(70 days)
Not Found
Yes
The document explicitly states that the device has been modified to support extensions that can perform automated post-processing using artificial intelligence algorithms.
No
Explanation: The device is described as a software platform for visualization and post-processing of medical images for diagnostic purposes, supporting analysis of clinical data by technicians and physicians. It does not mention any therapeutic function.
Yes
The device provides "basic visualization and enables external post-processing extension for medical images used for diagnostic purposes," and is designed to "support technicians and trained physicians in qualitative and quantitative measurement and analysis of clinical data." This indicates its role in assisting in the diagnosis of medical conditions.
Yes
The device is described as a "software platform" and its functionalities are entirely software-based (visualization, data transfer, interfaces, configuration). While it interacts with medical images and potentially other systems (PACS, CT devices), the device itself, as described, is solely software. The modifications also relate to software deployment and features.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: The core function of an IVD is to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- This device processes medical images: The text clearly states that AI-Rad Companion (Engine) is a software platform for processing and visualizing medical images (DICOM data). It works with images obtained from modalities like CT, not biological samples.
- The intended use is image analysis: The intended use and device description focus on supporting technicians and physicians in the qualitative and quantitative analysis of clinical data derived from medical images.
Therefore, while it's a medical device used for diagnostic purposes, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" is marked "Not Found," indicating no mention of PCCP approval.
Intended Use / Indications for Use
AI-Rad Companion (Engine) is a software platform that provides basic visualization and enables external post-processing extension for medical images used for diagnostic purposes. The software platform is designed to support technicians and trained physicians in qualitative and quantitative measurement and analysis of clinical data. The software platform provides means for storing of data and for transferring data into other systems such as PACS systems. The software platform provides an interface to integrate processing extensions.
AI-Rad Companion (Engine) functionality includes:
· Interface for multi-modality and multi-vendor Input / Output of DICOM Data
· Check of data validity using information for DICOM tags
- · Interface for extensions that provide post-processing functionality
- · Confirmation user interface for visualization of medical images processed by extensions
- · Configuration user interface for configuration of the medical device and extensions
Product codes (comma separated list FDA assigned to the subject device)
LLZ, JAK
Device Description
AI-Rad Companion (Engine) is a software platform that provides basic visualization and enables external post-processing extension for medical images used for diagnostic purposes. The software platform provides means for storing of data and for transferring data into other systems such as PACS systems. The software platform provides an interface to integrate processing extensions by supporting:
- Interface for multi-modality and multi-vendor Input / Output of DICOM Data ●
- Check of data validity using information for DICOM tags ●
- Interface for extensions that provide post-processing functionality
- Confirmation user interface for visualization of medical images processed by extensions ●
- Configuration user interface for configuration of the medical device and extensions ●
As an update to the previously cleared device, the following modifications have been made:
- Modified Indications for Use Statement 1)
- Support of software version VA10A: 2)
- a. Deployment of software on Siemens cloud infrastructure
- b. Improved method to access and configure optional post-processing extensions
- Modified workflow to visualize and confirm output of optional post-processing C. extension
-
- Subject device claims list
Al-Rad Companion (Engine) is designed to support the operating user in qualitative and quantitative analysis of clinical data
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Multi-modality
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Technicians and trained 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests were conducted to test the functionality of Al-Rad Companion (Engine). Software validations and bench testing have been conducted to the performance claims as well as the claim of substantial equivalence to the predicate devices.
Al-Rad Companion has been tested to meet the requirements of conformity to multiple industry standards. Non-clinical performance testing demonstrated that Al-Rad Companion complies with the following voluntary FDA recognized Consensus Standards listed in Table 2 below.
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, and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the Subject Device Al-Rad Companion (Engine) software version VA10A during product development.
The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
Bench testing in the form of Unit, Subsystem and System Integration testing were performed to evaluate the performance and functionality of the new features and software updates. All testable requirements in the Engineering Requirements Specifications kevs, Subsystem Requirements Specifications keys, and the Risk Management Hazard keys have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process. The software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans. Electrical safety and EMC testing requirements are addressed as part of the host system (CT device or PACS system) to ensure compliance with the application IEC standards.
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. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. The responsibility for compliance with IEC 80001-1-2010 is the hospital.
Al-Rad Companion (Engine) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process and clinical data based software validation. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer report and feedback form. Customer employees are adequately trained in the use of this equipment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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February 1, 2019
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Blvd. MALVERN PA 19355
Re: K183272
Trade/Device Name: AI Rad Companion (Engine) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, JAK Dated: November 21, 2018 Received: November 23, 2018
Dear Ms. Mangum:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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.
Hole 2. Nils
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name AI-Rad Companion (Engine)
Indications for Use (Describe)
AI-Rad Companion (Engine) is a software platform that provides basic visualization and enables external post-processing extension for medical images used for diagnostic purposes. The software platform is designed to support technicians and trained physicians in qualitative and quantitative measurement and analysis of clinical data. The software platform provides means for storing of data and for transferring data into other systems such as PACS systems. The software platform provides an interface to integrate processing extensions.
AI-Rad Companion (Engine) functionality includes:
· Interface for multi-modality and multi-vendor Input / Output of DICOM Data
· Check of data validity using information for DICOM tags
- · Interface for extensions that provide post-processing functionality
- · Confirmation user interface for visualization of medical images processed by extensions
- · Configuration user interface for configuration of the medical device and extensions
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Pablishing Services (301) 443-6740 EF
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510(K) SUMMARY
FOR
AI-RAD COMPANION (ENGINE) Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Date Prepared: January 18, 2019
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1.Submitter
Importer/Distributor
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869
Manufacturing Site
Siemens Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany Establishment Registration Number 3004977335
Contact Person
Kimberly Manqum Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448 - 6477 Email: kimberly.mangum@siemens-healthineers.com
2.Device Name and Classification
| Product Name: | Al-Rad Companion (Engine) |
|---|---|
| Trade Name: | Al-Rad Companion (Engine) |
| Classification Name: | Picture Archiving and Communication System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
| Secondary Product Code | JAK |
3.Predicate Device Primary Predicate Device: syngo.CT View&GO Product Name: Propriety Trade Name: syngo.CT View&GO 510(k) Number: K170952 Clearance Date: April 28, 2017
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Classification Name: Picture Archiving and Communications System Classification Panel: Radiology Requlation Number: 21 CFR §892.2050 Device Class: Class II Primary Product Code: LLZ Secondary Product Code JAK There are currently no recalls for this device Recall Information:
4.Device Description
Al-Rad Companion (Engine) is a software platform that provides basic visualization and enables external post-processing extension for medical images used for diagnostic purposes. The software platform provides means for storing of data and for transferring data into other systems such as PACS systems. The software platform provides an interface to integrate processing extensions by supporting:
- Interface for multi-modality and multi-vendor Input / Output of DICOM Data ●
- Check of data validity using information for DICOM tags ●
- Interface for extensions that provide post-processing functionality
- Confirmation user interface for visualization of medical images processed by extensions ●
- Configuration user interface for configuration of the medical device and extensions ●
As an update to the previously cleared device, the following modifications have been made:
- Modified Indications for Use Statement 1)
- Support of software version VA10A: 2)
- a. Deployment of software on Siemens cloud infrastructure
- b. Improved method to access and configure optional post-processing extensions
- Modified workflow to visualize and confirm output of optional post-processing C. extension
-
- Subject device claims list
Al-Rad Companion (Engine) is designed to support the operating user in qualitative and quantitative analysis of clinical data
5.Indications for Use
Al-Rad Companion (Engine) is a software platform that provides basic visualization and enables external post-processing extension for medical images used for diagnostic purposes. The software platform is designed to support technicians and trained physicians in qualitative and quantitative measurement and analysis of clinical data. The software platform provides means for storing of data and for transferring data into other systems such as PACS systems. The software platform provides an interface to integrate processing extensions.
Al-Rad Companion (Engine) functionality includes:
- Interface for multi-modality and multi-vendor Input / Output of DICOM Data ●
- Check of data validity using information for DICOM tags
- Interface for extensions that provide post-processing functionality .
- Confirmation user interface for visualization of medical images processed by extensions ●
- . Configuration user interface for configuration of the medical device and extensions
6. Comparison of Technological Characteristics with the Predicate Device
The subject device Al-Rad Companion (Engine) is within the same classification regulation as the primary predicate device. The subject device supports a specific indication for use that is reflective of device specific performance, but the intended use and fundamental scientific technology remain unchanged from the primary predicate device.
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A tabular comparison of the subject device and predicate devices is provided as Table 1 below.
| Feature | Subject Device | Predicate Device
(K170952) | Comparison Results |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software | Software version
VA10A | SOMARIS/8 VB20A | Equivalent. The subject device
supports a new version of software
that is deployable on the Siemens
cloud infrastructure |
| Extensibility | Extendable via
additional post-
processing
extensions | Extendable via
additional post-
processing tools | Equivalent. The subject device
has been modified to support
extensions that can perform
automated post-processing using
artificial intelligence algorithms |
| Visualization | Standard
visualization tools
(window levels,
MPR, MIP, VRT) | Standard
visualization tools
(window levels,
MPR, MIP, VRT) | Same |
| Image
Distribution and
Archiving | In the Distribution
step it is shown to
which DICOM nodes
a series will be sent
when saving the
case, or to which
node a series has
already been sent.
The user can select
(or deselect)
whether a series will
be sent to any
DICOM node or to a
subset of nodes. | Sending of DICOM
data to DICOM
nodes possible in
the export
functionality | Equivalent. The subject device
has been modified to support
transfer to a preconfigured DICOM
node |
| User Interface
Confirmation | Confirmation UI | syngo.via GUI | Equivalent. The subject device
has been modified to provide only
basic functionality for confirmation
of processed results |
| User Interface
Configuration | Configuration UI | syngo.via GUI -
configuration | Equivalent. The subject device
has been modified to expose
configuration options of existent
extensions |
| Archiving/Storing | CD-R, film, DVD,
USB, Network | CD-R, film, DVD,
USB, Network | Equivalent. The subject device
has been modified to only store
meta data |
| Communication | DICOM compatible | DICOM compatible | Same |
Table 1: Predicate Device Comparable Properties
7.Performance Data
Non-Clinical Testing Summary
Performance tests were conducted to test the functionality of Al-Rad Companion (Engine). Software validations and bench testing have been conducted to the performance claims as well as the claim of substantial equivalence to the predicate devices.
Al-Rad Companion has been tested to meet the requirements of conformity to multiple industry standards. Non-clinical performance testing demonstrated that Al-Rad Companion complies with the following voluntary FDA recognized Consensus Standards listed in Table 2 below
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| 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 |
| 5-114 | General I
(QS/RM) | Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2015 | 06/27/2016 | IEC |
| | General I
(QS/RM) | Medical devices - Part 1: Application of
usability engineering to medical devices
[Including CORRIGENDUM 1 (2016)] | 2/3/2016 | IEC |
Table 2: Voluntary Conformance Standards
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, and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the Subject Device Al-Rad Companion (Engine) software version VA10A during product development.
The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
Bench testing in the form of Unit, Subsystem and System Integration testing were performed to evaluate the performance and functionality of the new features and software updates. All testable requirements in the Engineering Requirements Specifications kevs, Subsystem Requirements Specifications keys, and the Risk Management Hazard keys have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process. The software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans. Electrical safety and EMC testing requirements are addressed as part of the host system (CT device or PACS system) to ensure compliance with the application IEC standards.
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. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. The responsibility for compliance with IEC 80001-1-2010 is the hospital.
Summary
Al-Rad Companion (Engine) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process and
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clinical data based software validation . The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer report and feedback form. Customer employees are adequately trained in the use of this equipment.
8. General Safety and Effectiveness Concerns:
The device labeling contains instructions for use as well as necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a system related Risk analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing according to the Risk Management process. In order to minimize electrical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
9.Conclusions
Al-Rad Companion (Engine) has the same intended use as the primary predicate device. The indication for use has been modified to include a more succinct summary of device specific performance, but is still within the scope of the intended use and regulatory classification as the predicate devices. The fundamental technological characteristics such as image visualization and image manipulation are the same as the predicate device. The result of all testing conducted was found acceptable to support the claim of substantial equivalence. The predicate device was cleared based on non-clinical supportive information including bench testing and software validations. The results of these tests demonstrate that the predicate devices are adequate for the intended use. The comparison of technological characteristics, non-clinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate device that is currently marketed for the same intended use. For the subject device, Al-Rad Companion (Engine), Siemens used the same testing with the same workflows as used to clear the predicate device to demonstrate safety and performance of the technical workflow. Since both devices were tested using the same methods. Siemens believes that the data generated from the Al-Rad Companion (Engine) software testing supports a finding of substantial equivalence.