(118 days)
Not Found
No
The document describes standard CT image processing techniques (like ADMIRE for noise reduction) and performance metrics, but does not mention AI, ML, or related concepts like deep learning or neural networks.
No.
The device is described as a Computed Tomography (CT) system intended to generate images as an "aid in diagnosis," not for treatment or therapy.
Yes
The device is a Computed Tomography (CT) system that generates images "as an aid in diagnosis," explicitly stating its role in diagnostic processes.
No
The device description explicitly states it is a "mobile computed tomography (CT) scanner system" and details hardware components like a "continuously rotating tube-detector system" and a "motorized trolley" or mounting to a vehicle floor. While it includes software, it is fundamentally a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SOMATOM On.site is a Computed Tomography (CT) system. It generates images of the internal structures of the body using X-rays. It does not analyze samples taken from the body.
- Intended Use: The intended use is to generate and process images as an aid in diagnosis. This is a function of medical imaging, not in vitro diagnostics.
- Device Description: The description details a mobile CT scanner, its components, and how it produces images. There is no mention of analyzing biological samples.
Therefore, while this device is a medical device used for diagnosis, it falls under the category of medical imaging systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 26 cm field-of-view, for the head and neck.
The images delivered by the system can be used by a trained staff as an aid in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
Siemens intends to market a new software version, SOMARIS/10 syngo CT VB10 for the SOMATOM On. platform cleared in K193277 (clearance date July 22nd, 2020).
In software version syngo CT VA35 (K193277), the SOMATOM On. platform consists of two Computer Tomography (CT) scanner systems: SOMATOM On.scene for Mobile Stroke Units and SOMATOM On.site with an optional motorized base for in-hospital usage.
With the new software version SOMARIS/10 synqo CT VB10, the two SOMATOM On. scanners are rebranded as one scanner model only, SOMATOM On.site. The brand name SOMATOM On.scene is not used anymore.
The SOMATOM On.site with software version syngo CT VB10 is a mobile computed tomography (CT) scanner system that will be offered in two variants:
- . SOMATOM On.site for Intensive Care Unit (ICU) Mobile CT scanner affixed to a motorized trolley for use in hospital situations. The scanner can be moved from patient bed to patient bed to perform scanning at the point of care. Although it might be used in other environments like emergency rooms or angiography labs, the main location where this scanner will be used, will be the intensive care unit (ICU).
- . SOMATOM On.site for Mobile Stroke Unit (MSU) Mobile CT Scanner that is mounted to the floor of a diagnostic room or vehicle. The system main place where the scanner will be mounted is in a mobile stroke unit (MSU), which is a specific type of ambulance.
The subject device SOMATOM On.site with SOMARIS/10 syngo CT VB10 is a mobile Computed Tomography X-ray Systems which features a continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM On.site with software SOMARIS/10 syngo CT VB10 produces CT images in DICOM format, which can be used by trained staff for postprocessing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis and treatment preparation. The computer system integrated with the CT scanner is able to run optional post processing applications.
Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system.
The platform software for SOMATOM On.site is syngo CT VB10 (SOMARIS/10 syngo CT VB10). It 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 synqo CT VB10 is designed to provide a plugin interface to integrate potential advanced post-processing tasks, tools, or extendable functionalities.
New software version synqo CT VB10 (SOMARIS/10 synqo CT VB10) is a modified software version based on syngo CT VA35 (SOMARIS/10 syngo CT VA35) which was cleared for the predicate device in K193277.
Software version SOMARIS/10 syngo CT VB10 will be offered ex-factory and as a mandatory exchange for the applicable existing SOMATOM On.site.
The subject device SOMATOM On.site will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use is same for subject and primary predicate device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-ray
Anatomical Site
head and neck
Indicated Patient Age Range
Adult/ pediatric protocols are mentioned in relation to the examination protocols. "Adult/ pediatric protocols for head and neck examination".
Intended User / Care Setting
Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system.
Use Environment: Radiology suite, Operating room (OR), Emergency Department/ Emergency room (ER/ED), clinic, patient rooms, exam rooms, mobile radiology vehicles, Intensive Care Unit (ICU), and Mobile Stroke Unit (MSU).
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Non-clinical testing (integration and functional), including phantom tests were conducted for the SOMATOM On.site during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
The general purpose of each test is to verify and validate the functionality of the subject device modifications.
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.
Bench Testing performed for specific features:
- FAST kV:
- Objective: To demonstrate that image quality (in terms of contrast-to-noise ratio) at different kV settings is consistent when using FAST kV, and that radiation dose levels are reduced at 80 kV.
- Results: For iodine and calcium contrast material inserts in a cylindrical 20 cm water phantom with corresponding FAST kV settings 'vascular' and 'bone/calcium', CNR values at 80 kV and 120 kV are consistent (deviations well below 15%). In comparison to 120 kV, dose levels at 80 kV are slightly reduced (-5%) with the 'bone/calcium' setting and are substantially reduced (-44%) with the 'vascular' setting of FAST kV.
- CARE Dose4D:
- Objective: To demonstrate comparable performance of CARE Dose4D in SOMATOM On.site and the predicate device SOMATOM go.Up, leading to reduced dose levels at consistent image quality.
- Results: Phantom-based measurements on the subject device SOMATOM On.site (head and neck scans) and the predicate device SOMATOM go.Up (whole body diagnostic scanner) showed equivalent performance results for CARE Dose4D with respect to radiation dose (CTDIvol) and image noise levels.
- X-CARE:
- Objective: To demonstrate comparable performance of X-CARE in SOMATOM On.site and the predicate device SOMATOM go.Up, leading to reduced dose levels to the eye lenses at consistent image quality.
- Results: Phantom-based measurements on the subject device SOMATOM On.site (head and neck scans) and the predicate device SOMATOM go.Up showed equivalent performance results for X-CARE with respect to radiation dose (CTDIvol) and image noise levels.
- ADMIRE:
- Objective: To demonstrate that ADMIRE reduces image noise at the Somatom On.site CT scanner and maintains a natural image impression without noticeable loss of sharpness. Also, that mean CT values do not vary when ADMIRE reconstruction is used instead of WFBP.
- Results: The water value and the CT value of the PTFE object remain constant with increasing ADMIRE strength settings and compared to the WFBP reconstruction. Sharpness (edge MTF function) is constant with increasing ADMIRE strength setting and WFBP. Image noise decreases compared to WFBP and with increasing ADMIRE strength. Image impression is maintained as the shape of the noise distribution remains Gaussian with any ADMIRE strength setting.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found in the provided text.
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.
Not Found
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
September 3, 2024
Siemens Medical Solutions USA, Inc. % Kenny Bello Regulatory Affairs Professional 810 Innovation Drive KNOXVILLE, TN 37932
Re: K241295
Trade/Device Name: SOMATOM On.site Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: July 31, 2024 Received: July 31, 2024
Dear Kenny Bello:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-regulatory
2
assistance/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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
SOMATOM On.site
Indications for Use (Describe)
This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 26 cm field-of-view, for the head and neck.
The images delivered by the system can be used by a trained staff as an aid in diagnosis.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/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.
510(k) Summary for K241295
SOMATOM On.site CT Scanner System
with software version SOMARIS/10 syngo CT VB10
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. Contact Details
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
Siemens Healthineers AG Siemensstr. 1 -OR- Rittigfeld 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335
Note: Descriptions in this submission use the short company name Siemens. Brand name on all products is Siemens Healthineers.
Submitter Contact Person:
Kenny M Bello Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive Knoxville, TN 37932 Phone: (205) 856-6099 monsuru.bello@siemens-healthineers.com
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Image /page/5/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a pattern of orange dots arranged in a circular shape.
II. Device Name and Classification
| Product name: | SOMATOM On.site |
|---|---|
| Trade name: | SOMATOM On.site |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
III. Predicate Device
Primary predicate device:
| Trade Name: | SOMATOM On. CT scanner systems
(with SOMARIS/10 syngo CT VA35 software) |
|-----------------------|------------------------------------------------------------------------------------|
| 510(k) Number: | K193277 |
| Clearance Date: | July 22, 2020 |
| 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. |
Secondary predicate device:
| Trade Name: | SOMATOM go.Up (with SOMARIS/10 syngo CT VB10 software) |
|---|---|
| 510(k) Number: | K233650 |
| Clearance Date: | March 26, 2024 |
| 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:
K233650 was a bundle submission with various Siemens CT Scanner Systems, including the CT scanner systems SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite, SOMATOM X.ceed.
K193277 was a bundle submission with the following Siemens CT Scanner Systems: SOMATOM On.site and SOMATOM On.scene
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Image /page/6/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 cluster of orange dots arranged in a circular pattern.
IV. Device Description
Siemens intends to market a new software version, SOMARIS/10 syngo CT VB10 for the SOMATOM On. platform cleared in K193277 (clearance date July 22nd, 2020).
In software version syngo CT VA35 (K193277), the SOMATOM On. platform consists of two Computer Tomography (CT) scanner systems: SOMATOM On.scene for Mobile Stroke Units and SOMATOM On.site with an optional motorized base for in-hospital usage.
With the new software version SOMARIS/10 synqo CT VB10, the two SOMATOM On. scanners are rebranded as one scanner model only, SOMATOM On.site. The brand name SOMATOM On.scene is not used anymore.
The SOMATOM On.site with software version syngo CT VB10 is a mobile computed tomography (CT) scanner system that will be offered in two variants:
- . SOMATOM On.site for Intensive Care Unit (ICU) Mobile CT scanner affixed to a motorized trolley for use in hospital situations. The scanner can be moved from patient bed to patient bed to perform scanning at the point of care. Although it might be used in other environments like emergency rooms or angiography labs, the main location where this scanner will be used, will be the intensive care unit (ICU).
- . SOMATOM On.site for Mobile Stroke Unit (MSU) Mobile CT Scanner that is mounted to the floor of a diagnostic room or vehicle. The system main place where the scanner will be mounted is in a mobile stroke unit (MSU), which is a specific type of ambulance.
SOMATOM On.site
SOMARIS/10 syngo CT VB10
A: for Intensive Care Unit (ICU)
Image /page/6/Figure/11 description: This image shows a Siemens Healthineers SOMATOM On.site mobile CT scanner. The scanner is white with orange accents and has a large, circular gantry. The gantry is open in the front, and there is a gray cover over the opening. The scanner is mounted on a wheeled base, making it easy to move around.
B: for Mobile Stroke Unit (MSU)
Image /page/6/Figure/13 description: The image shows a Siemens Healthineers SOMATOM On.site mobile head CT scanner. The scanner is white with an orange circular opening where the patient's head is placed for scanning. The Siemens Healthineers logo is visible at the top of the scanner.
Figure 1: SOMATOM On.site with software version SOMARIS/10 syngo CT VB10 in two variants. A: as a mobile CT scanner for Intensive Care Unit (ICU). The scanner is mounted on a trolley with wheels. B: as a mobile CT for Mobile Stroke Unit (MSU). The CT scanner is mounted in a vehicle.
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Image /page/7/Picture/0 description: The image shows the logo for Siemens Healthineers. 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 arranged in a circular pattern.
The subject device SOMATOM On.site with SOMARIS/10 syngo CT VB10 is a mobile Computed Tomography X-ray Systems which features a continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM On.site with software SOMARIS/10 syngo CT VB10 produces CT images in DICOM format, which can be used by trained staff for postprocessing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis and treatment preparation. The computer system integrated with the CT scanner is able to run optional post processing applications.
Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system.
The platform software for SOMATOM On.site is syngo CT VB10 (SOMARIS/10 syngo CT VB10). It 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 synqo CT VB10 is designed to provide a plugin interface to integrate potential advanced post-processing tasks, tools, or extendable functionalities.
New software version synqo CT VB10 (SOMARIS/10 synqo CT VB10) is a modified software version based on syngo CT VA35 (SOMARIS/10 syngo CT VA35) which was cleared for the predicate device in K193277.
Software version SOMARIS/10 syngo CT VB10 will be offered ex-factory and as a mandatory exchange for the applicable existing SOMATOM On.site.
The subject device SOMATOM On.site will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use is same for subject and primary predicate device.
V. Indications for Use
This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 26 cm field-of-view, for the head and neck.
The images delivered by the system can be used by a trained staff as an aid in diagnosis.
VI. Indications for Use Comparison
Subject Device Indications for Use:
This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 26 cm field-of-view, for the head and neck.
The images delivered by the system can be used by a trained staff as an aid in diagnosis.
Primary Predicate Device Indications for Use:
This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 25 cm field-of-view, primarily for the head and neck.
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Image /page/8/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.
The images delivered by SOMATOM On.site and On.scene can be used by a trained physician as an aid in diagnosis.
Secondary Predicate Device 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 trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.
This CT system can be used for low dose lung cancer screening in high risk populations.
High risk populations are 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.
Comparison:
Compared to the primary predicate device:
In the sentence "This computed tomography system is intended to generate and process crosssectional images by computed reconstruction of x-ray transmission data within a 25 cm field-of-view, for the head and neck.":
- . "25 cm field-of-view" is replaced with "26 cm field-of-view". The field-of-view was inconsistently listed among the documents of the predicate device. However, 26 cm field-ofview is the correct field-of-view of the predicate device and the subject device.
- . "primarily for the head and neck" is replaced with "for the head and neck". In contrast to the predicate device, the subject device is only intended for head and neck scans.
In the sentence "The images delivered by SOMATOM On.scene can be used by a trained physician as an aid in diagnosis ":
- . "trained physician" is replaced with "trained staff". It can be assumed a trained physician is part of the trained staff.
To consider that in the US, the standard of care is for physicians to perform diagnosis/treatment, Siemens added the following statement in the 510(k) summary:
"Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system."
- . "SOMATOM On.site and SOMATOM On.scene" have been replaced with "system", since with software version synqo CT VB10, the two SOMATOM On. scanners will be rebranded as one scanner model only.
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Image /page/9/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" are several orange dots arranged in a pattern.
Compared to the secondary predicate device:
- The subject device does not contain the phrase "treatment preparation and radiation therapy planning" in the sentence "The images delivered by the system can be used by a trained staff as an aid in diagnosis." because SOMATOM On.site does not support intervention procedures and radiation therapy planning.
- . SOMATOM On.site is not used in lung cancer screening. Therefore, the following part is not included in the indication for use statement of SOMATOM On.site.
"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."
VII. Comparison of Technological Characteristics with the Predicate Device
Supported by the subject device, SOMARIS/10 syngo CT VB10 software version is a further development of the SOMARIS/10 syngo CT VA35 software version which is cleared in K193277.
The SOMATOM On.site with SOMARIS/10 syngo CT VB10 software version provides the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software features of SOMATOM On.site have been modified or improved in comparison to the predicate devices to support enhanced device functionality compared to the predicate devices.
The new syngo CT VB10 software reuses all unmodified software features of the legacy software syngo CT VA35 cleared in K193277.
The intended use and fundamental scientific technology for the SOMATOM On.site remain unchanged from the predicate devices.
At a high level, the subject and predicate devices are based on the same subset of technological elements:
- System Acquisition - Continuously rotating tube detector system
- . Iterative Reconstruction – Support of various iterative reconstruction principles
- A gantry translation system
- Stellar Detector technology
- Tin filtration technology
- Power Generator
- Remote Scan Control
- Standard CARE technologies
- Standard FAST technologies
- Standard GO technologies
- HD FoV ●
Compared to the predicate devices referenced in this submission, the subject device SOMATOM On.site with SOMARIS/10 syngo CT VB10 support the following modifications:
-
- Modified hardware
-
- Modified software
-
- Modified accessories
10
Image /page/10/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" are several orange dots that are arranged in a pattern.
-
- Modified indications for use
-
- Rebranding as one scanner model with two configurations, ICU and MSU
The configuration table and comparison table use the following terms to describe various technological characteristics in comparison to the primary and secondary predicate devices information:
Table 1: Overview of term definition
| Term | Definition |
|---|---|
| Modified | The feature is modified from the predicate devices |
| Enabled | The feature is currently supported by other cleared Siemens CT systems. This |
| feature will be supported for the subject device with software version | |
| SOMARIS/10 syngo CT VB10 and is unmodified from cleared version. | |
| New | The feature is newly supported for Siemens CT Scanners and the subject |
| device |
1) Modified Hardware
Table 2: Overview of hardware modifications of SOMATOM On.site with software version SOMARIS/10 syngo CT VB10 compared to the predicate devices.
| # | Hardware property | Subject device |
|---|---|---|
| SOMATOM On.Site | ||
| (ICU and MSU variants) | ||
| with SOMARIS/10 syngo CT VB10 | ||
| 1. | CARE 2D Camera | modified |
| (compared to the secondary predicate | ||
| device SOMATOM go.Up) | ||
| 2. | Tin Filter for Topogram | enabled |
| (compared to the secondary predicate | ||
| device SOMATOM go.Up) |
2) Modified Software (syngo CT VB10)
Table 3: Overview of software modifications of SOMATOM On.site with software version SOMARIS/10 syngo CT VB10 compared to the predicate devices.
| # | Software property | Subject device |
|---|---|---|
| SOMATOM On.Site | ||
| (ICU and MSU variants) | ||
| with SOMARIS/10 syngo CT VB10 | ||
| 1. | Check&GO – Metal detection | enabled |
| # | Software property | Subject device |
| SOMATOM On.Site | ||
| (ICU and MSU variants) | ||
| with SOMARIS/10 syngo CT VB10 | ||
| (compared to the secondary predicate | ||
| device SOMATOM go.Up) | ||
| 2. | myExam Companion - myExam | |
| Compass/myExam Cockpit | enabled | |
| (compared to the secondary predicate | ||
| device SOMATOM go.Up) | ||
| 3. | Bolus Tracking | enabled |
| (compared to the secondary predicate | ||
| device SOMATOM go.Up) | ||
| 4. | Test Bolus | enabled |
| (compared to the secondary predicate | ||
| device SOMATOM go.Up) | ||
| 5. | ADMIRE | enabled |
| (compared to the secondary predicate | ||
| device SOMATOM go.Up) | ||
| 6. | FAST kV | enabled |
| (compared to the secondary predicate | ||
| device SOMATOM go.Up) | ||
| 7. | CARE Dose4D | enabled |
| (compared to the secondary predicate | ||
| device SOMATOM go.Up) | ||
| 8. | X-CARE | enabled |
| (compared to the secondary predicate | ||
| device SOMATOM go.Up) | ||
| 9. | FAST Planning | enabled |
| (compared to the secondary predicate | ||
| device SOMATOM go.Up) | ||
| 10. | CT View&GO | modified |
| (compared to the primary SOMATOM | ||
| on.site and the secondary predicate device | ||
| SOMATOM go.Up) | ||
| 11. | Recon&GO | modified |
| (compared to the primary SOMATOM | ||
| on.site and the secondary predicate device | ||
| SOMATOM go.Up) |
11
Image /page/11/Picture/0 description: The image shows the logo for Siemens Healthineers. 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 arranged in a circular pattern.
12
Image /page/12/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.
A tabular summary of the comparable hardware properties between the subject device On.site with software version syngo CT VB10 and the predicate devices are listed in Table 5 below (modifications are in gray shaded sections).
Toble 4: Comprison of hardware (HV) technologics between the subject device SOMATOM On.site with syltware version syngo CTVB10 ond the predicote devices.
| Hardware (HW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Scanner | Head sized computed
tomography scanner with
continuously rotating tube
and detector | Head sized computed
tomography scanner with
continuously rotating tube
and detector | Whole body computed
tomography scanner with
continuously rotating tube
and detector | Same as the primary
predicate device |
| System configuration | Single source | Single source | Single source | Same as the primary
and the secondary
predicate device |
| Use environment | Radiology suite, Operating
room (OR), Emergency
Department/ Emergency room
(ER/ED), clinic, patient rooms,
exam rooms, mobile radiology
vehicles, Intensive Care Unit
(ICU), and Mobile Stroke Unit
(MSU) | Radiology suite, Operating
room (OR), Emergency
Department/ Emergency room
(ER/ED), clinic, patient rooms,
exam rooms, mobile radiology
vehicles, Intensive Care Unit
(ICU), and Mobile Stroke Unit
(MSU) | Professional Healthcare
Facility | Same as the primary
predicate device |
| X-ray tube | Stationary anode | Stationary anode | Rotary anode | Same as the primary
predicate device |
| Tube
technology | Monoblock: Integrates tube
and generator to one
component | Monoblock: Integrates tube
and generator to one
component | Chronon | Same as the primary
predicate device |
| Hardware (HW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
| Tube
current (mA) | 1...25 | 3...25 | 13...400 | Range of mA was
extended at the lower
end to increase
flexibility for scans with
lower mA and thus
lower dose especially
for topogram scans. |
| Tube voltage
kV steps | 80, 120 | 80, 120 | 80, 110, 130 | Same as the primary
predicate device |
| tube cooling | Liquid | Air and liquid | Liquid | Same as the secondary
predicate device
Focus on liquid cooling
allows to get rid of air
cooling and reduce the
number of
components in the
system by reducing the
air fan, which was
needed. |
| Focal spot size (mm) | 1.1 x 1.6 | 1.1 x 1.6 | 0.8 x 0.4
0.8 x 0.7 | Same as the primary
predicate device |
| Generator
power max (kW) | 3 | 3 | 32 | Same as the primary
predicate device |
| Hardware (HW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
| Detector
material | Lightning UFC | Lightning UFC | Lightning UFC | Same as the primary
and the secondary
predicate device |
| Detector
technology | Stellar based technology | Stellar based technology | Stellar based technology | Same as the primary
and the secondary
predicate device |
| Detector
physical rows | 32 | 32 | 32 | Same as the primary
and the secondary
predicate device |
| Detector
Z axis coverage (mm) | 24 | 24 | 22.4 | Same as the primary
and the secondary
predicate device |
| Detector
slice width (mm) | 0.75 | 0.75 | 0.7 | Same as the primary
predicate device |
| Detector
DAS channel No./row | 416 | 416 | 768 | Same as the primary
predicate device |
| Detector
Max. number of slices | Acquired: 32
Reconstructed: 32 | Acquired: 32
Reconstructed: 32 | Acquired: 32
Reconstructed: 64 | Same as the primary
predicate device |
| Translation/table | Translation on fixed base | Translation on fixed base | Translating patient table | Same as the primary
predicate device |
| Max. scan range (cm) | 25 | 25 | 160 or 200 depending on the
patient table used | Same as primary
predicate device |
| Hardware (HW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
| | | | | |
| Gantry
scan FoV (cm) | 26 | 26 | 50 | Same as the primary
predicate device |
| Gantry
rotation time (sec) | 1.0 | 1.0 | 0,8, 1.0, 1.5 | Same as the primary
predicate device |
| Gantry
bore diameter (cm) | 35 | 35 | 70 | Same as the primary
predicate device |
| Gantry tilt (degrees) | No tilt | No tilt | Yes (+/-25°) | Same as the primary
predicate device |
| Selectable filtration | Tin Filter/Tin Filtration
technology | N.A. | Tin Filter/Tin Filtration
technology | Same as the secondary
predicate device
Tin filtration allows to
lower the dose on
topogram scans. |
| Recon speed
(images/sec) | 20 for FBP | 13 for FBP | • 30 fps for FBP
• 75 fps for FBP
(depending on the IRS) | Recon speed increased
due to new hardware
(image reconstruction
system) with increased
performance |
| Spiral scan | yes | yes | yes | Same as the primary
predicate device |
| Hardware (HW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
| System Configuration | Single source | Single source | Single source | Same as the primary
predicate device |
| Patient support | Patient support mounts
directly to the scanner and is
pre-aligned to alleviate
imaging artifacts or loss of
quality | Patient support mounts
directly to the scanner and is
pre-aligned to alleviate
imaging artifacts or loss of
quality | Patient support is part of
patient table which is
mounted to scanner and is
pre-aligned laterally; requires
operator to align vertically to
center patient to alleviate
imaging artifacts or loss of
quality | Same as the primary
predicate device |
| Radiation shielding | Yes
Gantry shielded internally with
lead
Externally contain lead lined
full-length drapes to entirely
contain the scattered
radiation from all angles
Operator can stand at side of
machine.
Wearing of protective
shielding is optional. | Yes
Gantry shielded internally with
lead
Externally contain lead lined
full-length drapes to entirely
contain the scattered
radiation from all angles
Operator can stand at side of
machine.
Wearing of protective
shielding is optional. | No
requires to be installed in a
shielded room with door light
and interlock | Same as the primary
predicate device |
| CARE 2D Camera | integrated into the gantry
front to observe the patient
during examination | N/A | integrated into the gantry
front and back to observe the
patient during examination | Equivalent
In software version
syngo CT VB10, a 2D |
| Hardware (HW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
| | | | | Camera hardware is
integrated into the
gantry front. This
allows to observe the
patient from the front
of the system when
the front radiation
shield was closed. The
bore light illuminates
the bore so the
patient's face can be
seen on the 2D Camera
images. |
| Scanner Mobility | | | | |
| Mobile/ Fixed | Mobile/ fixed
• SOMATOM On.site for
Intensive Care Unit (ICU):
Mobile CT scanner affixed to
an optional motorized trolley
for use in hospital trauma
situations.
• SOMATOM On.site for
Mobile Stroke Unit (MSU):
Fixed CT Scanner that can be
mounted to the floor of a | Mobile/ fixed
• SOMATOM On.site:
Mobile CT scanner affixed to
an optional motorized trolley
for use in hospital trauma
situations.
• SOMATOM On.scene:
Fixed CT Scanner that can be
mounted to the floor of a
diagnostic room or vehicle,
e.g. Mobile Stroke Unit (MSU) | fixed | Same as the primary
predicate device
Note: Rebranding of
the CT system as
SOMATOM On.site
only with two variants,
ICU and MSU;
mobile/fixed method is
unchanged compared |
| Hardware (HW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
| | diagnostic room or vehicle,
e.g. Mobile Stroke Unit (MSU) | | | to the primary
predicate device. |
| Mobile method | 2 independent motorized rear
wheels with 2 front caster
wheels | 2 independent motorized rear
wheels with 2 front caster
wheels | N/A | Same as the primary
predicate device |
| Mobile speed | 2.8 mph max | 2.5 mph max | N/A | Equivalent
Slightly increased by
0.3 mph mobile speed
to meet customers'
satisfaction |
| Break | yes | yes | N/A | Same as the primary
predicate device |
| Drive handle | Yes (ICU variant) | Yes (ICU variant) | N/A | Same as the primary
predicate device |
| Integrated Drive
camera | Yes (ICU variant) | Yes (ICU variant) | N/A | Same as the primary
predicate device |
| Scanner power | | | | |
| External power | 100 - 240 Vac
50/60 Hz
0.825 kW | 100 - 240 Vac
50/60 Hz
1.2 kW | 200 - 400 VAC
50/60 Hz
50 kW | Equivalent
Reduced external
power consumption
due to new battery
technology |
| Hardware (HW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
| Internal power
storage | 1 x 48 V Lithium-ion battery | 4 x 12 V sealed lead-acid
battery | No | Change of technology
from lead-acid
batteries to Lithium-
ion batteries in order
to increase battery
capacity and lifetime. |
| Electrical safety | Circuit breakers and isolation
transformer | Circuit breakers and isolation
transformer | Circuit breakers | Same as the primary
predicate device |
| EMERGENCY-stop key | yes | yes | yes | Same as the primary
predicate device |
| Operator Interface | | | | |
| Operator Control
Interface on Scanner | Integrated touch monitor +
button panel | integrated touch screen tablet
PC + physical keyboard+
button panel | Removable touch screen +
button panel | Changed from tablet to
touch monitor &
desktop PC setup.
Increased performance
of desktop PC, bigger
and tiltable screen. |
| Remote control | Wired remote control for
service | Optional wired | Wired/ wireless | Same as the primary
predicate device |
| Workstation | No, access through integrated
touch monitor | No, access through tablet PC | syngo Acquisition Workplace | Equivalent to the
primary device
The display in the
subject device is a |
| Hardware (HW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
| | | | | touch monitor while in
the primary predicate
device the display was
a tablet PC. The
interface provides a
similar user
experience, while the
performance of the
backend PC could be
increased. |
| Keyboard/mouse | Virtual keyboard and touch
interaction on integrated
touch monitor | included | included | Equivalent
In the subjective device
keyboard and mouse
interactions are all
performed with a
virtual keyboard and
touch interactions on
the screen. |
13
Image /page/13/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots that are arranged in a curved line.
14
Image /page/14/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots that are arranged in a gradient pattern.
15
Image /page/15/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 series of orange dots arranged in a pattern.
16
Image /page/16/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots that are arranged in a curved line.
17
Image /page/17/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots arranged in a pattern.
18
Image /page/18/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 series of orange dots arranged in a pattern.
19
Image /page/19/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots that are arranged in a curved line.
20
Image /page/20/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 words is a graphic of orange dots arranged in a circular pattern.
21
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 below it. To the right of the words is a graphic of orange dots.
Toble 5: Comparison of software (SW) technologics the subject device SOMATOM On.site with software version syngo CT VB00 and the predicted evices.
| Software (SW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. Scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating System | Windows based
SOMARIS/10 syngo CT VB10
Note: the short version syngo CT
VB10 is also used as labeling
information | Windows based
SOMARIS/10 syngo CT VA35
Note: the short version syngo
CT VA35 is also used as labeling
information | Windows based
SOMARIS/10 syngo CT VB10
Note: the short version syngo CT
VB10 is also used as labeling
information | New software version |
| Workplace | • syngo Acquisition Workplace
— Touch UI works as
integrated Image Computing
System (ICS) to enable all-in-
one concept for mobile CT | • syngo Acquisition Workplace
— Touch UI works as
integrated Image Computing
System (ICS) to enable all-in-
one concept for mobile CT | syngo Acquisition Workplace
named as "myExam Console"
— Gantry-integrated ICS | Same as the primary
predicate device |
| | • Image reconstruction System
(IRS) | • Image reconstruction System
(IRS) | • Image reconstruction System
(IRS)
• 2nd Acquisition Workplace
named as "myExam Satellite" | |
| Standard system
software | • syngo Examination
• syngo Viewing
• syngo Filming | • syngo Examination
• syngo Viewing
• syngo Filming | • syngo Examination
• syngo Viewing
• syngo Filming | Same as the primary
predicate device |
| Software (SW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. Scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
| | • syngo Archiving &
Networking | • syngo Archiving &
Networking | • syngo Archiving &
Networking | |
| Detector
firmware | Stellar detector firmware
supported | Stellar detector firmware
supported | Stellar detector firmware
supported | Same as the primary
and the secondary
predicate device |
| Protocols | • Examination Protocols for
Head and Neck
• Protocol supporting contrast
bolus-triggered data
acquisition
• Adult/ pediatric protocols for
head and neck examination
• Protocol overwrite
protection
• Administrator privileges for
protocol creation | • Examination Protocols for
Head and Neck
• Protocol supporting contrast
bolus-triggered data
acquisition
• Adult/ pediatric protocols for
head and neck examination
• Protocol overwrite
protection
• Administrator privileges for
protocol creation | • Protocols for Radiation
Therapy Planning support
patient marking
• Protocols that allow scanning
with support of an external
respiratory gating system
(ANZAI, Varian RGSC)
• Protocol supporting contrast
bolus-triggered data
acquisition
• Contrast media protocols
(including coronary CTA)
• Adult protocols
• Pediatric protocols
• Flex Dose Profile
• Dual Energy acquisition
(TwinBeam DE and
TwinSpiral DE)
• Dynamic imaging (Flex 4D
Spiral) | Same as the primary
predicate device |
| Software (SW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. Scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
| | | | • Protocols supporting
Intervention (scan modes: i-
sequence, i-spiral, i-Fluoro)
• Protocol overwrite
protection
• Administrator privileges for
protocol creation
• Protocols for
DirectBreathhold
• Protocols supporting Cardiac
Scanning | |
| Touch UI – user
modes | Touch screen display with two
modes:
• Basic User mode (Touch UI)
Routine examination workflow,
e.g. plan, control, and acquire
diagnostic scans.
• Advanced mode (Advanced
UI)
Contains more advanced
functionalities, such as quality
assurance, as well as
administration and
configuration tasks. | Touch screen display with two
modes:
• Basic User Mode (Scan&GO)
Routine examination workflow,
e.g. plan, control, and acquire
diagnostic scans.
• Advanced mode (Advanced
UI)
Contains more advanced
functionalities, such as quality
assurance, as well as
administration and
configuration tasks. | Touch screen display on
Scan&GO mobile tablet:
provides mainly supportive
functions required for planning
and controlling scans;
not intended to be used for
image acquiring, image storage
and image reconstruction. | Same user modes as
the primary predicate
device |
| Software (SW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. Scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
| | Connecting or removing scan
ranges
Modifying parameters | Connecting or removing scan
ranges
Modifying parameters | | |
| Advanced
Reconstruction | Recon&GO:
• Inline Anatomical ranges
(Parallel/Radial)
• Inline table and bone
removal | Recon&GO:
no integrated advanced
visualization tools | Recon&GO:
• Spectral Recon
• Inline Results DE SPP
• Inline Anatomical ranges
(Parallel/Radial)
• Inline Spine and Rib Ranges
• Inline table and bone
removal | Compared to the
primary predicate
device, a subset of
advanced
visualization tools
(Recon&GO - Inline
results) is now
integrated within the
Recon&GO of the
subject device
SOMATOM On.site
with syngo CT VB10.
Same as the
secondary predicate
device the
visualization tools
Inline Anatomical
ranges
(Parallel/Radial) and
Inline table and bone
removal are now
integrated within |
| Software (SW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. Scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
| | | | | Recon&GO of the
subject device. |
| Image viewing | CT View&GO offers:
• basic post-processing viewer
(CT View&GO)
• 2D and 3D (MPR, VRT, MIP
and minIP)
• Evaluation tools, Filming,
Printing
• Basic manipulation tools: ROI
HU Threshold, Automated
table and bone removal | CT View&GO offers:
• basic post-processing viewer
(CT View&GO)
• 2D and 3D (MPR, VRT, MIP
and minIP)
• Evaluation tools, Filming,
Printing | CT View&GO offers:
• basic post-processing viewer
(CT View&GO)
• 2D and 3D (MPR, VRT, MIP
and minIP)
• Evaluation tools, Filming,
Printing
• Interactive Spectral Imaging
(ISI)
• Basic visualization tools:
Endo View
• Basic manipulation tools: DE
ROI , ROI HU Threshold,
Average, Automated Bone
and Table removal | Compared to the
primary predicate
device, the CT
View&GO function of
the subject device
SOMATOM On.site
with syngo CT VB10
supports more
visualization and
manipulation tools.
Same as the
secondary predicate
device ROI HU
Threshold and
Automated Table and
Bone removal are
now integrated in the
subject device
SOMATOM On.site
with syngo CT VB10 |
| Software (SW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. Scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
| Post-Processing
interface | • Recon&GO Inline Results:
Software interface to post-
processing algorithms which
are unmodified when loaded
onto the CT scanners and
510(k) cleared as medical
devices in their own right.
• software interfaces for post-
processing functionalities to
provide advanced
visualization tools to prepare
and process medical images
for diagnostic purpose.
Note: The clearance of
standalone Advanced
Visualization Application
software is mandatory
precondition.
These advanced visualization
tools are designed to support
the technician & physician in
the qualitative and
quantitative measurement &
analysis of clinical data
acquired and reconstructed | • Recon&GO Inline Results:
Software interface to post-
processing algorithms which
are unmodified when loaded
onto the CT scanners and
510(k) cleared as medical
devices in their own right.
• software interfaces for post-
processing functionalities to
provide advanced
visualization tools to prepare
and process medical images
for diagnostic purpose.
Note: The clearance of
standalone Advanced
Visualization Application
software is mandatory
precondition.
These advanced visualization
tools are designed to support
the technician & physician in
the qualitative and
quantitative measurement &
analysis of clinical data
acquired and reconstructed | • Recon&GO Inline Results:
Software interface to post-
processing algorithms which
are unmodified when loaded
onto the CT scanners and
510(k) cleared as medical
devices in their own right.
• software interfaces for post-
processing functionalities to
provide advanced
visualization tools to prepare
and process medical images
for diagnostic purpose.
Note: The clearance of
standalone Advanced
Visualization Application
software is mandatory
precondition.
These advanced visualization
tools are designed to support
the technician & physician in
the qualitative and
quantitative measurement &
analysis of clinical data
acquired and reconstructed | Same as the primary
and the secondary
predicate device. |
| Software (SW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. Scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
| | by Computed Tomography
scanners. | by Computed Tomography
scanners. | by Computed Tomography
scanners. | |
| Check&GO | Check&GO
Quality check of the images
before sending them to the
reading workplace, e.g. PACS
Check&GO – Metal detection
detects metal objects on or near
the patient, including objects
required for the examination,
for example, ECG wires. | Check&GO
Quality check of the images
before sending them to the
reading workplace, e.g. PACS | Check&GO
Quality check of the images
before sending them to the
reading workplace, e.g. PACS
Check&GO – Metal detection
detects metal objects on or near
the patient, including objects
required for the examination,
for example, ECG wires. | Same as the
secondary predicate
device |
| myExam
Companion -
myExam
Compass/myExam
Cockpit | • myExam Compass
collects information about the
current patient to dynamically
adapt the scan parameters or
exchange recon jobs according
to the patient's characteristics
• myExam Cockpit
option of displaying, modifying,
creating, and deleting Clinical
Decision Trees (CDTs).
myExam Compass functionality
offers the possibility to
activate/deactivate diagnostic | N/A | • myExam Compass
collects information about the
current patient to dynamically
adapt the scan parameters or
exchange recon jobs according
to the patient's characteristics
• myExam Cockpit
option of displaying, modifying,
creating, and deleting Clinical
Decision Trees (CDTs).
myExam Compass functionality
offers the possibility to
activate/deactivate diagnostic | Same as the
secondary predicate
device |
| Software (SW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. Scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
| | scan ranges, Bolus Tracking and
Test Bolus ranges. myExam
Cockpit allows to define these
new settings. | | scan ranges, Bolus Tracking and
Test Bolus ranges. myExam
Cockpit allows to define these
new settings. | |
| Cybersecurity | IT security functionalities
supported | IT security functionalities
supported | IT security functionalities
supported (IT Hardening) | Same as the primary
predicate device |
| Teamplay | Support of teamplay protocols | Support of teamplay protocols | Support of teamplay protocols | Same as the primary
and the secondary
predicate device |
| HD FoV | supported | supported | supported | Same as the primary
predicate device |
| Standard
Technologies | FAST Features
CARE Features
GO technology | FAST Features
GO technology | FAST Features
CARE Features
GO technology | Same as the
secondary predicate
device |
| Dose modulation | FAST kV
CARE Dose 4D
X-CARE
Topogram with Tin Filter
Technology | N/A | FAST kV
CARE Dose 4D
X-CARE
Topogram with Tin Filter
Technology | Same as the
secondary predicate
device |
| FAST Planning | Selects the body region on the
topogram image that is to be
detected for the recon range | N/A | Selects the body region on the
topogram image that is to be
detected for the recon range | Same as the
secondary predicate
device |
| Software (SW)
property | Subject device
SOMATOM On.site
SOMARIS/10 syngo CT VB10 | Primary predicate device
SOMATOM On. Scanners
SOMARIS/10 syngo CT VA35
(K193277) | Secondary predicate device
SOMATOM go.Up
SOMARIS/10 syngo CT VB10
(K233650) | Assessment of the
substantial
equivalency (SE) |
| Iterative
Reconstruction
Methods | iMAR
ADMIRE | iMAR
SAFIRE | iMAR
SAFIRE | With software
version VB10, SAFIRE
is descoped and
replaced by ADMIRE,
because of improved
algorithm
performance.
ADMIRE was
originally approved
with K133646 and it
is the same as the
SOMATOM go.
Platform with
SOMARIS/10 syngo
CT VB10 (K233650).
K233650 is a bundle
510(k) with various
Siemens CT scanner
systems including
SOMATOM go.Up. |
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Image /page/22/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.
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Image /page/23/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 series of orange dots arranged in a pattern.
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Image /page/24/Picture/0 description: The image contains 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 words is a graphic of orange dots arranged in a circular pattern.
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Image /page/25/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 words is a graphic of orange dots arranged in a circular pattern.
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SIEMENS ::•
Healthineers ::•
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Image /page/28/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 words is a graphic of orange dots arranged in a circular pattern.
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Any differences in technological characteristics do not raise different questions of safety and validation is completed. Test results show that the subject device SOMATOM On.site with syngo CT VB10 is comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices.
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VIII. Performance Data
Non-Clinical Testing
Non-clinical testing, (integration and functional) including phantom tests were conducted for the SOMATOM On.site during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
The general purpose of each test 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 6 below.
| Feature/Non-clinical
| supportive testing | Bench Testing performed |
|---|---|
| FAST kV | The bench test evaluates the performance of FAST kV. |
| The objective of the test is to demonstrate: | |
| - That image quality (in terms of contrast-to-noise ratio) at the | |
| different kV settings offered by the system is consistent when | |
| using FAST kV. |
- That radiation dose levels are reduced at 80 kV. |
| | The test results show: |
| | - For iodine and calcium contrast material inserts in a cylindrical
20 cm water phantom with corresponding FAST kV settings |
| Feature/Non-clinical
supportive testing | Bench Testing performed |
| | 'vascular' and 'bone/calcium', CNR values at 80 kV and 120 kV are consistent (deviations well below 15%). |
| | In comparison to 120 kV, dose levels at 80 kV are slightly reduced (-5%) with the 'bone/calcium' setting and are substantially reduced (-44%) with the 'vascular' setting of FAST kV. |
| CARE Dose4D | The bench test evaluates the performance of CARE Dose4D in the subject device SOMATOM On.site as compared to the predicate device SOMATOM go.Up. |
| | The objective of the bench test is to demonstrate: |
| | comparable performance of CARE Dose4D in SOMATOM On.site and the predicate device SOMATOM go.Up. |
| | CARE Dose4D leads to reduced dose levels at consistent image quality. |
| | Phantom-based measurements have been performed on the subject device SOMATOM On.site (intended for head and neck scans) and the predicate device SOMATOM go.Up (whole body diagnostic scanner). The performance of CARE Dose4D is assessed with respect to radiation dose (CTDIvol) and image noise levels (image quality). |
| | The evaluation showed equivalent performance results for CARE Dose4D in the subject device SOMATOM On.site and the predicate device SOMATOM go.Up. It can be concluded the performance of the CARE Dose4D functionalities is comparable to those of the predicate device SOMATOM go.Up. Consequently, the results and the conclusions of the clinical publications listed in the bench testing are transferable also for the subject device SOMATOM On.site. |
| | CARE Dose4D is a well-established tube current modulation (TCM) technology, which is offered on Siemens and Siemens Healthineers CT systems since the early 2000s. The bench test document lists various clinical publications that show the dose reduction potential of TCM in general and specifically of CARE Dose4D. |
| X-CARE | The bench test evaluates the performance of X-CARE in the subject device SOMATOM On.site as compared to the predicate device SOMATOM go.Up. |
| | The objective of the bench test is to demonstrate: |
| | comparable performance of X-CARE in SOMATOM On.site and the predicate device SOMATOM go.Up. |
| | X-CARE leads to reduced dose levels to the eye lenses at consistent image quality. |
| | Phantom-based measurements have been performed on the subject device SOMATOM On.site (intended for head and neck scans) and the |
| Feature/Non-clinical
supportive testing | Bench Testing performed |
| | predicate device SOMATOM go.Up (whole body diagnostic scanner). The
performance of X-CARE is assessed with respect to radiation dose
(CTDIvol) and image noise levels (image quality). |
| | The evaluation showed equivalent performance results for X-CARE in the
subject device SOMATOM On.site and the predicate device SOMATOM
go.Up. It can be concluded the performance of the X-CARE functionality
is comparable to those of the predicate device SOMATOM go.Up.
Consequently, the results and the conclusions of the clinical publications
listed in the bench testing are transferable also for the subject device
SOMATOM On.site. |
| | X-CARE is a well-established, organ-based tube current modulation
technology, which is offered on Siemens and Siemens Healthineers CT
systems since the early 2010s. The bench test document lists various
clinical publications that show the organ dose reduction potential of X-
CARE. |
| ADMIRE | The bench test evaluates the characteristics of the iterative
reconstruction algorithm ADMIRE on the On.site. |
| | The objectives of this test are to demonstrate that ADMIRE reduces
image noise at the Somatom On.site CT scanner and maintains a natural
image impression without noticeable loss of sharpness. The mean CT
values, and specifically the water value, do not vary when ADMIRE
reconstruction is used instead of a weighted filtered back-projection
WFBP. |
| | The test results show: |
| | The water value and the CT value of the PTFE object remain
constant with increasing ADMIRE strength settings and
compared to the WFBP reconstruction. The sharpness, demonstrated with an edge MTF function of the
PTFE object, is constant with increasing ADMIRE strength setting
and compared to the WFBP reconstruction. The image noise decreases compared to the WFBP setting and
with increasing ADMIRE strength. Image impression is
maintained as the shape of the noise distribution remains
Gaussian with any ADMIRE strength setting. |
Table 6: Non-clinical performance testing (bench testing).
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Image /page/32/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.
A list of recognized and general consensus standards considered for the subject device is provided as Table 7 and Table 8 below.
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| Date of
Entry | Recognition
Number | Standard
Developing
Organization | Standard
Designation Number
and Date | Title of Standard |
|------------------|-----------------------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 12/19/2022 | 12-349 | NEMA | PS 3.1 - 3.20 2022d | Digital Imaging and
Communications in
Medicine (DICOM) Set |
| 07/06/2020 | 12-325 | NEMA | XR 25-2019 | Computed Tomography
Dose Check |
| 07/06/2020 | 12-330 | NEMA | XR 28-2018 | Supplemental
Requirements for User
Information and System
Function Related to Dose in
CT |
| 12/23/2019 | 12-328 | IEC | 61223-3-5 Edition 2.0
2019-09 | Evaluation and routine
testing in medical imaging
departments - Part 3-5:
Acceptance tests and
constancy tests - Imaging
performance of computed
tomography X-ray
equipment [Including:
Technical Corrigendum 1
(2006)] |
| 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 |
| 07/07/2021 | 12-336 | IEC | 60601-1-3 Edition
2.2 2021-01
CONSOLIDATED
VERSION | Medical electrical
equipment - Part 1-3:
General requirements for
basic safety and essential
performance - Collateral
Standard: Radiation
protection in diagnostic X-
ray equipment |
| 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- |
| Date of
Entry | Recognition
Number | Standard
Developing
Organization | Standard
Designation Number
and Date | Title of Standard |
| 12/23/2019 | 5-125 | ANSI AAMI
ISO | 14971: 2019 | ray equipment for
computed tomography |
| | | ISO | 14971 Third Edition
2019-12 | Medical devices -
Applications of risk
management to medical
devices |
| 01/14/2019 | 13-79 | ANSI AAMI
IEC | 62304:2006/A1:2016 | Medical device software -
Software life cycle
processes [Including
Amendment 1 (2016)] |
| | | IEC | 62304 Edition 1.1
2015-06
CONSOLIDATED
VERSION | Medical device software -
Software life cycle
processes |
| 05/30/2022 | 19-46 | ANSI AAMI | ES60601-
1:2005/(R)2012 &
A1:2012,
C1:2009/(R)2012 &
A2:2010/(R)2012
(Cons. Text) [Incl.
AMD2:2021] | Medical electrical
equipment - Part 1: General
requirements for basic
safety and essential
performance (IEC 60601-
1:2005, MOD) [Including
Amendment 2 (2021)] |
| 12/21/2020 | 19-36 | ANSI AAMI
IEC | 60601-1-2:2014
[Including AMD
1:2021] | Medical electrical
equipment - Part 1-2:
General requirements for
basic safety and essential
performance - Collateral
Standard: Electromagnetic
disturbances -
Requirements and tests |
| | | IEC | 60601-1-2 Edition 4.1
2020-09
CONSOLIDATED
VERSION | Medical electrical
equipment - Part 1-2:
General requirements for
basic safety and essential
performance - Collateral
Standard: Electromagnetic
disturbances -
Requirements and tests |
| Date of
Entry | Recognition
Number | Standard
Developing
Organization | Standard
Designation Number
and Date | Title of Standard |
| 07/06/2020 | 5-129 | ANSI AAMI
IEC | 62366-
1:2015+AMD1:2020
(Consolidated Text) | Medical devices Part 1:
Application of usability
engineering to medical
devices, including
Amendment 1 |
| | | IEC | 62366-1 Edition 1.1
2020-06
CONSOLIDATED
VERSION | 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 |
| 12/21/2020 | 5-132 | IEC | 60601-1-6 Edition 3.2
2020-07
CONSOLIDATED
VERSION | Medical electrical
equipment - Part 1-6:
General requirements for
basic safety and essential
performance - Collateral
standard: Usability |
| 12/23/2019 | 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 |
| 12/20/2021 | 12-341 | IEC | 62563-1 Edition 1.2
2021-07
CONSOLIDATED
VERSION | Medical electrical
equipment - Medical image
display systems - Part 1:
Evaluation methods |
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Table 8: 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+A2:2020 | Medical electrical
equipment - part 1:
general requirements
for basic safety and
essential performance | ANSI AAMI ES60601-
1:2005/(R)2012 &
A1:2012,
C1:2009/(R)2012 &
A2:2010/(R)2012 (Cons.
Text) [Incl. AMD2:2021] |
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| Standard
Developing
Organization | Standard Designation
Number and Date | Title of Standard | How was Standard Used |
|----------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| 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 9 below.
Table 9: FDA Guidance Document and Effective Date
| FDA Guidance Document | Issue date |
|---|---|
| User Fees and Refunds for Premarket Notification Submissions (510(k)s): | |
| Guidance for Industry and Food and Drug Administration Staff | 10/05/2022 |
| Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug | |
| Administration Staff | 04/21/2022 |
| Electronic Submission Template for Medical Device 510(k) Submissions | 10/2/2023 |
| Deciding When to Submit a 510(k) for a Change to an Existing Device | 10/25/2017 |
| The 510(k) Program: Evaluating Substantial Equivalence in Premarket | |
| Notifications [510(k)] | 07/28/2014 |
| Content of Premarket Submissions for Software Contained in Medical | |
| Devices | 06/14/2023 |
| Off-The-Shelf Software Use in Medical Devices | 09/27/2019 |
| Applying Human Factors and Usability Engineering to Medical Devices | 02/03/2016 |
| Pediatric Information for X-ray Imaging Device Premarket Notifications | 11/28/2017 |
| Cybersecurity in Medical Devices: Quality System Considerations and Content | |
| of Premarket Submissions | 09/27/2023 |
| Electromagnetic Compatibility (EMC) of Medical Devices | 06/06/2022 |
| Design Considerations and Pre-market Submission Recommendations for | |
| Interoperable Medical Devices | 09/06/2017 |
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions | |
| for Medical Devices | 09/14/2018 |
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Verification and Validation
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.
Cybersecurity
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.
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 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.
IX. Conclusions
Verification and validation and phantom testing were performed. The non-clinical data supports the safety of the device and the hardware and software verification and validation demonstrates that the subject device SOMATOM On.site performs as intended in the specified use conditions. The data included in this submission demonstrates that the SOMATOM On.site with the described modifications performs comparably to the predicate devices currently marketed for the same intended use. The conclusion drown from the non-clinical tests demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate devices.