(30 days)
No
The document describes standard CT imaging, reconstruction, and post-processing techniques. While it mentions "FAST Isocentering" and "FAST Range" which involve automated processes based on video streams, there is no explicit mention or description of AI or ML algorithms being used for these or any other functions. The focus is on hardware updates, software updates for existing functionalities, and mobile workflow.
No
This device is a diagnostic tool (computed tomography system) used to generate images for diagnosis, treatment preparation, and radiation therapy planning, not for delivering therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the images delivered by the system "can be used by a trained physician as an aid in diagnosis" and "can be used by trained staff as an aid in diagnosis." It also mentions "low dose lung cancer screening," which is a diagnostic application.
No
The device description explicitly states that the submission is for a software update that includes support for additional hardware for the go. platform and is part of a Computed Tomography X-ray System, which is a hardware device. While there is a software component (Scan&GO), the overall device being cleared is a CT system with updated software, not a standalone software-only device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device is a Computed Tomography (CT) system. It generates images of the inside of the body using X-rays. It does not perform tests on biological samples.
- Intended Use: The intended use is to generate and process images for aid in diagnosis, treatment preparation, and radiation therapy planning. This is consistent with the function of an imaging device, not an IVD.
Therefore, this CT system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JAK, LLZ
Device Description
Siemens intends to update software version, SOMARIS/10 syngo CT VA30 (Update) for Siemens SOMATOM Computed Tomography (CT) Scanner Systems with mobile workflow and 3D Camera options.
This update includes support of additional hardware for the go. platform and includes reuse of optional postprocessing applications for Recon&GO for all scanners subject of this submission.
The SOMATOM CT Scanner Systems that support the same software platform update include:
- . SOMATOM go.Up
- . SOMATOM go.Now
- SOMATOM go.Top .
- SOMATOM go.All .
- . SOMATOM ao.Sim
- . SOMATOM go.Open Pro
- SOMATOM X.cite
- Scan&GO Mobile Medical Application (optional mobile workflow component) .
The subject device SOMATOM go. platform and SOMATOM X.cite with SOMARIS/10 syngo CT VA30 (update) are Computed Tomography X-ray Systems which feature one continuously rotating tube detector system and function according to the fan beam principle. The SOMATOM go. platform and SOMATOM X.cite with software SOMARIS/10 syngo CT VA30 (update) produces CT images in DICOM format. These images can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors. These images 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 Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the SOMATOM X.cite and SOMATOM go. platform CT scanners. Scan&GO can be operated on a Siemens provided tablet or personal computer that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient. Specifically Scan&GO allows control/display of the following software interactions via a wireless tablet or personal computer with WiFi connection that meets certain minimum requirements:
- Selection of patients o
- Selection of pre-defined protocols O
- Scan parameter display O
- Patient table position display and gantry tilt parameter display O
- Tools and instruction message area, O
- Patient table position planning area O
- Physiological data display O
- Patient data display (e.g. date of birth, name) O
- Display of acquired topogram and tomogram images O
- Finalization of exam (close patient) O
- Mobile Organizer, O
- Patient Instruction Language ("API languages") O
- Control function for RTP Laser systems O
- Control of moodlight functions O
- predefined workflow associated question/answer dialog O
NOTE: Scan&GO does not support storage of images. Additionally, Scan&GO cannot trigger a scan or radiation release.
The software version for the SQMATOM go, platform and SOMATOM X.cite, syngo CT VA30 (update) (SOMARIS/10 syngo CT VA30 (update)), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform SOMARIS/10 syngo CT VA30 (update) is designed to support a software plugin interface to reuse a subset of stand-alone, cleared processing software applications. Software update version syngo CT VA30 (update) (SOMARIS/10 syngo CT VA30 (update)) shall support additional software features and hardware options, which was cleared for the primary predicate device in K191891, and supports the same plugin interfaces for the optional Scan&GO mobile workflow and integration of post-processing tasks as the predicate devices.
The SOMATOM go. platform and SOMATOM X.cite will support the following modifications/further developments in comparison to the predicate devices:
- New/Modified Hardware
- Software version SOMARIS/10 syngo CT VA30 (update)
Mentions image processing
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 trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography x-ray system
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician, trained staff
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Non-clinical test (integration and functional) including phantom tests were conducted for the SOMATOM go. platform CT Scanner Systems and SOMATOM X.cite during product development.
The modifications described in this Premarket Notification were supported with verification and validation testing.
The general purpose of each tests is to verify and validate the functionality of the subject device modifications.
Testing will cover all related subsystems that contribute to the device modifications. Test levels are defined. For each test level several test activities are performed. The test specification and acceptance criteria are related to the corresponding requirements. Various test activities are performed to specific modifications on different test levels to ensure safe and effective integration in the system. Three test levels are defined:
System Validation test:
- Acceptance test (workflow and user manual test) .
- Legal and Regulatory test ●
System Verification test: - System Integration Test (functional) ●
- . Functionality verification
- . Image Quality (IQ) Evaluation
Tests are conducted for all software components developed in product development and for the complete product itself. Several activities are considered for this process, including creation of test specifications that relate to software/hardware requirements including tests to address risk mitigations that are identified, documented and traced by hazard keys.
Additional evaluation tests are performed as bench tests to support the new device or device modification on Non-Clinical Performance Testing as listed in table S5-06 below.
FAST Isocentering: Clinical data based software validation to assess accuracy of patient isocenter proposal for feature. Conducted tests for the subject device FAST Isocentering demonstrated that there was a lower isocenter deviation for the subject device in comparison to the predicate device.
FAST Range: Based on manually triggered camera images, comparison and measurement of deviation of manual annotation of patient landmark and based on video stream images supporting the feature proposed patient landmark. Conducted test demonstrated a lower deviation for landmark boundaries for the subject device in comparison to the predicate device.
All factory contrast protocols are within the limits as prescribed by the approved labeling of Ultravist® or Visipaque®. (including coronary CTA contrast protocol)
With software version VA30 the additional hardware support the information shown on the in-room monitor in the same way as it is shown on the tablets.
Wireless Coexistence Testing: Testing for co-existence considered for following scenarios: Co-Channel Testing, Adjacent Channel Testing, RF Interference Testing, Separation Distance/Location Testing.
Scan&GO is designed to allow dynamic frequency selection and transmission power control by default in accordance with IEEE 802.11h. Adjacent channel testing is addressed by the fact that Scan&GO does not support shared medium access to Siemens Wi-Fi network. RF interference was tested by successfully ensuring that wireless communications were actively transmitting in situations where possible interference may exist. Recommended distance and router locations requirements are documented in the user documentation.
Customer Use Testing:
- . Internal Clinical Use Test. The CT scanner customer environment is simulated in Siemens Test Cabins. For such a test, customers with clinical expertise are typically invited to perform tests.
- External Clinical Use Test: The CT scanner is tested in the environment of the . clinic/hospital. Typically we perform these tests with selected customer before rollout of the CT scanner.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test (integration and functional) including phantom tests were conducted for the SOMATOM go. platform CT Scanner Systems and SOMATOM X.cite during product development.
The modifications described in this Premarket Notification were supported with verification and validation testing.
The general purpose of each tests is to verify and validate the functionality of the subject device modifications.
Testing will cover all related subsystems that contribute to the device modifications. Test levels are defined. For each test level several test activities are performed. The test specification and acceptance criteria are related to the corresponding requirements. Various test activities are performed to specific modifications on different test levels to ensure safe and effective integration in the system. Three test levels are defined:
System Validation test:
- Acceptance test (workflow and user manual test) .
- Legal and Regulatory test ●
System Verification test: - System Integration Test (functional) ●
- . Functionality verification
- . Image Quality (IQ) Evaluation
Tests are conducted for all software components developed in product development and for the complete product itself. Several activities are considered for this process, including creation of test specifications that relate to software/hardware requirements including tests to address risk mitigations that are identified, documented and traced by hazard keys.
Additional evaluation tests are performed as bench tests to support the new device or device modification on Non-Clinical Performance Testing as listed in table S5-06 below.
FAST Isocentering: Clinical data based software validation to assess accuracy of patient isocenter proposal for feature. Conducted tests for the subject device FAST Isocentering demonstrated that there was a lower isocenter deviation for the subject device in comparison to the predicate device.
FAST Range: Based on manually triggered camera images, comparison and measurement of deviation of manual annotation of patient landmark and based on video stream images supporting the feature proposed patient landmark. Conducted test demonstrated a lower deviation for landmark boundaries for the subject device in comparison to the predicate device.
All factory contrast protocols are within the limits as prescribed by the approved labeling of Ultravist® or Visipaque®. (including coronary CTA contrast protocol)
With software version VA30 the additional hardware support the information shown on the in-room monitor in the same way as it is shown on the tablets.
Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the subject device SOMATOM CT Scanner Systems in accordance with the following standards: 60601-2-44, and 60601-1-2.
Wireless Coexistence Testing: Testing for co-existence considered for following scenarios: Co-Channel Testing, Adjacent Channel Testing, RF Interference Testing, Separation Distance/Location Testing.
Customer Use Testing: - . Internal Clinical Use Test. The CT scanner customer environment is simulated in Siemens Test Cabins. For such a test, customers with clinical expertise are typically invited to perform tests.
- External Clinical Use Test: The CT scanner is tested in the environment of the . clinic/hospital. Typically we perform these tests with selected customer before rollout of the CT scanner.
All tests performed meet the pre-determined acceptance criteria and demonstrate that Scan&O is safe and effective for the intended use. Multiple tablets for visualisation purpose, using the same Scan&GO installation and feature configuration, does not change the intended use.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K192061, K173637, K143196, K191040, K123584, K192065, K192763
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
April 1, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
Siemens Medical Solutions USA, Inc. % Ms. Tabitha Estes Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932
Re: K200524
Trade/Device Name: SOMATOM X.cite and SOMATOM go.Platform CT Scanners including: SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go. Open Pro, Scan&GO Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, LLZ Dated: February 28, 2020 Received: March 2, 2020
Dear Ms. Estes:
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 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
1
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
2
Indications for Use
510(k) Number (if known)
Device Name
SOMATOM X.cite and SOMATOM Go Platform CT Scanners including; SOMATOM go.Now, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim and SOMATOM go.Open Pro , Scan&Go
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
"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."
3
Indications for Use
510(k) Number (if known)
Device Name Scan & Go
Indications for Use (Describe)
This in-room scan application is a planning and information system the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.
The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subnart D) | Over-The-Counter Use (21 CFR 801 Subnart 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."
4
510(K) SUMMARY
FOR
SOMATOM GO. PLATFORM & SOMATOM X.CITE CT SCANNER SYSTEMS - Software version SOMARIS/10 syngo CT VA30 (Update)
Submitted by: Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 Date Prepared: February 28, 2020
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.
l. Submitter
Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 Establishment Registration Number 1034973
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:
Tabitha Estes Requlatory Affairs Siemens Medical Solutions USA, Inc. (865) 804-4553 (work cell) (865) 218-3019 FAX tabitha.estes@siemens-healthineers.com
5
II. Device Name and Classification
| Product Name: | SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite |
|---|---|
| Trade Name: | SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Product Name: | Scan&GO |
|---|---|
| Propriety Trade Name: | Scan&GO |
| Classification Name: | Computed Tomography X-ray System |
| Secondary Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Secondary CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | JAK |
| Secondary Product Code: | LLZ |
III. Predicate Device
Primary Predicate Device:
| Trade Name: | SOMATOM X.cite, Scan&GO |
|---|---|
| 510(k) Number: | K191891 |
| Clearance Date: | November 06, 2019 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Requlation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | There are currently no recalls for this device |
Reference Device:
Trade Name:
SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro,
| Scan&GO | |
|---|---|
| 510(k) Number: | K192061 |
| Clearance Date: | November 21, 2019 |
| 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. |
Note: K192061 was a bundle submission with various Siemens CT Scanner Systems, including SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro and Scan&GO software. In this submission, the predicate devices SOMATOM go.Top and Scan&GO are applicable, to demonstrate substantial equivalence of technological characteristics.
6
IV. Device Description
Siemens intends to update software version, SOMARIS/10 syngo CT VA30 (Update) for Siemens SOMATOM Computed Tomography (CT) Scanner Systems with mobile workflow and 3D Camera options.
This update includes support of additional hardware for the go. platform and includes reuse of optional postprocessing applications for Recon&GO for all scanners subject of this submission.
The SOMATOM CT Scanner Systems that support the same software platform update include:
- . SOMATOM go.Up
- . SOMATOM go.Now
- SOMATOM go.Top .
- SOMATOM go.All .
- . SOMATOM ao.Sim
- . SOMATOM go.Open Pro
- SOMATOM X.cite
- Scan&GO Mobile Medical Application (optional mobile workflow component) .
The subject device SOMATOM go. platform and SOMATOM X.cite with SOMARIS/10 syngo CT VA30 (update) are Computed Tomography X-ray Systems which feature one continuously rotating tubedetector system and function according to the fan beam principle. The SOMATOM go. platform and SOMATOM X.cite with software SOMARIS/10 syngo CT VA30 (update) produces CT images in DICOM format. These images can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors. These images 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 Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the SOMATOM X.cite and SOMATOM go. platform CT scanners. Scan&GO can be operated on a Siemens provided tablet or personal computer that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient. Specifically Scan&GO allows control/display of the following software interactions via a wireless tablet or personal computer with WiFi connection that meets certain minimum requirements:
- Selection of patients o
- Selection of pre-defined protocols O
- Scan parameter display O
- Patient table position display and gantry tilt parameter display O
- Tools and instruction message area, O
- Patient table position planning area O
- Physiological data display O
- Patient data display (e.g. date of birth, name) O
- Display of acquired topogram and tomogram images O
- Finalization of exam (close patient) O
- Mobile Organizer, O
- Patient Instruction Language ("API languages") O
- Control function for RTP Laser systems O
- Control of moodlight functions O
- predefined workflow associated question/answer dialog O
NOTE: Scan&GO does not support storage of images. Additionally, Scan&GO cannot trigger a scan or radiation release.
The software version for the SQMATOM go, platform and SOMATOM X.cite, syngo CT VA30 (update) (SOMARIS/10 syngo CT VA30 (update)), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform SOMARIS/10 syngo CT VA30 (update) is designed to support a software plugin interface to reuse a subset of stand-alone, cleared processing software
7
applications. Software update version syngo CT VA30 (update) (SOMARIS/10 syngo CT VA30 (update)) shall support additional software features and hardware options, which was cleared for the primary predicate device in K191891, and supports the same plugin interfaces for the optional Scan&GO mobile workflow and integration of post-processing tasks as the predicate devices.
The SOMATOM go. platform and SOMATOM X.cite will support the following modifications/further developments in comparison to the predicate devices:
1) New/Modified Hardware
- Table S5-01: Overview of Hardware modifications
2) Software version SOMARIS/10 syngo CT VA30 (update)
- Table S5-02: Overview Software modifications ●
The configuration table and comparison table use the following terms to describe various technological characteristics in comparison to the predicate device information:
| Term | Definition |
|---|---|
| N/A | The feature is not supported for the subject device |
| New | The feature is newly supported for Siemens CT Scanners and the subject device |
| Modified | This feature is modified from the previously cleared version |
| Unmodified | This feature remains unchanged from the predicate device |
| Enabled | This feature is currently supported by other cleared Siemens CT systems or |
| cleared Siemens stand alone software applications. This feature will be supported | |
| for the subject device with software version SOMARIS/10 syngo CT VA30 | |
| (update) and is substantial equivalent from it's cleared version. |
Table S5-01: Overview of Hardware Modifications in comparison to the corresponding predicate devices
| | CT Scanner Systems with
SOMARIS/10 syngo CT
VA30 (update) | Subject
Devices | Subject
Devices | Subject
Devices | Subject
Devices | Subject
Devices | Subject
Devices |
|---|-----------------------------------------------------------------|--------------------|--------------------|------------------------------|------------------------------------|--------------------|--------------------|
| | # hardware properties | SOMATOM
go.Now | SOMATOM
go.Up | SOMATOM
go.All/
go.Top | SOMATOM
go.Sim /
go.Open Pro | SOMATOM
X.cite | Scan&GO |
| 1 | 3D Camera | N/A | Enabled | Enabled | Enabled | Unmodified | N/A |
| 2 | Optional hardware for
Scan&GO to support inroom
monitor. | Unmodified | Unmodified | Unmodified | Unmodified | Unmodified | Modified |
Table S5-02: Overview Software modifications of SOMATOM go. platform and SOMATOM X.cite with syngo CT VA30 (update) in comparison to the corresponding predicate devices
| | CT Scanner Systems with
SOMARIS/10 syngo CT
VA30 (update) | Subject Devices | Subject Devices | Subject Devices | Subject Devices | Subject Devices | Subject Devices |
|---|-----------------------------------------------------------------------------|-------------------|------------------|------------------------------|-----------------------------------|-------------------|-----------------|
| | Software properties | SOMATOM
go.Now | SOMATOM
go.Up | SOMATOM
go.All/
go.Top | SOMATOM
go.Sim/
go.Open Pro | SOMATOM
X.cite | Scan&GO |
| 1 | Recon&GO - Inline Results
● LungCAD
● Anatomical
Ranges | Unmodified | Unmodified | Unmodified | Enabled | Enabled | N/A |
| 2 | Recon&GO - Inline Results
● RT Automatic
Contouring
(DirectORGANS) | N/A | N/A | N/A | Enabled | Enabled | N/A |
| 3 | Recon&GO - Inline Results
● CaScoring | N/A | N/A | Enabled | Enabled | Enabled | N/A |
| 4 | Contrast media protocol
(additional protocol for
coronary CTA) | N/A | N/A | Modified | Modified | Modified | N/A |
| 5 | FAST Integrated Workflow
(including FAST 3D
Camera) | N/A | Enabled | Enabled | Enabled | Unmodified | Unmodified |
8
A comparison of these modifications with respect to the predicate devices is provided in the "Comparison of Technological Characteristics with the Predicate Device" section below. Software version SOMARIS/10 syngo CT VA30 (update) will be offered as an optional upgrade for the existing SOMATOM CT go.platform Systems and SOMATOM X.cite.
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.
Scan&GO:
The in-room scan application is a planning and information system designed to perform the necessary functions required for planning and controlling scans of supported Siemens CT scanners. It allows users to work in close proximity to the scanner.
The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols.
VI. Comparison of Technological Characteristics with the Predicate Device
The subject devices (SOMATOM go. platform scanners, SOMATOM X.cite scanners and optional Scan&GO mobile workflow software application) provide the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software features of the SOMATOM go. platform and SOMATOM X.cite have been modified in comparison to the predicate devices to support additional hardware options and to reuse a subset of cleared postprocessing algorithms. The subject devices CT scanner hardware is unmodified as cleared with K192061 and K191891. The hardware modification in combination with the subject devices support a mobile workflow option with personal computer configuration and 3D Camera workflow for patient positioning.
Software version SOMARIS/10 syngo CT VA30 (update) supports software features that are designed as a software platform update including Recon&GO Inline Result technologies which provide interfaces to directly access a subset of optional post processing applications and are designed to enhance the user workflow.
The intended use and fundamental scientific technology for the SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro and SOMATOM X.cite remains unchanged from the predicate devices.
At a high level, the subject and predicate devices are based on the following same technoloqical 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
9
- Chronon, Athlon or Vectron X-ray Tube ●
- Stellar detector technology ●
- . Maximum power Generator
- High Power 70, High Power 80 (High mA@low kV) .
- . Iterative Reconstruction Methods
- Mobile Medical application Software functionality (Scan&GO) ●
- Mobile workflow (Tablet)
- Support of interfaces to access 3D Camera operation for fast patient positioning workflow ●
- . Scanner display and control functionality
- Remote Scan Control
- Support of Intervention Workflow - Guide&GO
- Optional Injector Arm
- . Long scan range
- DirectDensity™ Reconstruction, which provides CT images with an HU-like scaling that is ● nearly proportional to relative electron density or relative mass density
- . Respiratory Scan - Functions
The following technological differences exist between the subject device SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro. SOMATOM X.cite and the primary predicate device SOMATOM X.cite cleared in K191891 and the predicate device SOMATOM go.Top cleared in K192061:
- Software version SOMARIS/10 syngo CT VA30 (update) (enable additional . hardware/software options)
- Mobile workflow include Scan&GO installation on personal computer ●
- Various additional post processing software plug-in options for Recon&GO Inline Results ●
- Optional advanced CARE examination including new protocol for contrast media ●
The following technological differences exist between the subject device Scan&GO and the predicate device Scan&GO cleared in K191891:
- . Optional hardware support for personal computer configuration
A summary of the differences between the subject device CT scanner configurations is provided as Table S5-03 and Table S5-04 below.
The tabular summary of the comparable hardware properties between the subject devices SOMATOM go. platform CT Scanner Systems with software version SOMARIS/10 syngo CT VA30 (update) and the predicate device SOMATOM X.cite are listed in Table S5-03 below (modifications are in gray shaded sections).
There are no hardware changes for subject device SOMATOM X.cite in comparison to the predicate device SOMATOM X.cite cleared in K191891.
10
| Hardware
Property | SOMATOM go. platform - Device Comparison (Single Source Systems)
Subject Device | | | | | | Predicate
SOMATOM
X.cite
K191891 |
|---------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------|---------------------------------------------------------------------------------|-------------------------------------------|------------------------------------------------------------------|-------------------------------------------|------------------------------------------------------------------------------------|
| | SOMATOM
go.Now | SOMATOM
go.Up | SOMATOM
go.All | SOMATOM
go.Top | SOMATOM
go.Sim | SOMATOM
go.Open
Pro | |
| Scanner
Generator
max. power | 32 kW | 32 kW | 75 kW | 75 kW | 75 kW | 75 kW | 105 kW |
| Detector
technology | Stellar | Stellar | Stellar | Stellar | Stellar | Stellar | Stellar |
| Detector
volumen
coverage | 11.2 mm | 22.4 mm | 22.4 mm | 38.4 mm | 19.2 mm | 38.4 mm | 38.4 mm |
| Detector
physical rows | 16 | 32 | 32 | 64 | 32 | 64 | 64 |
| Detector
slice width | 0.7 mm | 0.7 mm | 0.7 mm | 0.6 mm | 0.6 mm | 0.6 mm | 0.6 mm |
| Detector
DAS channel
No. | 768 | 768 | 768 | 840 | 920 | 920 | 840 |
| Detector
image slices | 32 | 64 | 64 | 128 | 64 | 128 | 128 |
| Tube
Technologie | Chronon | Chronon | Athlon | Athlon | Athlon | Athlon | Vectron |
| Tube
kV steps | | (in 20kV steps)
80 kV to 130kV | (in 10kV steps)
70 kV to 140 kV | | | | (in 10kV
steps)
70 kV to
150 kV |
| Tube
max. current | 400 mA | 400 mA | 825 mA | 825 mA | 825 mA | 825 mA | 1200 mA |
| Tube
tube focus | 0.8 x 0.4
0.8 x 0.7 | 0.8 x 0.4
0.8 x 0.7 | 1.0 x 1.2
0.8 x 0.8 | 1.0 x 1.2
0.8 x 0.8 | 1.0 x 1.2
0.8 x 0.8 | 1.0 x 1.2
0.8 x 0.8 | 0.6 x 0.7
0.8 x 1.1 |
| Tube
heat capacity | 3.5 MHU | 3.5 MHU | 6 MHU | 6 MHU | 6 MHU | 6 MHU | >30 MHU |
| Gantry
bore size | 70 cm | 70 cm | 70 cm | 70 cm | 85 cm | 85 cm | 82 cm |
| Gantry
FoV | 50 cm | 50 cm | 50 cm | 50 cm | 60 cm | 60 cm | 50 cm |
| Gantry
rotation time
(sec) | 0.8, 1.0, 1.5 | 0.8, 1.0, 1.5 | 0.33, 0.5, 1.0 | 0.33, 0.5, 1.0 | 0.35, 0.5, 1.0 | 0.35, 0.5, 1.0 | 0.3, 0.5, 1.0 |
| Gantry
Tilt [degrees] | N/A | +/-25 | +/-25 | +/-25 | +/-25 | +/-25 | +/-25 |
| Patient Table
type | Vector:
1.250 m
Vario 1 and
Vario RT:
1.600 m
with table
extension | | Vario 1 (1.600 m, Vario 2 (2.000m and
Vario RT: 1.600 m with table extension | | Vario 2 (2.000m and
Vario RT: 1.600 m with
table extension | | Vario RT:
1.600 m,
Vario 2:
2.000 m |
| Max. Scan
length
Topogram | 1680 mm | 1680 mm
2080 mm | 1680 mm
2080 mm | 1680 mm
2080 mm | 1680 mm
2080 mm | 1680 mm
2080 mm | 1680 mm
2080 mm |
| Max. Scan
length
Image
acquisition | 1600 mm | 1600 mm,
2000 mm | 1600 mm,
2000 mm | 1600 mm,
2000 mm | 1600 mm,
2000 mm | 1600 mm,
2000 mm | 1600 mm,
2000 mm |
| Spectral
filtration
option | Tin Filter
supported | Tin Filter
supported | Tin Filter
supported | Combined
Split
Filter/Tin
Filter | Tin Filter
supported | Combined
Split
Filter/Tin
Filter | Combined
Split Filter /
Tin Filter
supported,
plus extra
Tin Filter |
| 3D Camera
for patient
positioning | N/A | | | supported | | | supported |
| High Power
70 | N/A | N/A | 825 mA
(@ 70 kV) | 825 mA
(@ 70 kV) | 825 mA
(@ 70 kV) | 825 mA
(@ 70 kV) | 1200 mA
(@ 70 kV) |
| High Power
80 | N/A | N/A | 825 mA
(@ 80 kV) | 825 mA
(@ 80 kV) | 825 mA
(@ 80 kV) | 825 mA
(@ 80 kV) | 1200 mA
(@ 80 kV) |
Table S5-03: SOMATOM go. platform comparable hardware properties
11
The tabular summary of the comparable software properties between the subject devices with software version SOMARIS/10 syngo CT VA30 (update) and the predicate devices are listed in Table S5-04 below (modifications are in gray shaded sections).
| Subject Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| SOMATOM go.Now, | |||
| SOMATOM go.Up, | |||
| SOMATOM go.All, | |||
| SOMATOM go.Top, | |||
| SOMATOM go.Sim, | |||
| SOMATOM go.Open Pro, | |||
| SOMATOM X.cite | |||
| (syngo CT VA30 (update)) | SOMATOM X.cite | SOMATOM go.Top | |
| Properties | |||
| software | |||
| (K191891) | (K192061) | ||
| Operating | |||
| System | Windows based | ||
| SOMARIS/10 syngo CT VA30 (update) (with additional | |||
| software options) | Windows based | ||
| SOMARIS/10 syngo CT VA30 (update) | Windows based | ||
| SOMARIS/10 syngo CT VA30 (update) | |||
| Acquisition | |||
| Workplace | syngo Acquisition Workplace (AWP) | syngo Acquisition Workplace (AWP) | syngo Acquisition Workplace (AWP) |
| syngo Viewing, syngo Filming | |||
| and syngo Archiving & | |||
| Networking | syngo Viewing, syngo Filming | ||
| and syngo Archiving & | |||
| Networking | syngo Viewing, syngo Filming | ||
| and syngo Archiving & | |||
| Networking | |||
| Image Reconstruction | Image Reconstruction | Image Reconstruction | |
| Stellar Detector | Stellar detector firmware | ||
| supported | Stellar detector firmware | ||
| supported | Stellar detector firmware | ||
| supported | |||
| Teamplay | Support teamplay Protocols | Support teamplay Protocols | Support teamplay Protocols |
| Support of : | Support of : | Support of : | |
| Protocols for Radiation | |||
| Therapy Planning support | |||
| patient markingProtocols that allow | |||
| scanning with support of | |||
| an external respiratory | |||
| gating system (ANZAI, | |||
| Varian RGSC)Protocol supporting | |||
| contrast bolus-triggered | |||
| data acquisitionContrast media protocols | |||
| (including coronary CTA)Pediatric ProtocolsFlex Dose ProfileTwinBeam DETwinSpiral DEFlex 4D Spiral | Protocols for Radiation | ||
| Therapy Planning support | |||
| patient markingProtocols that allow | |||
| scanning with support of | |||
| an external respiratory | |||
| gating system (ANZAI, | |||
| Varian RGSC)Protocol supporting | |||
| contrast bolus-triggered | |||
| data acquisitionContrast media protocolsPediatric ProtocolsFlex Dose ProfileTwinBeam DETwinSpiral DEFlex 4D Spiral | Protocols for Radiation | ||
| Therapy Planning support | |||
| patient markingProtocols that allow | |||
| scanning with support of | |||
| an external respiratory | |||
| gating system (ANZAI, | |||
| Varian RGSC)Protocol supporting | |||
| contrast bolus-triggered | |||
| data acquisitionContrast media protocolsPediatric ProtocolsFlex Dose ProfileTwinBeam DETwinSpiral DEFlex 4D Spiral | |||
| Protocols | |||
| Recon&GO – | |||
| Advanced | |||
| Reconstruction. | Advanced reconstruction tools | ||
| supported: |
- Spectral Recon (Dual Energy
Reconstruction) - Inline Results DE SPP
(Spectral Post-Processing) - Inline Results DE Ranges
(Parallel/Radial) / Inline DE | Advanced reconstruction tools
supported: - Spectral Recon (Dual
Energy Reconstruction) - Inline Results DE SPP
(Spectral Post-Processing) - Inline Results DE Ranges
(Parallel/Radial) / Inline DE | Advanced reconstruction tools
provided to supported: - Spectral Recon (Dual Energy
Reconstruction) - Inline Results DE SPP
(Spectral Post-Processing) - Inline Results DE Ranges
(Parallel/Radial) / Inline DE |
| Post-
Processing
plug in
functions
Enabled via
software | Heart Isolation,
Coronary Tree,
Vessel Ranges (LAD,
RCA, CX),
Cardiac Ranges | Heart Isolation,
Coronary Tree,
Vessel Ranges (LAD,
RCA, CX),
Cardiac Ranges | Heart Isolation,
Coronary Tree,
Vessel Ranges (LAD,
RCA, CX),
Cardiac Ranges |
| | Subject Device | Predicate Device | Predicate Device |
| | SOMATOM go.Now, | SOMATOM X.cite | SOMATOM go.Top |
| | SOMATOM go.Up, | | |
| Properties | SOMATOM go.All, | | |
| software | SOMATOM go.Top, | | |
| | SOMATOM go.Sim, | | |
| | SOMATOM go.Open Pro, | | |
| | SOMATOM X.cite | | |
| | (syngo CT VA30 (update)) | (K191891) | (K192061) |
| interface
Recon&GO -
Inline Results
varies methods
of cleared
software
applications | Vascular ranges (Aorta,
Carotis L Int., Carotic R
Int., Runoff L, Runoff R)
Inline Table removal
Inline Bone removal | Vascular ranges (Aorta,
Carotis L Int., Carotic R
Int., Runoff L, Runoff R)
Inline Table removal
Inline Bone removal | Vascular ranges (Aorta,
Carotis L Int., Carotic R
Int., Runoff L, Runoff R)
Inline Table removal
Inline Bone removal |
| | LungCAD
Anatomical ranges
(Parallel/Radial) | N/A | LungCAD
Anatomical ranges
(Parallel/Radial) |
| Note 1: Detailed
informations
about the subset
of enabled
syngo
functionalities
are listed below. | Radial Rib Ranges
Parallel Rib Ranges
Spine Range | Radial Rib Ranges
Parallel Rib Ranges
Spine Range | Radial Rib Ranges
Parallel Rib Ranges
Spine Range |
| | 3D and 4D image
visualization,
manipulation and manual
contouring tools for
preparation and response
assessment of
radiotherapy treatment. | 3D and 4D image
visualization,
manipulation and manual
contouring tools for
preparation and response
assessment of
radiotherapy treatment. | 3D and 4D image
visualization,
manipulation and manual
contouring tools for
preparation and response
assessment of
radiotherapy treatment. |
| | CaScoring
(Not supported by SOMATOM
go.Now and go.Up) | Automated CaScoring
function is supported via
stand alone software
application syngo.CT
CaScoring (K192763) | Automated CaScoring
function is supported via
stand alone software
application syngo.CT
CaScoring |
| | RT Automatic Contouring
(DirectORGANS)
(Not supported by SOMATOM
go.Now, go.Up, go.All,
go.Top) | Automatic Contouring
function is supported via
stand alone software
application syngo.via RT
Image Suite (K192065) | Automatic Contouring
function is supported via
stand alone software
application syngo.via RT
Image Suite (K192065) |
| Cybersecurity
HD FoV | IT Hardening
HD FoV 4.0 | IT Hardening
HD FoV 3.0 | IT Hardening
HD FoV 4.0 |
| Standard
technologies | • FAST Features
• CARE Features
• GO technology | • FAST Features
• CARE Features
• GO technology | • FAST Features
• CARE Features |
| | DirectDensity™
(including relative electron
density and relative mass
density) | DirectDensity™
(including relative electron
density and relative mass
density) | DirectDensity™
(including relative electron
density and relative mass
density) |
| DirectDensity™ | | | |
| breath-hold
technique | Respiratory Motion
Management support breath
hold triggered spiral scans
with manual breath hold
triggered examinations. | Respiratory Motion
Management support breath
hold triggered spiral scans
with manual breath hold
triggered examinations. | Respiratory Motion
Management support breath
hold triggered spiral scans
with manual breath hold
triggered examinations. |
| Respiratory
gating scan
modes | Respiratory gated spiral and
respiratory triggered sequence
scan modes | Respiratory gated spiral and
respiratory triggered
sequence scan modes | Respiratory gated spiral and
respiratory triggered sequence
scan modes |
| Iterative
Reconstruction
Methods | SAFIRE
iMAR | SAFIRE
iMAR | SAFIRE
iMAR |
Table S5-04: SOMATOM go. platform and SOMATOM X.cite comparable software properties
12
Note 1: Detail information to support Recon&GO
The summary below in Table S05 provides detailed information about the subset of functionalities enabled by Recon&GO - Post-Processing plug in functions.
13
| Table $5-05: Overview of Recon&GO Inline Results post-processing methods supported by subject | |
|---|---|
| devices supporting syngo CT VA30 (update) |
| Supported post-processing plug in
functions | 510(k) information of the medical device
software application that support same
established post-processing methods |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Recon&GO – Inline Results
- Heart Isolation,
- Coronary Tree,
- Vessel Ranges (LAD, RCA, CX),
- Cardiac Ranges | Primary Predicate Device:
K191891 – SOMATOM X.cite
Reference Device:
K173637 – syngo.CT Coronary Analysis |
| Recon&GO – Inline Results - Vascular ranges (Aorta, Carotis L Int.,
- Carotic R Int., Runoff L, Runoff R)
- Inline Table removal
- Inline Bone removal | Primary Predicate Device:
K191891 – SOMATOM X.cite
Reference Device:
K173637 – syngo.CT Vascular Analysis |
| Recon&GO – Inline Results - LungCAD | Predicate Device:
K192061 – SOMATOM go.Top
Reference Device:
K143196 – syngo.CT LungCAD |
| Recon&GO – Inline Results - Anatomical ranges (Parallel/Radial) | Predicate Device:
K192061 – SOMATOM go.Top
Reference Device:
K191040 - syngo.via |
| Recon&GO – Inline Results - Radial Rib Ranges
- Parallel Rib Ranges
- Spine Range | Primary Predicate Device:
K191891 – SOMATOM X.cite
Reference Device:
K123584 – syngo.CT Bone Reading |
| Recon&GO – Inline Results - 3D and 4D image visualization,
manipulation and manual contouring tools
for preparation and response assessment
of radiotherapy treatment. | Primary Predicate Device:
K191891 – SOMATOM X.cite
Reference Device:
K192065 – syngo.via RT Image Suite |
| Recon&GO – Inline Results - CaScoring
(Not supported by SOMATOM go.Now and
go.Up) | Reference Device:
K192763 – syngo.CT CaScoring |
| Recon&GO – Inline Results
RT Automatic Contouring
(DirectORGANS)
(Supported by SOMATOM go.Sim, SOMATOM
go Open Pro and SOMATOM X cite ) | Reference Device:
K192065 – syngo.via RT Image Suite |
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 go. platform CT Scanner Systems and SOMATOM X.cite during product development.
14
The modifications described in this Premarket Notification were supported with verification and validation testing.
The general purpose of each tests is to verify and validate the functionality of the subject device modifications.
Testing will cover all related subsystems that contribute to the device modifications. Test levels are defined. For each test level several test activities are performed. The test specification and acceptance criteria are related to the corresponding requirements. Various test activities are performed to specific modifications on different test levels to ensure safe and effective integration in the system. Three test levels are defined:
System Validation test:
- Acceptance test (workflow and user manual test) .
- Legal and Regulatory test ●
System Verification test:
- System Integration Test (functional) ●
- . Functionality verification
- . Image Quality (IQ) Evaluation
Tests are conducted for all software components developed in product development and for the complete product itself. Several activities are considered for this process, including creation of test specifications that relate to software/hardware requirements including tests to address risk mitigations that are identified, documented and traced by hazard keys.
Additional evaluation tests are performed as bench tests to support the new device or device modification on Non-Clinical Performance Testing as listed in table S5-06 below.
| # | Feature/Non-Clinical
Supportive Testing | Document Title | Testing Performed |
|----|--------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 01 | FAST Integrated
Workflow | FAST 3D Camera
Evaluation | FAST Isocentering: Clinical data based software
validation to assess accuracy of patient isocenter
proposal for feature. Conducted tests for the
subject device FAST Isocentering demonstrated
that there was a lower isocenter deviation for the
subject device in comparison to the predicate
device.
FAST Range: Based on manually triggered
camera images, comparison and measurement of
deviation of manual annotation of patient
landmark and based on video stream images
supporting the feature proposed patient landmark.
Conducted test demonstrated a lower deviation for
landmark boundaries for the subject device in
comparison to the predicate device. |
| 02 | Contrast media protocol | Siemens
Healthineers factory
contrast protocols
and comparison to
approved drug
labeling | All factory contrast protocols are within the limits
as prescribed by the approved labeling of
Ultravist® or Visipaque®. (including coronary CTA
contrast protocol) |
| 03 | Scan&GO supported
hardware | Bench test:
Scan&GO Mobile
Medical
Application
Software
(supporting) | With software version VA30 the additional
hardware support the information shown on the in-
room monitor in the same way as it is shown on
the tablets. |
Table S5-06: Non-Clinical Performance Testing
15
| # | Feature/Non-Clinical
Supportive Testing | Document Title | Testing Performed |
|---|--------------------------------------------|--------------------------------------|-------------------|
| | | optional PC and
Monitor hardware) | |
Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the subject device 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 S5-07 and Table S5-08 below.
| Date of
Recognition | Recognition
Number | Standard
Developing
Organization | Standard
Designation
Number and Date | Title of Standard |
|------------------------|-----------------------|----------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 06/27/2016 | 12-300 | NEMA | PS 3.1 - 3.20 (2016) | Digital Imaging And Communications
In Medicine (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 Information And System
Function Related To Dose In CT |
| 6/27/2016 | 5-40 | ANSI AAMI
ISO | 14971:2007/(R)2010
(Corrected 4 October
2007) | Medical Devices - Applications Of
Risk Management To Medical
Devices |
| | | ISO | 14971 Second
Edition 2007-03-01 | Medical Devices - Applications Of
Risk Management To Medical
Devices |
| 01/14/2019 | 13-79 | IEC | 62304 Edition 1.1
2015-06
CONSOLIDATED
VERSION | Medical Device Software - Software
Life Cycle Processes |
| 07/09/2014 | 19-4 | ANSI AAMI | ES60601-
1:2005/(R)2012 And
A1:2012, | C1:2009/(R)2012 And
A2:2010/(R)2012 (Consolidated
Text) Medical Electrical Equipment -
Part 1: General Requirements For
Basic Safety And 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: General Requirements For
Basic Safety And Essential
Performance -- Collateral Standard:
Electromagnetic Disturbances --
Requirements And Tests |
| 12/23/2016 | 5-114 | ANSI AAMI
IEC | 62366-1:2015 | Medical Devices - Part 1: Application
Of Usability Engineering To Medical
Devices |
| 07/09/2014 | 12-273 | IEC | 60825-1 Edition 2.0
2007-03 | Safety Of Laser Products - Part 1:
Equipment Classification, And
Requirements [Including: Technical
Corrigendum 1 (2008), Interpretation
Sheet 1 (2007), Interpretation Sheet
2 (2007)] |
| 06/27/2016 | 12-302 | IEC | 60601-2-44 Edition
3.2: 2016 | Medical Electrical Equipment - Part
2-44: Particular Requirements For
The Basic Safety And Essential
Performance Of X-Ray Equipment
For Computed Tomography |
| 01/14/2014 | 12-269 | IEC | 60601-1-3 Edition
2.1 2013-04 | Medical Electrical Equipment - Part
1-3: General Requirements For
Basic Safety And Essential
Performance - Collateral Standard:
Radiation Protection In Diagnostic X-
Ray Equipment |
Table S5-07: Recognized Consensus Standards
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| Date of
Recognition | Recognition
Number | Standard
Developing
Organization | Standard
Designation
Number and Date | Title of Standard |
|------------------------|-----------------------|----------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 06/27/2016 | 5-89 | IEC | 60601-1-6 Edition
3.1 2013-10 | Medical Electrical Equipment - Part
1-6: General Requirements For
Basic Safety And Essential
Performance - Collateral Standard:
Usability |
| 03/14/2011 | 12-226 | IEC | 61223-2-6 Second
Edition 2006-11 | Evaluation And Routine Testing In
Medical Imaging Departments - Part
2-6: Constancy Tests - Imaging
Performance Of Computed
Tomography X-Ray Equipment |
| 01/30/2014 | 12-270 | IEC | 61223-3-5 First
Edition 2004-08 | Evaluation And Routine Testing In
Medical Imaging Departments - Part
3-5: Acceptance Tests - Imaging
Performance Of Computed
Tomography X-Ray Equipment
[Including: Technical Corrigendum 1
(2006)] |
| 06/07/2018 | 12-309 | IEC | 60601-2-28 Edition
3.0 2017-06 | Medical Electrical Equipment - Part
2-28: Particular Requirements For
The Basic Safety And Essential
Performance Of X-Ray Tube
Assemblies For Medical Diagnosis |
| 06/27/2016 | 12-299 | IEC | 62563-1 Edition 1.1 | Medical Electrical Equipment -
Medical Image Display Systems -
Part 1: Evaluation Methods |
| Table S5-08: General Use Consensus Standards |
|---|
| Standard
Developing
Organization | Standard
Designation
Number and
Date | Title of Standard | How was Standard Used |
|----------------------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| IEC | 60601-
1:2005+A1:2012 | Medical electrical equipment
- part 1: general
requirements for basic safety
and essential performance | Covered by ANSI AAMI ES60601-
1:2005/(R)2012 and A1:2012 as part of
EMC testing. |
| IEC/ISO | 17050-1 | Conformity Assessment -
Supplier's declaration of
conformity - Part 1: General
requirements | Declaration of conformance to FDA
recognized consensus standards. |
| IEC/ISO | 17050-2 | Conformity assessment -
Supplier's declaration of
conformity - Part 2:
Supporting documentation. | General consensus standards not currently
recognized by FDA. |
A list of applicable guidance documents considered for this submission is provided as Table S5-09 below.
| 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)s
Document issued on February 21, 2019 |
| 3. | Guidance for Industry and FDA Staff: The Special 510(k) Program - Guidance for Industry and FDA Staff
Document 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 Substantial
Equivalence in Premarket Notifications [510(k)]
Document Issued on July 28, 2014 |
17
| 6. | Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submission for Software in Medical Devices
Document issued on May 11, 2005 |
|-----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7. | Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in Medical Devices
Document issued on September 9, 1999 |
| 8. | Guidance for Industry and FDA Staff: Applying Human Factors and Usability Engineering to Medical Devices.
Document issued February 3, 2016 |
| 9. | Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging Device Premarket Notifications.
Document issued on November 28, 2017 |
| 10. | Guidance for Industry and FDA Staff: Content of Premarket Submissions for Management of Cybersecurity in Medical devices.
Document issued on October 2, 2014 |
| 11. | Guidance for Industry and FDA Staff: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices
Document issued on July 11, 2016 |
| 12. | Guidance for Industry and Food Drug Administration Staff: Design considerations and Pre-Market Submission recommendations for Interoperable Medical devices
Document 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 Devices
Document 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 requirements by implementing 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.
Additionally, Siemens conforms to the requirements for Radio Frequency Wireless Technology as defined in FDA quidance document "Radio Frequency Wireless Technology in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued on August 14, 2013" by adhering to the EMC and risk based verification and validation requirements in design, testing, and labeling of the wireless remote control components of the subject devices.
The Radio Frequency Wireless Technology of the optional Remote Scan Control and supporting Control Device tablet for Scan&GO complies to 47 CFR part 15 subpart c – Intentional Radiators. All Radio device labels will show an FCC ID code to show compliance. Shielding requirement applicable to the CT Scanners and respective Scatter Radiation diagrams for typical room installations are provided in the User Documentation and Planning Guide of the intended Scanners in accordance to IEC60601-2-44.
Wireless Coexistence Testing
Siemens has considered several measures to address wireless coexistence by design to ensure the safe operation of the wireless components in combination with the applicable system supported functionality. Wireless technology in the system setup to perform a task in a given shared environment where other systems have an ability to perform their tasks and may or may not be using the same set of rules has been considered. According to FDA guidance 'Radio Frequency Wireless Technology in Medical Devices" Siemens has addressed the safety, effectiveness, and high likelihood of coexistence with other devices of this technology in our product design by our Risk Management Process, Failure Mode and Effects Analysis (FMEA) Process, and Requirement Engineering Process.
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As part of the risk management process, hazardous situations associated with the Scan&GO and its connection to the host system via Wi-Fi were addressed as part of the Risk Management process.
Testing for co-existence considered for following scenarios:
- . Co-Channel Testing
- Adjacent Channel Testing .
- . RF Interference Testing
- Separation Distance/Location Testing .
Scan&GO is designed to allow dynamic frequency selection and transmission power control by default in accordance with IEEE 802.11h. Adjacent channel testing is addressed by the fact that Scan&GO does not support shared medium access to Siemens Wi-Fi network. RF interference was tested by successfully ensuring that wireless communications were actively transmitting in situations where possible interference may exist. Recommended distance and router locations requirements are documented in the user documentation.
Customer Use Testing
The following clinical use testing was conducted to demonstrate Scan&GO's performance in the intended clinical environment:
- . Internal Clinical Use Test. The CT scanner customer environment is simulated in Siemens Test Cabins. For such a test, customers with clinical expertise are typically invited to perform tests.
- External Clinical Use Test: The CT scanner is tested in the environment of the . clinic/hospital. Typically we perform these tests with selected customer before rollout of the CT scanner.
All tests performed meet the pre-determined acceptance criteria and demonstrate that Scan&O is safe and effective for the intended use. Multiple tablets for visualisation purpose, using the same Scan&GO installation and feature configuration, does not change the intended use.
Additional Supportive 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.
Summarv
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, mechanical, 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 devices are also tested using the same test methods and workflows as used for the predicate devices. The non-clinical data supports the safety of the device and the hardware and software verification and validation
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demonstrates that the SOMATOM go. platform and SOMATOM X.cite should perform as intended in the specified use conditions. The data included in this submission demonstrates that the SOMATOM go. platform and SOMATOM X.cite with described modifications performs comparably to the predicate devices currently marketed for the same intended use. Since the subject and predicate devices were tested using the same methods, Siemens believes that the data generated from the SOMATOM go. platform and SOMATOM X.cite testing supports a finding of substantial equivalence.