(104 days)
No
The document describes advanced visualization and measurement tools for medical images, but does not mention AI or ML in the device description, intended use, or performance studies. The modifications listed are related to specific clinical tools and data support, not AI/ML capabilities.
No.
This device is designed for advanced visualization and processing of medical images for diagnostic purposes, assisting technicians and physicians in analysis and diagnosis, rather than providing direct therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "syngo. CT Clinical Extensions is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose" and that "Result images created with the syngo. CT Clinical Extensions software package can be used to assist trained technicians or physicians in diagnosis."
Yes
The device is described as a "software bundle" and its function is to provide "advanced visualization tools to prepare and process medical images". It operates on existing post-processing platforms and interfaces with imaging modalities, but the device itself is presented solely as software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: 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: The description clearly states that syngo.CT Clinical Extensions is a software package that provides advanced visualization and processing tools for medical images acquired from modalities like CT and MR scanners. It assists technicians and physicians in analyzing these images for diagnostic purposes.
- Lack of Biological Sample Analysis: There is no mention of the software analyzing biological samples or performing tests on them. Its function is solely focused on processing and visualizing medical images.
Therefore, while it is a medical device used for diagnostic purposes, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
syngo.CT Clinical Extensions is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners). An interface shall enable the connection between the syngo.CT Clinical Extensions software package and the interconnected CT Scanner system. Result images created with the syngo.CT Clinical Extensions software package can be used to assist trained technicians or physicians in diagnosis.
Product codes
JAK
Device Description
syngo.CT Clinical Extensions is a software bundle that offers tools to support special clinical evaluations. syngo.CT Clinical Extensions can be used to create advanced visualizations and measurements on clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners or other medical imaging modalities (e.g. MR scanners). syngo.CT Clinical Extensions is an extension of the previously cleared primary predicate device post-processing application software syngo.CT Extended Functionality and includes the following modifications in comparison to the primary predicate device:
- New Marketing Name: syngo.CT Clinical Extensions
- Modified Indications for Use Statement
- Support of software version SOMARIS/8 VB30 which supports the following functionality:
a. Vascular Tool modification:
i. Modified Coronary Vessel Tracing Support
ii. Heart and Coronary Tree Isolation Tools
iii. Support of MR data
iv. Support of additional workflow improvement visualization tools
b. Oncology Tool modification:
i. Support of Mean Diameter Value
ii. Support of Lung Lesion Segmentation Tool
c. Support of Dual Energy Tool
d. Support of Endoscopic View Tool
e. Editing of Pre-generated Results
Depending on the clinical question, the user can select functionality which supports the explicit clinical fields as listed below. The syngo.CT Clinical Extensions software package is designed to operate on syngo-compatible post-processing platforms, software version SOMARIS/8 VB30 or later.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT) scanners, MR scanners
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
technicians and physicians
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 tests (integration and functional) were conducted for syngo.CT Clinical Extensions during product development. Performance tests were conducted to test the functionality of the syngo.CT Clinical Extensions. The modifications described in this Premarket Notification were supported with verification/validation testing. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests (integration and functional) were conducted for syngo.CT Clinical Extensions during product development. Performance tests were conducted to test the functionality of the syngo.CT Clinical Extensions. The modifications described in this Premarket Notification were supported with verification/validation testing. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence. Siemens claims conformance to the following performance standards: Digital Imaging and Communications in Medicine (DICOM) Set; PS 3.1 – 3.20, Medical Device Software - Software Life Cycle Processes; 62304:2006 (1st Edition), Medical devices – Application of risk management to medical devices; 14971 Second Edition 2007-03-01, Medical devices - Part 1: Application of usability engineering to medical devices IEC 62366-1:2015, AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - part 1: general requirements for basic safety and essential performance (IEC 60601-1:2005, mod).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K163341, K150745, K971717, K130749
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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March 8, 2018
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Blvd., 65-1A MALVERN PA 19355
Re: K173625
Trade/Device Name: syngo.CT Clinical Extensions Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 30, 2018 Received: February 1, 2018
Dear Ms. Mangum:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Sauer
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173625
Device Name
syngo.CT Clinical Extensions
Indications for Use (Describe)
syngo. CT Clinical Extensions is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners).
An interface shall enable the connection between the syngo.CT Clinical Extensions software package and the interconnected CT Scanner system.
Result images created with the syngo. CT Clinical Extensions software package can be used to assist trained technicians or physicians 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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510(K) SUMMARY FOR SYNGO.CT CLINICAL EXTENSIONS Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: March 6, 2018
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
Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869
Manufacturing Site
Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen, Germany Establishment Registration Number 3004977335
Contact Person
Kimberly Manqum Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com
II. Device Name and Classification
| Product Name: | syngo.CT Clinical Extensions |
|---|---|
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90JAK |
III. Predicate Device Primary Predicate Device:
| Trade Name: | syngo.CT Extended Functionality |
|---|---|
| 510(k) Number: | K163341 |
| Clearance Date: | 02/09/2017 |
| Classification Name: | System, X-Ray, Tomography, Computed |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | This predicate has not been subject to a design-related recall |
4
Secondary Predicate Device:
| Trade Name: | syngo.CT Single Source Dual Energy |
|---|---|
| 510(k) Number: | K150745 |
| Clearance Date: | 08/11/2015 |
| Classification Name: | System, Image Processing, Radiological |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | This predicate has not been subject to a design-related recall |
Secondary Predicate Device:
| Trade Name: | syngo Fly Through |
|---|---|
| 510(k) Number: | K971717 |
| Clearance Date: | 09/03/1997 |
| Classification Name: | System, X-Ray, Tomography, Computed |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | This predicate has not been subject to a design-related recall |
Secondary Predicate Device:
| Trade Name: | syngo.MR Vascular Analysis |
|---|---|
| 510(k) Number: | K130749 |
| Clearance Date: | 08/20/2013 |
| Classification Name: | System, Image Processing, Radiological |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
| Subsequent Product Code | LNH |
| Recall Information: | This predicate has not been subject to a design-related recall |
Reference Device:
Trade Name: 510(k) Number: Clearance Date: Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Recall Information:
syngo.PET&CT Oncology K093621 02/23/2010 System, Image Processing, Radiological Radiology 21 CFR § 892.2050 Class II LLZ This reference device has not been subject to a design-related recall
Reference Device:
Trade Name: 510(k) Number: Clearance Date: Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Recall Information:
syngo.CT Coronary Analysis K100637 05/26/2010 System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750 Class II JAK This reference device has not been subject to a design-related recall
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IV. Device Description
syngo.CT Clinical Extensions is a software bundle that offers tools to support special clinical evaluations. syngo.CT Clinical Extensions can be used to create advanced visualizations and measurements on clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners or other medical imaging modalities (e.g. MR scanners). syngo.CT Clinical Extensions is an extension of the previously cleared primary predicate device post-processing application software syngo.CT Extended Functionality and includes the following modifications in comparison to the primary predicate device:
-
- New Marketing Name: syngo.CT Clinical Extensions
-
- Modified Indications for Use Statement
-
- Support of software version SOMARIS/8 VB30 which supports the following functionality:
- a. Vascular Tool modification:
- i. Modified Coronary Vessel Tracing Support
- ii. Heart and Coronary Tree Isolation Tools
- iii. Support of MR data
- iv. Support of additional workflow improvement visualization tools
- b. Oncology Tool modification:
- i. Support of Mean Diameter Value
- ii. Support of Lung Lesion Segmentation Tool
- ﻥ Support of Dual Energy Tool
- Support of Endoscopic View Tool ರ
- Editing of Pre-generated Results e.
Depending on the clinical question, the user can select functionality which supports the explicit clinical fields as listed below. The syngo.CT Clinical Extensions software package is designed to operate on syngo-compatible post-processing platforms, software version SOMARIS/8 VB30 or later. Table 1 below provides a listing of all tools as well as the modification status in comparison to the predicate devices for this software version:
Table 1: syngo.CT Clinical Extensions Tool Packages
| Tool | Description | Modification Status |
|---|---|---|
| Vascular | ||
| Tool | Provides tools and layouts for vascular assessment. This | |
| feature has been modified from the predicate primary device | ||
| to support the following: | ||
| Semi-automatic vessel tracing tool that allows | ||
| tracing with less user-interaction Heart and Coronary Tree isolation tools that allow | ||
| removal and isolation of myocardial structures Support of MR Angiography data Workflow improvement tools that allow management | ||
| and documentation of measurements | Modified from the | |
| primary predicate | ||
| device | ||
| Oncology | ||
| Tool | Provides tools for localization and evaluation of nodules. This | |
| feature has been modified from the predicate primary device | ||
| to support the following: | ||
| Mean Diameter Value Tool that allows display of the | ||
| mean diameter of a lesion Lung Lesion Segmentation Tool that allows semi- | ||
| automatic segmentation of solid and sub-solid | ||
| nodules. The unmodified Lung Lesion | ||
| Segmentation Tool was cleared in a reference | ||
| device under K093621. | Modified from the | |
| primary predicate | ||
| device | ||
| Osteo Tool | Provides a set of routine tools for the assessment of bone | |
| mineral content. | Unmodified from the | |
| primary predicate | ||
| device |
6
| Tool | Description | Modification Status |
|---|---|---|
| Neuro DSA | ||
| Tool | Provides a set of tools for assessment of the cerebral | |
| vasculature by removing interfering bone structures. | Unmodified from the | |
| primary predicate | ||
| device | ||
| Dual Energy | ||
| Tool | Provided tools for the Evaluation of low/high kV images from | |
| dual energy data. | Newly supported but | |
| unmodified from the | ||
| secondary predicate | ||
| device | ||
| Endoscopic | ||
| View Tool | Provides the possibility to interactively fly through tubular | |
| structures which are either filled by low-intensity (e. g. air- | ||
| filled) or high-intensity (blood filled) material. | Newly supported but | |
| unmodified from the | ||
| secondary predicate | ||
| device | ||
| ROI HU | ||
| Threshold | ||
| Tool | Supports the user in the evaluation of HU value distributions | |
| within a user defined region of interest. | Unmodified from the | |
| primary predicate | ||
| device |
V. Indications for Use
syngo.CT Clinical Extensions is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners). An interface shall enable the connection between the syngo.CT Clinical Extensions software package and the interconnected CT Scanner system. Result images created with the syngo.CT Clinical Extensions software package can be used to assist trained technicians or physicians in diagnosis.
VI. Comparison of Technological Characteristics with the Predicate Device
As with the primary predicate device, the subject device is a bundle software package consisting of previously cleared unmodified and modified software applications that provide advanced visualization and measurement tools. Software version SOMARIS/8 VB30 supports additional post-processing application features for MR datasets, dual energy images, and endoscopic visualization tools. At a high-level, the subject and predicate devices are based on the following same or similar technological characteristics as listed in Table 2 below:
| Feature | Subject Device
syngo.CT Clinical Extensions | Predicate Device
and Supported
Functionality | Comparison Result |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Software
Version | SOMARIS/8 VB30 | Primary Predicate Device:
K163341, clearance date
2/9/2017
SOMARIS/8 VB20 | Modified to support
additional
functionality |
| Vascular
Tool | The Vascular Tool provides tools and
layouts for vascular assessment.
Additionally, the subject device Vascular
Tool supports additional tools for vascular
assessment and support of MR data. | Primary Predicate Device:
K163341, clearance date
2/9/2017 | Modified to support
additional
assessment tools
and MR data |
| Table 2: Technological Characteristic Comparison | |||
|---|---|---|---|
| The Vascular Tool provides | |||
| tools and layouts for | |||
| vascular assessment and | |||
| CT data. | |||
| Oncology | |||
| Tool | The oncology Tool offers tools for | ||
| localization and evaluation of nodules. | |||
| Additionally, the subject device provides | |||
| the possibility to calculate the mean | |||
| diameter value and supports lung lesion | |||
| segmentation tools. | Primary Predicate Device: | ||
| K163341, clearance date | |||
| 2/9/2017 | |||
| The oncology extension | |||
| offers tools for localization | |||
| and evaluation of nodules. | Modified to support | ||
| mean value | |||
| calculation and lung | |||
| lesion segmentation | |||
| tools | |||
| Osteo | |||
| Tool | The Osteo extension is used for the | ||
| evaluation of Bone Mineral Density (BMD) | |||
| values (mg CA-HA/ml) of the lumbar spine | |||
| based on Osteo CT scans. | Primary Predicate Device: | ||
| K163341, clearance date | |||
| 2/9/2017. | |||
| The Osteo extension is used | |||
| for the evaluation of Bone | |||
| Mineral Density (BMD) | |||
| values (mg CA-HA/ml) of the | |||
| lumbar spine based on | |||
| Osteo CT scans. | Unmodified from the | ||
| primary predicate | |||
| device | |||
| Neuro | |||
| DSA Tool | Bone removal tool from a CT angiography | ||
| dataset. | Primary Predicate Device: | ||
| K163341, clearance date | |||
| 2/9/2017. | |||
| Bone removal tool from a CT | |||
| angiography dataset. | Unmodified from the | ||
| primary predicate | |||
| device | |||
| Dual | |||
| Energy | |||
| Tool | Evaluation of low/high kV images from | ||
| dual energy data. | Secondary Predicate | ||
| Device: | |||
| K150745, clearance date | |||
| 8/11/2015 | |||
| Evaluation of low/high kV | |||
| images from dual energy | |||
| data. | Unmodified from the | ||
| secondary predicate | |||
| device K150745 | |||
| Endoscop | |||
| ic View | |||
| Tool | Fly through tubular structures which are | ||
| either filled by low-intensity (e.g. air-filled) | |||
| or high-intensity (e.g. blood-filled) | |||
| material. | Secondary Predicate | ||
| Device: | |||
| K971717, clearance date | |||
| 9/3/1997 | |||
| Fly through tubular | |||
| structures which are either | |||
| filled by low-intensity (e.g. | |||
| air-filled) or high-intensity | |||
| (e.g. blood-filled) material. | Unmodified from the | ||
| secondary predicate | |||
| device K971717 | |||
| ROI HU | |||
| Threshold | Evaluation of HU value distributions within | ||
| a user defined region of interest. | Primary Predicate Device: | ||
| K163341, clearance date | |||
| 2/9/2017. | Unmodified from the | ||
| primary predicate | |||
| device | |||
| Evaluation of HU value | |||
| distributions within a user | |||
| defined region of interest | |||
| Pre- | |||
| generated | |||
| results | Support of pre-generated results and the | ||
| ability to edit pre-generated results | Primary Predicate Device: | ||
| K163341, clearance date | |||
| 2/9/2017. | Modified from the | ||
| primary predicate | |||
| device to support | |||
| editing of pre- | |||
| generated results | |||
| Support of pre-generated | |||
| results |
7
8
Anv 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 device, syngo.CT Clinical Extensions 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 Summary
Non-clinical tests (integration and functional) were conducted for syngo.CT Clinical Extensions during product development. Performance tests were conducted to test the functionality of the syngo.CT Clinical Extensions. The modifications described in this Premarket Notification were supported with verification/validation testing. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence. Siemens claims conformance to the following performance standards listed in Table 3:
| Recognition
Number | Product
Area | Title of Standard | Publication
Date | Standards
Development
Organization |
|-----------------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|------------------------------------------|
| 12-300 | Radiology | Digital Imaging and Communications in
Medicine (DICOM) Set; PS 3.1 – 3.20 | 06/27/2016 | NEMA |
| 13-32 | Software | Medical Device Software -Software Life
Cycle Processes; 62304:2006 (1st
Edition) | 08/20/2012 | AAMI, ANSI,
IEC |
| 5-40 | Software/
Informatics | Medical devices – Application of risk
management to medical devices; 14971
Second Edition 2007-03-01 | 08/20/2012 | ISO |
| 5-95 | General I
(QS/RM) | Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2015 | 06/27/2016 | IEC |
| 19-4 | General II
(ES/EMC) | AAMI / ANSI ES60601-1:2005/(R)2012
and A1:2012, Medical electrical
equipment - part 1: general requirements
for basic safety and essential
performance (IEC 60601-1:2005, mod) | 07/09/2014 | AAMI, ANSI |
Software Verification and Validation
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. 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
9
identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation supports the claim of substantial equivalence.
Siemens Healthcare conforms to the Cybersecurity requirementing a process of preventing unauthorized access, modifications, misuse 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 quidance document "Content of Premarket Submissions for Management of Cybersecurity Medical Devices issues on October 2, 2014" is included within this submission.
Summary
This subject device combines seven advanced visualization and measurement tools into one software bundle package. The fundamental software technology which is provided within the scope of the advanced tools is already cleared and remains unchanged in comparison to the predicate devices. The Indications for Use for the subject device has been adapted to provide a more specific description of the subject device syngo.CT Clinical Extensions functionality, but does not represent a new intended use in comparison to the predicate devices. The modifications described in this Premarket Notification were supported with verification and validation testing. The Risk analysis was completed and risk control implemented to mitigate identified hazards.
General Safety and Effectiveness Concerns
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. syngo.CT Clinical Extensions is designed to fulfill the requirements of the applicable safety and performance standards as listed above.
VIII. Conclusions
The predicate devices were cleared based on non-clinical testing including verification and validation, and supportive literature. The results of these tests demonstrate that the predicate devices are adequate for the intended use. The subject device is also tested using the same methods as used for the predicate devices. The comparison of technological characteristics, nonclinical performance data, and software validation included in this submission demonstrates that the subject device is as safe and effective when compared to the predicate devices that are currently marketed for the same intended use. Since both devices were tested using the same methods, Siemens believes that the data generated from the syngo.CT Clinical Extensions testing supports a finding of substantial equivalence.