firmware supported for predicatedevice stellar detector design | |
| Teamplay | Support teamplay Protocols | Support teamplay Protocols | |
| Protocols(Single Source CTScanner Systems) | Support of :• Dual Spiral Dual Energy Protocols• Protocols for Radiation Therapy Planning• Dual Spiral Dual Energy Protocolsfor radiation therapy planning• Protocols that allow triggering ofbreath hold scanning from externaldevice. | Support of :• Dual Spiral Dual Energy Protocols• Protocols for Radiation Therapy Planning | |
| Protocols(Dual Source CTScanner Systems) | Support of :• Protocols for Radiation Therapy Planning• Protocols that allow triggering ofbreath hold scanning from externaldevice. | Support of :• Protocols for Radiation Therapy Planning | |
| Cybersecurity | IT Hardening (improved) | IT Hardening | |
| HD FoV | HD FoV (modification 4.0) | HD FoV 3.0 | |
| Option for PatientInstructions. | Support Automatic Patient Instruction(API) Interface. | Support Automatic Patient Instruction (API)Interface. | |
| FAST CARE | FAST, CARE Features supported | FAST, CARE Features supported | |
| FAST DE Results | FAST DE Results with enhanced dialogbox for individual image post-processingparameter settings and labeling | FAST DE Results | |
| FAST IntegratedWorkflow* | FAST Integrated Workflow stepssupported:• FAST Isocentering• FAST Range• FAST Direction*(full workflow only in combination withFAST 3D Camera) | FAST Integrated Workflow steps supported:• FAST Isocentering• FAST Range• FAST Direction*(full workflow only in combination with FAST 3DCamera) | |
| FAST 3D Camera | FAST 3D Camera supported whichprovides more accurate proposals for | FAST 3D Camera supported which providesproposals for patient positioning and patient outline. | |
| Subject Device | Predicate Device | ||
| Dual Source:• SOMATOM Force,• SOMATOM Drive,• SOMATOM Definition Flash | • Siemens SOMATOM CT Scanner System(K173630)• SOMATOM Edge Plus (K173607) | ||
| Properties software | Single Source:• SOMATOM Definition Edge,• SOMATOM Definition AS/AS+• SOMATOM Definition AS Open,• SOMATOM Confidence• SOMATOM Edge Plus | ||
| (syngo CT VB20) | (K173630 / K173607) | ||
| patient positioning and patient outline. | |||
| DirectDensityTM | DirectDensityTM | ||
| DirectDensityTM | (including electron density and massdensity) | (including electron density) | |
| Respiratory ScanPost-Processing | Respiratory Scan Post-ProcessingIncluding automated transfer of t-MaxIP& t-MinIP series to DICOM node. | Respiratory Scan Post-ProcessingManual function for transferring t-MaxIP & t-MinIPseries to DICOM node. | |
| Precision Matrix resolutionsupport image matrix sizes of 768x768pixels and 1024x1024 pixel (auto modesupported) | Matrix resolution 512x512(auto mode not supported) | ||
| Precision Matrix(SOMATOM Forceonly) | |||
| DirectBreathholdTM (automated triggersupported)(not for SOMATOM Force) | Respiratory Motion Management support breathhold triggered spiral scans with manual breath holdtriggered examinations. | ||
| breath-hold technique | |||
| Extended i-ControlFunction | i-Control Function(IVM support all key function's) | i-Control Function of 1st(limited IVM key functions set) | |
| Software | Support Auto Tasking card UI - withinteractive settings of syngo.via Data Role | Support Auto Tasking card UI - showing selectedsyngo.via Data Role | |
| • Software Update: Smart RemoteService (SRS) or Anytime Softwareenergy saving techniques in UIsupported• improved user doc | • Software Update: Smart Remote Service (SRS)• limited energy saving techniques | ||
| User Interface | |||
| IterativeReconstructionMethods | • ADMIRE• SAFIRE• iMAR | • ADMIRE• SAFIRE• iMAR |
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Table 7: Software Comparison for Subject Devices (Single Source CT Scanner System) and Predicate Devices
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Image /page/17/Picture/0 description: The image contains the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.
Any differences in technological characteristics do not raise different questions of safety and effectiveness. Siemens believes that the subject device is substantially equivalent to the predicate devices. Testing and validation is completed. Test results show that the subject devices, the SOMATOM CT Scanner Systems, are comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices.
VII. Performance Data
Non Clinical Testing
Non-clinical test (integration and functional) including phantom tests were conducted for the SOMATOM CT Scanner Systems during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the SOMATOM CT Scanner Systems in accordance with the following standards: 60601-2-44, and 60601-1-2. A list of recognized and general consensus standards considered for the subject devices is provided as Table 9 below.
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Healt
| Table 8: Recognized Consensus Standards | ||||
|---|---|---|---|---|
| Date ofRecognition | RecognitionNumber | StandardDevelopingOrganization | StandardDesignationNumber and Date | Title of Standard |
| 06/27/2016 | 12-300 | NEMA | PS 3.1 - 3.20 (2016) | Digital Imaging And Communications InMedicine (DICOM) Set |
| 03/14/2011 | 12-225 | NEMA | XR-25 | Computed Tomography Dose Check |
| 01/27/2015 | 12-287 | NEMA | XR-28 2013 | Supplemental Requirements For User InformationAnd System Function Related To Dose In CT |
| 6/27/2016 | 5-40 | ANSI AAMI ISO | 14971:2007/(R)2010(Corrected 4 October2007) | Medical Devices - Applications Of RiskManagement To Medical Devices |
| ISO | 14971 Second Edition2007-03-01 | Medical Devices - Applications Of RiskManagement To Medical Devices | ||
| 01/14/2019 | 13-79 | IEC | 62304 Edition 1.12015-06CONSOLIDATEDVERSION | Medical Device Software - Software Life CycleProcesses |
| 07/09/2014 | 19-4 | ANSI AAMI | ES60601-1:2005/(R)2012 AndA1:2012, | C1:2009/(R)2012 And A2:2010/(R)2012(Consolidated Text) Medical Electrical Equipment- Part 1: General Requirements For Basic SafetyAnd Essential Performance (IEC 60601-1:2005,MOD) |
| 09/17/2018 | 19-8 | ANSI AAMI IEC | 60601-1-2:2014 | Medical Electrical Equipment -- Part 1-2: GeneralRequirements For Basic Safety And EssentialPerformance -- Collateral Standard:Electromagnetic Disturbances -- RequirementsAnd Tests**Existing SOMATOM Definition Flash systemsconform to ANSI AAMI IEC 60601-1-2:2007.SOMATOM Definition Flash is no longer beingmanufactured or being delivered ex-factory.Software version SOMARIS/7 syngo CT VB20supports updates of legacy SOMATOM DefinitionFlash scanner systems. |
| 7212/23/2016 | 5-114 | ANSI AAMI IEC | 62366-1:2015 | Medical Devices - Part 1: Application OfUsability Engineering To Medical Devices |
| 07/09/2014 | 12-273 | IEC | 60825-1 Edition 2.02007-03 | Safety Of Laser Products - Part 1: EquipmentClassification, And Requirements [Including:Technical Corrigendum 1 (2008), InterpretationSheet 1 (2007), Interpretation Sheet 2 (2007)] |
| 06/27/2016 | 12-302 | IEC | 60601-2-44 Edition3.2: 2016 | Medical Electrical Equipment - Part 2-44:Particular Requirements For The Basic SafetyAnd Essential Performance Of X-Ray EquipmentFor Computed Tomography |
| 01/14/2014 | 12-269 | IEC | 60601-1-3 Edition 2.12013-04 | Medical Electrical Equipment - Part 1-3: GeneralRequirements For Basic Safety And EssentialPerformance - Collateral Standard: RadiationProtection In Diagnostic X-Ray Equipment |
| 06/27/2016 | 5-89 | IEC | 60601-1-6 Edition 3.12013-10 | Medical Electrical Equipment - Part 1-6: GeneralRequirements For Basic Safety And EssentialPerformance - Collateral Standard: Usability |
| 03/14/2011 | 12-226 | IEC | 61223-2-6 SecondEdition 2006-11 | Evaluation And Routine Testing In MedicalImaging Departments - Part 2-6: Constancy Tests- Imaging Performance Of ComputedTomography X-Ray Equipment |
| 01/30/2014 | 12-270 | IEC | 61223-3-5 FirstEdition 2004-08 | Evaluation And Routine Testing In MedicalImaging Departments - Part 3-5: Acceptance Tests |
| Table 8: Recognized Consensus Standards | ||||
| Date ofRecognition | RecognitionNumber | StandardDevelopingOrganization | StandardDesignationNumber and Date | Title of Standard |
| - Imaging Performance Of ComputedTomography X-Ray Equipment [Including:Technical Corrigendum 1 (2006)] | ||||
| 06/07/2018 | 12-309 | IEC | 60601-2-28 Edition3.0 2017-06 | Medical Electrical Equipment - Part 2-28:Particular Requirements For The Basic SafetyAnd Essential Performance Of X-Ray TubeAssemblies For Medical Diagnosis |
| 06/27/2016 | 12-299 | IEC | 62563-1 Edition 1.1 | Medical Electrical Equipment - Medical ImageDisplay Systems - Part 1: Evaluation Methods |
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| Table 9: General Use Consensus Standards | |||
|---|---|---|---|
| StandardDevelopingOrganization | StandardDesignationNumber and Date | Title of Standard | How was Standard Used |
| IEC | 60601-1-2:2007* | Medical Electrical Equipment --Part 1-2: General RequirementsFor Basic Safety And EssentialPerformance -- CollateralStandard: ElectromagneticDisturbances - RequirementsAnd Tests | This standard in not applicable for new SiemensCT scanners delivered ex-factory.* Existing SOMATOM Definition Flashsystems are conform to ANSI AAMI IEC60601-1-2:2007. SOMATOM Definition Flashis no longer being manufactured or beingdelivered ex-factory. Software versionSOMARIS/7 syngo CT VB20 supports updatesof legacy SOMATOM Definition Flash scannersystems. |
| IEC | 60601-1:2005+A1:2012 | Medical electrical equipment -part 1: general requirements forbasic safety and essentialperformance | Covered by ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 as part of EMCtesting. |
| IEC/ISO | 17050-1 | Conformity Assessment -Supplier's declaration ofconformity - Part 1: Generalrequirements | Declaration of conformance to FDA recognizedconsensus standards. |
| IEC/ISO | 17050-2 | Conformity assessment -Supplier's declaration ofconformity - Part 2: Supportingdocumentation. | General consensus standards not currentlyrecognized by FDA. |
A list of applicable guidance documents considered for this submission is provided as Table 10 below.
| FDA Guidance Document and Effective Date | |
|---|---|
| 1. | Guidance for Industry and FDA Staff – User Fees and Refunds for Premarket Notification Submissions 510(k)Document issued on October 2, 2017 |
| 2. | Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy for 510(k)sDocument issued on February 21, 2019 |
| 3. | Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s - Guidance for Industryand FDA StaffDocument issued on August 12, 2005 |
| 4. | Guidance for Industry and FDA Staff: Deciding when to submit a 510(k) for a change to an existing device.Document issued on October 25, 2017 |
| 5. | Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating SubstantialEquivalence in Premarket Notifications [510(k)]Document Issued on July 28, 2014 |
Table 10: FDA Guidance Documents
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| FDA Guidance Document and Effective Date | |
|---|---|
| 6. | Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submission for Software in MedicalDevicesDocument issued on May 11, 2005 |
| 7. | Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in Medical DevicesDocument issued on September 9, 1999 |
| 8. | Guidance for Industry and FDA Staff: Applying Human Factors and UsabilityEngineering to Medical Devices.Document issued February 3, 2016 |
| 9. | Guidance for Industry and FDA Staff: Pediatric Information for X-ray ImagingDevice Premarket Notifications.Document issued on November 28, 2017 |
| 10. | Guidance for Industry and FDA Staff: Content of Premarket Submissions forManagement of Cybersecurity in Medical devices.Document issued on October 2, 2014 |
| 11. | Guidance for Industry and FDA Staff: Information to Support a Claim ofElectromagnetic Compatibility (EMC) of Electrically-Powered Medical DevicesDocument issued on July 11, 2016 |
| 12. | Guidance for Industry and Food Drug Administration Staff: Design considerations and Pre-Market Submissionrecommendations for Interoperable Medical devicesDocument Issued on September 6, 2017 |
| 13. | Guidance for Industry and Food Drug Administration Staff:Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical DevicesDocument issued on September 14, 2018 |
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. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claims of substantial equivalence.
Siemens conforms to the Cybersecurity requirementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity Medical Devices issues on October 2, 2014" is included within this submission.
Summary
The features described in this premarket notification are supported with verification and validation testing. dosimetry and imaging performance, and analysis of phantom images to assess device and feature performance 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.
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 system related Risk analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing according to the Risk Management process. In order to minimize electrical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
VIII. Conclusions
The predicate devices were cleared based on the results of non-clinical testing including verification and validation, phantom tests, and supportive literature. The subject device is also tested using the same methods as used for the predicate devices. The non-clinical data supports the device and the hardware and software verification and validation demonstrates that the subject device SOMATOM CT Scanner Systems
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Image /page/21/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern. There is a black line underneath the word "Healthineers".
should perform as intended in the specified use conditions. The data included in this submission demonstrates that the SOMATOM CT Scanner Systems perform comparably to the predicate devices currently marketed for the same intended use. Since all predicate devices were tested using the same methods, Siemens believes that the data generated from the SOMATOM CT Scanner Systems 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.